oversight

Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems With Approved Devices

Published by the Government Accountability Office on 1997-01-29.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting Office

GAO              Report to Congressional Committees




January 1997
                 MEDICAL DEVICE
                 REPORTING
                 Improvements Needed
                 in FDA’s System for
                 Monitoring Problems
                 With Approved Devices




GAO/HEHS-97-21
      United States
GAO   General Accounting Office
      Washington, D.C. 20548

      Health, Education, and
      Human Services Division

      B-266228

      January 29, 1997

      The Honorable James M. Jeffords
      Chairman
      The Honorable Edward M. Kennedy
      Ranking Minority Member
      Committee on Labor and Human Resources
      United States Senate

      The Honorable Thomas J. Bliley, Jr.
      Chairman
      The Honorable John D. Dingell
      Ranking Minority Member
      Committee on Commerce
      House of Representatives

      The Food and Drug Administration (FDA) is responsible for protecting the
      American public from unsafe and ineffective medical devices, which range
      from simple household items, such as thermometers, to implanted heart
      valves. More than 100,000 medical device products are currently in use in
      the United States, including a substantial number that health care
      professionals use every day to diagnose, treat, or prevent illness; improve
      the quality of patients’ lives; and support and sustain life. Over the past 15
      years, the U.S. medical device industry has grown from 5,900 to 16,900
      firms. More than $40 billion was spent on such devices in the United States
      in 1994.1

      FDA’s  adverse event reporting system gathers information about problems
      associated with marketed medical devices, which enables FDA and the
      medical device industry to work together to take corrective action on
      device problems and, when appropriate, to alert the public to potentially
      hazardous devices to prevent injury or death. Although medical device
      manufacturers have been required to report malfunctions and
      device-related injuries and deaths to FDA since 1984, hospitals and other
      facilities that use devices were not required to report these matters and,
      consequently, rarely did so.

      Recognizing this problem, the Congress enacted the Safe Medical Devices
      Act of 1990 (SMDA 90), which expanded the reporting requirements to
      include user facilities, such as hospitals and nursing homes, and medical


      1
       Medical Device Regulation: Too Early to Assess European System’s Value as Model for FDA
      (GAO/HEHS-96-65, Mar. 6, 1996).



      Page 1                                              GAO/HEHS-97-21 Medical Device Reporting
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                   device distributors.2 SMDA 90 required user facilities to report device-related
                   adverse events to FDA and manufacturers of devices. SMDA 90 also required
                   us to report on user facilities’ compliance with the act’s reporting
                   requirements. To carry out this responsibility, we sought answers to five
                   questions: (1) Has the enactment of SMDA 90 led to an increase in reporting
                   of device-related adverse events to FDA? (2) Have the amount and quality
                   of information from user facilities enhanced FDA’s ability to quickly
                   identify and take action on device problems? (3) How have manufacturers
                   and FDA responded to device problems identified in user facility reports?
                   (4) How well does FDA communicate device problem trends and corrective
                   actions taken to user facilities and the public? (5) What changes, if any,
                   need to be made to the user facility reporting requirements and FDA’s
                   adverse event reporting system to improve medical device problem
                   reporting?

                   To address these questions, we met with officials from FDA’s Center for
                   Devices and Radiological Health (CDRH) to discuss the agency’s efforts to
                   implement the user facility reporting requirements of the act and
                   procedures used to process, review, and take action on adverse event
                   reports. We analyzed data from FDA’s adverse event reporting system on
                   device-related incidents that occurred during fiscal years 1987 through
                   1995. We also contacted representatives of the medical device community
                   (manufacturers, user facilities, and nonprofit organizations with health
                   care-related objectives) to discuss their views on the user facility reporting
                   requirements and on whether or not changes to the law and FDA’s adverse
                   event reporting system are needed. Appendix I provides a more detailed
                   description of our scope and methodology. We did our work between April
                   1995 and January 1997 in accordance with generally accepted government
                   auditing standards.


                   Although the amount of information reported to FDA about medical device
Results in Brief   problems has increased dramatically since SMDA 90 was enacted, FDA does
                   not systematically act to ensure that the reported problems receive prompt
                   attention and appropriate resolution. As a result, FDA’s adverse event
                   reporting system is not providing an early warning about problem medical
                   devices as SMDA 90 intended.

                   During fiscal years 1991 through 1994, FDA received almost four times as
                   many adverse event reports from device manufacturers as it did during
                   fiscal years 1987 through 1990. However, the extent to which user facility

                   2
                    P.L. 101-629, Nov. 28, 1990.



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reporting under SMDA 90 directly accounted for the increased volume of
reports is unclear because, until recently, FDA did not require
manufacturers to disclose whether serious injury reports originated from
user facilities or from some other source. This increased volume made it
difficult for FDA to process and review reports in a timely manner. To
address this problem, FDA chose to give priority to death and serious injury
reports, which resulted in its delaying for nearly 2 years processing and
reviewing almost 50,000 malfunction reports. Malfunction reports are
essential in alerting FDA to potentially serious device problems before they
result in death or serious injury. To better manage the reporting workload
in the future, FDA has initiated several changes to the adverse event
reporting system, such as consolidating reporting system components and
using electronic reporting.

FDA  has received significantly fewer adverse event reports from user
facilities than it expected. Moreover, much of the information that user
facilities did provide was of poor quality and incomplete, in part because
FDA did not issue the final medical device reporting regulation in a timely
manner or periodically educate user facilities about their responsibilities
under SMDA 90. For example, our comparison of death reports submitted by
manufacturers and user facilities found that user facilities did not report
about 5,000 device-related deaths to FDA between fiscal years 1992 and
1995, which may have been required by law. FDA learned about these
deaths because they were reported by manufacturers.

Although FDA contends that it notifies manufacturers and user facilities
about imminent hazards and industrywide safety concerns, it does not
routinely document the corrective actions it takes—or those taken by
manufacturers—to address reported medical device problems. As a result,
it is unclear how manufacturers and FDA have responded to device
problems reported by user facilities. Further, FDA does not keep track of
the length of time it takes to process, review, and initiate action on serious
device-related problems or the time that elapses before manufacturers
resolve the problems.

Manufacturer and user facility representatives told us they do not know
how FDA uses adverse event reports to protect the public health. Although
feedback to medical device users could increase knowledge about the
performance of medical devices, improve patient safety awareness, and
assist users in making device purchase decisions, FDA does not routinely
communicate the results of analyses of medical device problems and
corrective actions to the medical device user facility community.



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                 FDA  and representatives of both medical device users and manufacturers
                 believe that the reporting system is overburdened with reports and data
                 that may not be necessary to detect and resolve device problems. FDA is
                 studying the feasibility of using a statistical sample of user facilities to
                 reduce the volume of reports it has to review. However, concerns exist
                 about whether a sample of users can provide FDA with the information that
                 it needs to protect the public health. Further, while FDA’s initiatives may
                 improve the adverse event reporting system, they do not ensure timely
                 resolution of device problems, user facility compliance with SMDA 90, or
                 systematic dissemination of adverse event-related information to the
                 medical device community.


                 To protect the public from harmful medical devices, the 1976 Medical
Background       Device Amendments to the Federal Food, Drug, and Cosmetic Act
                 expanded FDA’s responsibility for regulating medical devices in the United
                 States. FDA uses three primary mechanisms to ensure that all medical
                 devices are safe and effective for their intended use:

             •   Premarket review is a system of checks, reviews, and controls intended to
                 be applied before new devices are approved and made available to the
                 public.
             •   On-site inspections of device manufacturers’ facilities are intended to
                 ensure compliance with FDA laws and regulations, including good
                 manufacturing practices (GMP), and prevent the production and marketing
                 of defective devices.
             •   The adverse event reporting system is intended to provide FDA with early
                 warning of problems associated with devices after they become available
                 for public use. This monitoring system gathers information about device
                 problems that could necessitate withdrawing a device from the market or
                 taking other corrective actions.

                 Among other things, the act authorized FDA to establish a reporting system
                 for adverse events associated with the use of medical devices. As a result,
                 FDA established the Mandatory Medical Device Reporting (MDR) system.
                 Under this system, since 1984, manufacturers of medical devices have
                 been required to report to FDA—and maintain records on—device-
                 related deaths, serious injuries, and malfunctions3 that, should they recur,
                 would be likely to result in death or serious injury. A system called the
                 Medical Device and Laboratory Problem Reporting Program (PRP) was

                 3
                  “Malfunction” refers to the failure of a device to meet one of its performance specifications or to
                 otherwise perform as intended. Performance specifications include all claims made in the labeling for
                 the device.



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established to receive voluntary reports from health care professionals.
FDA’s responsibility is to audit manufacturers’ performance to identify
systemic problems and trends associated with an individual firm, a
specific device, or the entire device industry, issuing guidance as
necessary.

The Office of Surveillance and Biometrics (OSB) within CDRH operates the
adverse event reporting system. OSB reviews adverse event reports on
medical devices to identify, manage, and resolve public health issues;
prepares safety alerts and public health advisories;4 and provides
regulatory guidance on adverse event reporting issues. CDRH estimates that
it spent approximately $8 million5 and used about 80 full-time-equivalent
(FTE) positions6 in support of the medical device reporting program in
fiscal year 1996. This represents an increase of about $606,000 and three
FTEs over medical device reporting program expenditures in fiscal year
1995.

When FDA receives an adverse event report, OSB health care analysts
evaluate and compare the report with other information contained in FDA
databases. A decision is then made about whether or not the device
problem poses a potential risk to the public health. If so, depending on the
nature and severity of the risk, an analyst may initiate a follow-up
investigation, which generally involves a written request for additional
information or an inspection of the manufacturer or user facility. (App. II
provides a detailed description of FDA’s report evaluation process.)

For years, FDA’s implementation and enforcement of the medical device
reporting regulation have concerned the Congress. Studies issued by our
office, the former Office of Technology Assessment, and the Office of
Inspector General of the Department of Health and Human Services (HHS)
have found significant weaknesses in FDA’s ability to gather information
about medical devices in use. For example, in 1986, we found that less

4
 A safety alert is issued by FDA in response to an identified problem that has resulted in a death, a
serious injury, or both and that requires immediate action. A public health advisory is issued in
response to a potential death, serious injury, or both.
5
 This estimate includes all of the CDRH and field office dollars expended for the medical device
reporting program. It includes computer support, contract costs for data entry of the adverse event
report information, operating expenses, and salary costs (excluding benefits) associated with CDRH
and field personnel.
6
 This estimate reflects resources expended by CDRH as well as by FDA’s field force for the medical
device reporting program. In addition to the actual program FTEs for OSB, the estimate includes
(1) CDRH FTEs for support services for the program, such as computer and administrative/
management assistance, and (2) field FTEs used to follow up on manufacturer and user facility
reports.



Page 5                                                  GAO/HEHS-97-21 Medical Device Reporting
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                      than 1 percent of the device problems occurring in hospitals were reported
                      to FDA and that, the more serious the problem with the device, the less
                      likely it was to be reported to FDA.7 In a follow-up study, we concluded that
                      the problem still existed despite full-scale implementation of the medical
                      device reporting regulation.8


SMDA 90 and Related   To improve the flow of information about medical device problems to
Regulations           FDA’s adverse event reporting system, the Congress passed SMDA 90, which
                      requires user facilities and device distributors to report device-related
                      serious illnesses, serious injuries, and deaths. User facilities are a vital link
                      in the network of reporters because they can provide accurate and
                      complete information on adverse events, patient outcomes, and device
                      interactions, all of which are critical to manufacturers and FDA in
                      identifying serious problems with devices and taking action to protect
                      lives.

                      SMDA 90  requires the establishment of a network of communication about
                      device-related events among user facilities, distributors, manufacturers,
                      and FDA. The act requires that user facilities report to FDA—and to device
                      manufacturers, if known—when they become aware of information that
                      reasonably suggests that a device caused or contributed to a death. User
                      facilities are also required to report to manufacturers when they become
                      aware of information that reasonably suggests that a device caused or
                      contributed to a serious injury or serious illness.9 In the event that the
                      manufacturer of the device is unknown, the facility is required to report a
                      serious injury or illness directly to FDA. User facilities are required to
                      submit reports within 10 work days of becoming aware of such situations.
                      The act also requires that user facilities submit to FDA semiannual
                      summaries of all the adverse event reports they submitted to
                      manufacturers and FDA during the previous 6 months. Table 1 summarizes
                      the medical device reporting requirements for user facilities, distributors,
                      and manufacturers.



                      7
                       Medical Devices: Early Warning of Problems Is Hampered by Severe Underreporting
                      (GAO/PEMD-87-1, Dec. 19, 1986).
                      8
                       Medical Devices: FDA’s Implementation of the Medical Device Reporting Regulation
                      (GAO/PEMD-89-10, Feb. 17, 1989).
                      9
                       SMDA 90 defines a “serious injury or serious illness” as one that is life threatening, results in
                      permanent impairment of a body function or permanent damage to the body, or necessitates
                      immediate medical or surgical intervention to preclude permanent impairment of a body function or
                      permanent damage to a body structure. However, the 1992 amendments to the Federal Food, Drug,
                      and Cosmetic Act deleted the requirement that an injury require immediate intervention to preclude
                      permanent impairment or damage in order to qualify as a reportable adverse event.


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Table 1: Summary of Medical Device
Reporting Requirements, 1996         Reason for report                      Recipient                         Deadline
                                     User facility
                                     Deaths                                 FDA and manufacturer, if          Within 10 work days
                                                                            known
                                     Serious injuriesa                      Manufacturer; FDA only if         Within 10 work days
                                                                            manufacturer unknown
                                     Semiannual report of deaths            FDA                               January 1 and July 1
                                     and serious injuries
                                     Distributor
                                     Deaths and serious injuries            FDA and manufacturer              Within 10 work days
                                     and illnesses
                                     Malfunctions                           FDA and manufacturer              Within 10 work days
                                     Manufacturer
                                     Deaths, serious injuries, and          FDA                               Within 30 calendar days
                                     malfunctions
                                     Basic baseline data on each FDA                                          At same time report is
                                     device that is the subject of a                                          submitted (within 30
                                     report                                                                   calendar days)
                                     Events that require remedial           FDA                               Within 5 work days
                                     action and certain other
                                     types of events designated
                                     by FDA
                                     a
                                         For purposes of the reporting requirements, serious illnesses are considered “serious injuries.”



                                     In addition, SMDA 90 required the Secretary of HHS to promulgate regulations
                                     implementing the reporting requirements for user facilities by November
                                     28, 1991, and for distributors, by May 28, 1992. In November 1991, FDA
                                     issued what it called a “tentative medical device reporting regulation,”
                                     which provided user facilities and distributors with nonbinding interim
                                     operating guidance on complying with SMDA 90 reporting requirements.10 In
                                     addition to the statutory requirement that user facilities and distributors
                                     report serious medical device-related events to FDA and manufacturers, the
                                     tentative medical device reporting regulation provided nonmandatory
                                     guidance. This guidance instructed user facilities to establish and maintain
                                     written procedures that include (1) training and educational programs to
                                     inform employees about how to identify and report reportable events,



                                     10
                                       SMDA 90 provided that the proposed regulation affecting distributors would become effective if FDA
                                     did not issue its final regulation within 18 months of the act. Because FDA took more than 18 months
                                     to issue its final regulation, the proposed regulation became final by operation of law. FDA did not
                                     issue its final regulation affecting distributors until September 1993. FDA told us it will propose
                                     revoking its final regulation and replacing it with a regulation that is consistent with the final medical
                                     device reporting regulation for manufacturers and user facilities.



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                           (2) internal systems for documenting and reporting adverse events, and
                           (3) documentation and recordkeeping guidelines.

                           In December 1995, 4 years after the tentative medical device reporting
                           regulation was issued, FDA published the final regulation for user facilities
                           and manufacturers. As of July 31, 1996, they are both required to report
                           device-related events under a uniform system of reporting.11 Also under
                           the final medical device reporting regulation, manufacturers are required
                           to submit baseline reports12 and annual certifications13 to FDA. FDA can
                           issue various types of written notification to inform a user facility that it
                           has not complied with the medical device reporting regulation, which
                           could result in civil monetary penalties or warning letters.

                           Finally, SMDA 90 required the Secretary of HHS to report to the Congress no
                           later than November 1993 on such matters as the safety benefits of the
                           user facility reporting requirements, the burdens placed on FDA and device
                           user facilities by the reporting requirements, and the cost-effectiveness of
                           the user facility reporting requirements. As of December 1996, FDA had not
                           issued its report.


The New Reporting System   In 1992, in response to the broadened reporting requirements of SMDA 90,
                           CDRH established the Manufacturer and User Device Experience (MAUDE)
                           system to replace the PRP and MDR systems. From 1992 to 1996, voluntary
                           reports from user facilities, distributors, and health professionals were
                           input into the MAUDE system; as of April 1996, the MAUDE system contained
                           approximately 20,000 such reports.

                           During this same period, FDA continued to enter manufacturer reports into
                           the MDR system. FDA plans to begin entering into the MAUDE system
                           manufacturers’ reports that give July 31, 1996, or later as the date the

                           11
                             The final medical device reporting regulation requires user facilities and manufacturers to develop
                           and maintain written procedures for reporting medical device-related events. Included must be
                           (1) procedures for timely and effective identification and evaluation of events, (2) a standardized
                           review process and procedure for determining whether or not events are reportable, (3) procedures to
                           ensure the timely submission of complete reports, and (4) procedures to ensure adequate
                           documentation and recordkeeping.
                           12
                             A baseline report provides basic device identification information (such as the brand name, device
                           family designation, and model number) and marketing and distribution information.
                           13
                             The final medical device reporting regulation requires chief executive officers or firm representatives
                           to annually certify that they have filed reports for all their firms’ reportable events. However, FDA has
                           stated that it will revise the certification requirement and issue a subsequent regulation to address
                           concerns from the industry that the certification requirement “may raise liability concerns and may
                           exceed the intent of Congress.”



                           Page 8                                                  GAO/HEHS-97-21 Medical Device Reporting
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                         manufacturer learned of an adverse event. FDA expects to have moved all
                         the data from the PRP and MDR systems into the MAUDE system by
                         January 1997.

                         Finally, in 1993, FDA established the Medical Products Reporting
                         Program—called “MedWatch”—to encourage health professionals to
                         report adverse events and product problems to FDA, simplify reporting, and
                         improve the postmarket product information in FDA’s adverse event
                         reporting system. MedWatch consists of two forms used to elicit the
                         information needed to monitor the safety of marketed devices: the form
                         3500 is completed by health professionals for voluntary reporting, and the
                         form 3500A is completed by user facilities, distributors, and manufacturers
                         for required reporting. Using the 3500A was voluntary until the final
                         medical device reporting regulation became effective in July 1996.


                         Although the flow of information to FDA about medical device problems
Growth in Reporting      increased dramatically after SMDA 90 became effective in late 1991, the
Results in Significant   extent to which SMDA 90 is directly responsible for this growth is unclear
Backlogs                 because the majority of reports were provided by manufacturers rather
                         than by user facilities. The increased volume posed problems for CDRH’s
                         adverse event reporting system, and CDRH experienced significant delays in
                         processing and reviewing reports of potentially hazardous device
                         problems. These delays could hinder the timely identification and
                         resolution of device problems. Moreover, the annual volume of reporting
                         is expected to rise significantly in fiscal year 1997 due, in part, to increased
                         reporting requirements under the final medical device reporting
                         regulation. To speed processing and analysis of reports, FDA has initiated
                         several changes to its adverse event reporting system.


Manufacturer Reports     Manufacturer reports of medical device problems increased dramatically
Have Increased           after SMDA 90 went into effect in 1991. It is unclear whether user facilities
Significantly            reporting under SMDA 90 directly accounted for the increased volume of
                         reports because, until recently, FDA did not systematically collect
                         information on the source of complaints.14 Device manufacturers
                         submitted over 370,400 of the approximately 407,700 (91 percent) adverse
                         event reports that FDA received from all sources during fiscal years 1991
                         through 1995. A comparison of two 4-year periods, fiscal years 1987
                         through 1990 and 1991 through 1994, illustrates the rapid growth of

                         14
                           The final medical device reporting regulation requires manufacturers to indicate on the form 3500A
                         the source of the complaint.



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                                        manufacturer reporting since SMDA 90 enactment. CDRH data show that
                                        during fiscal years 1987 through 1990, manufacturers submitted about
                                        75,200 death, serious injury, and malfunction reports in response to the
                                        1984 medical device reporting regulation—an average of about 19,000
                                        reports per year. But, during fiscal years 1991 through 1994, the number of
                                        adverse event reports submitted by manufacturers soared to 282,700—an
                                        average of more than 70,600 reports per year. (See fig. 1.)


Figure 1: Adverse Event Reports Filed
by Manufacturers, Fiscal Years          200   Reports in Thousands
1987-90 and 1991-94
                                        180

                                        160

                                        140

                                        120

                                        100

                                         80

                                         60

                                         40

                                         20

                                          0

                                                1987-1990              1991-1994
                                                Fiscal Years



                                                         Death

                                                         Serious Injury

                                                         Malfunction



                                        Note: Excludes 95 reports categorized as “other” that were filed during fiscal years 1991 through
                                        1994.




                                        FDA officials believe the upward trend in reporting is due to (1) the
                                        unanticipated, large volume of problems associated with silicone gel-filled
                                        breast implants, which accounted for nearly one-third of all of the
                                        manufacturer event reports submitted to FDA during fiscal years 1992




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                          through 1994, and (2) increased compliance by manufacturers with the
                          1984 medical device reporting regulation and SMDA 90.


System Could Not Handle   CDRH  has had considerable difficulty processing and reviewing the heavy
Volume of Reports         volume of adverse event reports in a timely manner. Between March 1994
                          and April 1995, a backlog of about 48,900 malfunction reports from
                          manufacturers accumulated at CDRH. Many of the malfunction reports were
                          not entered into the adverse event reporting system and available for
                          complete review and assessment until 1996. Although FDA assigns
                          malfunction reports a lower priority than reports of death and serious
                          injury, processing malfunction reports quickly is critical because of their
                          potential to alert FDA to device problems that could cause or contribute to
                          a death or serious injury if the malfunction were to recur. Entering all
                          adverse event reports into the system promptly allows FDA analysts to
                          perform more complete reviews and assessments on device problems.
                          Further, entering event reports expeditiously is important because an
                          event report, regardless of whether it requires immediate action, can
                          become part of a group of reports that ultimately stimulates corrective
                          action on a device problem.

                          Two factors contributed to the backlog, according to FDA. First, FDA
                          received an unanticipated, heavy volume of breast implant adverse event
                          reports. Second, FDA lacked funds to increase hiring for the former medical
                          device reporting contractor (United States Pharmacopeial Convention,
                          Inc.) that performed data processing functions related to the reports. FDA
                          told us that it recognized the potential impact of the increasing backlog
                          and decided to enter death and serious injury reports immediately, leaving
                          less serious injury and malfunction reports to be entered when resources
                          permitted. FDA also emphasized that it screened the malfunction reports
                          for hazards that required immediate attention and that it believes the
                          public health was not compromised by the backlog.


Volume Expected to        In addition, the volume of reporting from all sources is projected to rise in
Continue to Increase      fiscal year 1997 due, in part, to increased reporting requirements under the
                          final medical device reporting regulation. Additional reports that are
                          required include imminent hazard reports15 and baseline reports for
                          manufacturers. FDA estimates that its fiscal year 1997 reporting workload



                          15
                           Manufacturers are required to file a report within 5 work days after becoming aware of events that
                          necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.



                          Page 11                                                GAO/HEHS-97-21 Medical Device Reporting
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                         will exceed 152,000 reports, up 52 percent from the approximately 100,000
                         reports received in 1995.16


FDA Is Acting to Speed   CDRH is taking steps to minimize backlogs and speed report reviews
Processing and Improve   through changes it made to the final medical device reporting regulation
Analysis                 and through computer innovations. To minimize the effects of potential
                         backlogs caused by large increases in reporting, a CDRH official told us, FDA
                         wrote the final medical device reporting regulation with the flexibility for
                         FDA to modify the timing and content of adverse event reports. FDA may,
                         upon written request or at its own discretion, grant to user facilities or
                         manufacturers an exemption or variance from any of the reporting
                         requirements or change the frequency of reporting.

                         Also, CDRH is in the process of developing an electronic data interchange
                         (EDI) system to allow firms to submit their adverse event reports
                         electronically. Currently, most of the reports are manually transmitted and
                         then entered into FDA computers. The EDI system will function as a single
                         system that receives device reports and distributes them for automated
                         data entry into FDA computers. CDRH believes the EDI system, once
                         embraced by the device industry, will reduce the likelihood of a significant
                         backlog in coding and data entry of reports. EDI requirements and
                         standards are currently being developed and will be piloted in fiscal year
                         1997.

                         In addition, CDRH is developing alternative methods of analyzing event
                         reports through enhancements to the computerized MAUDE system. For
                         many years, CDRH has used several adverse event databases that are not
                         integrated for analysis of reports. As a result, gaps have existed in the
                         information available to analysts, and this information has also been
                         redundant.

                         CDRH’s goal, according to officials, is to reduce its dependency on the
                         individual review of reports and move toward aggregate analysis and other
                         methods of statistical review. The MAUDE system is expected to enable
                         analysts to identify generic product problems and problem-reporting
                         trends across industries and product lines, thereby helping analysts to
                         more efficiently determine appropriate courses of action on device
                         problems. MAUDE will also include a trend and statistical analysis
                         subsystem that will allow analysts to compute statistical trends, such as

                         16
                          The total number of reports projected for fiscal year 1997 excludes estimates for manufacturer and
                         distributor annual certification reports because FDA is revising the medical device reporting
                         certification requirement and, thus, is not enforcing the regulation as currently written.



                         Page 12                                               GAO/HEHS-97-21 Medical Device Reporting
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                       increases in frequency or severity of reported events for a particular
                       model, family, or type of device.


                       Despite the surge in reporting by manufacturers, user facilities’
User Facilities Have   participation in reporting device-related events to FDA has been
Not Adequately         significantly lower than expected. Moreover, the quality of the medical
Reported Adverse       device reports that have been received from user facilities has frequently
                       been poor. Our analysis of CDRH data shows, for example, that many user
Events                 facilities may be underreporting deaths to FDA and that some facilities are
                       reporting events they are not required to report. Further, user facilities’
                       reports are often late, inaccurate, or incomplete. User facility reports of
                       device problems are important to manufacturers and FDA because only the
                       user facility’s physicians and staff have direct access to the patient and the
                       device, as well as the clinical skills necessary to detect any adverse effects.
                       Thus, the user facility is in the best position to obtain information that
                       manufacturers and FDA need to determine whether a device presents a
                       public health risk. Without sufficient high-quality reports from user
                       facilities, therefore, FDA’s ability to analyze device problems and assess the
                       public health risk is hampered. Finally, FDA attributed user facilities’
                       inadequate reporting to FDA’s delay in issuing a final medical device
                       reporting regulation to fully enforce the law, a low level of awareness
                       about SMDA 90 among user facilities caused by turnover of user facility
                       staff, limited educational and compliance efforts by FDA, and concerns
                       among user facility staff that reporting adverse events could raise liability
                       issues.


User Facilities Have   In 1990, the Congressional Budget Office estimated that the user facility
Reported Much Less     reporting regulation would result in an increase of about 40,000 adverse
Frequently Than        event reports per year for FDA. Nevertheless, during fiscal years 1992
                       through 1995, FDA received a total of only about 12,700 event reports from
Anticipated            user facilities, or an average of about 3,200 reports per year (see fig. 2).




                       Page 13                                   GAO/HEHS-97-21 Medical Device Reporting
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Figure 2: Adverse Event Reports
Received by FDA From User Facilities,   5000   Adverse Event Reports
Fiscal Years 1992-95

                                        4000




                                        3000




                                        2000




                                        1000




                                           0

                                                  1992      1993   1994   1995
                                                  Fiscal Year




                                        During the 4-year period, more than 80 percent of the user facility event
                                        reports were for serious injuries and illnesses (52 percent) and
                                        malfunctions (29 percent). Death reports accounted for less than
                                        10 percent of the device-related incidents reported. (See fig. 3.)




                                        Page 14                                  GAO/HEHS-97-21 Medical Device Reporting
                                        B-266228




Figure 3: Percentage of User Facility
Reports Submitted by Event Type,
Fiscal Years 1992-95                                                                            Other


                                                                     •                          8%
                                                                                                Deaths
                                                      • 11%



                                              29%
                                                •
                                                                         52% •                  Serious Injuries/Illnesses




                                                                                                Malfunctions



                                        Note: The 1992 Medical Device Amendments authorized FDA to issue regulations requiring user
                                        facilities to report other significant adverse events to FDA. FDA is drafting regulations, which will
                                        be proposed through notice and comment procedures.




User Facilities May Be                  Before SMDA 90’s reporting requirements became effective in late 1991, user
Underreporting Deaths to                facilities were not required to submit device-related adverse event reports
FDA                                     to manufacturers and FDA. Consequently, FDA’s knowledge about unsafe
                                        devices involved in adverse events, such as deaths, was generally confined
                                        to reports from manufacturers, which were themselves sometimes limited
                                        by the degree of their compliance with the 1984 medical device reporting
                                        regulation. In contrast, user facility reporting under SMDA 90 is intended to
                                        provide FDA with more complete information on devices that pose hazards
                                        to the public health. In cases of death, SMDA 90 requires user facilities to
                                        submit a report to FDA and manufacturers, if known, within 10 work days
                                        of receiving information that reasonably suggests that a device has caused
                                        or contributed to a patient death. However, our analysis of CDRH data
                                        revealed that user facilities may have underreported thousands of patient
                                        deaths to FDA. Without the user facilities’ perspective on these events,
                                        FDA’s adverse event reporting system has significantly less information
                                        about medical device problems to use in identifying problems and
                                        assessing the public health risk.




                                        Page 15                                                 GAO/HEHS-97-21 Medical Device Reporting
                                       B-266228




                                       We found that during fiscal years 1992 through 1995, manufacturers
                                       reported 5,976 deaths to FDA, while user facilities reported only 978
                                       deaths—a difference of 4,998 death reports (see fig. 4). According to CDRH
                                       officials, FDA has taken no action to determine the extent to which the
                                       discrepancy in reporting is due to underreporting by user facilities to FDA.
                                       Nevertheless, a CDRH official told us that the difference in the number of
                                       death reports received is a gross estimate of possible underreporting.
                                       Accurately determining the number of facilities that actually did not report
                                       deaths would require CDRH to use manufacturers’ reports to identify the
                                       user facilities that may not have reported a death and then determine if the
                                       death was required to be reported—a task the official said would be very
                                       time consuming.


Figure 4: Comparison of Death
Reports Filed by User Facilities and   2000   Deaths Reported
Manufacturers, Fiscal Years 1992-95
                                       1800

                                       1600

                                       1400

                                       1200

                                       1000

                                        800

                                        600

                                        400

                                        200

                                          0

                                                 1992                 1993   1994              1995
                                                 Fiscal Year



                                                          User Facility

                                                          Manufacturer




                                       The official also stated that the difference in the number of deaths
                                       reported could be due, in part, to the different criteria that manufacturers
                                       and user facilities were required to use in deciding whether to report an




                                       Page 16                                      GAO/HEHS-97-21 Medical Device Reporting
                       B-266228




                       event. For example, under the 1984 medical device reporting regulation,
                       manufacturers were required to submit all event reports from health care
                       professionals, even if the firm believed or knew that the event was not
                       related to its device.17 In contrast, SMDA 90 only requires user facilities to
                       report deaths they believe were caused or contributed to by medical
                       devices. The official also pointed to subjective factors that may account
                       for differences in reporting. For example, facilities have immediate access
                       to a physician’s assessment of the relationship between a device, event,
                       and patient and, thus, may decide that an event was unrelated to a device.
                       Device firms, on the other hand, do not have direct access to this
                       information.

                       Although these factors may, in part, explain the discrepancy in reporting,
                       they appear to conflict with the results of an analysis of user facility
                       reports conducted by FDA. In 1993, FDA reported receiving 2,834 event
                       reports from user facilities, of which only 664 should have been submitted.
                       However, during the same period, 47,605 reports of death and serious
                       injury were received from manufacturers. FDA concluded that since most
                       event reports are sent to manufacturers by health care facilities, there was
                       “obviously gross underreporting or misunderstanding” by user facilities.18

                       Once fully operational, the MAUDE system will be able to match and
                       cross-reference all reports from manufacturers, distributors, user facilities,
                       and health professionals so that an analyst will have a complete picture of
                       the event. Thus, the analyst will be better able to determine, for example,
                       whether or not a death report was submitted by a user facility, as required
                       by law. If a death occurred and the user facility did not report it, the
                       analyst can notify the district offices within the Office of Regional
                       Operations, which is responsible for monitoring compliance with SMDA 90
                       reporting.


Late and Incomplete    The submission of timely and accurate reports of device problems is
Reports Hamper         important for FDA’s early warning system to operate effectively. Generally,
Identification and     when FDA receives complete reports, they can be reviewed and assessed
                       for public health risks without additional follow-up to obtain information
Assessment of Device   on aspects of the reported incident. However, our review of CDRH statistics
Problems               shows that many user facility reports are not submitted to FDA in a timely


                       17
                        Under the final medical device reporting regulation, manufacturers have the responsibility for
                       determining the cause of each event and whether it must be reported to FDA.
                       18
                        CDRH, Food and Drug Administration User Facility Reporting Quarterly Bulletin (Washington, D.C.:
                       FDA, spring 1993).



                       Page 17                                               GAO/HEHS-97-21 Medical Device Reporting
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manner and that they frequently lack essential information on the device
problem. Untimely and poor quality reports limit FDA’s ability to identify
device problems and assess the risk to the public health. Several examples
of such problems with reports follow.

First, SMDA 90 requires user facilities to submit reports of deaths to FDA and
the manufacturer, if known, within 10 work days of becoming aware of the
event. User facilities are also required to forward reports of serious
injuries to manufacturers—or FDA, if the manufacturer is
unknown—within 10 work days of becoming aware of the event. However,
CDRH data show that as of August 1995, 40 percent, or 746, of 1,875
required death and serious injury reports took longer than 10 days to be
submitted to FDA. We could not determine how late the reports were
submitted to FDA because CDRH could not provide the information from its
MAUDE system.


In addition, many user facilities are not providing FDA a semiannual
summary of all adverse event reports they submitted to manufacturers and
FDA during the previous 6 months, as required. CDRH data indicate that
34 percent, or 713, of the 2,075 user facilities that filed individual event
reports did not submit corresponding semiannual reports. Semiannual
reports can be used by CDRH as a check to determine whether
manufacturers have submitted all device-related events that have occurred
during the period to FDA. Without semiannual reports, CDRH’s ability to
detect underreporting by manufacturers is limited.

Third, many of the user facility event reports lacked information critical to
identifying and acting on device problems. A December 1995 analysis of
user facility event reports received during fiscal years 1992 through 1995
disclosed that 1,367 reports omitted the device type; 1,033 did not identify
the event category (such as death or serious injury); and 5,865 did not
include information on patient outcome. The submission of device reports
with incomplete or erroneous information requires analysts to contact the
user facility to request additional information on the event and ultimately
slows review and action on reported health hazards.

Fourth, manufacturers are also receiving poor quality reports from user
facilities. Medical device reports from user facilities have generally been
incomplete and untimely, according to representatives of the National
Electrical Manufacturers Association (NEMA). Health Industry
Manufacturers Association officials said they have also received some




Page 18                                  GAO/HEHS-97-21 Medical Device Reporting
                         B-266228




                         incomplete reports and that many of the user facility reports go directly to
                         FDA instead of to the manufacturer.


                         Finally, most of the adverse event reports that FDA has received from user
                         facilities are not even required by SMDA 90. By increasing the agency’s
                         workload, extraneous reports can slow CDRH’s review of adverse events
                         that truly merit the agency’s attention. For example, the act requires user
                         facilities to submit event reports to manufacturers when they receive
                         information that suggests a device may have caused or contributed to a
                         serious injury or illness. Only in instances in which the manufacturer of
                         the device is unknown is a serious injury or illness to be reported to FDA.
                         However, of the 5,199 serious injury and illness reports FDA had received
                         from user facilities as of June 1995, 3,588 (69 percent) did not need to have
                         been sent to FDA because the user facility knew the manufacturer and
                         identified it in the report. Moreover, during fiscal years 1992 through 1995,
                         user facilities submitted 3,678 malfunction reports that were not required
                         by SMDA 90. FDA encourages facilities to submit reports of device
                         malfunctions to manufacturers. Thus, at least 57 percent (7,266 out of
                         12,688) of the reports user facilities submitted to FDA during the 4-year
                         period were not required by the act.

                         CDRH officials told us they hope that requiring user facilities to use the
                         form 3500A for reporting device-related events to manufacturers and FDA,
                         along with more complete guidance and instructions, will minimize the
                         submission of incorrect, insufficient, and unnecessary information and
                         improve the quality of reporting.


User Facilities Need     We found that user facilities need additional training on the medical device
Additional Training to   reporting requirements. In 1992, FDA conducted an extensive outreach
Improve Reporting        campaign to educate user facilities about medical device reporting. FDA
                         mailed the tentative final regulation to over 150,000 facilities and
                         individuals and participated in numerous conferences and training
                         sessions. Yet, in 1993, a three-state study conducted by the departments of
                         health in Colorado, Texas, and Massachusetts for FDA determined that only
                         46 percent of the 468 user facilities surveyed knew about the reporting
                         requirements. Thus, despite FDA’s efforts, the studies indicated that many
                         user facilities in the three states were unaware of or unclear about their
                         reporting responsibilities.

                         Moreover, CDRH learned through reviews of 119 user facilities’ written
                         medical device reporting procedures that only 9 facilities had procedures



                         Page 19                                  GAO/HEHS-97-21 Medical Device Reporting
B-266228




consistent with those in the tentative final regulation (that is, they
provided definitions of event terminology, descriptions of educational
programs to teach employees how to identify and report device-related
events, internal systems for documenting and reporting device-related
events, and separate medical device reporting incident files). CDRH
concluded that many facilities would benefit from additional educational
efforts.

FDA attributed user facilities’ lack of adherence to FDA’s tentative final
regulation to several additional factors. First, a CDRH official told us that
before the final medical device reporting regulation became effective in
July 1996, the only requirements that were legally enforceable were the
requirements of SMDA 90, which do not provide sufficient detail on medical
device reporting. As a result, user facilities had to rely on guidance in the
tentative final medical device reporting regulation to establish the
program’s requirements. This guidance was not enforceable, and, as the
official pointed out, user facilities did not have to follow it because doing
so was voluntary.

In addition, FDA officials said that planning and performing compliance
inspections are difficult because FDA has a limited number of investigators
available to conduct the inspections that are required at over 70,000
regulated facilities. However, FDA believes that, by working closely with
the Joint Commission on Accreditation of Healthcare Organizations and
the Health Care Financing Administration, it will be better able to monitor
user facility compliance with SMDA 90.

The CDRH official cited above also believes that CDRH’s educational efforts
during the early 1990s may have been ineffective because facilities may
have lost, misrouted, or simply discarded the guidance on medical device
reporting. He added that, given the reportedly high mobility of health care
facility personnel, replacement staff may not have received the guidance
and, consequently, may have been unaware of the law. Finally, both FDA
officials and representatives of the medical community told us that
another deterrent to user facility reporting is the concern user facility staff
have with the institutional and professional liability that may result from
reporting device problems, particularly if the problem is related to user
error.

Efforts to educate user facilities about medical device reporting include
distributing material through various health care organizations and FDA’s
electronic bulletin board, which can be accessed from a personal



Page 20                                   GAO/HEHS-97-21 Medical Device Reporting
                          B-266228




                          computer. In addition, CDRH plans to continue to publish a quarterly User
                          Facility Reporting Bulletin that provides information to user facilities on
                          various medical device reporting issues. Finally, CDRH held a
                          teleconference with user facilities in May 1996 to discuss matters
                          concerning the final medical device reporting regulation.


                          For its early warning system to be effective, FDA must be able to rapidly
FDA Does Not              process, review, and assess the potential risk of device problems to the
Document Corrective       public health. These assessments must result in an appropriate course of
Actions Adequately        action to resolve device problems. Our review of a sample of adverse
                          event reports and discussions with CDRH officials revealed that for many
                          years FDA has not routinely documented the final corrective actions taken
                          by manufacturers and FDA to resolve the problems identified in these
                          reports. As a result, we were not able to determine how manufacturers and
                          FDA have responded to user facility adverse event reports. In cases in
                          which resolutions of problems are undocumented, FDA has little assurance
                          that problems with devices are being corrected. FDA also has limited
                          information both to share with other reporters who have encountered
                          difficulties with similar devices about preventing potentially hazardous
                          situations and for its own use in analyzing subsequent problems with
                          similar devices. Moreover, without adequate documentation, FDA has little
                          assurance that the many reports received are, in fact, useful and result in
                          better protection of the public health.

                          CDRH  attributed its lack of documentation to the large volume of adverse
                          event reports and limited staff resources. In spite of not having
                          systematically documented the actions taken in response to reports
                          received, CDRH did provide us with several examples of corrective actions
                          it has taken. In addition, FDA said it plans to maintain more complete data
                          on corrective actions that are taken in response to event reports submitted
                          after July 31, 1996. Finally, FDA cannot assess its performance as an early
                          warning system for device problems because it does not keep track of the
                          length of time that it takes to review and resolve serious device problems.


FDA Does Not Routinely    In previous work, we found that over two-thirds of the adverse event
Document Resolutions of   reports received by FDA from 1985 through 1987 lacked a clear-cut
Reported Problems         determination, such as a recall, a voluntary action by the manufacturer, or
                          even an indication that the information submitted by the manufacturer
                          was insufficient to process the case.19 To encourage greater use of medical

                          19
                            GAO/PEMD-89-10, Feb. 17, 1989.



                          Page 21                                  GAO/HEHS-97-21 Medical Device Reporting
B-266228




device reporting data, we recommended that FDA fully document its use of
these data in acting to correct device problems, especially by ensuring that
such actions were recorded in the database. FDA agreed with our
recommendation and reported that changes were under way to improve its
handling of event reports. However, we found during our recent analysis
of adverse event reports and discussions with CDRH officials that CDRH has
not begun routinely documenting the final dispositions of device problems
in individual event reports.

To determine how manufacturers and FDA have responded to user facility
reports, we reviewed 30 reports of events that manufacturers became
aware of through user facility reports from 1992 through 1995. The reports
documented 1 death, 20 injuries, and 9 malfunctions. Our initial review
showed that 29 of the 30 reports contained neither the final determination
of the cause of the device problem reported nor a description of the
corrective action taken by the manufacturer or FDA. The remaining report
described a serious injury that was allegedly caused by a faulty ventilator.
FDA later found the injury to have been unrelated to the device.


We reviewed the 30 reports with an FDA analyst to obtain an update on
each adverse event. In 16 out of 30 cases, the cause of the event had not
yet been identified, and FDA planned to continue to monitor the devices.20
Twelve reports were reviewed by analysts upon initial receipt, but no
further action was documented. Two malfunction reports were assigned to
ad hoc groups to determine whether the devices posed an immediate
health risk to the public; the groups determined that no additional action
was needed.

A CDRH official explained that, under FDA’s medical device reporting
system, the decisions that analysts make on adverse event reports are not
routinely documented, and statistics are not maintained on the types of
corrective actions taken by FDA and manufacturers.21 The official recalled
that during the early 1980s, CDRH closed each case with a conclusion about
the probable cause and effect of the event but that this was too resource
intensive. When the number of reports increased significantly, CDRH chose
to focus on reviewing the reports rather than on documenting how they
were resolved.



20
 Upon receipt of additional information on the serious injury report involving a ventilator, FDA
designated the report for further monitoring.
21
  See app. II for a description of the process used by analysts to evaluate device reports.



Page 22                                                  GAO/HEHS-97-21 Medical Device Reporting
                          B-266228




                          The official also emphasized that documenting problem resolutions is only
                          an issue with regard to reports that can be or are investigated, which is a
                          relatively small subset of all reports received. Moreover, complete
                          documentation of the resolution of a problem is dependent upon a number
                          of factors that FDA cannot control. According to the official, in some cases
                          FDA has great difficulty obtaining required information from user facilities
                          on device-related events so that it can assess the public health risks. As an
                          example, he cited the following scenario: A manufacturer receives a report
                          that one of its disposable devices has failed. However, the device in
                          question has been discarded by the user facility before the manufacturer
                          can examine it and perform tests on it. Consequently, the manufacturer is
                          unable to adequately report pertinent information, and FDA’s ability to
                          ascertain the problem, its causes, and any resolutions is hampered.

                          Despite the problems associated with receiving complete information on
                          device problems, the official acknowledged that providing a close-out
                          record for each report could, among other things, provide reporters with
                          feedback to encourage reporting and provide FDA with a pool of
                          information that could be used to ascertain the impact or probable
                          outcome of any subsequent reports on similar problems with the device.


FDA Has Documented        Although CDRH does not routinely link corrective actions to reported
Some Corrective Actions   medical device problems, it provided us examples of how it has
                          nevertheless identified and acted on serious problems with devices in
                          several instances. The following examples show that well documented
                          events, analysis, and corrective actions are invaluable in responding to
                          reported problems.


Hospital Bed Side Rails   Between January 1990 and June 1995, FDA received 102 reports of head and
                          body entrapment incidents involving hospital bed side rails. These reports
                          indicated that 68 deaths, 22 injuries, and 12 entrapments without injury
                          had occurred in hospitals, long-term care facilities, and private homes.
                          FDA’s analysis of the reports showed that the entrapments actually
                          involved side rails, headboards, footboards, and mattresses. The majority
                          of these adverse events involved elderly patients who were suffering from
                          confusion, restlessness, lack of muscle control, or a combination of these
                          conditions.

                          In July 1995, a CDRH ad hoc group decided that a safety alert should be
                          issued to apprise health care professionals of the entrapment hazards



                          Page 23                                  GAO/HEHS-97-21 Medical Device Reporting
                             B-266228




                             associated with hospital beds and of ways to prevent them.22 CDRH
                             consulted with the Consumer Product Safety Commission and the
                             Canadian government, as well as with numerous professional
                             organizations and manufacturers, to obtain their comments as it developed
                             the alert. CDRH reported that 94,000 copies of the alert were distributed to
                             the user facility community.


Dialysate Solution Storage   A dialysis nurse reported an incident involving eight patients who
Containers                   exhibited several symptoms, including severe hypotension, during dialysis.
                             Three of these patients died. A top priority inspection revealed the
                             patients had high serum aluminum levels. After further investigation, it
                             was found that the dialysis solution was being stored in a pump containing
                             aluminum, metered to the patients through such a pump, or both, and that
                             the aluminum had leached into the dialysate concentrate. A safety alert
                             that discussed the potential hazard created when patients are exposed to
                             dialysate with excessive aluminum levels was issued in May 1992.23


Apnea Monitor                In February 1985, an infant was disconnected from its apnea monitor but
                             the electrodes with the lead wires were left attached to the infant. A
                             sibling plugged the lead into the power cord, electrocuting the infant. CDRH
                             assembled a committee of experts to investigate the hazard. At that time,
                             about 50,000 apnea monitors—of 20 different models—were on the
                             market. The committee decided that a voluntary plan of action would be
                             most effective because of the speed with which it could be implemented.

                             In June 1985, CDRH issued a safety alert summarizing the reported events
                             and outlining steps to guard against future incidents.24 CDRH also sent
                             letters to 31 manufacturers of breathing frequency monitors and heart
                             monitors for home use requesting that each firm evaluate its device for the
                             electrode problem and, when necessary, consider design changes to
                             prevent insertion of the lead connectors into AC power cords or outlets.
                             All 31 device firms either changed their lead designs or explained to CDRH
                             why their device did not present a hazard.




                             22
                              FDA, “Entrapment Hazards With Hospital Bed Side Rails,” a safety alert (Washington, D.C.: FDA,
                             Aug. 23, 1995).
                             23
                              FDA, “Aluminum and Other Trace Contaminations in Dialysis Facilities,” a safety alert (Washington,
                             D.C.: FDA, May 20, 1992).
                             24
                               FDA, “Electrocution of an Infant,” a safety alert (Washington, D.C.: FDA, June 1985).



                             Page 24                                                GAO/HEHS-97-21 Medical Device Reporting
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                       An FDA analysis also shows that many other adverse event reports were
                       used to resolve device problems. For example, FDA reported that from 1985
                       through 1995, 1,099 of its 4,365 classified recalls (25 percent) were
                       associated with event reports. FDA also reports using information in
                       adverse event reports for other health-related purposes, including
                       identifying areas in which user education can be improved, analyzing
                       premarket approval applications, developing medical device standards,
                       and monitoring device problems in foreign countries.

                       In the near future, CDRH expects to have better data on corrective actions
                       taken by manufacturers in response to user facility reports. The final
                       medical device reporting regulation requires manufacturers to list on the
                       form 3500A a corrective action taken—such as a recall, repair, relabeling,
                       or other modification—for each device associated with an adverse event
                       report. According to a CDRH official, manufacturers are now also required
                       to refer to the user facility’s unique reporting number when submitting an
                       adverse event report.


FDA Does Not Record    Maintaining reliable productivity indicators on the length of time FDA takes
How Long It Takes to   to process, review, and initiate action on device problems and on the time
Respond to Reported    that passes before manufacturers correct the problems would better
                       ensure that serious device problems are receiving prompt attention. It
Device Problems        would also allow FDA to better measure its adverse event reporting
                       system’s performance as an early warning system. However, CDRH does not
                       have statistics available on these areas of performance. Thus, FDA has no
                       reliable way of knowing how long it takes to respond to reported device
                       problems.

                       According to FDA, once the enhancements to the MAUDE system are fully
                       operational, it will be able to provide FDA with better information on the
                       time FDA takes to process and review reports. However, FDA officials told
                       us that the MAUDE system will not be able to provide meaningful statistics
                       on the time FDA and manufacturers require to take action on reports.
                       According to FDA, given the complexity of the issues involved and the
                       volume of reports received, any performance indicator based on the length
                       of time needed to correct reported problems would not provide statistics
                       that are reliable. FDA contends that this is an inherent attribute of any
                       system that builds on reports accumulated over many years.

                       While FDA may not be able to develop reliable measures of performance
                       based on the time taken to correct device problems, it can track the time



                       Page 25                                 GAO/HEHS-97-21 Medical Device Reporting
                       B-266228




                       needed by FDA analysts to initiate action on reports. As a result of report
                       reviews, FDA analysts may request additional information from
                       manufacturers and user facilities about the severity of the event and any
                       corrective action taken, request an inspection of the manufacturer’s
                       facility, request ad hoc meetings to discuss issues pertaining to a problem
                       device, or determine that a report requires no further action and archive
                       the report for future research and monitoring. Once one of these initial
                       courses of action is taken by an analyst, FDA can document the date the
                       action was taken in the adverse event reporting system, thereby providing
                       FDA with a more complete measure of its response time.



                       Another important facet of the adverse event reporting system is the
FDA Provides Limited   communication of trends in device-related problems and corrective
Feedback on Adverse    actions taken to ensure the safety and efficacy of medical device products.
Event Trends and       Feedback to the medical device community on reported problems and
                       corrective actions could increase the knowledge of user facilities and
Corrective Actions     manufacturers about the performance of devices, assist users in making
                       device purchase decisions, and improve awareness of patient safety.
                       However, CDRH does not have a system for routinely communicating
                       adverse event reporting trends and remedial actions taken on device
                       problems to specific reporters of device problems and the medical device
                       community at large. Although FDA occasionally issues safety alerts and
                       public health advisories, which inform the medical device community
                       about health risks associated with devices, it does not provide user
                       facilities and other medical device reporters with direct feedback on the
                       status and outcomes of individual device investigations. Nor does it
                       publish composite statistics on event trends and problem resolutions.
                       Consequently, many adverse event reporters are unaware of the
                       dispositions of their complaints and have little assurance that the agency
                       is taking action on the device problems reported. Both user facilities and
                       the industry have suggested that FDA provide more feedback on how it
                       uses adverse event reports.

                       A CDRH official told us that FDA does not have a notification system for
                       advising individual user facilities and other reporters about the status and
                       outcomes of reports because significant staff time would be required to
                       provide feedback to reporters on the more than 100,000 event reports
                       received annually. The official said further that often no feedback is
                       available because FDA does not follow up on each event that is reported.
                       Voluntary reporters receive an acknowledgment letter, but it does not
                       provide specific feedback about their report. FDA does, however,



                       Page 26                                  GAO/HEHS-97-21 Medical Device Reporting
                     B-266228




                     disseminate safety alerts and public health advisories regarding medical
                     device problems to user facilities; it also periodically features alerts in its
                     User Facility Reporting Bulletin. From the beginning of fiscal year 1994
                     through June 1996, FDA issued three safety alerts and seven public health
                     advisories.

                     User facility and industry officials believe that FDA could better protect the
                     public health by publishing statistics on adverse event trends and
                     corrective actions that result from medical device reports. For example, a
                     senior official at a teaching hospital in Baltimore, Maryland, told us that
                     although the adverse event reporting system has received an increased
                     quantity of data, he has seen no analysis of this information that would
                     provide device users with suggestions on courses of action that could be
                     taken to prevent incidents from recurring. Similarly, representatives of the
                     Medical Device Manufacturers Association (MDMA) told us that since the
                     early phases of medical device reporting, their members have derived little
                     benefit from the hundreds of thousands of reports stored within the
                     agency’s databases. MDMA representatives believe the public should know
                     what benefits have been derived from reporting. In addition, a senior
                     executive of a New Jersey hospital said he was disappointed that a
                     database has not been developed that can be searched for information
                     about problem medical devices to help his hospital learn more about the
                     performance of devices and assist in device purchase decisions. Similar
                     views were repeatedly expressed in responses to a 1994 FDA questionnaire
                     sent to user facilities: Over 642 of the 4,419 participating user facility
                     officials—or 15 percent—indicated that they wanted more feedback from
                     FDA on adverse event reports.


                     According to FDA, the MAUDE system will be used to work closely with the
                     device community to identify safety problems; explore the most effective
                     strategies for resolving problems; and provide feedback to user facilities,
                     manufacturers, and the public.


                     Some representatives of the medical device community believe that
Medical Device       reducing the volume of adverse event reports could help FDA more
Community Suggests   effectively manage the reporting system. Suggestions for improving
Ways to Improve      reporting include (1) requiring a statistical sample of user facilities, rather
                     than all user facilities, to report device-related events to FDA and
Reporting            manufacturers and (2) eliminating malfunction reporting by manufacturers
                     to FDA.




                     Page 27                                    GAO/HEHS-97-21 Medical Device Reporting
                             B-266228




Require Only a Statistical   According to the President of the Emergency Care Research Institute
Sample of User Facilities    (ECRI), a nonprofit research agency that operates a worldwide medical
to Report                    device reporting system, FDA’s adverse event reporting system is hampered
                             by prolific and duplicative data that divert resources away from analysis to
                             data entry. ECRI contends that the adverse event reporting system, as
                             currently configured, makes it difficult for FDA to effectively recognize,
                             track, cross reference, investigate, and follow up on significant medical
                             device problems.

                             ECRIbelieves that FDA should free all user facilities but hospitals from the
                             reporting requirement and employ statistical sampling techniques to limit
                             even the number of hospitals required to report device-related problems to
                             manufacturers and FDA. Sampling, according to ECRI, would reduce
                             duplication, speed processing and analysis, and free up resources to
                             devote to analysis and educating hospitals about medical device reporting.

                             NEMA members, however, believe that developing a user facility reporting
                             program predicated on reports from only a small number of entities would
                             pose at least two implementation problems. First, NEMA members believe,
                             in general, that statistical sampling is beneficial only when it pertains to
                             identical devices from one manufacturer. If statistical sampling is used in
                             the device industry, they contend, the possibility exists that problems
                             identified with a given type of device could be incorrectly generalized to
                             apply to devices that do not possess the same attributes. Such a
                             generalization could impose additional costs on the manufacturer if it had
                             to repeatedly spend resources on investigating incident reports that turned
                             out to be groundless.

                             Second, statistical sampling is also problematic from the perspective of
                             the user facility, in that not all user facilities are alike. In the opinion of
                             NEMA members, the only useful approach to a statistical sampling program
                             would be to confine the sample size to a small number of user facilities
                             that share similar patient populations and operating characteristics, such
                             as Public Health System facilities or Veterans Administration facilities.

                             According to the safety coordinator at a hospital in Boston, Massachusetts,
                             statistical sampling would not be a good idea because, given the demands
                             on the user facility community to provide quality health care, if reporting
                             were not required, facilities would not report medical device-related
                             problems. He believes that medical device reporting is an important
                             prerequisite for good patient care and that user facilities must be required




                             Page 28                                   GAO/HEHS-97-21 Medical Device Reporting
                            B-266228




                            by law to report medical device-related incidents in order for them to
                            consistently do so.

                            CDRH’s director told us that CDRH frequently receives adverse event reports
                            from user facilities that are not very helpful in identifying and resolving
                            device problems. He went on to say that CDRH would prefer to receive
                            fewer, but more helpful reports. As a result, CDRH is planning a pilot study
                            to determine the feasibility of adopting the statistical sampling approach
                            to medical device reporting. Under this approach, FDA would educate a
                            smaller population of user facilities in reporting device problems, which
                            might improve the quality of reporting and increase manufacturers’ and
                            FDA’s knowledge about device problems.


                            CDRH  recently issued a “Request for Proposals for a Sentinel System” that
                            asked prospective bidders to develop a design for a pilot study involving
                            about 10 to 20 user facilities. Bidders are required to recruit and negotiate
                            with user facilities interested in participating in the pilot study. Staff of the
                            user facilities that are chosen to participate will be trained in the medical
                            device reporting requirements and user facility responsibilities.
                            Participating facilities will be monitored, and the adverse events reported
                            will be qualitatively evaluated for 12 months. User facilities will receive
                            feedback and refresher training as needed. Depending on the results of the
                            pilot study, CDRH envisions that a representative sample of user facilities
                            could be used either to supplement the existing system or as a
                            replacement for the universe of user facilities, if approved by the
                            Congress.


Eliminate the Requirement   Another industry suggestion for improving FDA’s adverse event reporting
That Manufacturers Report   system is to eliminate malfunction reporting. Currently, manufacturers are
Malfunctions                required to report to FDA malfunctions that are likely to cause or
                            contribute to a death or serious injury should they recur. During fiscal
                            years 1991 through 1995, reports of device malfunctions accounted for
                            about one-third of all reports submitted by manufacturers. Industry
                            officials contend that the medical device reporting system is so
                            overburdened that FDA does not have an opportunity to evaluate the
                            reports of device malfunction and that such reporting is costly and
                            burdensome. Thus, these officials believe malfunctions should no longer
                            be considered reportable events. They contend that manufacturers have
                            systems in place to review and evaluate product malfunctions and that
                            these evaluations are available to FDA during the routine inspections that
                            FDA makes of their facilities.




                            Page 29                                    GAO/HEHS-97-21 Medical Device Reporting
              B-266228




              The purpose of the 1984 medical device regulation was to provide FDA with
              more information about device problems, such as malfunctions, so that the
              agency could learn about potential device problems before they
              endangered the lives of people. A CDRH official told us that deciding
              whether to eliminate malfunction reporting is the choice between having
              an adverse event reporting system that is proactive and one that is
              reactive. Further, he stated that if the objective of medical device
              reporting is to find out that a device is dangerous after it has caused or
              contributed to a death or serious injury, then malfunction reporting can be
              eliminated. However, if the objective is to become aware of problems
              before they have caused a death or serious injury, then malfunction
              reporting should not be eliminated. CDRH, he said, would prefer to retain
              malfunction reporting so that FDA can continue to learn of potential public
              health problems and resolve them before a serious injury or a death
              occurs.


              The quantity of information reported to FDA about medical device
Conclusions   problems has increased dramatically since SMDA 90’s reporting
              requirements became effective in 1991. Because FDA has not ensured that
              reported device problems receive prompt attention and appropriate
              resolution, however, its adverse event reporting system is not providing an
              early warning about device problems. Without reliable statistics that
              measure the length of time that FDA takes to review and initiate action on
              device problems and systematic documentation of how all reported
              problems are resolved, FDA cannot ensure that the system is serving as an
              early warning system for unsafe and ineffective devices. Moreover,
              because FDA has not identified and followed up with user facilities that
              may have underreported thousands of patient deaths, its ability to analyze
              device problems and assess the public health risk may be significantly
              hampered. Finally, without feedback from FDA to user facilities about
              device problem trends and corrective actions taken, user facilities do not
              receive information that could help them determine which devices to
              purchase, and they have little assurance that FDA is taking action on their
              adverse event reports.

              FDA’s new MAUDE system is now providing opportunities for FDA to correct
              weaknesses in its adverse event reporting system. In July 1996, FDA began
              requiring manufacturers to list on the form 3500A corrective actions that
              are initiated to resolve medical device adverse events. This improvement
              will provide the MAUDE system with the information that FDA needs to
              systematically document solutions to device problems and help it



              Page 30                                 GAO/HEHS-97-21 Medical Device Reporting
                          B-266228




                          communicate more effectively with user facilities. In addition, once the
                          MAUDE system is fully operational, it will be able to generate productivity
                          data on the time FDA takes to process and review adverse event reports. If
                          FDA expands this capability to include the time it requires to initiate action
                          on reports, it will be able to more easily measure its performance as an
                          early warning system. The MAUDE system will also enable FDA to identify
                          and follow up with user facilities that do not submit reports of
                          device-related deaths to FDA. If FDA uses the MAUDE system in this way, FDA
                          will be able to ensure that user facilities are complying with the law and
                          also obtain the user facilities’ perspectives on these events.

                          Limiting the number of user facilities required to report medical device
                          problems could improve the quality of data FDA receives without
                          jeopardizing its ability to identify device problems. On the other hand,
                          fewer reporters could mean that problems would be less likely to be
                          identified and resolved, especially for devices with relatively low usage
                          rates. An evaluation of whether the identification and correction of device
                          problems would better be accomplished through the current system or
                          through a smaller user facility reporting program may help FDA decide
                          which approach is better for protecting the public health. Furthermore,
                          although FDA’s initiatives may improve its reporting system, they do not
                          address its difficulty in ensuring prompt resolution of device problems,
                          compliance with SMDA 90, and dissemination of trend analysis and
                          corrective actions taken to the medical device community.


                          To improve FDA’s adverse event reporting system’s ability to serve as an
Recommendations to        early warning system about medical device problems as intended by SMDA
the Commissioner of       90, we recommend that the Commissioner of FDA

the Food and Drug
                      •   collect and maintain reliable statistics on the time it takes to process,
Administration            review, and initiate action on adverse event reports;
                      •   use reports of death provided by manufacturers and others to identify user
                          facilities that may not be reporting to manufacturers, FDA, or both in
                          violation of SMDA 90;
                      •   document corrective actions on adverse event reports that result from
                          analysis and investigations of device problems; and
                      •   collect and disseminate adverse event trend analysis and corrective
                          actions taken by manufacturers and FDA to the medical device community.

                          Finally, we recommend that FDA’s study of an adverse event reporting
                          system based on a representative sample of user facilities focus on



                          Page 31                                   GAO/HEHS-97-21 Medical Device Reporting
                   B-266228




                   whether this approach can provide manufacturers and FDA with the
                   quantity and quality of information needed to rapidly identify and correct
                   problems with devices that have varying usage rates.


                   FDA  agreed with our recommendations for improving its adverse event
Agency Comments    reporting system. However, FDA believes that the three components of its
and Our Response   postmarket surveillance system together provide an adequate early
                   warning system for device problems and help to ensure that the public is
                   protected. Specifically, FDA believes that (1) medical device reports are
                   supplemental in nature and that its entire postmarket surveillance system,
                   its GMP regulations, and other related activities combined constitute the
                   most comprehensive source of information regarding marketed medical
                   devices; (2) the deficiencies in the adverse event reporting system cited in
                   our report are being corrected; and (3) adverse event reports from all
                   sources are promptly and thoroughly reviewed, and appropriate actions
                   are taken to protect the public health.

                   While we agree that FDA uses several sources of information to monitor
                   marketed devices, we disagree with their suggestion that the adverse event
                   reporting system serves mainly as a supplement to other components of
                   the postmarket surveillance system. This suggestion conflicts with FDA’s
                   response to a recent congressional inquiry in which FDA characterized the
                   adverse event reporting system as “critically” important to its postmarket
                   surveillance system because it provides a balance with its premarket
                   evaluation of new medical devices. FDA also characterized the adverse
                   event reporting system as a “safety net” that allows the agency to move
                   new technologies into the marketplace more rapidly because problems
                   with devices that were not detected at the premarketing stage can be
                   identified and corrected through the adverse event reporting system.
                   Moreover, FDA’s implication that it relies more heavily on its GMP
                   compliance program than on the medical device reporting system to help
                   protect the public health is worrisome. The GMP program is intended to
                   assess the safety and effectiveness of devices before, rather than after,
                   they reach users. Yet in an earlier study of the program, we documented
                   that FDA did not inspect many manufacturers of medium- and high-risk
                   devices at least once every 2 years, as required by law; the quality of the
                   inspections that were performed was frequently poor; and the inspections
                   did not detect quality assurance problems.25



                   25
                    Medical Technology: Quality Assurance Needs Stronger Management Emphasis and Higher Priority
                   (GAO/PEMD-92-10, Feb. 13, 1992).



                   Page 32                                           GAO/HEHS-97-21 Medical Device Reporting
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While we acknowledge that FDA has recognized weaknesses in the adverse
event reporting system and has instituted improvements to correct them,
none of these improvements has been tested and proven effective. For
example, although the form 3500A may provide FDA with the information it
needs to better protect the public health, voluntary use of the form by user
facilities since 1992 has shown that many data quality problems exist.
Further, it is too early to tell if mandatory use of the form 3500A will result
in improved reporting.

Although FDA has provided some information that associates medical
device reports with recalls and other administrative and regulatory
activities, the adverse event reporting system does not routinely identify
the actions that were initiated to correct the problems detailed in event
reports. Nor does the system provide data on how long it takes the agency
to respond to serious device problems. In our view, an effective adverse
event reporting system should permit FDA to readily determine how each
event report was handled and that all problems reported received prompt
attention and resolution.

FDA’s written comments on a draft of this report are reproduced in
appendix III. FDA also provided technical comments clarifying aspects of
its adverse event reporting system, which we have incorporated in this
report where appropriate.


We are sending copies of this report to other congressional committees
and Members with an interest in this matter, and we will make this report
available to others upon request. If you or your staff have any questions
about this report, please call me on (202) 512-7119 or John C. Hansen,




Page 33                                   GAO/HEHS-97-21 Medical Device Reporting
B-266228




Assistant Director, on (202) 512-7105. Others who contributed to this
report are Darryl Joyce, Lynn Filla-Clark, Barbara Mulliken, and Joan
Vogel.




Bernice Steinhardt
Director, Health Services Quality
  and Public Health




Page 34                                GAO/HEHS-97-21 Medical Device Reporting
Page 35   GAO/HEHS-97-21 Medical Device Reporting
Contents



Letter                                                                                             1


Appendix I                                                                                        38

Scope and
Methodology
Appendix II                                                                                       41

FDA’s Adverse Event
Report Evaluation
Process
Appendix III                                                                                      43

Comments From the
Food and Drug
Administration
Related GAO Products                                                                              56


Tables                 Table 1: Summary of Medical Device Reporting Requirements,                  7
                         1996
                       Table I.1: Organizations Interviewed Regarding SMDA 90 and                 40
                         FDA’s Adverse Event Reporting System

Figures                Figure 1: Adverse Event Reports Filed by Manufacturers, Fiscal             10
                         Years 1987-90 and 1991-94
                       Figure 2: Adverse Event Reports Received by FDA From User                  14
                         Facilities, Fiscal Years 1992-95
                       Figure 3: Percentage of User Facility Reports Submitted by Event           15
                         Type, Fiscal Years 1992-95
                       Figure 4: Comparison of Death Reports Filed by User Facilities             16
                         and Manufacturers, Fiscal Years 1992-95




                       Page 36                                GAO/HEHS-97-21 Medical Device Reporting
Contents




Abbreviations

CDRH       Center for Devices and Radiological Health
ECRI       Emergency Care Research Institute
EDI        electronic data interchange
FDA        Food and Drug Administration
FTE        full-time-equivalent
GMP        good manufacturing practices
HHS        Department of Health and Human Services
MAUDE      Manufacturer and User Device Experience
MDMA       Medical Device Manufacturers Association
MDR        mandatory medical device reporting
NEMA       National Electrical Manufacturers Association
OSB        Office of Surveillance and Biometrics
PRP        Medical Device and Laboratory Problem Reporting Program
SMDA 90    Safe Medical Devices Act of 1990


Page 37                             GAO/HEHS-97-21 Medical Device Reporting
Appendix I

Scope and Methodology


                 We conducted our review of the Food and Drug Administration’s (FDA)
                 implementation of the Safe Medical Devices Act of 1990 (SMDA 90) at FDA’s
                 Office of Surveillance and Biometrics (OSB), Center for Devices and
                 Radiological Health (CDRH). We reviewed prior GAO reports related to FDA’s
                 medical device adverse event reporting system as well as studies
                 conducted by the Emergency Care Research Institute and device
                 manufacturer associations. We also interviewed CDRH officials about
                 policies and procedures used to process, review, and act on adverse event
                 reports. With these officials, we also discussed FDA’s efforts to implement
                 the user facility reporting requirements of SMDA 90 and to publish the final
                 medical device reporting regulation required by the act.

                 We analyzed computerized data from FDA’s adverse event reporting system
                 on trends in device-related events from fiscal years 1987 through 1995 to
                 determine whether the volume of reporting of device problems had
                 changed since the user facility reporting requirement became effective in
                 1991. We also reviewed statistics compiled by CDRH on the extent to which
                 user facilities had filed adverse event reports with FDA during fiscal years
                 1992 through 1995 in accordance with the act. Specifically, we examined
                 whether user facilities had done the following:

             •   reported deaths to FDA and manufacturers,
             •   reported serious injuries and serious illnesses to FDA only when the
                 manufacturer’s name was unknown,
             •   reported these deaths and serious injuries and illnesses to FDA within 10
                 work days of becoming aware of them, and
             •   submitted a semiannual report to FDA summarizing device-related events
                 that took place during the previous 6 months.

                 In addition, we reviewed FDA field office inspections of user facilities’
                 compliance with the SMDA 90 reporting requirements. We were unable to
                 obtain statistics from CDRH on corrective actions that have been initiated
                 by manufacturers and FDA because CDRH does not routinely document the
                 final resolutions (such as recalls, seizures, and warning letters) in
                 individual adverse event reports. However, to illustrate how
                 manufacturers and FDA have handled user facility reports, we reviewed 30
                 event reports that were submitted to FDA by manufacturers in response to
                 user facility reports of problems with devices during fiscal years 1992
                 through 1995 and discussed the status of each report with a CDRH analyst.

                 Finally, we interviewed representatives of organizations within the
                 medical device community (four hospitals, two parent corporations of



                 Page 38                                 GAO/HEHS-97-21 Medical Device Reporting
Appendix I
Scope and Methodology




health care providers, two nonprofit organizations, one nursing home
association, and three device manufacturer associations). We discussed
with them their experiences with user facility reporting and whether
changes to SMDA 90 and FDA’s adverse event reporting system were needed
to improve reporting. We identified these organizations through a review
of the literature and through a list of contacts obtained from FDA. Table I.1
provides the name, location, and a brief description of each organization
interviewed.




Page 39                                  GAO/HEHS-97-21 Medical Device Reporting
                                       Appendix I
                                       Scope and Methodology




Table I.1: Organizations Interviewed
Regarding SMDA 90 and FDA’s            Organization                                 Description
Adverse Event Reporting System         Beth Israel Hospital, Boston, Mass.          A 408-bed tertiary care hospital affiliated
                                                                                    with Harvard University
                                       Columbia/HCA, Health Care Corporation,       Parent corporation of 340 hospitals and
                                       Nashville, Tenn.                             130 ambulatory surgery centers
                                                                                    throughout the United States
                                       Johns Hopkins University Hospital,           A 1,000-bed tertiary care hospital that
                                       Baltimore, Md.                               provides a variety of treatments and
                                                                                    patient care and serves as a referral center
                                       Rahway Hospital, Rahway, N.J.                A 300-bed acute care, full service hospital
                                       New Britain General Hospital, New Britain,   A 330-bed teaching hospital
                                       Conn.
                                       American Health Care Association,            A federation of 50 state and District of
                                       Washington, D.C.                             Columbia nursing home affiliates
                                       Mayo Foundation, Rochester, Minn.            A not-for-profit corporation composed of
                                                                                    health care facilities in several states
                                       Public Citizen, Washington, D.C.             A nonprofit public interest organization
                                                                                    with objectives related to health care that
                                                                                    monitors government agencies charged
                                                                                    with health care functions
                                       Emergency Care Research Institute,           A nonprofit health services research
                                       Plymouth Meeting, Penn.                      agency whose mission is to improve
                                                                                    patient care, ECRI operates a Consumer
                                                                                    Reports-like medical product evaluation
                                                                                    program and a broader health care
                                                                                    technology assessment program that
                                                                                    encompasses devices, drugs,
                                                                                    biotechnologies, and medical and surgical
                                                                                    procedures.
                                       Medical Device Manufacturers Association,    A national trade association representing
                                       Washington, D.C.                             100 independent manufacturers of medical
                                                                                    devices, diagnostic products, and health
                                                                                    care information systems
                                       Health Industry Manufacturers Association,   A national trade association representing
                                       Washington, D.C.                             more than 700 manufacturers of medical
                                                                                    devices, diagnostic products, and health
                                                                                    information systems
                                       National Electrical Manufacturers            A national trade association representing
                                       Association, Rosslyn, Va.                    manufacturers of diagnostic X-ray,
                                                                                    computed tomography, magnetic
                                                                                    resonance imaging, ultrasound imaging,
                                                                                    and radiation therapy equipment




                                       Page 40                                       GAO/HEHS-97-21 Medical Device Reporting
Appendix II

FDA’s Adverse Event Report Evaluation
Process

              FDA  receives adverse event and product problem reports from user
              facilities, manufacturers, distributors, and health care professionals. User
              facilities, manufacturers, and distributors use a standard form 3500A for
              reporting device-related events. User facilities and distributors must report
              patient information, the type of adverse event, a description of the event,
              relevant laboratory data and patient history, the name of the manufacturer,
              and certain other information about the device. Manufacturers must report
              such information as the source of reported information; the type of event
              reported to them; whether the device was returned to the manufacturer for
              evaluation; methods of evaluation and results of manufacturer review;
              and, if applicable, the type of remedial action taken (recall, repair,
              relabeling, or inspection). Health professionals report adverse events and
              product problems voluntarily on a form 3500.

              Event reports are entered into an adverse event database, with the
              appropriate quality control checks, by FDA’s data entry contractor,
              Logistics Applications, Inc. Thereafter, OSB evaluation teams consisting of
              15 specialized health care professionals (14 nurses and 1 nuclear medicine
              technologist) retrieve the reports from the database via the computer for
              review. Analysts may each have responsibility for all products associated
              with an assigned medical specialty area, such as radiology, ophthalmology,
              or orthopedics, or they may be responsible for specific types of products
              associated with larger clinical areas, such as general hospital, general
              surgery, and cardiology. Analysts’ reviews focus on identifying the device
              problems that pose the greatest risk to the public health. Deaths are given
              first priority, but serious injuries and illnesses are also important
              concerns, unless they are not considered life threatening.

              To assess the nature and magnitude of a problem, the analysts use their
              clinical expertise to evaluate the data submitted in the adverse event
              report, as well as other information, such as premarket submissions on
              similar devices, recall information, and literature reviews on adverse
              events or reported problems. Known complications and problems
              associated with a particular device are screened by a computer and a
              sample of these reports is assigned to the appropriate analyst for review.
              Reports of particular importance, such as pediatric deaths, are routinely
              sent to the appropriate analyst either prior to or concurrent with the data
              entry process. This provides the analyst an opportunity to commence an
              investigation while the actual report is undergoing data entry.

              On the basis of their evaluation of reported events, the analysts determine
              if any follow-up investigation is needed. These investigations generally



              Page 41                                  GAO/HEHS-97-21 Medical Device Reporting
Appendix II
FDA’s Adverse Event Report Evaluation
Process




involve written requests for additional information from a manufacturer,
user facility, or voluntary reporter on aspects of a reported incident or an
inspection of either the manufacturer or the user facility.

Written requests may ask for such patient data as an evaluation of the
reported incident by a health care practitioner; a patient history,
underlying diagnosis, or both; and autopsy results relevant to the reported
event. Similarly, requests for device data may include product identifiers
such as model, lot, and catalog numbers of a device; the length of time a
device has been in use; the disposition of a device involved in a reported
event; results of any manufacturer failure testing; and copies of device
labeling and instructions for use. This information enables the analyst to
better assess the cause of a reported problem. In addition, information
may be requested on the number of devices manufactured, distributed,
and in use, which assists in determining the exposure of the population at
risk. The analyst may also request that a manufacturer provide information
on the frequency and severity of a reported event, as well as any corrective
action taken by a manufacturer to address a reported problem.

In addition, the analyst may request an inspection of the manufacturer’s
facility when immediate follow-up on a reported event is necessary or
when the reported event suggests the need for an FDA investigation. Upon
receipt of the results of the investigation, the analyst evaluates the data
and assesses whether or not further FDA action is needed. If warranted, the
adverse event report and any related information are forwarded to the
appropriate group within FDA for consideration of regulatory action, such
as recall or device user notification through safety alerts, public health
advisories, a press release warning the public of potential hazards
associated with the device in use, or all three. If the analyst determines
that no further action is needed, the adverse event report is archived for
future research and monitoring.




Page 42                                  GAO/HEHS-97-21 Medical Device Reporting
Appendix III

Comments From the Food and Drug
Administration




               Page 43     GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 44                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 45                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 46                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 47                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 48                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




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Appendix III
Comments From the Food and Drug
Administration




Page 50                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




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Appendix III
Comments From the Food and Drug
Administration




Page 52                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 53                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 54                           GAO/HEHS-97-21 Medical Device Reporting
Appendix III
Comments From the Food and Drug
Administration




Page 55                           GAO/HEHS-97-21 Medical Device Reporting
Related GAO Products


              Medical Device Regulation: Too Early to Assess European System’s Value
              as Model for FDA (GAO/HEHS-96-65, Mar. 6, 1996).

              Medical Technology: Quality Assurance Needs Stronger Management
              Emphasis and Higher Priority (GAO/PEMD-92-10, Feb. 13, 1992).

              Medical Device Problem Reporting: A Case Study of a Home Apnea
              Monitor (GAO/T-PEMD-90-10, July 17, 1990).

              Medical Devices: Underreporting of Serious Problems With a Home Apnea
              Monitor (GAO/PEMD-90-17, May 31, 1990).

              Medical Devices: Underreporting of Problems, Backlogged Systems, and
              Weak Statutory Support (GAO/T-PEMD-90-2, Nov. 6, 1989).

              Medical Devices: The Public Health at Risk (GAO/T-PEMD-90-2, Nov. 6, 1989).

              Medical Device Recalls: Examination of Selected Cases (GAO/PEMD-90-6,
              Oct. 19, 1989).

              Medical Device Recalls: An Overview and Analysis 1983-88
              (GAO/PEMD-89-15BR, Aug. 30, 1989).

              Medical Devices: FDA’s Implementation of the Medical Device Reporting
              Regulation (GAO/PEMD-89-10, Feb. 17, 1989).

              Medical Devices: FDA’s 510(k) Operations Could Be Improved
              (GAO/PEMD-88-30, July 11, 1988).

              Medical Devices: FDA’s Forecasts of Problem Reports and FTEs Under H.R.
              4640 (GAO/PEMD-88-30, July 11, 1988).

              Medical Devices: Early Warning of Problems Is Hampered by Severe
              Underreporting (GAO/T-PEMD-87-4, May 4, 1987).

              Medical Devices: Early Warning of Problems Is Hampered by Severe
              Underreporting (GAO/PEMD-87-1, Dec. 19, 1986).




(108236)      Page 56                                  GAO/HEHS-97-21 Medical Device Reporting
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