oversight

Medical Devices: Underreporting of Serious Problems With a Home Apnea Monitor

Published by the Government Accountability Office on 1990-05-31.

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

                                                                 ;,   .   w
               United   States   General   Accounting   Office
               Report to the Chairman, Subcommittee                       ‘*-r
               on Health and the Environment,
           .   Committee on Energy and Comrkerce,
               House of Representatives

May 1990
               MEDICAL DEVICES
               Underreporting of
               Serious Problems With
               a Home Apnea Monitor
      United States
GAO   General Accounting  Office
      Washington, D.C. 20548

      Program Evaluation    and
      Methodology  Division

      B-237533

      May 31,199O

      The Honorable Henry Waxman
      Chairman, Subcommittee on Health and the Environment
      Committee on Energy and Commerce
      House of Representatives

      Dear Mr. Chairman:

      In February 1989, we reported to the Subcommittee that our review of
      the implementation of the medical device reporting regulation had found
      evidence that some medical device manufacturers may have been over-
      reporting problems with devices, while others either were not reporting
      at all or were underreporting.’ In its comments on the report, the Food
      and Drug Administration (FDA) said that our conclusion that the indus-
      try was underreporting was “questionable” and that FDA’s medical
      device reporting regulation compliance inspection strategy was suffi-
      cient to identify compliance problems. Since the release of our report,
      we have received additional information from several sources that sug-
      gests that problems are underreported and that underreporting is not
      always identified through FDA'S inspection program.’

      On September 18, 1989, you asked us to investigate a citizen’s report to
      the General Accounting Office (GAO) of numerous unreported deaths of
      patients associated with the Aequitron Medical, Inc., Model 8200 home
      apnea monitor and to include our investigation in our ongoing review of
      FDA'S postmarketing surveillance of medical devices for the Subcommit-
      tee. With the concurrence of the Subcommittee staff, we undertook a
      case study based on three specific questions: (1) How many complaints
      involving the death of patients have been associated with the Model
      8200 apnea monitor? (2) Did the device manufacturer comply with FDA'S
      existing problem-reporting regulations and procedures? (3) When FDA
      received information from the device manufacturer or other sources
      that Model 8200 had been associated with numerous deaths, what
      actions did FDA take in response to that information? This letter presents
      our findings, conclusions, and recommendations.


      ‘See IJ.S. General Accountmg Office, Medical Devices: FDA’s Implementation of the Medical Device
      Reporting Regulation, GAO/PEMD-8%10       (Washington, D.C.: February 1989), p. 3.

      ‘The sources included citizen reports, device industry publications, consultation with members of our
      expert review panel, and rewew of indwidual recalls in connection with our earlier report entitled
      Medud Dewce Recalls: Exammation of Selected Cases, GAO/PEMD-90-6             (Washington, D.C.: October
       1989).




      Page 1                          GAO/PEMD-90.17      Underreporting    Home Apnea Monitor      Problems
             5237533




             overall efficacy of the FDA medical device reporting regulation compli-
             ance program and, in particular, the finding that a number of FDA
             inspections had discovered instances in which reportable serious inju-
             ries and deaths had been recorded in a manufact,urer’s files but not
             reported to the agency.

             This study of an apnea monitor is consistent with our earlier finding of
             differences in the interpretation of medical device reporting require-
             ments.’ In this case, a manufacturer’s interpretation of the requirements
             has resulted in the underreporting of serious problems associated with
             its device. It also illustrates a weakness in the compliance inspection
             process. Although the manufacturer had been the subject of several
             inspections, it was nearly 4 years after the medical device reporting reg-
             ulation went into effect before FDA'S inspection program identified and
             attempted to resolve the underreporting.

                                                       ___.       __-
             Medical devices include almost everything, other than drugs, that
Background   health-care professionals use to diagnose, treat, or prevent illness,
             improve human functioning, and support and sustain life.” More than
             1,700 different types of medical devices are available in the United
             States today. They represent an industry of more than $14 billion a
             year. FDA is authorized to regulate medical devices during all phases of
             their development, testing, production, distribution, and use.

             FDA has identified the apnea monitor as a “critical device.” Critical
             devices are intended for surgical implant into the body or to support or
             sustain life. Their failure to perform when used properly in accordance
             with instructions provided in the labeling can be reasonably expected to
             result in a significant injury to the user.


              “Medical   Devices, p. 4.

              “Section 201(h) of the Federal Food. Drug, and Cosmetic ACT of 1938, w amended by the Medical
              Device Amendments of 1976, defines “drvice” as an instrument, apparatus, implement, machine, con-
              trivance, implant, in vittw rragvnt, or other similar or related art~rlc, inchrding any compment, part,
              or accessory, that is (1) rwogmzed m t.hr official National Formulxy       or the 1J.S. Pharmacopeia or any
              supplement to them, (2) mntendtsd for USCin the diagnosis of disease or other conditions or in the cure,
              mitigation, treatment, or prevention of disease, in humans or other animals, or (3) intended to affect
              the structure or any function of thr human body or bodies of other animals, and that dws not achieve
              any of its principal intended pwposcs through chrmical action within or on the body and does not
              depend upon being metabolized in order to achieve any of its principal intended purposes The effect
              of the amendments was to enlarge the 1938 definitmn of “device” to include (1) devices intended for
              use in the diagnosis of concbtions other than diwasc. wrh as pregnancy, (2) m vitro diagnostic prod-
              ucts, and (3) specific productr prcv~wsly regulated as new drugs, including soft contxt 1~~s. bone
              cement, and wltures




              Page 3                           GAO/PEMLNO-17        Underreporting    Home Apnea Monitor       Problems
                                           FL237533




                                           Aequitron Medical, Inc., Model 8200 home apnea monitor. The table con-
                                           tained 82 complaints with four categories of information for each com-
                                           plaint.!’ (The table is reproduced in appendix I.)

                                           Our investigation of the origin and contents of the HID file determined it
                                           to be a list of complaints derived from the device manufacturer’s “haz-
                                           ard, injury, or death” GMP record. The list contained complaints that the
                                           device manufacturer had received about its Model 8200 apnea monitor
                                           dated between January 1983 and January 1989.1”

                                           Our analysis of the HID file showed that it listed 68 complaints in which
                                           the word “death” was included in the category of reasons for the
                                           device’s return to the manufacturer. Further research found that a simi-
                                           lar list drawn from the manufacturer’s general complaint record con-
                                           tained 2 additional complaints in which the word “death” was included.
                                           There were therefore a total of 70 complaints in which the allegation of
                                           a patient’s death was included in the complaint description11 The
                                           remaining 14 complaints in the HID file were complaints that included
                                           allegations of either hazards to safety or injuries. (See table 1. The
                                           remainder of the table is discussed below.)


Table 1: Complaints and Medical Device Reporting Regulation Reports on Aequitron Medical, Inc., Model 6200 Apnea Monitor
                                                                          Medical device reporting regulation reports to FDA
                              Complaints in Aequitron’s files                 Before FDA’s May        After FDA’s May
                      In “H/l/Death File”    In “general” file Total            1968 inspection       1966 inspection    Total
Deaths                                68                      2        70                                   5                           2
                                                                                                                                                -- 7
Nondeaths                             14                     66        60                                  78                         193        271
Total                                 62                     66       150                                  63                        195’        276
                                           a150 of these reports were submltled in response to FDA compliance actlons




                                           “The four data categories for each complaint were serial number, date, reason for return, and analy-
                                           sis. It is important to note that with regard to the “analysis” category, the general limitations of the
                                           technology employed in apnea monitors or the specific limitations of the design of a particular model
                                           may cause a monitor to fail to detect apnea events in some circumstances. Such an occurrence is
                                           known as a “false negative.” If this happens, later testing of the monitor would not necessarily reveal
                                           that a component had malfunctioned, and the device could be found to be “within specifications.”

                                           “‘Model 8200 was introduced Into the market m June 1982. According to the manufacturer, approxi-
                                           mately 30,000 of the monitors were distributed between 1982 and 1987, but it is not possible to
                                           cstrnate the number in actual II.% or their frequency of use.

                                           ’ ‘The manufacturer confimwd     I hat these were complaints alleging a death had been associated with
                                           the use of the device.




                                           Page 6                           GAO/PEMD-90-17     Underrepmthg      Home Apnea Monitor         Problems
                            B-237533




                            record, FDA found that 10 unreported complaints should have been
                            reported, including 4 that alleged the death of patientsl:l

                            It is important to note that not all incidents in which a device is associ-
                            ated with the death of a patient must necessarily be reported to FDA
                            under the medical device reporting regulation. The regulation requires
                            reporting of incidents to FDA only if the information in the possession of
                            the manufacturer “reasonably suggests” that a device may have caused
                            or contributed to a death or a serious injury. If a health care profes-
                            sional states that this has happened, then the manufacturer is required
                            to file a medical device reportt.14But in the case of a report from a
                            layperson, if an immediate investigation by the manufacturer reveals
                            that a patient was not connected to an apnea monitor at the time of
                            death, or that the monitor’s alarm sounded and the caregiver was
                            alerted even though the patient could not be revived, then a report
                            might not be required. FDA has characterized the circumstances in which
                            home apnea monitors are used and the limitations of the technology
                            they employ as sometimes making it difficult to determine whether a
                            problem is reportable under the medical device reporting regulation.

                                                          -
Question 3: FDA’s Actions   When FDA received information from the device manufacturer or other
                            sources that Model 8200 had been associated with numerous deaths,
                            what actions did FDA t,ake in response to that information? One of the
                            principal tools of FDA'S postmarketing surveillance of medical devices is
                            biennial inspections for compliance with the GMP regulation. In addition,
                            FDA conducts “for cause” inspections when they are warranted by com-
                            plaints or other evidence of problems with devices.‘” FDA assesses device
                            manufacturers’ compliance with the medical device reporting regulation
                            by executing a special medical device reporting inspection program as




                            “‘A more da&d        discusswn of Ihls rewew IS contained in the following     section of this report on
                            FDA’s acrions.

                            “The “per      se” reporting rule states that whenever a health care professional advises a manufacturer
                            that one of    its devices may have caused or contributed to a serious iqjjury or death, the manufacturer
                            is “per se”   m receipt of information that “reasonably suggests” that a device may have caused or
                            contributed     to a serious injury or death, and it therefore must report the event. It does not, however,
                            imply that    reports from perx~ns other than health care professionals are not reportable.

                            “A pt-inc~pal rationale for “for GWX” inspections is information developed by FDA analysts who
                            monitor and compare reports submitted through FDA’s voluntary problem-reportii    program, device
                            recalls, and the medical deww reporting system.




                            Page 7                             GAO/PEMDCW-17        Undermpmting      Home Apnea Monitor       Problem
5237633




“per se” provision of the medical device reporting regulation and com-
pany policy, Aequitron did not submit these types of reports.

In our earlier study of the implementation of the medical device report-
ing regulation, we reported that the evidence suggested an undeter-
mined amount of overreporting by some device manufacturers and that
others were either not reporting or underreporting.lH The most fre-
quently identified dimension of noncompliance noted by FDA inspectors
was failure to establish adequate procedures for handling complaints to
determine their reportability (20 percent of all such citations for the
first series of medical device reporting regulation compliance inspec-
tions and 53 percent for the second series).“’ We also encountered varia-
tions in the interpretation of reporting requirements among the FDA
officials and staff we interviewed.

As a result of the October 1988 notice-of-adverse-findings letter and
negotiations between FDA officials and the apnea monitor manufacturer,
the manufacturer agreed to review its complaint records and revise its
medical device reporting policy. Subsequently, Aequitron submit,ted
medical device reports on 6 of the 10 incidents listed in the notice-of-
adverse-findings letter. including 2 of the complaints in the HID file
involving deaths. These 2 reports of death were submitted 1 year and 9
months, respectively, after the events they described. The manufacturer
also submitted 144 reports of malfunctions involving confirmed alarm
failuresYil Aequitron thus submitted at least 150 medical device reports
in response to FDA compliance actions. (See table 1.)

Aequitron also submitted a revised medical device reporting policy to
FDA, and FDA notified the manufacturer that its revised policy was ade-
quate. We found certain aspects of the revised reporting policy to be
inconsistent with the medical device reporting regulation. Specifically,
we believe that it is improper to condition the reporting criteria on the
confirmation or observation of a malfunction. (Our complete analysis is
contained in appendix III.)




 %e   Medical Devices,   p.61.
 “‘See Medical Devices, p. 59.

‘“Apnea monitor alarms meet FDA‘s definition of a “critical device component”-that     is, any rompo-
nent of a critical device whose failure to perform can be reasonably expected to czuw the fadurr of a
critical device or to affed its safety or effectiveness




Page 9                           GAO/PEMD-99-17    Underreporting   Home Apnea Monitor     Problems
                      B-237533




                      FDA  did not provide evidence that its inspection procedures included any
                      systematic evaluation of trends in the frequency, type, or severity of
                      complaints involving the failure of alarms that were made to the manu-
                      facturer or reported under the medical device reporting regulation.
                      There were also no comparisons of overall complaint rates of alarm fail-
                      ures of Aequitron’s Model 8200 to those of other monitors. The inclusion
                      of these procedures in the inspection program could have served to more
                      quickly identify both problems of underreporting and potentially seri-
                      ous device problems.



Conclusions,
Recommendations,
and Agency Comments

Conclusions           We conclude that the evidence from the current case of an apnea moni-
                      tor is consistent with our earlier finding that there are differences in the
                      interpretation of medical device reporting requirements among device
                      manufacturers and between manufacturers and FDA.” In this case, the
                      manufacturer’s interpretation resulted in an undetermined amount of
                      underreporting of serious problems with a device.

                      We found that FDA'S review of a sample of Aequitron’s records deter-
                      mined that some complaints alleging that the device was associated with
                      hazards to safety, injuries, or death had not, been reported to the agency
                      because of the manufacturer’s interpretation of the medical device
                      reporting requirements.

                      As a result of FDA'S intervention in this case and the device manufac-
                      turer’s review of its o\vn records, 144 additional medical device reports
                      of malfunctions were submitted. We believe that malfunction reports
                      should be considered as seriously as reports of serious injury or the
                      death of a patient, especially as a preventive measure. Malfunction
                      reports describe problrm occurrences that were not associated with the
                      injury or death of a pat,ient. Ilowcvcr. if thr problem should recur, it
                      may result in injury or even death.




                      Page 11                GAO’PEMLWO-17   Underreporting   Home Apnea Monitor   Problems
                          B-237633




                          and consider developing specific guidance for the manufacturers of any
                          devices, such as apnea monitors, for which determining reportability is
                          thought to present special difficulties.


Agency Comments and Our   The Department of Health and Human Services (HHS) agreed with our
                          recommendations and reported that FDA had taken actions consistent
Response                  with them. FDA conducted a comprehensive good manufacturing prac-
                          tices and medical device reporting regulation inspection of Aequitron
                          and is currently reviewing the results to determine what regulatory
                          action is warranted. The agency is also considering the development of
                          device-specific guidance on medical device reporting and has established
                          a study group to analyze the medical device reporting regulation and
                          program, identify problems, and recommend solutions.

                          HHS'S  general comments indicated a concern that this case study is not
                          an accurate representation of the way the medical device reporting reg-
                          ulation is implemented by most device manufacturers and that its find-
                          ings cannot be generalized to the program as a whole. We agree that the
                          case does not by itself support generalizations about the implementation
                          of the medical device reporting regulation. The general statements in the
                          report about the implementation of the medical device reporting regula-
                          tion and its associated compliance inspection program are based on our
                          earlier, general study of these issues. The case does, however, illustrate
                          the principal findings of that report regarding compliance with the med-
                          ical device reporting regulation. HHS'S comments, along with our detailed
                          responses, are reproduced in appendix IV.

                          HHS  also provided technical comments on the report. We reviewed them
                          and made changes in the report as appropriate. In one technical com-
                          ment worth noting, HHS agreed with our opinion in appendix III,
                          acknowledging that FDA'S Center for Devices and Radiological Health
                          made an error in allowing Aequitron to condition its reporting of com-
                          plaints on the confirmation or observation of a malfunction. HHS stated
                          that the firm was notified of the correct interpretation at the time of the
                          inspection referred to above.


                          This review was a follow-up to our earlier general overview of FDA'S
Objective, Scope, and     implementation of the medical devices reporting regulation. The objec-
Methodology               tive of this study was to conduct a case study of medical device problem
                          reporting and FDA act,ions related to the Aequitron Medical, Inc., Model



                          Page 13                GAO/PEMKNC-17   Underreporting   Home Apnea Monitor   Problems
Page 15
Contents




Abbreviations

FDA        Food and Drug Administration
GAO        General Accounting Office
GMP        Good Manufacturing Practices
1111s      Department of Health and Human Services
HID        Hazard, Injury, Death


Page 17               GAO/PEMD-SO.17   Underrepmting   Home Apnea Monitor   Problems
                                   Appendix    I
                                   H/I/Death       Pile




Number       Serial number            Date Reason/return                                           Analysis
40                  110139            12/86 Checkout only-death                                    Dewce rn-spec
41                  204165            12/86 Checkout death-no-alarm                                Devrce In-spec       .__~_
42                  108272             l/87 Checkout only-death                                    Devrce rn-spec
43                  204768             l/87 Checkout only~death                                    Devrce rn-spec
44                   54319             1187 Checkout o&death                                       Devrce In-soec
         -
45                  101216             4/87 Checkout only~death                                    Devrce In-spec
46                  110870             4187 Checkout death-no alarm                                Devrce in-soec
47                  108197             4/87 Checkout only-death                                    Devrce In-spec
48                  105515             6/87 Checkout only~death                                    Devrce in-spec
49                   63510             6/87 Checkout only-death                                    Device In-spec
50                   54121             8/87 Checkout only-death                                    Devrce rn-spec
51                  106034             6/87 No 10 set apnea alarm                                  Dewce rn-spec
52                  202394            lo/87 Checkout only-death                                    Devrce In-spec
53                   60184            lo/87 Checkout death-no apnea alarm                          Devrce In-spec
54                   66740            12/87h~o~nly-death-                                          Devrce In-spec
55                  110447            12/87 Checkout only-death                                    Dewce In-spec
____
56                   63934              l/88 Checkout-death-no alarm                               Devrce fully functconal
57                  111579              7/88 Checkout death                                        No other details avail
                      __-
58                  104348              S/88 Checkout only-death                                   Devrce rn-spec
59                  103552              l/88 Checkout only~death                                   Devrce In-spec
60                   50657              1i88 Checkout onlv-death                                   Device In-scec
61                  204894              l/88 Checkout only~death                 .__-_-~___        Device rn spec
62                  104635              l/88 Checkout only-death                                   Devrce in-spec
63                    52877             2/88 Checkout only~death-                                  Dewce In-spec
64                  201228              3/88 Checkout only-death                                   Dewce fully functronal
                                                                                                                    -.__
65                    66086             3188 Checkout death-no audible alarm                       Devrce In-sbec
66                    62873             3/88 Checkout only-death                                   Devrce In-spec
67                    50903             3/88 Checkout onlvdeath                                    Device rn-scec
68                    54569             3/88 Checkout death-no alarm                               Devrce fully functronal_-
69                  250197              4/88 Checkout only-death                                   Device rn-spec
70                  205002               l/88 Checkout only-no apnea alarm                          Devrce rn-spec
71                  108359               l/88 Checkout only~no brady alarm                          Devtce fully functronal
72                  250215    -L
                                        6/88.-~_.
                                                  Checkout onlv-death                               Device In-saec
73                  202134              6/88 Checkout death-no alarm                                Devrce rn-spec
74                  205881              8/87 Checkout only-death                                    Devrce crave constant_- al
75                  110094              6/88 Checkout only-death                                    Device not recerved
76                  201785              5/88 Checkout only-no alarm                                 Device not received
77                    66250            11/88 Checkout onlv-death -                             ~___ Devrce rn-soec
78                  201785             1 l/88 No apnea alarm-pt Ok                                  Devrce In-spec
79                    51130              l/69 Checkout only-death not rn use                        Dewce In-spec
80                   109126            1 l/f38 Checkout no audible alarm
                                                                               -~.__          ~   -~ -~ In-spec
                                                                                                    Devrce
                                                                                                                         (contrnued)



                                    Page 19
Appendix 11

Chronology of Contacts Between FDA
and Aequitron

                    This chronology has been adapted from one supplied to us by FDA'S
                    Center for Devices and Radiological Health during our data collection.
                    We did not use every entry we were given but selected items from the
                    original chronology that were germane to the subject of this report.


August 18,1984      $71~conducted a GMPinspection of the manufacturer, covering the manu-
                    facturing of Model 8200. No significant deviations were noted.


December 19,1984    FDA  conducted a limited inspection of the manufacturer in response to a
                    complaint of the failure of Model 8200 to sound its alarm and a device
                    distributor’s complaint of overheating wires in the monitor. After
                    10,000 units were distributed, the manufacturer received 91 units
                    returned with burned wires as well as 17 returned with problems relat-
                    ing to the alarm.

                    FDA  inspected the device distributor to follow up on a complaint about a
                    Model 8200 monitor that delayed in sounding its alarm, although the
                    light came on. Follow-up revealed that Model 8200 was designed with a
                    6-second delay. The distributor had approval from the manufacturer to
                    eliminate the delay by replacing the switch if the customer so requested.
                    During this inspection, the distributor identified a problem with “burn
                    out” or “melting” wires with 6 of approximately 300-350 units.

                    The manufacturer had repeatedly attributed the problem with the
                    burned wires to user intervention and not design. However, an indepen-
                    dent engineering firm hired by the distributor believed the problem was
                    design-related. The distributor was not aware of any serious injuries or
                    deaths relating to “burn out,” and the manufacturer disputed the find-
                    ings of the engineering firm.

                                           -
December 28, 1984   FDA conducted a limited inspection of the device distributor to collect
                    recall data on 30 Model 8200 monitors that the distributor had replaced
                    in home visits and to collect a failed unit for laboratory analysis.


January 4,1985      An FDAdistrict office submitted a recall recommendation to FDA’SCenter
                    for Devices and Radiological Health for the 30 Model 8200 monitors that
                    the device distributor had replaced. The recommendation noted that
                    there was much confusion regarding the “burn out” problem and specifi-
                    cally requested a technical evaluation concerning the validity of the


                    Page 21                GAO ‘PEMD-90-17   Underreporting   Home Apnea Monitor   Problems
                   Appendix n
                   Chronology of Contacts    Between    FDA
                   and Aequitron




                   that the action constituted a “Safety Alert” and that FDA testing con-
                   firmed the information presented by the manufacturer. The manufac-
                   turer agreed to submit a 510(k) application to add a circuit breaker to
                   the device to resolve the “burn out” problem.


June 25,1985       The manufacturer sent. a letter to the distributors informing them about
                   the “burn out” problem.


July 25, 1985      FDA    classified the manufacturer’s             .June 25 letter as a “Safety Alert.”


August 7,1985      In its Weekly Enforcement Report,                  FDA     published information on the
                   manufacturer’s “Safety Alert.”


December 26,1985   The manufacturer sent a letter to FDA that requested a “Certificate of
                   Export” for five models of monitors of various kinds, including Aequi-
                   tron’s Model 8200.


February 3,1986    FDAsent a letter to the manufacturer approving the export of four of the
                   monitors but denying the manufacturer’s December 26 request to export
                   Model 8200.


February 11,1986   Responding to FDA'S denial of a request for export, the manufacturer
                   claimed it was in compliance and requested that the export of Model
                   8200 be approved.


March 4, 1986       FDA   approved the export of Model 8200.


January 27,1987     FDA  conducted a GM? inspection and reviewed all injury and death com-
                    plaints received by t,hc manufacturer since 1985. FDA'S inspector ques-
                    tioned whether two of the complaints on the Model 8200 monitor should
                    have been reported under the medical device reporting regulation.’


                    ‘This inspection was not m~-lr~Ivd m t hc chronology    provide by FDA but was documented m a sepa-
                    rat? mspctction report




                    Page 23                         GAO/PEMD-SO-17         Underreporting   Home Apnea Monitor   Problems
                    Appendix II
                    Chronology    of Contacts   Between   FDA
                    and Aequitron




                    adverse-findings letter be issued for the manufacturer’s failure to sub-
                    mit 10 medical device reporting regulation reports for Model 8200.


May 20,1988         FDA conducted an inspection in response to an anonymous letter alleging
                    that six Model 9216 apnea monitors, intended for hospital use, had
                    caught fire. The inspection confirmed that the failure resulted from a
                    transistor that had been used in a circuit application outside its electri-
                    cal specifications.


June 6,1988         The manufacturer wrote to inform FDA that it had instituted a field
                    replacement program and a labeling change for all the Model 9216 hos-
                    pital apnea monitors.


June 15,1988        FDA    visited the manufacturer and collected recall data.


July 18,1988        FDA  classified the manufacturer’s field replacement and labeling change
                     for Model 9216 as a Class II recall.


October 18,1988      In response to the deficiencies in medical device reporting found in the
                     May 1988 inspection, FDA issued a notice-of-adverse-findings letter to
                     the manufacturer. FDA also conducted an inspection of the manufacturer
                     in response to five complaints received by FDA on Model 8200.2


December 28, 1988    The manufacturer responded to the October 1988 notice-of-adverse-
                     findings letter, stating that it would change its reporting policies and
                     practices.


June 22,1989         FDA  notified the manufacturer by letter that it appeared to have ade-
                     quately addressed the concerns listed in October 1988 notice-of-adverse-
                     findings letter and that a review of the manufacturer’s revised medical
                     device reporting regulation policy found that the reporting guidelines
                     appeared to be adequate.


                     ‘This inspection was not included in the chronology    provided   by FDA but was documented in a sepa-
                     rate inspection report.




                     Page 25                          GAO/PEMB9&17         Underreporting    Home Apnea Monitor    Problems
Appendix III
Our Analysis of Aequitron’s   Medical   Device
Reporting Criteria




a manufacturer receives or becomes aware of information from a
layperson that its device may have caused or contributed to serious
injury or death, the medical device reporting regulation requires the
manufacturer to determine whether the information “reasonably sug-
gests” a link between the operation of the device and the injury or
death. Information from a layperson reasonably suggests the link if a
reasonable person would reach that conclusion. Thus, if a reasonable
person would conclude that the device may have caused or contributed
to serious injury or death, a report must be made.

The regulation does not require, expressly or by implication, that a mal-
function need occur or be suspected in order for a reasonable person to
conclude that the device is implicated in serious injury or death. A rea-
sonable person may conclude that the device may in some way have
caused or contributed to serious injury or death, thus necessitating a
report by the manufacturer, even when serious injury or death is attrib-
utable to user error, poor maintenance, or the use of the device beyond
its useful life.

 FDA'Srationale for this approach is explained in guidance accompanying
 the publication of the final regulation in the Federal Register:

 “One comment asserts that a death or serious injury should not be required to be
 reported unless it is associated with or related to a device malfunction.

 “FDA disagrees with the comment. A device that performs to its specifications or
 otherwise performs as intended does not ‘malfunction’ as defined in the final rule.
 However, because of flaws m its labeling or because of user error    , such a device
 could cause or contribute to a serious injury or death.




 “In this context, the phrase ‘contribute to’ means to play a part in the serious injury
 or death.” (49 Fed. Reg. 36.330 (1984); see also 49 Fed. Reg. 36,338 (1984))

 FDA believes that it needs to be notified of deaths resulting from user
 error and problem labeling because these could indicate the need for
 educational programs, user notification, voluntary recalls, or corrective
 labeling to prevent future deaths or serious injuries. (49 Fed. Reg.
 36,331.332, 36,339 (1984))




  Page 27                       GAO/PEMD-90-17   Underreporting   Home Apnea Monitor   Problems
Appendix JII
Our Analysis of Aequitron’s   Medical   Device
Reporting Criteria




a report to FLIAwould be required if the information given to the com-
pany suggests to a reasonable person that a recurrence of a malfunction
would likely cause or contribute to a future serious injury or death. In
the second, the per se rule would require a report. As explained above,
neither confirmation nor observation of a malfunction is required before
a company may be required to report to FDA.




 Page 29                       GAO/PEMD-9017     Underreporting   Home Apnea Monitor   Pmblems
        Appendix IV
        Comments From the Department            of Health
        and Human Services




                                                                                                                      -


       COMMENTS OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
     ON THE GENERAL ACCOUNTING OFFICE (GAO) DRAFT REPORT ENTITLED
     "MEDICAL DEVICES:   UNDERREPORTING OF SERIOUSl9PgROOBLBNSWITH A
                  HOME APNEA MONITOR,"  MARCH 9,


Although    we agree  that    implementation       of the Medical       Devices
Reporting     (MDR) Regulations      has been slower          than we would like
and the regulations      are subject       to interpretation,         we disagree
with    the following   conclusions       of the draft        report.

1.      Although       the report         states        that     the study         design        precludes
        generalization            to the medical             devices         industry,        it
        proceeds       to make statements                  such as "...there              are
        persistent         differences           in the interpretation                   of the
        medical      device       reporting          requirements,..."               and "...we           have
        received       additional         information            from several            sources        which
        suggested        that     problem        underreporting              does occur          and that
        it is not adequately                 identified          through         FDA's inspection
        program."          We believe          these       and similar           generalizations
        without      apparent        foundation            should     be deleted           or
        sufficient         data should           be presented            to substantiate              the
        allegations          and allow         the Food and Drug Administration
         (FDA) to evaluate             their       validity        in the context             of the
        overall      MDR program          and competing              priorities.

         We believe          that     the case study             of apnea monitors                 is not an
         accurate        representation            of how MDR is implemented                         by most
         firms      and the report             is skewed,          setting      forth        a worst-
         case scenario            rather       than a balanced              presentation             of NDR
         implementation.                The report         characterizes             implementation
         of MDR as "flawed"                 based upon this              one case.           Yet,      FDA has
         received        thousands          of reports         from other          firms       that      have
         led to regulatory                actions       such as recalls,                seizures,         and
         injunctions,           as well        as safety         alerts,       bulletins           and even
         withdrawals           of premarket           applications            (PNA) and premarket
         notifications             (510(k)).         MDR is primarily                 intended         to
         elicit       reporting         from health          care professionals                  who
         generally          are in a position              to observe          product         performance
         first      hand and be able              to appropriately               assess        the
         reportability            of an event.             Unlike        most other          devices,
         however,        apnea monitors             are prescription               devices          used in
         home care settings                 where health           care professionals                  are
         unlikely         to observe          use failures           and problems            first-hand.
         Many reports            are,     therefore,         made by nonprofessionals.
         Evaluation           of data on apnea monitors                     both by the
         manufacturer            and FDA is,          therefore,           more complicated                than
          for most other             devices.

 2.      The report        faults   FDA inspection                   strategy     for failing      to
         identify     serious     problems    and              for     failing   to recognize
         that     the firm was misinterpreting                         the regulations,       thus
         resulting       in underreporting.




         Page 31                             (;AO/PEMD-90.17UnderreportingHomeApnea                     MonitorProblems
             AppendixIV
             CommentsFromtheDepartmentofHealth
             andHumanServices




                                                                                                 3


incorrectly          created       a presumption         against     reporting      unless      an
event      was confirmed.             However,       the preamble       to the NDR
regulation         indicates        that    while      mere allegation         is
insufficient,            confirmation        is unnecessary.            Aequitron's
criteria        were also worded so as to make the time frames                             work
against       reporting.           In fact,       the presumption         should    be to
report       unless      testing      shows, within          the time     frames,     that    there
is no reasonable               suggestion      there      has been a malfunction.

GAO also      correctly        notes    that     the Aequitron         criteria     Suggest
that    a health       care professional            must    observe      a malfunction
before     he/she      reports     it    (unless      tests    confirm       the
malfunction).            However,     the rule        that   an event        is per se
reportable       is invoked        when the health           care professional          reoorts
the malfunction           even if he/she           has not observed            it.

It should      also   be noted   that     in its   response      to FDA's
Inspectional        Observations     (Form FDA-483)        given    to the             firm    at
the conclusion        of a full    GNP inspection        from September                 1989
through      November     1989, Aequitron      changed     its   policy.               Aequitron
stated:
                       "At this  point,     Aequitron       wishes      to advise      FDA that
                      the company has elected           voluntarily        to report        a
                      incidents   of death      or serious         injury    that    the company
                      becomes aware of as NDR events                 to FDA whether
                       justified  or not.        . . . This action         was taken        by
                      Aequitron   voluntarily         to avoid       any debate      pertaining
                      to an appropriate        construction          and interpretation         of
                      the NDR regulation."

This         action by Aequitron         was precipitated              by FDA's Minneapolis
District’s        discovery       of Aequitron's           error       in interpretation            of
the NDR as stated             in their       reporting       criteria.          As a result         of
Aequitron's         change      in policy,       the firm        has been submitting
significantly          more NDR reports             than had previously              been the
case.        FDA will      continue       its normal       postmarket         surveillance
efforts        of reviewing        every     NDR report        that      is submitted      and
determining         reporting       rates.        If a significant            fluctuation        from
the normal        reporting        occurs,      FDA will       follow       up to determine
the cause.          By following          these     procedures          FDA will     be able     to
immediately         determine        if the firm deviates                from the course         of
action       it had committed           to follow.

Finally,      it should     be noted   that   in the Fiscal    Year 1991                      budget
proposal      the Administration       has requested     an increase  of                      eight
full     time   equivalents      and $600,000    for the NDR program.

Our      comments          on the    recommendations        are   as follows.




              page33                         GAO/PEMD-L)O-l7Underreportin~HomeApneaMonitorProblems
                   Appendix IV
                   Comments From the Department       of Health
                   and Human Services




                   The following are       GAO'S    comments on the         HHS   April 27, 1990, letter

                   IIHSprovided three types of comments on our report-general     com-
                   ments, comments on our recommendations, and technical comments. Our
                   responses to the first two are contained in this appendix. We have
                   responded to the technical comments by revising the body of the report
                   as appropriate.


                        agreed with our recommendation that a comprehensive good manu-
Comments on        HHS
                   facturing practices and medical device reporting regulation compliance
Recommendations    inspection of Aequitron Medical, Inc., giving special attention to all com-
                   plaints listed in the HID file should be conducted. A full GMP inspection,
                   including a determination of medical device reporting regulation compli-
                   ance of Aequitron was conducted in December 1989, after we completed
                   our fieldwork. The agency is currently evaluating the results of this
                   inspection to determine what, if any, regulatory action is warranted.

                   HHS  also concurred with our recommendation to review its medical
                   device reporting regulation and its guidance to device manufacturers on
                   problem reporting for clarity and effectiveness and to consider develop-
                   ing specific guidance for the manufacturers of devices such as apnea
                   monitors for which determining reportability is thought to present spe-
                   cial difficulties. HHS stated that FDA has established a medical device
                   reporting regulation study group to analyze the medical device reporting
                   program and regulation, identify problems, and recommend solutions.
                   ISIS expects that this study group will complete its work later this fiscal
                   year.


                   We agree that our case study does not by itself indicate how the medical
General Comments   device reporting regulation is implemented by most firms. We have
                   stated in the report that this case illustrates some of the concerns that
                   we identified in our earlier study of the implementation of the medical
                   device reporting regulation.’ This earlier report was based on the more
                   than 50,000 medical device problem reports received during the first 3
                   years of the regulation’s implementation, as well as the results of com-
                   pliance inspections on 575 manufacturing establishments. It also
                   reviewed FDA'S report-processing and data-handling procedures and
                   included analyses of regulatory actions and other initiatives FDA took on

                   ‘Se? 11,s. General Accounting Officr, Medical Devices: FDA’s Implementation of the Medical Dcwre
                   litwtting   Regulation. GAOPEMD-89-10      (Washington, D.C : February 1989). p. 4.




                   Page 35                         GAO/PEMD-90-17    Underreporting   Home Apnea Monitor     Problems
Appendix IV
Comments From the Department   of Health
and Human SeWiCeS




 first years of the program’s operations. The point here is that manufac-
turers are obliged by regulation to review problem reports and make
judgments about whether the events described warrant a report to FDA.




Page 37                    GAO,‘PEMD-90-17   Underreporting   Home Apnea Monitor   Problems
Page 39   GAO/PEtdD99.17   Undemporting   Home A9nea Monitor   Problent,
..




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Related GAO Products


              Medical Devices: Early Warning of Problems Is Hampered by Severe
              Underreporting, GAOIPEMD-87-l. Washington, D.C.: December 1986.

              “Medical Devices: Early Warning of Problems Is Hampered by Severe
              Underreporting,” statement of Eleanor Chelimsky, GAO/T-PEMD-87-4.
              Washington, D.C.: May 1987.

              Medical Devices: FDA'S Forecasts of Problem Reports and FTEs Under
              H.R. 4640, GAO/PEMD-88-30. Washington, D.C.: July 1988.

              Medical Devices: FDA'S Implementation of the Medical Device Reporting
              Regulation, GAO/PEMDRR-10. Washington, DC.: February 1989.

              Medical Device Recalls: An Overview and Analysis 1983-88, GAO/
              PEMD-89.15BR. Washington, DC.: August 1989.

              Medical Device Recalls: Examination of Selected Cases, GAO/PEMD-90-6.
              Washington, DC.: October 1989.

              “Medical Devices: The Public Health at Risk,” statement of the Comp-
              troller General, GAO:/T-PEMD-90-z. Washington, D.C.: November 1989.

              “Medical Devices: IJnderreporting of Problems, Backlogged Systems, and
              Weak Statutory Support,” statement of Eleanor Chelimsky, GAO/T-
              PEMD-90-3. Washington, D.C.: November 1989.




(973293)      page40                GAO/PEMDSO-l7UnderreportingHomeApneaMonitorProblems
Major Contributors to This Report


                        Gerald L. Dillingham, Assistant Director
Program Evaluation      L. Joseph Sonnefeld, Evaluator
and Methodology         Elaine L. Vaurio, Evaluator
Division

                        Julian P. Klazkin, Attorney
Office of the General
Counsel




                         Page 38                GAO/PEMD-90.17Underreporting Home Apnea Monitor Pmblems
Appendix IV
Comments From the Department   of Health
and Human Services




the basis of medical device problem reports. It is our earlier report that
forms the basis for general statements about the implementation of the
regulation and its associated compliance inspection program. The pre-
sent report’s conclusion is only that the evidence in the Aequitron case
was consistent with the findings of our earlier work.

In addition, we did not find support in the text or preamble of the medi-
cal device reporting regulation or in associated guidance for HHS'S state-
ment that the medical device reporting regulation is primarily intended
to elicit reporting from health care professionals. The regulation is
focused on the reporting responsibilities of device manufacturers who
learn of potentially serious problems associated with the use of their
product, regardless of the source of information. In the report, we have
acknowledged that the determination that a complaint is reportable may
be more difficult for home apnea monitors than for some other devices,
in part because many reports of problems with home monitors are
received from laypersons as opposed to health care professionals.

The report does not fault FDA'S inspection strategy, although we agree
that it would have been desirable to conduct the first Aequitron compli-
ance inspection earlier than 2 years after the promulgation of the regu-
lation. We agree that the inspection scheduling strategy appears
reasonable. It is only the effectiveness of the inspection program in
establishing and resolving the problem with the firm’s reporting criteria,
despite the more-frequent-than-normal inspections, that the report calls
into question.

The remainder of nns’s general comments review the manufacturer’s
compliance history and FDA'S actions in more detail but are not inconsis-
tent with our report. ~11sdoes give a quotation from Aequitron’s
response to the “Inspectional Observations” given to the firm at the con-
clusion of the GMP and medical device reporting regulation compliance
inspection conducted between September and November 1989. In this
response, Aequitron stated that it planned to submit reports on all inci-
dents involving serious injury or deaths that the company becomes
aware of. This response was not available to us during the period of our
data collection, but we are concerned that this reporting policy may not
represent a satisfactory general solution to the interpretation of medical
device reporting regulation requirements in the case of home apnea
monitors. Rather, it could tend to contribute to the problem of “overre-
porting” identified during our earlier review. This problem appeared to
affect FDA'S ability to handle the volume of reports submitted during the



Page 36                    GAO/PEMD-90-17   Underreporting   Home Apnea Monitor   Problems
         AppendkIV
         Comments From the Department       of Health
         and HnmanSen-ifes




                                                                                                  4


GAO Recommendation

We reconrmend that   FDA take the following                        actions     to improve   the
effectiveness    of medical   device    problem                  reporting       and to ensure
the overall   safety  and effectiveness        of                medical      devices.

1.         Conduct    a comprehensive         good manufacturing           practices   (GWP)
           and    medical    device   reporting       regulation        compliance
           inspection      of Aequitron       Medical      Incorporated,        giving
           special    attention     to e        complaints       listed     in the HID
           file.

HIi.      Comment
In December       1989 FDA completed       a full     GWP inspection       that
included      the WDR compliance      status      of Aequitron     Medical
Incorporated.         The results   of the inspection          are currently
under review       in FDA.    We, therefore,        do not believe      another
such inspection        is warranted     at this     time.

GAO Recommendation

2.         Review       its medical       device      reporting    regulation        and its
           guidance        to device      manufacturers         on problem     reporting     for
           clarity        and effectiveness;            and consider     developing
           specific        guidance     for    the manufacturers         of any devices,
           such as apnea monitors,                for    which determining
           reportability          is thought        to present     special     difficulties.

 fitiS    Comments

 We concur.           FDA has established                an WDR study          group to analyze
 the WDR program            and regulation,              identify       problems       and recommend
 solutions.           This group has been working                      on the WDR and plans            to
 have its       study      completed         later     this     fiscal     year.       The concept
 of developing           specific         guidance       for certain         industries,
 devices,       etc.,      has been discussed               by the CDRH and is part                 of
  this    study    group's        objectives.             In addition,         a new guidance
 document       for device          firms      has been drafted            and is currently
  under review         in FDA.          It should         be noted,       however,       that    the MDR
  regulation        covers      some 1,700 categories                  of devices        and
  30,000     - 40,000        individual          devices.          It would be virtually
  impossible        for FDA to craft               language        that would inform            a firm
  about     every     event     that      the Agency would want reported                      for each
  device     and/or       every     generic        category.




 (Additional           technical      comments     were provided          and have       been
incorporated,             where    anpropciats,       throughout        the reQ0Kt.j




         Page34                         GAO/PEMD-SO-17Underreporting            HomeApneaMonitar            Problems
        Appendix IV
        Comments From the Department            of Health
        and Human Services




                                                                                                        2

       PDA agrees       with      GAO that      it took longer        than we would have
       liked    to reach        full     implementation        of the MDR regulation.
       The first       of these        inspections       of Aequitron      did not occur
       until     1987, at which            time all     complaints      in the "H/I/Death
       File"     (HID)    file      were evaluated         for compliance.      The
       inspectional          program       appears    to have been successful          in
       uncovering       violations.

       Moreover,         under normal           circumstances,            FDA would have
       inspected         Aequitron       biennially.             However,         because       of
       problems       with     the firm,          FDA has visited            the firm at least
       ten times         in the last          6 years.         A great       deal of regulatory
       activity        occurred       with      this     firm    as a result            of those
       inspections          including         recalls,        safety      alerts,         etc.      It was
       during     one of these            inspections          that     the MDR problems                 were
       discovered          and appropriate             recall      action       initiated.            It
       should      also     be noted        that     the Aequitron           WDR policy           in
       effect      at the time         of the 1987 inspection                     appears       to more
       closely       follow       the MDR regulation               as written           than does the
       firm's      later      policy      found during           the May 1988 inspection.
       The firm        was issued         a Notice          of Adverse        Findings         (NAF) as
       a result        of the May 1988 inspection.                        Subsequent
       inspections          have shown that              the firm's         HID complaint             file
       was not always             complete        during      previous        inspections.

       We believe     that    in this       case FDA's inspectional           program
       was reasonable.          We did adopt        an enhanced     program       on
       October     1, 1988.       Districts      are now directed         to conduct                        an
       MDR inspection        during      the course    of every      other     "good
       manufacturing       practices"         (GMP) inspection       unless     certain
       situations     exist,      in which case,        "for   cause"     inspections
       are to be made as needed.

       Also,      the time required             for FDA to identify            the
       underreporting           problem       is not,       in our opinion,        a
       reflection        of failure        of the inspection            strategy.       As
       previously        noted,      this     firm was inspected            at least    twice
       as often        as would be expected               during    the time period        of
       GAO’s      study.     As problems            were identified,         regulatory
       actions       were initiated           that     resulted     in the submission         of
       additional        reports       to FDA and the modification                 of the
       firm's       MDR reporting         criteria.           See above.

The GAO report          correctly     observes      that     Aequitron's         stated
reporting      criteria       were overly      liberal.         As noted       in FDA's
Center     for Devices        and Radiological           Health     (CDRR) guidance
document      "Medical       Device   Reporting        Questions       and Answers,"            a
report     from a layperson,          in contrast         to a report        from a health
care professional,             can be analyzed         to decide       whether       it
reasonably       suggests        that the event        occurred       (p. 19).          Aequitron




         Page 32                            GAO/PEMD-90-17         Underreporting      Home Apnea Monitor        Problems
Appendix

Comments From the Department of Health and
Human Services

Note: GAO comments




                                                                                                                                         -1
supplementing those in the
report text appear at the
end of thts appendix.
                                DEPARTMENTOF       HEALTH    & HUMAN    SERVICES                            O,flce 01 lnSw?ctOlGeneral




                                                                          APR 27lm


                             MS. Eleanor      Chelimsky
                             Assistant      Comptroller       General
                             United    States    General
                                Accounting     Office
                             Washington,      D.C.      20548

                             Dear   Ms.   Chelimsky:

                             Enclosed   are the Department's         comments on your draft         report,
                             "Medical   Devices:      Underreporting      of Serious      Problems    with     a Home
                             Apnea Monitor."        The comments represent          the tentative     position     of
                             the Department      and are subject       to reevaluation       when the final
                             version   of this    report    is received.

                             The Department        appreciates        the opportunity          to     comment    on this
                             draft report       before     its   publication.

                                                                         Sincerely        yours,




                                                                               ector      General

                             Enclosure




                                    Page 30                      GAO/PEMDWl7         Undrrreporting     Home Apnea Monitor       Problems
Appendix III
Our Analysis of Aequitron’s   Medical   Device
Reporting criteria




Second, when a report of a malfunction is received, confirmation of its
existence by the manufacturer is not a precondition for the manufac-
turer’s obligation to report. FDA explains in its published guidance why
the regulations do not permit the manufacturer to refrain from report-
ing merely because it is unable to confirm a malfunction:

“FDA believes that it IS not speculative, inefficwnt, meffective, or uneconomical for
the agency to require the submissmn of information about reportable events before
such events have been confirmed by the manufac%urer or importer.         It would bc
irresponsible for FDA to wait for confirmation of a reportable event by a manufac-
turer or importer bcfow requiring reporting of any information about such went.”
(49 Fed. Reg. 36.330 (September 14, 1984)

Thus, although confirmation of a device malfunction may help a manu-
facturer determine whether its device actually caused or contributed to
serious injury or death. lack of confirmation does not mean that a report
is not required.

Aequitron’s reporting criterion requiring that a health care professional
observe a malfunction before it will report (unless a test by Aequitron
confirms the malfunction) is also inconsistent with the medical device
reporting regulation. When a health care professional notifies a com-
pany that one of its devices may have caused or contributed to serious
injury or death, the company must file a report with FDA. No “reasona-
ble person” analysis need be performed because, under the regulation,
information from a health care professional reasonably suggests “per
se” the required link. thereby triggering the reporting requirement. (49
Fed. Reg. 36,336 (1984)) The company has no discretion in this circum-
stance, even if it cannot confirm a device malfunction or can attribute
the serious injury or death to user error. poor maintenance, or use of the
device beyond its useful life. Nothing in the regulation requires that a
health care professional must have observed a malfunction before the
professional’s report will be accepted as per SCreasonably suggesting
that the device may have caused or contributed to a serious injury or
death.

 Finally, Aequitron’s reporting criteria are also inconsistent with the reg-
 ulation in situations in which the company is made aware of a malfunc-
 tion that did not result, in serious injury or death but that may cause or
 contribute to a future one. Aequitron’s criteria suggest that a report to
 FDA is not required if ( 1) the company cannot confirm a malfunction
 reported to it by a layperson or (2) the company is notified by a health
 care professional who did not observe the malfunction. In the first case,



 Page 28                        GAO/PEMD-W-17    Underreporting   Home Apnea Monitor   Problems
Appendix III

Our Analysis of Aequitron’s Medical Device
Reporting Criteria

               The Aequitron reporting criteria set out the conditions under which it
               must report to FDA when it receives information that one of its devices
               has malfunctioned. It appears that Aequitron’s policy is not to report to
               FDA when someone other than a health care professional notifies the
               company that one of its devices has malfunctioned and may have caused
               or contributed to serious injury or death, unless the company is able to
               confirm a malfunction within a specified time. Additionally, if an initial
               report of a malfunction associated with serious injury or death comes
               from a health care professional, Aequitron’s criteria appear to require
               either that the professional must have observed the malfunction or that
               the malfunction be confirmed before the company reports to FDA.
               Reports of malfunctions not resulting in serious injuries or death, but
               with the possibility of causing either in the future, are handled in simi-
               lar fashion. FDA indicated in a letter to Aequitron that its reporting crite-
               ria appeared to be adequate. We believe these policies are inconsistent
               with FDA'S medical device reporting regulation (21 C.F.R. 803) in several
               respects.

                Under the medical device reporting regulation, a manufacturer must file
                a report with FDA whenever it receives information from a person other
                than a health care professional from which a reasonable person would
                conclude (that is, information that reasonably suggests) or a statement
                from a health care professional concluding that a device (1) may have
                caused or contributed to a serious injury or death or (2) has malfunc-
                tioned and a recurrence of the malfunction would be likely to cause or
                contribute to serious injury or death. (21 C.F.R. 803.3(f), 803.24(a))

                According to Aequitron’s reporting criteria, Aequitron will not report
                under the following circumstances (among others):

                “The reported malfurr~~tion was not observed by a health care professional and the
                reported malfunction vannot be confirmed by testing of the device by adequately
                trained persomwl w11hm reporting time frames as established by the
                regulation.   ”

                Thus, Aequitron’s criteria seem to contemplate that, in order for a
                report to be required, there must have been a report of a malfunction,
                and the malfunction must either have been confirmed by Aequitron or
                have been observed by a health care professional. These criteria appear
                to be inconsistent with the regulation in several respects.

                First, the requirement to report is not limited by the regulation to only
                situations in which a malfunction is reported to the manufacturer. When


                Page 26                   GAO/PEMD9017    Underreporting   Home Apnea Monitor   Problems
                   Appendix II
                   Chronology of Contacts   Lktween   FDA
                   and Aequitron




February 12,1988   The manufacturer requested an export certificate for a second home
                   apnea monitor, Model 9200, plus three other devices.


March 9, 1988      The manufacturer submitted a medical device reporting regulation
                   report indicating that Model 9200 failed to sound its alarm. According to
                   the manufacturer, this was the first failure confirmed by the manufac-
                   turer’s testing. Testing confirmed a lo-percent failure rate in the alarm
                   component. The manufacturer had 24 reported failures of 4,800 units in
                   distribution. The failures were related to a variation in voltage that
                   would be likely to occur only when the monitor is running on its battery.


March 14,1988      The manufacturer notified FDA of a recall of Model 9200, having issued a
                   letter to dealers recommending the following: specified monitors should
                   be used with only a particular model of battery charger and with AC
                   power, the specified units should not be used on battery power only, and
                   the monitor’s audible alarm should be verified daily. The manufacturer
                   advised that an interim solution would be made pending a permanent
                   one. FDA visited the manufacturer to collect data on the recall.


April 4, 1988      FDA classified manufacturer’s    action as a Class I recall, based on a health
                    hazard evaluation determining that the alarm problem presented a high
                    risk. FDA sent a letter to the manufacturer advising that FDA was classi-
                    fying the manufacturer’s action as a Class I recall.


April 6, 1988       FDA disapproved the February 12 export request for Model 9200 but
                    approved export of three other devices noted in its February 12, 1988,
                    request.


April 15, 1988      Following FDA'S March 14 inspection of the manufacturer, FDA sent a
                    notice-of-adverse-findings letter to the manufacturer, noting deficiencies
                    in inventory control.


May 11,1988         FDA conducted a GMI' inspection of the manufacturer,    including a medical
                    device reporting regulation compliance inspection. Six deficiencies were
                    noted on the observation form; the manufacturer promised to correct all
                    the deficiencies. The FLhi district, office recommended that a notice-of-



                    Page 24                       GAO/PEMD90-17   Underreporting   Home Apnea Monitor   Problems
                                                                                                   -
                  Appendix II
                  Chronology  of contact.3   Between   FDA
                  and Aequltmn




                  recall, with an engineer to review the electronics test conclusion and a
                  physician to evaluate the delayed-alarm feature.


January 8,1985    FDA  inspected the manufacturer to follow up on the recall recommenda-
                  tion for Model 8200. The inspection determined that the manufacturer
                  believed that the device distributor had modified the 30 units without
                  approval.


January 29,1985   FDA conducted a limited inspection of the manufacturer    in response to an
                  assignment from the FDA Center for Devices and Radiological Health to
                  collect mechanical and electrical drawings to assist in an analysis of the
                  units and as follow-up to a medical device reporting regulation report on
                  Model 8200. The manufacturer’s analysis revealed the monitor to be
                  performing within specifications. FDA'S inspector recommended routine
                  follow-up.


May 28,1985       The manufacturer submitted 30 medical device reporting regulation
                  reports on Model 8200. All were unrelated to the problem with burned
                  wires. The manufacturer considered all 30 to be random failures. Most
                  monitors were repaired and returned to the customers.


May 31,1985        FDA hand delivered a letter to the manufacturer advising of the results
                   of FDA'S evaluation of the health hazard involved in the “burn out” prob-
                   lem with Model 8200. The letter indicated that the risk to users was high
                   and that there was not enough evidence to show that the problem was
                   limited to the 30 units modified by the distributor. The manufacturer
                   indicated that it would prepare a list of options for dealing with the
                   “burn out” problem and present them to FDA.


June 18,1985       At a meeting between FDA and the manufacturer regarding the May 30
                   health hazard evaluation letter, the manufacturer reasserted that the
                   wire “burn out” problem with Model 8200 occurs not during use but as
                   the device is being set up. The manufacturer indicated that it was going
                   to issue a letter to distributors and that it believed that the letter would
                   constitute a “Safety Alert.” FDA staff concurred with the manufacturer




                   Page 22                         GAO/PEMD9I%17   Underreporting   Home Apnea Monitor   Problema
                         Appendix I
                         H/I/Death File




Number   Serial number     Date Reason/return                                       Analysis
81              206310     IljE8    No alarm/no Ilght-In hospital pt.Ok              Ic u4/cap c5
62              106327       l/69   Checkout only-death/alarmed                      Device in-spec




                         Page 20                        GAO/PEMLWO-17Underreporting HomeApnea Monitor Problems
Appendix I

H/I/Death F’ile



Number             Serial number        Date Reason/return                                      Analvsis
                            50461       l/83    Checkout only~death                             Device in-spec
                                        6/83    Checkout-death-no alarm noted                   Device In-sDec
3                           51048       7183    Checkout o&death                                Device In-soec
4                           52362       8/83    Checkout-death brady alarm                      Device   In-spec
5                           52435       9183    Checkout-death-bradv    alarm                   Device   In-soec
6                           53512       9/83    No apnea alarm-brady alarm (seizure)            Device   In-spec
7                           54078      1l/83    ElectrIcal burn (unfounded)                     Device   In-spec
a                           53360      12/83    Checkout onlv~death                             rhme     I”-S”PC
9                           54441       l/84    No audible alarm (unfounded)                    Device in-spec
10                          51224       2/84    Checkout only death (unit not In use)           Not received
11                          51994       7184    Checkout only death                             Device In-spec
12                --        52944       8/84    Checkout-no apnea alarm                         Device In-spec
13                          52306       8/84    Checkout only-death                             Device In-spec
14                          60034      12/84    No apnea alarm (perlodlc breathing)             Device in-spec
15                          53228      1 l/84   Checkout only~death                             Device In-spec
16                          xxxxx      12/84    Death                                           Device status unknown
17                                     IO/84    Death-no audible alarm                          Device In-snec
18                            64183    1 l/84   Death checkout only                             Device In-spec
19                            54711    12/84    Death-no alarm                                  Device In-spec
20                            64512    12/84    Checkout only-death                             Device In-spec
21                     .-  -101467       l/85   Checkout only-death                             Device In-spec
22                          102224      5/85    Checkout only-death                             Device In-spec
23                          102842      8/85    Checkout only~death                             Device In-spec
24                          101457      8/85    Checkout only-death                             Device In-spec
25                          102748      8/85    No apnea alarm                                  Device In-spec
26                            53881    lo/85    Checkout-death~no alarm                         Device In-spec
27                            54775    lo/85    Checkout only~death                             Device In-spec
28                        ..- 60496    12/85    Checkout-death-no alarm                         Device In-spec
29           .-             106149     12/85    Electrical burn~(unfounded)                     Device In-spec
30                            52701      l/86   Checkout only-deatti                            Device In-spec
31                            65221      l/86   Checkout only~death                             Device i In-spec
32                          65942       2/86    Checkout only~death                             Device In-spec
33                          52950       6/86    Checkout-death-no alarm                         Device In-soec
34                          62944       6/86    Checkout-death (shock/burni                     Device status unknown
35                         201411       7186    Death                                           Device status unknown
36                         101472       7/86    Checkout only-death                             Device fullv functlonal
37                          54267       8/86    Checkout only-death                             Device in-spec
38                --        66150      1i/86    Check&t only-death                              Device In-spec
39                         109286      12/86    Checkout only-death                             Device In-spec
                                                                                                                    (continued)




                                      Page 18                      GAO/PEMD-W-17Underreporting Home Apnea Monitor Problems
Contents


Letter                                                                                                   1

Appendix I                                                                                              18
H/I/Death File
Appendix II                                                                                             21
Chronology of
Contacts Between FDA
and Aequitron
Appendix III                                                                                            26
Our Analysis of
Aequitron’s Medical
Device Reporting
Criteria
Appendix IV                                                                                             30
Comments From the       Comments on Recommendations                                                     36
                                                                                                        36
Department of Health    General
                             Comments
and Human Services
Appendix V                                                                                              38
Major Contributors to   Program Evaluation and Methodology Division                                     38
                        Office of the General Counsel                                                   38
This Report
Related GAO Products                                                                                    40

Table                   Table 1: Complaints and Medical Device Reporting
                            Regulation Reports on Aequitron Medical, Inc., Model
                            8200 Apnea Monitor




                        Page 16              GAO/PUKB9@17   Underreporting   Home Apnea Monitor   Problems
B-237533




8200 home apnea monitor. Our fieldwork was conducted from Septem-
ber 1989 through December 1989.

The information on which this report is based was obtained from multi-
ple sources and required both qualitative and quantitative analysis. We
conducted a selective review of the available technical literature, includ-
ing apnea monitor engineering studies and the National Institutes of
Health consensus report on the status of apnea monitors, in order to
provide ourselves with background for identifying and understanding
the relevant issues.‘?

We systematically reviewed FDA documents, including records of inspec-
tions and regulatory actions related to the device manufacturer, and cor-
respondence between FDA and the device manufacturer. We also
analyzed reports submitted to FDA under the medical device reporting
regulation. To clarify, supplement, and confirm the documentary evi-
dence, we conducted structured interviews with representatives of the
device manufacturer, FDA officials in the Center for Device Radiological
Health, district and regional offices, and other knowledgeable persons.
Our review was conducted in accordance with generally accepted gov-
ernment auditing standards.

We will send copies to the Secretary of Health and Human Services, to
the Director of the Center for Devices and Radiological Health, and upon
request to others who are interested.

If you have any questions or would like additional information, please
call me at (202) 275-1864 or Dr. Michael J. Wargo, Director of Program
Evaluation in Physical Systems Areas, at (202) 275-3092. Other major
contributors to this report are listed in appendix V.

Sincerely yours,




Eleanor Chelimsky
Assistant Comptroller General



“Satwnal   Institutes of Health   Infantile   Apnea and Home Momtoring    (Bethesda, Md.. October 19%).




Page 14                           GAO/PEMD-90-17       Underrepurting    Home Apnea Monitor    Problems
                  B-237533




                  Although FDA has provided all registered device manufacturers with
                  some guidance on reporting requirements in the form of a “questions
                  and answers” document, the example we have presented suggests a
                  potentially serious problem in the manufacturer’s interpretation of the
                  requirements and formulation of a reporting policy based on that inter-
                  pretation, rather than random or isolated failures to report.

                  Our study illustrates the serious consequences that shortcomings in the
                  implementation of the medical devices reporting regulation and subse-
                  quent inspection program can have. In this case, FDA did not have infor-
                  mation on a number of adverse experiences with the device in question
                  when the agency made critical decisions with respect to recalls and
                  other regulatory actions. FDA found that this manufacturer’s interpreta-
                  tion of the reporting requirements differed from the agency’s in ways
                  that put it in noncompliance with the regulation. The compliance inspec-
                  tion program did not identify and resolve these differences for a sub-
                  stantial period of time after the regulation went into effect. During that
                  time, FDA was unable to make valid comparisons of the monitor’s prob-
                  lem rates or trends with those of other, similar monitors made by other
                  manufacturers, thus compromising one of the most important uses for
                  data from the medical devices regulation. It was beyond the scope of our
                  study to conduct an in-depth review of the device manufacturer’s prob-
                   lem reporting policies, but we did analyze certain aspects of the manu-
                   facturer’s revised reporting policy.

                  The design of our study precludes generalizing to other devices or manu-
                  facturers. However, the findings, taken with the findings of our earlier
                  report, raise a concern that the problem-reporting and inspection issues
                  may pertain to a much broader segment of the device manufacturing
                  industry and to the safety and effectiveness of medical devices in gen-
                  eral. Therefore, we believe they are worth further attention by FDA.


Recommendations   We recommend that FDA take the following actions to improve the effec-
                  tiveness of medical device problem reporting and to ensure the overall
                  safety and effectiveness of medical devices.

                  1. Conduct a comprehensive good manufacturing practices and medical
                  device reporting regulation compliance inspection of Aequitron Medical,
                  Inc., giving special attention to all complaints listed in the HID file.

                  2. Review its medical device reporting regulation and its guidance to
                  device manufacturers on problem reporting for clarity and effectiveness


                  Page12                 (;AO/PEMD-9017UnderreportingHomeApneaMonitorProblems
5237533




The time required in this case for FDA to identify the underreporting
problem raises questions about the effectiveness of the agency’s inspec-
tion program and its capacity to identify potentially serious device
problems through monitoring complaints. The inspection strategy is
designed to include special emphasis on firms manufacturing the types
of devices that have demonstrated reportable problems and scheduling
more frequent medical device reporting regulation inspections for those
manufacturers.

Nine of the complaints in the HID file involving alarm problems and the
death of patients are dated before the manufacturer underwent its first
GMP inspection. By the end of the manufacturer’s third year of opera-
tions and before a second FDA inspection, it had received an additional 7
complaints of alarm problems and deaths. According to the device man-
ufacturer, all the complaints that had been received with allegations of
hazards, injuries, or deaths were placed in the appropriate GMP record.
The first GMP inspection, in 1984, found “no significant deviations.” Dur-
ing the second inspection in 1984, in response to a complaint of the mon-
itor’s failure to sound its alarm, FDA noted that the manufacturer had 17
monitors returned for problems with the alarm.

During this time, there were several inspections and other interactions
between the manufacturer and FDA about a variety of problems associ-
ated with various models of apnea monitors. FDA reported that during an
inspection in January 1987, it reviewed all complaints of hazards, inju-
ries, and deaths received since 1985. It was not until a May 1988 inspec-
tion, 4 years after the first GMP inspection, that FDA dealt with the
reportability of complaints about alarms. By that time, FDA had received
a total of 83 medical device reporting regulation reports on the moni-
tor.2L (See table 1.) More than 88 percent of these involved allegations of
an alarm failure, including the death of two patientsY2



 “Many of these reports did not originate m complaints to the manufacturer. Reports must be made
 under the medical device reporting regulation, not only in response to complaints but also whenever a
 manufacturer acquires informatmn from any source that reasonably suggests that one of its devices
 may have caused or contributed to serious 1q~uz-yor death or has malfunctioned in such a way that, if
 the malfunction were to recur. it would be likely to cause or contribute to serious i&y  or death.
 Some of the other sources of such mfonnation include the manufacturers’ own research, testing, or
 servicing of their devices as ~41 as the mcdlcal and scientific literature.

 “‘Of 278 reports submitted by September 1989, consisting of 271 malfunction reports and 7 reports
 of deaths, the manufx~urer’s  tests confirmed that Model 8200 had malfunctioned in 271 of the com-
 plaints. However, Aequitron’s tests did not confirm that the device had malfunctioned in any of the 7
 complaints in which the death of a patient occurred




 Page 10                        GAO/PEMD.90.17      Underrepmting    Home Apnea Monitor     Problems
B237633




part of its GMP inspections. The results of these inspections can lead to
additional actions by the agency.l’l

We found that between August 1984 and June 1989, FDA had various
contacts with Aequitron, including at least eight formal inspections.
Three were GMP inspections, and two of these included the medical
device reporting component. Five were “for cause,” including three that
were initiated in response to complaints FDA had received. One was a
follow-up to a medical device report on Model 8200, and one was a fol-
low-up to an FDA district office’s recommendation to recall Model 8200.
(A selective chronology of contacts between FDA and Aequitron Medical,
Inc., is given in appendix II.)

During a May 1988 GMP inspection, FDA examined the manufacturer’s
complaint records and identified 10 unreported complaints that FDA
inspectors believed met the medical device reporting regulation’s defini-
tions of reportable events. Four of these complaints contained allega-
tions of the death of patients. As a result of this May 1988 inspection, a
notice-of-adverse-findings letter indicating “noncompliance” with the
medical device reporting regulation was issued to the manufacturer in
October 1988.‘;

According to FDA'S inspection report, Aequitron’s complaint records
were reviewed for the previous 15 months (January 1987 through April
1988). However, the earliest of the unreported complaints in the HID file
that FDA cited in its notice-of-adverse-findings letter was dated only 6
months prior to the inspection, in October 1987.

Representatives of the manufacturer stated that FDA'S finding of “non-
compliance” resulted from a difference in the interpretation of the medi-
cal device reporting rcquirrments. According to the manufacturer, many
of the unreported complaints had not been made by health care profes-
sionals and could not be confirmed by the company within the required
reporting time. Therefore. in accordance with its interpretation of the


“‘According to FDA, the mspv&on strategy adopted by the agency will result in a medical device
reporting regulation compliance inswction for every firm manufacturing medium-risk (class II) and
high-risk (clazs III) deviws HTleast NMX ewry 4 years an d incorporating manufacturers of low-risk
(class I) devices less freqwntl!,

 “A notice-of-adverse-findln#s  letter may be sent to a manufacturer when an inspection reveals that a
manufacturer or indwidual is m vwlation of the laws and regulations or when there LSinformation
that an existing condition or prwtw    may lead to a violation if left uncorrected (although the agency
has concluded that the narurc of thv wolation does not require immediate action against the manufac-
turer or indiwdual).




 Page 8                        GAO/PEMD-90-17      Underrrporting    Home Apnea Monitor      Problems
                         R237533




Question 2: Compliance   Did the device manufacturer comply with FDA'S existing problem-report-
                         ing regulations and procedures? FDA'S primary source of information
                         about problems associated with the use of medical devices consists of
                         the manufacturer’s reports generated by the requirements of the medi-
                         cal device reporting regulation (21 C.F.R. 803). This regulation requires
                         that device manufacturers telephone an initial report to FDA on serious
                         injuries and deaths within 5 calendar days, and it requires that this be
                         followed by a more complete written report within 15 working days.
                         Reportable malfunctions that do not involve serious injury or death
                         must be reported within 15 working days of the manufacturer’s receiv-
                         ing the device-problem information. One important source of informa-
                         tion that leads to medical device reports is complaints to the
                         manufacturer, which can be made by health care professionals or other
                         users of devices.LY

                         We compared the 70 complaints that contained the word “death” with
                         FDA'S record of medical device reports and found that 14 complaints
                         were dated before the medical device reporting regulation was promul-
                         gated. The significance of this is that before the regulation was promul-
                         gated, the device manufacturers’ obligations were fulfilled by
                         maintaining general complaint records and making them available to FDA
                         during GMP inspections. We found 56 complaints associated with deaths
                         whose listed dates fell after the medical device reporting regulation was
                         implemented. Only 4 reports in FDA's medical device reporting data base
                         as of September 1989 could be matched with the 56 complaints as hav-
                         ing been reported to FDA in accordance with the provisions of the regula-
                         tion. One additional medical device report on a death associated with
                         Model 8200 was reported to FDA during this time but could not be identi-
                         fied with a specific complaint on the HID file, because the manufacturer
                         had not submitted a serial number with the medical device report. Thus,
                         at, least 5 1 of the 56 complaints of death had not been reported before
                         F~)Abegan to take compliance actions.

                         The information in the HID file alone was not sufficient for us to make a
                         definitive judgment about the reportability of the complaints or to
                         establish causal connections between the device and the safety hazard,
                         injury, or death. The examination of the manufacturer’s complete record
                         for each complaint, which would be necessary for such assessment, was
                         beyond the scope of our review. In a partial review of the complaint
                                                        -
                         ’ ‘Accordmg to the GMI’ regulation. a complaint is a written or oral expression of dissatisfaction
                         wgarding the identRy, quahty. duratnlity, reliability, safety, effectiveness, or performance of a
                         device




                         Page6                              GAO/PE~-SB17UnderreportingHomeApneaMonitorProblems
                            5237633




                            Apnea is a prolonged lack of respiration that can result in low blood
                            oxygen levels, which can lead in turn to brain damage and death. The
                            condition can be induced by a variety of underlying medical disorders.
                            However, premature and low birthweight infants are particularly prone
                            to apnea.

                            Apnea monitors are electronic devices intended to detect episodes of
                            apnea. In a typical device, when either breathing or heart rate falls
                            below set levels or when the device’s electrical leads are improperly
                            attached to a patient, both audible alarms and flashing lights are trlg-
                            gered. Specialized models of apnea monitors are designed for hospital
                            and home use. To avoid lengthy hospital stays, home apnea monitors
                            have been increasingly used in recent years.



Findings

Question 1: Complaints of   How many complaints of the deaths of patients have been associated
Death                       with the Aequitron Medical, Inc., Model 8200 home apnea monitor? We
                            received information through our fraud hotline that there was evidence
                            of serious nonreporting or underreporting of problems associated with
                            Model 8200.’ We were also told that many of the unreported complaints
                            involved the deaths of the patients.

                            FDA'S good manufacturing    practices regulation requires that manufac-
                            turers maintain two types of records regarding the complaints they
                            receive from users about their products.* The first is a general record of
                            all users’ complaints. The second is a record exclusively devoted to com-
                            plaints alleging that hazards to safety, injuries, or deaths are associated
                            with a medical device.

                            Evidence subsequently provided to us included a table labeled “H/I/
                            Death File” (HID file) and identified as users’ complaints related to the


                            ‘This information was simultaneously provided to the staff of the Subcommittee on Health and the
                            Environment of the House Committee on Energy and Commerce.

                            ‘Section 520(f) of the 1938 Federal Food, Drug, and Cosmetic Act, added by the Medical Device
                            Amendments of 1976, authorizes FDA to promulgate regulations that specify practices in the manu-
                            factwe, packaging, storage, and installation of devices. The good manufacturing practices established
                            by the GMP regulation include controls over manufacturing, specifications, processing procedures,
                            device components, packaging, labeling, manufacturing equipment, and records.




                            Page 4                         GAO/PEMINO.17       UnderreportIng    Home Apnea Monitor     Problem
                   E-237533




                   With regard to the first question in the paragraph above, we found that
Results in Brief   Aequitron had received at least 70 complaints that the deaths of
                   patients were associated with the use of the Model 8200 monitor.” With
                   regard to the second question, we found that the manufacturer had
                   maintained the required record of complaints but had not fully complied
                   with the reporting requirements of the medical device reporting regula-
                   tion.’ A partial review of the manufacturer’s complaint record by FDA
                   found that 10 unreported complaints should have been reported, includ-
                   ing 4 that involved the death of patients. We could verify that only 6 of
                   the complaints of deaths dated after the implementation of the medical
                   device reporting regulation were reported to FDA. Two of these com-
                   plaints of death were reported only after FDA compliance actions, nearly
                    1 year after the events.

                   With regard to the third question, we found that when FDA received
                   information about the association of the monitor with deaths, it investi-
                   gated whether a sample of complaints should have been reported to FDA.
                   Following the investigation, FDA cited the device manufacturer for non-
                   compliance with the medical device reporting regulation and, in concert
                   with the manufacturer, reviewed the manufacturer’s problem-reporting
                   policy. FDA then reviewed and approved a revised problem-reporting pol-
                   icy submitted by the manufacturer. These actions resulted in the sub-
                   mission of more than 150 additional reports to FDA.

                   Our case study methodology precludes generalizing from these findings
                   and conclusions to other devices and manufacturers. Instead, the study’s
                   function is to illustrate some of the critical concerns that we identified in
                   our earlier generalized work on the implementation of the medical
                   device reporting regulation. Included there were concerns about the

                    ‘We found that an Acquitron dorument entitled “H/I/Death File” (or “Hazard, Irljury, Death (HID)
                   File”) contained information abstracted from the special section of the record of complaints reserved
                   for hazards to safety. injuries, and deaths that a dewe manufacturer is required to maintain under
                   the good manufacturing practxes (GMP) regulation (21 C.F.K. 820.198). The HID file listed 82 com-
                   plamts. 68 of which referred to deaths. Two additional complaints of death of were contained in a
                   similar list drawn from the “gt~~eral” portion of Aequitron‘s GMP record of complaints. (See appendix
                   1.) According to the manufacturer, the HID file contains complaints alleging that serious ir\juries or
                   deaths were associated wth rh(%dcmrr. hut some of the complaints do not allege that a malfunction
                   of the monitor occurred WV did not independently investigate each complaint on the list to determine
                   the circumstances of tht, evrnts: causal connerrwns between the device and the safety hazard, idjury,
                   or death; or the actual occwwnw     of thr wents listed.

                   ‘The medical deuce reportmy rcgulatlon, cffectwe December 13, 1984, requires that device manufac-
                   turers report to FDA whenrwr they hwomr aware of information that reasonably suggests that one
                   of their devices may hwc causrd or rontnbuted to a serious injury or death or has malfunctioned in
                   such a way that, if the malfunctmn were LU recur, the device would be likely to cause or mntribute to
                   a death or serious in,jwy or drath. Sw Mrdxal Devices for a detaded discussion of the medical device
                   reporting regulation




                    Page 2                         GAO/P&MD-90.17      Underreporting   Home Apnea Monitor      Problems