Medical Device Problem Reporting: A Case Study of a Home Apnea Monitor

Published by the Government Accountability Office on 1990-07-17.

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

   I   .

                   United States General Accounting Oftice        /

iiA0               Testimony


For Release         Medical    Device   Problem Reporting:
on Delivery         A Case    Study   of a Home Apnea Monitor
Expected    at
9:OO a.m . EDT
July   17, 1990

                    Statement     of
                    Carl   E. W isler,   Director     for   Planning
                       and Reporting
                    Program   Evaluation      and   Methodology        Division

                    Before    the
                    Subcommittee     on Health    and the Environment
                    Committee     on Energy   and.Commerce
                    House of Representatives

                                                                        GAO Form Ibu ,i2/87)
 Mr.       Chairman          and Members              of     the      Subcommittee:

            It    is    a pleasure            to      be here              today           to    discuss        some of           the       work

 that       the    General         Accounting                Office              (GAO)          has     done      in     the     area       of

medical           devices.           During           the      last         4 years,              we have            issued       eight

 reports          in    this     area        and      have      presented                    testimony          before           this

 Subcommittee              on two       previous              occasions.                        These      reports         and

testimonies               have     focused            on the          Food            and       Drug    Administration’s
 (FDA’s)          premarketing               review         processes                  for       devices       and device

recalls           and FDA’s          implementation                        of        the     medical        device          reporting


           Medical         devices           include          almost             everything,                other         than      drugs,
that       health-care            professionals                    use          to     diagnose,            treat,         or     prevent
illness,           improve         human       functioning,                      and         support        and        sustain          life.1

More       than        1,700     different             types          of        medical           devices         are      available             in

1Section         201(h)      of the Federal          Food,     Drug,    and Cosmetic           Act of
1938,      as amended by the Medical                   Device     Amendments          of 1976,
defines        “device”        as an instrument,           apparatus,          implement,        machine,
contrivance,            implant,       in vitro      reagent,       or other        similar      or
related       article,         including       any component,          part,      or accessory,
that     is (1) recognized               in the official          National        Formulary       or the
U.S. Pharmacopeia                or any supplement           to them,         (2) intended         for use
in 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 the human body or bodies                   of other        animals      and that
does not achieve              any of its        principal       intended        purposes       through
chemical         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 definition                 of “device”        to include       (1) devices          intended
for use in the diagnosis                    of conditions         other      than disease,          such
as pregnancy,             (2) in vitro        diagnostic        products,        and (3) specific
products         previously         regulated       as new drugs,         including         soft
contact       lenses,        bone cement,        and sutures.

    the      United           States             today.              They       represent                 an industry              of       more        than

    $17 billion                   a year.               FDA is          authorized                   to    regulate             medical            devices

    during           all      phases             of     their          development,                   testing,             production,

    distribution,                    and         use.

                In     February             1989,             we reported               to      this            Subcommittee                that        our

    review           of     the      implementation                      of      the     medical                 device         reporting

    r.egulation              had         found          evidence              that      some          medical             device            '

    manufacturers                    may have                 been      overreporting                      problems             with        devices,

    while        others            either             were       not        reporting                at    all      or     were

    underreporting.2                             In     its      comments              on the             report,          FDA said              that      our

    conclusion               that         the         industry           was         underreporting                       was    "questionable"

    and     that           FDA's         medical              device         reporting                regulation                compliance

    inspection               strategy                 was      sufficient               to     identify                 compliance               problems.

    Since        the        release             of      our      report,             we have              received          additional

    information                   from      several              sources             suggesting                  that      problems              are

    underreported                    and        that          underreporting                    is        not     always         identified

    through            FDA's         inspection                  program.3

                On September                    18,      1989,          you     asked          us to             investigate                a

    citizen's               report          to        GAO of           numerous              unreported                 deaths         of       patients

    2See U.S. General    Accounting   Office,     Medical     Devices:     FDA's
    Implementation    of the Medical    Device    Reporting     Regulation,
    GAO/PEMD-89-10    (Washington,   D.C.:    February     19891,    p. 3.

    3The sources         include      citizen       reports,       device     industry
    publications,          consultation         with    members of our expert              review
    panel,     and review        of individual          recalls       in connection       with    our
    deport      entitled      Medical       Device     Recalls:       Examination       of Selected
    Cases,     GAO/PEMD-90-6           (Washington,          D.C.:    October     1989).

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


           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

may      sometimes                  be reasonably                    expected             to     result                in    a significant

injury        to     the            user.

           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        triggered.                   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.


                  With         the      concurrence                 of      the        Subcommittee                      staff,        we undertook
     a case            study          based       on three                specific             questions:

                  --     How many              complaints                  involving                the      death           of    patients        have

                         been        associated               with          Aequitron’s                    Model          8200       home      apnea


                  --     Did     the       device            manufacturer                    comply               with       FDA’s      existing
                        problem-reporting                           regulations                     and      procedures?

                  --   What          actions           did      FDA take                   when      it      received              information
                       from          the    device            manufacturer                     or         other          sources        that     Model

                       8200          had       been      associated                   with          numerous              deaths?

    In     this        testimony,                I will           concentrate                     on the            findings,

    conclusions,                     and    recommendations                           of     this          case          study.4

               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     overall

    efficacy             of     the        FDA medical                device               reporting                regulation              compliance

    4See U.S. General                          Accounting     Office,                         Medical   Devices:
    Underreporting    of                       Serious    Problems                         With a Home Apnea                          Monitor,
    GAO/P -     -  -                                                                                  .
program             and,     in    particular,                  the         finding                  that      a number              of    FDA

inspections                 had discovered                  instances                      in        which       reportable                serious

injuries             and deaths             had         been      recorded                      in    a manufacturer's                       files           but

not    reported              to    the      agency.               The data                  on which               this        study         is      based

were       collected              between          September                    1989        and         December              1989.

           I will          begin         with      an overview                       of     our         findings              and

conclusions.                   Then,        I will          discuss                  our         findings              with         regard         to

each       of   the         evaluation             questions                    in    greater                detail.


           First,           we found            that      between                January                1983       and January                    1989,

Aequitron             had     received             at     least         70 complaints                           that          the     deaths            of

patients             were      associated                with         the        use        of        the      Model          8200        home       apnea


5We found that             an Aequitron          document         entitled         "H/I/Death          File"
(or "Hazard,           Injury,       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
device     manufacturer            is required         to maintain             under the good
manufadturing            practices        (GMP) regulation               (21 C.F.R.           820.198).
The HID file           listed      82 complaints,            68 of which             referred       to
deaths.        Two additional            complaints          of death          were contained              in a
similar      list      drawn from the "general"                    portion         of Aequitron's              GMP
record     of complaints.               According        to the manufacturer,                    the HID
file    contains         complaints         alleging       that      serious         injuries       or deaths
were associated             with     the device,         but some of the complaints                          do
not allege          that     a malfunction           of the monitor             occurred.           We did
not independently               investigate         each complaint              on the list           to
determine         the circumstances              of the events;              causal       connections
between     the device            and the safety           hazard,         injury,        or death;          or
the actual          occurrence         of the events           listed.

           Second,             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

regulation.6                   A partial               review          of     the      manufacturer's                     complaint

record       by      FDA found              that        10 unreported                    complaints                should            have         been

reported,               including           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          complaints               of        death       were      reported

only      after          FDA compliance                   actions,              nearly          1 year            after       the         events.

          And,       third,          we found             that         when      FDA received                     information                about
the      association                of     the     monitor             with      deaths,             it      investigated

whether          a sample            of     complaints                 should        have        been           reported             to     FDA.

Following            the       investigation,                     FDA cited              the     device            manufacturer                    for

noncompliance                 with        the      medical             device          reporting                regulation                and,      in

concert           with      the      manufacturer,                     reviewed           the        manufacturer's                       problem-

reporting            policy.               FDA then          reviewed               a revised               problem-reporting

policy       submitted               by the         manufacturer                    and        concluded             that       it

6The medical         device    reporting      regulation,         effective       December      13,
1984,     requires      that   device    manufacturers          report      to FDA whenever
they become aware of information                  that      reasonably        suggests     that     one
of their      devices       may have caused       or contributed            to a serious
injury      or death      or has malfunctioned            in such a way that,            if the
malfunction         were to recur,       the device         would be likely         to cause or
contribute        to serious      injury    or death.          See Medical        Devices:       FDA's
Implementation          for a detailed       discussion         of the medical          device
reporting       regulation.

"appeared                adequate."                These             actions                 resulted                   in        the     submission                  of

more       than          150 additional                      reports                 to     FDA.

           In     sum,       our        findings                  with         regard                 to    this         study            of         an apnea

monitor           are      consistent                 with           our         earlier                   finding             of       differences                   in

the      interpretation                    of     medical                  device                reporting                   requirements.7                           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              regulation                   went            into         effect               before             FDA's

inspection               program           identified                      and        attempted                    to        resolve                 the


          In      the      course         of      our             study,            we also                 learned                that         the         parents

and     other        laypersons                 who are                  the        primary                 users            of     home apnea

monitors           are       not     always            adequately                         informed                 about            the         limitations

and      risks       of      these        devices.                       The        current                 technology                    is,         for
example,           unable          to     detect              some             kinds             of        apnea,            and        some monitors

may be overly                 sensitive                to          interference                            from        electronic                     appliances

found       in     the       home or            the          motion             of        other             objects                near         them--for

example,           parents'              bodies              or     fluttering                         window            curtains.                     The

instructions                 and training                     that             accompany                    such         devices                may         not     make

such      limitations                sufficiently                         clear             to         permit           parents                 to     make         well-

7Medical           Devices:               FDA's              Implementation,                                p.     4.
informed           decisions             about      the        risks            of     using           the        devices             or    about

using      them         in      ways     that      minimize               the        risks.

         Let       me now turn                to   a more           detailed                discussion                   of    our         findings

with     regard            to     our    three      specific               evaluation                   questions.

Question           1:        Complaints            of     Death

         Our       first          evaluation            question                was:        How many               complaints                   of         the

deaths       of     patients             were      associated                   with        the        Aequitron               Medical,

Inc.,      Model           8200     home        apnea        monitor?

         We received                information                through               the      GAO hotline                     that         there

was     evidence             of    serious         nonreporting                      or     underreporting                       of        problems

associated              with       Model        8200.8          We were                also        told           that        many         of        the

unreported              complaints              involved            the     deaths                of    the        patients.

         FDA's          "good       manufacturing                   practices"                     regulation                  requires

that     manufacturers                  maintain             two     types             of     records              regarding                the

complaints              they       receive         from        users            about         their           products.9                    The                  '

first      is     a general              record         of     users"            complaints.                       The        second            is         a

record          exclusively              devoted          to       complaints                 alleging               that        hazards                   to

8This  information                      was     simultaneously                       provided                to    the        staff         of        the

9Section      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 manufacture,
packaging,       storage,       and installation          of devices.           The good
manufacturing         practices      established         by the regulation           include
controls      over manufacturing,            specifications,            processing
procedures,       device      components,        packaging,        labeling,      manufacturing
equipment,       and records.

 safety,          injuries,           or     deaths          are         associated               with      a medical               device.

           Evidence           subsequently                  provided            to     us        included          a table           labeled

“H/I/Death               File”       and     identified                  users’        complaints                 related           to    the

Aequitron               Medical,          Inc.,      Model           8200       home        apnea         monitor.             The table

contained               82 complaints               with          four      categories               of     information                  for

each       complaint.10

           We investigated                   the     origin              and    contents             of     the     HID      file         and

we determined                 that     it     was      in     fact         a list           of     complaints               derived

from       the     device          manufacturer’s                   “hazard,            injury,             or     death”           record.
This       is     the     record       required              by     the        GMP regulation.                      The      list

contained               complaints           that      the         device         manufacturer                   had    received

about       its     Model          8200     apnea          monitor             dated        between          January           1983        and

January           1989.11

10See footnote          5 above.         The four     data categories              for each
complaint       were serial        number,       date of complaint,             reason        for
return,     and analysis.            For 71 out of 82 complaints                     listed       on the
HID file,       the “analysis”           category     listed       the device          as “in-spec”
or “fully       functional      .”     It is important           to note with            regard      to the
analysis     category       that     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”             or
“fully    functional.”
llMode1           8200 was introduced        into    the market    in June 1982.
Accyrding            to the manufacturer,         approximately      30,000  of the
monitors           were distributed       between      1982 and 1987, but it is not
possible           to estimate      the number in actual        use or their    frequency
of use.



                      OUK       analysis                  of      th e       H ID file               showed             th a t        it        listed          68

            complaints               in      which              th e       word         “d e a th ”          was included                        in      th e       category

            O f reasons              for         th e          device’s                return           to      th e      m a n u facturer.                         Further

            research            fo u n d         th a t         a similar                 list         drawn            from          th e       m a n u facturer’s

            general            complaint                  record             c o n ta i n e d          2 a d d i tio n a l                 complaints                    in
            which       th e     word            “d e a th ”            w a s included.                        There             were        th e r e fo r e             a    to tal

            of    7 0 complaints                     in         which           th e      allegation                    of       a p a tie n t’s                d e a th        was

            included            in        th e     complaint                   description.12                                The remaining                          14

            complaints               in      th e         HID       file          were           complaints                  th a t        included

            allegations               o f either                    hazards               to      safety             or      injuries.                     (See          ta b l e

            1.      The remainder                         of     th e       ta b l e        is      discussed                    b e l o w .)

T a b l e 1: Complaints a n d Medical Device Reporting Regulation Reports o n Aequitron Medical, inc., M o d e l 8 2 0 0 A p n e a Monitor
                                                                                                  Medical device reporting regulation reports to F D A
                                      Complaints in Acquitron’s files                               B e fore F D A ’s M a y A fter F D A ’s M a y
                              in “H/i/Death File”.- -.In “g--
.-_. I__ .-. _.__ .-.-- _--__-.-.---_--                      e --.
                                                               n e r a.l ” ..--~-
                                                                           file   Total ..-. ._--      1 9 8 8 inspection    1 9 6 6 inspection    Total
  .-        _ .--~.---       -. -              6 8                             2    7 0
                                                   - - _ _ _ .-._.._.__ -_- __-.. -.- _ _ _ _ . _-                        5                      2      7
_ _ _ _ _ _ _ _ _ _. _ _ - --     __-_--        14                           6 6    8 0
                                       _- _ _ _ ._ .._.-_.. - .- - _ _ - -.I__ _-.- --_ -._._-_                         7 8                  1 9 3  2 7 1
Total                                          82                            68    150                                  83                   195’ 278
                                                                ‘1 5 0 of these reports w e r e submItled In r e s p o n s e to F D A c o m p l i a n c e acllons

            Q u e s tio n       2:         Compliance

                      Our       second             evaluation                     q u e s tio n           was:          Did         th e        device
            m a n u facturer               comply               with        F D A ’s        existing                problem-reporting
            regulations               and procedures?

            1 2 T h e m a n u facturer  c o n firm e d th a t    th e s e w e r e complaints     alleging
            th a t a d e a th h a d b e e n associated         with      th e u s e o f th e device.

                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       medical          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                      receiving              the      device-problem                         information.                       One

    important               source             of     information               that         leads           to    medical           device
    problem            reports            is        complaints            to        the      manufacturer,                    which              can     be

    made       by health-care                        professionals                    or     other           users       of      devices.13

               We compared                 the         70 complaints                      that        contained            the      word            “death”

    with       FDA’s         record             of    medical            device            problem            reports            and        found            that

    14 complaints                   were            dated      before           the        medical            device          reporting

    regulation               was promulgated.                           The         significance                  of     this       is           that
    before        the        regulation                 was promulgated,                         the         device        manufacturers’

    obligations                  were      fulfilled                  by maintaining                     general           complaint                    records

    and       making         them        available               to     FDA during                    GMP inspections.                            However,
    we found               56 complaints                    associated               with        deaths           whose          listed             dates

    fell       after         the        medical             device        reporting                   regulation              was -implemented.

    13According         to the GMP regulation,                                        a complaint        is a written                                   or
    oral     expression       of dissatisfaction                                      regarding      the identity,
    quality,      durability,       reliability,                                     safety,    effectiveness,        or
    performance         of a device.
Only        4 reports                      in    FDA’s         medical             device                 reporting            data        base        as       of

September                    1989      could            be confirmed                      as corresponding                           to    complaints

from        the         list          of        56 and,          therefore,                     as having              been          reported            to       FDA

in     accordance                     with            the    provisions                   of        the      regulation.                   One

additional                     medical             device            problem              report            on a death                associated                 with

Model            8200          was         reported            to      FDA during                    this       time         but      could         not         be

identified                     with         a specific                 complaint                 on the          HID         file,         because              the

manufacturer                        had         not     submitted                 a serial                 number           with      the     medical
device            problem              report.                 Thus,         at         least          51 of          the      56 complaints                      of

death            had         not      been            reported             before          FDA began                  to     take         compliance


            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                    record,           FDA found              that         10

unreported                     complaints                   should          have          been         reported,               including               4 that

alleged                the         death         of     patients.14

            It         is      important                to     note         that          not        all      incidents               in     which          a
device            is         associated                 with         the     death             of     a patient               must         necessarily

14A more                detailed                 discussion     of                 this  review   is contained                                    in      the
folloqing                section                 of this    report                   on FDA’S actions.

be     reported                 to          FDA under               the     medical              device             reporting             regulation.

The     regulation                          requires               reporting             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                      professional                    states             to         the

manufacturer                     that              this        has       happened,               then         the        manufacturer                     is

required                to      file              a medical               device         problem              report.15                  But         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

             The        third               question               our     study         addressed                  was:         What          actions                did

FDA take                when           it         received            information                     from     the         device         manufacturer

15According     to the “per se” reporting                 rule,      whenever      a health     care
professional      advises      a manufacturer         that      one of its       devices     may
have caused     or contributed         to a serious           injury     or death,       the
manufacturer      is “per se” in receipt              of information           that
“reasonably     suggests”        that  a device       may have caused            or contributed
to a serious      injury     or death     and must therefore              report      the event.
It does not,      however,       imply   that    similar        reports     from persons        other
than Dealth-care         professionals        are not reportable.

or     other     sources             that     Model        8200         had        been        associated              with         numerous


          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 complaints                   or

other      evidence             of     problems           with         devices.16                FDA assesses                  device

manufacturers'                  compliance             with        the        medical           device          reporting

regulation          by executing                   a special                 medical           device        reporting
inspection          program              as part          of     its         GMP inspections.                        The results               of

these      inspections                 can     lead       to     additional                actions           by      the      agency.lT

          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         problem          report        on Model             8200,           and     one       was a follow-up                    to     an

16A principal        rationale      for “for   cause”     inspections        is
information      developed        by FDA analysts      who monitor       and compare
reports     submitted       through    FDA's voluntary       problem-reporting
program,     device      recalls,     and the medical      device     reporting   system.
17According              to     FDA, the inspection          strategy        adopted   by the agency
will    result           in     a medical     device    reporting        regulation     compliance
inspection             for      every    firm  manufacturing         medium-risk       (class    II)
and high-risk                  (class    111) devices      at least        once every     4 years    and
incorporating                  manufacturers       of low-risk        (class     I) devices    less

FDA     district                office’s          recommendation                          to      recall             Model          8200.

           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                     definitions                   of         reportable                  events.            Four         of

these           complaints              contained              allegations                       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


           Representatives                       of     the     manufacturer                           stated             that       FDA’s         finding

of    “noncompliance”                       resulted            from          a difference                          in     the
interpretation                     of      the    medical           device                    reporting                  requirements.

According             to     the        manufacturer,                   many             of      the      unreported                    complaints

had       not      been      made          by health-care                         professionals                          and     could       not      be

confirmed            by      the        company          within              the         required               reporting                time.

Therefore,             in        accordance              with          its         interpretation                           of    the      “per       se”

provision             of     the        medical          device              reporting                  regulation                   and     company

policy,            Aequitron               did    not         submit              these          types          of        reports.

18A notice-of-adverse-findings                   letter    may be sent to a
manufacturer         when an inspection            reveals    that    a manufacturer      or
individual        is in violation          of the laws and regulations               or when
there      is information         that   an existing       condition     or practice      may
lead    to a violation          if left      uncorrected       (although    the agency has
concluded       that    the nature       of the violation           does not require
immediate       action     against     the manufacturer           or indmdual).

          In    our      earlier           study          of         the         implementation                           of         the     medical

device         reporting           regulation,                       we reported                     that           the         evidence

suggested             an undetermined                     amount                 of     overreporting                           by         some device

manufacturers                and        that      others               were           either             not        reporting                  or

underreporting.19                        The most               frequently                        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

inspections             and      53 percent                    for         the        second             series).20                         We also
encountered             variations                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                 submitted                  medical                device            problem               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.21                          The
19See       Medical          Devices:                  FDA’s           Implementation,                              p.     61.

20See       Medical          Devices:                  FDA’s           Implementation,                              p.     59.
21The manufacturer        and FDA subsequently         agreed                                                        that           4 of         the 10
complaints  cited      in the notice-of-adverse-findings                                                                          letter          were not
reporsable   incidents.




            manufacturer                  also            submitted           144      reports           of   malfunctions                          involving

            confirmed             alarm             failures.22                    Aequitron           thus      submitted                 at        least           150

            medical        device              problem             reports           in      response         to     FDA          compliance

            actions.             (See      table            1.)

                       After         we had               completed           the      data         collection             for          our         report,

            FDA conducted                  a comprehensive                          good      manufacturing                  practices                    and

            medical            device          reporting                regulation              inspection              of        Aequitron.                         FDA

            indicated             when         it      reviewed              our     draft          report       that        it         was         reviewing

            the      results          of       this         inspection                to     determ ine          what        regulatory                        action

            was warranted.

                       Aequitron               also         submitted               a revised            medical           device               reporting

            policy        to      FDA,         and         FDA notified                the     manufacturer                  that             its        revised
            policy        was        adequate.                    However,           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              requirement                on either                     the

            confirmation                  or        the     observation                of      a malfunction.23                          The
            Department               of    Health             and       Human Service                  (HHS)        agreed              with         this

            opinion.              The      agency             acknowledged                   that      the    Center              for      Devices                  and

            *2Apnea    monitor    alarms     meet FDA’s definition        of a “critical       device
            component”--that        is,   any component     of a critical      device    whose
            failure    to perform       can be reasonably      expected     to cause the failure
            of a critical      device     or to affect    its   safety    or effectiveness.

            23Medical             device      problem     reports     of malfunctions     were submitted.
            Malfunction               reports     describe      problems    whose occurrence     was not
            associated              with    the injury       or death    of a patient     but that  may
            result      in        injury      or even death        if they should     recur.

Radiological                    Health                (CDRH)             made an error                           in      allowing                    Aequitron                to
make       its      reporting                    of     complaints                      contingent                      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                we referred                         to        earlier.

           The      time            required                  in        this       case            for         FDA to             identify                   the

underreporting                       problem                  raises              questions                     about         the          effectiveness                       of

the       agency’s              inspection                         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     device                 that         have          demonstrated

reportable                problems                and              scheduling                     more         frequent                 medical                device
reporting                regulation                    inspections                          for         those          manufacturers.

           A number                 of     inspections                         took          place             after          complaints                       of     alarm

failure            had        been         received                     by     the       manufacturer.                                 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

operations                and before                        a second               FDA inspection,                                it       had         received               an

additional                seven            complaints                        of    alarm             problems                 and deaths.

According                to     the        device                  manufacturer,                         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.”                            During


         the      second        inspection                  in     1984,      in      response            to   a complaint                      of    the

         monitor’s          failure            to      sound          its     alarm ,         FDA noted              that         the

         manufacturer             had        17 monitors                    returned          for        problems           with         the         alarm .

                   Subsequently,                there              were      several          inspections               and        other

         interactions             between              the         manufacturer               and FDA about                  a variety                    of

         problems          associated               with           various         models           of    apnea       monitor.                   FDA

         reported          that       during           an inspection                    in    January          1987,         it         reviewed
         all      complaints            of    hazards,                injuries,              and     deaths          received              since

         1985.        It    was not            until             a May 1988             inspection,                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

         monitor.24               (See       table           1.)          More     than       88 percent               of     the        reports
         involved          allegations                 of        an alarm          failure,              including           the         death            of

         two      patients.25

         24Many of these           reports       did not originate             in 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      information         from any source            that
         reasonably       suggests       that     one of its devices              may have caused           or
         contributed        to serious         injury     or 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        injury       or death.         Some
         of the other         sources      of such information             include         the
         manufacturers’          own research,          testing,      or servicing             of their
         devices       as well    as the medical            and scientific           literature.

         250f 278 reports            submitted      by September    1989, consisting      of 271
         malfunction        reports      and 7 reports      of deaths,    the manufacturer’s
         tests     confirmed       that    Model 8200 had malfunctioned          in 271 of the
         complaints.          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.

          FDA did              not         provide               evidence          that        its         inspection                procedures

included              any      systematic                    evaluation               of     trends          in        the      frequency,

type I or             severity                 of    complaints               involving               the         failure             of        alarms

that      were         made          to      the          manufacturer                or     reported              under            the     medical

device          reporting                  regulation.                     There        were         also        no comparisons                         of

overall          complaint                   rates           of     alarm      failures               of     Aequitron’s                        Model

8200      to         those         of      other           monitors.               We believe                 that           the      inclusion              of

these       procedures                    in        the      inspection              program            or       in     the         monitoring               of

medical          device              reporting                   regulation                reports          at     CDRH could                    have

served          to     more         quickly                identify           both          problems             of     underreporting                       and

potentially                  serious                device          problems.

CONCLUDING                  REMARKS

           In        sum,      the         evidence                from     the       current              case        of      an apnea

monitor          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.26                In     this           case,          the     manufacturer’s                     interpretation

resulted              in     undetermined                        underreporting                  of     serious               problems              with      a


          We found                 that         FDA’s             review      of      a sample              of        Aequitron’s                 records

determined                  that        at      least            some complaints                     alleging                that         the     device

26See@ Medical                     Devices:                  FDA’s         Implementation,                        p.     62.

 was       associated                with            hazards            to    safety,           injuries,              or       death        had      not

 been        reported            to       the         agency            because         of      the      manufacturer’s                       incorrect

  interpretation                     of        the        medical            device          reporting              requirements.

             As a result                  of     FDA’s            intervention                  in     this         case        and     the       device

 manufacturer’s                      review               of     its     own records,more                       than        150 additional

 medical           device            problem               reports            were      submitted,                  including               144

 reports           of     device             malfunctions.                          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


             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                interpretation,                        rather          than      random           or       isolated

  failures           to       report.                 We believe                that         device-specific                     guidance             on

 problem           reporting                may be warranted                           for      some         types         of    devices.

             Our     study            illustrates                      the    serious           consequences                    that

* shortcomings                 in      the           implementation                    of     the      medical             devices

  reporting             regulation                    and        subsequent                 inspection              program            can       have.

  In    this       case,         FDA did                  not     have        information                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                        interpretation                       of     the

reporting               requirements               differed                 from         the       agency’s              in     ways        that          put

it     in    noncompliance                 with          the        regulation.                       However,            the        compliance

inspection                program         did      not          identify               and      resolve            these            differences

for       a substantial                 period           of      time        after           the       regulation                   went        into

effect.             During         that         time,          FDA did             not       make          valid        comparisons                    of

the       monitor’s             problem          rates           or     trends            with         those        of        other,            similar

monitors            made        by other           manufacturers,                         thus         compromising                       one    of       the

most        important            uses      for      data            collected                under          the     medical                device

reporting               regulation.

            The     design         of     our      study            precludes                  generalizing                    to    other

devices            or     manufacturers.                       However,                these          findings,               taken         with          our
earlier            findings,            raise           a concern                that          the     problem-reporting                              and
inspection                issues        may pertain                   to     a broader                 segment            of        the     device

manufacturing                   industry           and         to     the        safety              and    effectiveness                       of

medical            devices         in     general.                  Therefore,                  we believe                they            are    worth
further            attention            by FDA.

            That        concludes          my statement,                         Mr.      Chairman.                     I wi 11 be happy
to     respond            to    any     questions                that        you        or      members            of     the

Subcommi           ttee        may have.