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www.AdvaMed.org
Med
Advanced
September29,2004
Medical Technblogy
Association
:
Daniel Schultz,M.D.
Director
Centerfor Devices and $adiological HeaIth
Food and Drug Administption
9200 CorporateBlvd., HFZ-01
Rockville, MD 20850
Re: Adverse Events Ass@ciutedwith ReprocessedSingle Use Devices
Submitted to: Doekeg Mj. ~OBMM~.- Medical Devices; Reprocess&?Si&e-Use
Devices; Terrniraation o~Exemptions.@om Premurket ~0~~~~‘~~ ~e~~~erne~~ for
Submission of Validation Data.
1 Device User Fee and
Dear Dr. Schultz:
On behalf of AdvaMed’,Iweare writing to bring to the attentionof the Agency events
involving actualseriousinjury associatedwith the use of repmcessed,
“singleuse devices.
This is a follow-up to the letter from AdvaMed datedAugust 13 exp‘rrjssingconcernabout
CDRH’s recentdecisionFoextend,by 90 days,the deadlinefor th~d-~~y reprocessorsof
singleusedevices(SUDS)to provide adequateSupplementalValidation Submissionsas
specifiedby Section302’of MDUFMA.
Adverse Events Associated with Repmcessed Devices
An AdvaMed membercdmpanyrecentlyreceiveda report that a reproeessed~heart
positioner
failed during surgery. H&artpositionersare usedto mafupulatethe heartfor accessto vesseis
’AdvaMedis the world’s large&associationrepresentingmanufacturersof medicaldevices,diagnosticproducts,and
medicalinformationsystems,rar&ing from the large&to-thesmallestinnovatorsand companies.AdvaMed’s more than
1,100membersand subsidities manufacturenearly IH)percentof the $75 billion in healthcam teclmologyproducts
purchasedannuallyin the Unite&States,and morethan 30 percentof the $175biion purchasedammallyaroundthe world.
Nearly 70 percentof our membemhave fewer than$30 million in salesannually.
Bringing innovation to patient c;ise worldwide
I...
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1
Docket No. 02iV-0534 M D U F M A
Septem ber29,2004
Page 2 of 4
during beating heart bypassand other cardiacsurgicalprocedures, In the specific case,the
cardiovascularsurgeonout a patient’s heart when the positioner failed to properly hold the
heart during a CABG procedure.The surgeonwas forced to repair the laceration,exposing
the patient to excessivebleeding and a prolonged procedurethat m itself has risks such as
com prom isedhem odynam icsof the heart (leading to patient ins~~~~) and infection. Based
on a conversationwith the surgeon,the com panylearnedthat the positioner had been
reprocessedin such a m annerthat the foam gasketusedon the suction cup to grasp the heart
had decom poseddue to reprocessing.Subsequenttestingby the com panyconfirm ed this
specific failure m ode.
In another case,a reprocessedendoscopicvein harvestingsystemfailed when a piece of
shrink tubing broke free of the device and becam elodgedin a patient’s leg. In this case,the
physicianwas forced to ‘fish’the dislodgedpart out of Re patient’s leg. As in the heart
positioner case,the m alfunction exposedthe patient to excessivebleeding and a prolonged
procedure. Failure analysisof the returned deviceby the-originalequipm entm anufacturer
(OEM) found that the shrink tubing that broke free had deteriorateddue to m ultiple
sterilization cycles.
Theseunfortunateincidentsraise two fundam entalissuesthat m quire careful consideration
by the Agency:
1) In both instances!the hospital contactedthe ~E~-~~er,~~ the reprocessor,as
required by m I9FM A . Basedon thesecases,it appearsthat user,facilitiesdo not
understandthat reprocessorsare consideredm anufacturersand that OEMs are not
responsiblefor a$y perform anceassociatedwith reprocesseddevices;We believe this
speaksto the fact that additionaleducationwithin user facilities is neededon this
subject.
2) Sincethe O E M in thesesituation is not requiredto report the incident per M I3UBM A ,
this can lead to t@der-reportingor non-reportingof the failures associatedwith
reprocesseddevipes.Under-reportingcan lead FDA, hospitals,reprocessorsand the
public to haveinaccurateperceptionsof the safety and efficacy of reprocessed
devices.
Becauseof the public health implicationsassociatedwith the.failure of thesereprocessed
devices,the O E M plans;toprovide additional inform ation to FDA regarding thesecases.
Independent Testing af Reprocessed Heart Stabiiiiem
Two AdvaM edm embercom panieshave engagedin independenttesting of reprocessedheart
stabilizersand positioners.The first firm usedan independent,academ ic
imaging centerto evaluatethe cleanlinessand visible physicalaspeotsof
reprocessedheart stabilizersusing a scie&ically driven protacol, The evaluationis being
conductedat the requestof providerswho questionedwhether or not thesetypes of single use
Docket No. 02W0534 MDUFLMLQ
September 29,2004
Page 3 of 4
only devieescould be effeetively cleanedand sterilizedwithout ~~~~i~g
functionality.
The findings identified that 9 out of 10 reprocessedheart s~b~~~.~on~~
material
contaminationand bio-contamination(ident%& by Syto I6 positive staining). In addition, 6
of 10 reprocesseddeviceshad,somelevel of physicaldefect, with 2 &vices having partially
or totally occludedopeningsin parts of the hypotubeusedto provide sucti&t and which holds
the anastomoticsite stableduring beatingheart surgery. The 10 samplesevaluatedincluded
two different product generationsand samplesfrom both reprocessorswho re-sterilizethese
devices.
The secondmembercompanyalso usedan independenttest housefor their evaluationon the
effects of multiple reprocessingcycleson both heartstabilizersand positioners.Two out of 5
stabilizerswere found to be contaminatedafter one cycle of reprocessing,posing a high
potential risk for infection. Furthermore,thesestabilizersexhibited physiealdefectsafter
multiple cycles of reprocessing.As for positioners,all devices in@udedin the testing
exhibited the inability to properly maintain stabiliiation (suction)with the heart after 3
reprocessingcycles.
Thesedata clearly demonstratethatthe reprocessingofthese single use only deviceswas not
properly validated. As a result, the deviceswere not fully cleanedandexhibited material
degradationand biological contamination. The condition of the’reprocessedheart stabilizers
and positionersbrings into questionthe safetyand functionality of, thesedevices,potentially
puts patientsat risk and suggeststhat healthcareprovidersmay bemisinformed as to the
cleanlinessand equivalencyof reprocessedheart stabilizersand positionersto new devices.
Thesedata arebeing assembled‘forsubmissionto FDA by the OEMsin conjunction with a
requestto removethe exemptionfor heart stabilize& andpositioners.
Delays in Proper Cla@fkat;~on of Heart Stabilizers and P~s~bioncers
Heart stabilizersand positionerscontinueto be categorizedimproperly as exempt devices.
More than a year ago, on August 7,2003, AdvaMed submitteda coast letter to the
MDUIMA docket (#OZN-0534)urging that the “exemptionfor this device be terminatedand
that the FDA immediatelyplacethe deviceon List I,” the critical device list. As noted in our
August 7* letter, FDA appropriatelycategorizedthe device as “critical” accordingto the
Spauldingcriteria but hasfailed to placethe deviceon the critical >devicelist, As a result,
thesedeviceshave continuedto be viewed by reprocessorsas exemptfrom the requirement
to submit validation data. Basedon the-easecited above,aswell as the independentanalysis,
we believe thesedevicesposepotential;harmto patientsandthat FDA should immediately
terminatethe exemptionfrom premarketnotification.
In summary,AdvaMed remainsconcernedthat adverse,events
involving reprocessedsingle
use devicesarebeing underreportedeither due to the generallack of knowledgeof the proper
pathway for reporting sucheventsor the inability of usersto a~p~at~ly identify the
manufacturer(i.e., the reprocessor).AdvaMed believesthat the reprocessingof devices
Docket No. 02AW534 MDUFMA
September 29,2004
Page4 of4
designedfor single useis extremelydifficult and we shall continueto.~closelymonitor the
review resultsof the remaining 80% of the SupplementalV~~tio~ Subtissions for which
EDA has extended,thedeadline. Further,in light of Whigh WE fMot Subst~~Iy
ations have
Equivalent) rate for the SupplementalVahdation Subm@ionsfor wbi~
with
alreadybeenmade,we &e concernedaboutthe real publie healthfisks
As
we
have
seen,
serious
reprocessedsingle,usedevices,suchasthose describedabove,
injury eventsare real and have alreadybegunto occur.
Again, as noted in our August 13* letter to FDA, rep&eessedsingieuse vices &fiatremain
on the marketan additional 90 days,whosevalidation data may ~tim~ly be deemed
unacceptable,and particularly thosewhere.patientinjuries have occurred,may createa
significant risk to patients. For the reasonsdescribedh&rem,we believe this extension
clearly doesnot represemthe best interestsof thosepatients
‘. on wh<umreprocessedsingle use
devicesmay be used.
Respectfully,
d &JdL3s&cc
Tara Federici
AssociateVice President
Technologyand RegulatoryAffairs
cc:
Dan Troy, Esq.
Donna-BeaTillman, M.D.
JoanneLess,Ph.ID.
Tim Ulatowski
‘1