Reprocessing of Electrophysiology Catheters: Clinical ... · Pacing and Electrophysiology (NASPE) policy statement is to examine the basis of concerns about reprocessing catheters

NASPE POLICY STATEMENT

Reprocessing of Electrophysiology Catheters:Clinical Studies, Regulations, andRecommendations. A Report of the NASPE TaskForce on Reprocessing of ElectrophysiologicalCathetersBRUCE D. LINDSAY,* STEVEN P. KUTALEK,t DAVID S. CANNOM,+STEPHEN C. HAMMILL,§ and GERALD V. NACCARELLI||From the * Washington University School of Medicine, St. Louis, Missouri, tHahnemannUniversity Hospital, Philadelphia, Pennsylvania, *The Hospital of the Good Samaritan, LosAngeles, California, §St. Mary's Hospital Complex, Mayo Foundation, Rochester, Minnesota, and||Penn State College of Medicine, Hershey, Pennsylvania

IntroductionThe reuse of medical devices labeled for sin-

gle use evokes concern because of the possibilitythat this practice may increase procedural risks forpatients. The debate over this controversial issueextends well beyond the area of electrophysiolog-ical studies and is clouded by financial incentivesfor hospitals, manufacturers, and reprocessors. Itis compounded by the ambiguous criteria for "sin-gle use" labels and doubt about the uniformity ofreprocessing standards. The broad scope of singleuse devices (SUDs) that are frequently reprocessedis shown in Table I.̂ These devices vary consider-ably in their materials, technical complexity,fragility, and risk of reuse.

On February 10, 2000, the Subcommittee onOversight and Investigations of the Committee onCommerce of the United States House of Repre-sentatives presided over a hearing to examine therisks to patients, the need for informed consentwhen SUDs are reused, regulatory fairness, andappropriate regulatory measures.^ A subsequenthearing by the Senate Committee on Health, Edu-cation, Labor, and Pensions included the CeneralAccounting Office (GAO) report on medical SUDs.The purpose of this North American Society ofPacing and Electrophysiology (NASPE) policystatement is to examine the basis of concernsabout reprocessing catheters and the measuresproposed by the Food and Drug Administration(FDA) to address this issue.

Address for reprints: NASPE, 6 Strathmore Rd., Natick, MA01760. Fax: (508) 647-0124.

Received April 12, 2001; accepted April 16, 2001.

Development of Single Use Labels andReprocessing Policies

Prior to the late 1970s most medical deviceswere considered "reusable" and were hand wiped,soaked in disinfectants, and resterilized by heat.As the demand for disposable equipment rose,hospital administrators and physicians began tonotice that some products labeled "single useonly" were similar to devices that had been for-merly distributed as "reusable." For example, aletter written by USCI Cardiology & RadiologyProducts to a hospital explained that althoughUSCI had decided to change the label on a partic-ular device from reusable to single use, it hadmade no structural changes to the device. Specifi-cally, USCI stated "our manufacturing processesof Woven Dacron Intracardiac Electrodes have notchanged. These electrodes are made with the samematerials and in the same manner they have beenin the past."^

In response to what many physicians and hos-pital administrators perceived as an arbitrary la-beling policy, the practice of reprocessing SUDsevolved to reduce costs and the amount of medi-cal waste generated by the use of disposable de-vices. As this practice encompassed critical de-vices such as electrophysiological catheters, thecomplexity of decontamination and sterilizationprocedures increased. The role of hospital com-mittees made up of physicians, nurses, infectioncontrol specialists, risk managers, hospitallawyers, and professional reprocessors evolved tomonitor the safety of resterilization methods.Many hospital administrations believed this prac-tice was safe, some made use of third party repro-cessors, and others abandoned the practice alto-gether. Concerns about reprocessing often pertain

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Table I.

Frequently Reprocessed Single Use Devices

Surgical saw bladesSurgical drillsLaparoscopy scissorsOrthodontic (metal) bracesElectrophysiological cathetersElectrosurgical electrodes and pencilsRespiratory therapy and anesthesia breathing circuitsEndotracheal tubesBalloon angioplasty cathetersBiopsy forceps

to liability, the institution's technical expertise, orthe cost that quality assurance programs entail.

According to the FDA Compliance PolicyCuide, hospitals that reprocess SUDs assume fullliability and responsibility for their reprocessingactions and should ensure that the products areadequately cleaned and sterilized. They alsohave the responsibility to confirm that devicesafety, effectiveness, and quality are maintained.In essence, hospitals or third parties that reprocessSUDs become "manufacturers" and are subject tothe same regulatory requirements as other manu-facturers, including premarket requirements. Todate, the FDA has not actively enforced premarketrequirements against third parties, and with re-gard to electrophysiological catheters opinionsdiffer as to what these requirements should entail.

Third party reprocessors are currently re-quired to comply with a number of FDA regula-tory requirements, the most significant of which isthe Quality System Regulation.^ These extensiveregulations require the reprocessors to (1) controland monitor production processes to ensure that adevice conforms to its specifications, (2) validatewith a high degree of assurance that reprocessingmethods ensure that specified requirements aremet, and (3) establish and maintain procedures forreprocessed device acceptance to ensure that eachproduction run, lot, or batch meets acceptance cri-teria. A functional difference between reproces-sors and manufacturers is that reprocessors testevery reprocessed device before sending it back toa hospital, whereas the original manufacturers testonly a sample of their products. The purpose ofthese requirements is to assure that the repro-cessed device is clean, sterile, and able to performits originally intended clinical function. Theseregulations also stipulate that third party repro-cessors must make all required information anddata available for inspection by the FDA.

In his testimony to the Subcommittee onOversight and Regulations, Dr. Robert O'Halla,Vice President of Regulatory Affairs for the Medi-

cal and Diagnostic Group at Johnson and Johnson,and Chairman of the Association of DisposableDevice Manufacturers (ADDM) provided alarmingdata that raises serious concern that hospitals donot uniformly abide by the Quality System Regu-lation. He testified that ADDM members retrieved1,000 reprocessed devices from hospitals wherethey were awaiting use in patients. Approximately75% of the samples failed inspection due to thepresence of blood or proteinaceous matter, bacte-rial contamination, functional failures, or defec-tive packaging leading to nonsterile devices.^ Oneof the photographs presented by Mr. O'Halla to thesubcommittee illustrated tissue residue that hadnot been removed from an electrophysiologicalcatheter during cleaning. His testimony points tothe need for closer oversight of reprocessing andthe need for uniform standards to which thirdparty reprocessors and hospitals would be ac-countable.

The Basis and Impact of Single Use LabelingNo FDA regulations or formal standards dis-

tinguish the quality or functionality of reusable de-vices from SUDs. The discretion to label a devicefor single use lies solely with the device manufac-turer. In his testimony during the subcommitteehearing. Dr. David Feigal, Director of the Center forDevices and Radiological Health at the FDA, ac-knowledged that it has been the FDA's practice totake a manufacturer's request for single use labelsat face value and to evaluate how that devicewould perform as single use.'' The FDA evaluates adevice relative to its intended use by the manufac-turer. Its approval of a device for single use meansthat the device can be used safely once; however,the single use label does not specify that the devicecannot be used safely and reliably more than onceif it is reprocessed appropriately.

The Federal Food, Drug, and Cosmetic (FDC)Act requires that all new medical devices be ap-proved by the FDA through the premarket notifi-cation (510k) or premarket approval (PMA) pro-cess. Under the FDA's rules, reprocessing modifiesa SUD by changing its intended use to multipleuse. The implications are that reprocessors ofSUDs become manufacturers under the FDC Actand are subject to its regulatory requirements, in-cluding premarket notification requirements. In aletter dated July 9, 1999, the FDA stated that"third-party reprocessing of devices labeled forsingle use is unlawful unless those engaged inthese practices comply with all regulatory require-ments for manufacturers including premarket noti-fication requirements."** In the same letter the FDAqualified its position by stating "FDA has exer-cised and will continue to exercise regulatory dis-cretion for all premarket notification requirements,until a new FDA reprocessing position is adopted.

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The most significant regulatory requirement, atthis time, is compliance with the newly developedQuality System Regulation."

The impact of arbitrary single use labels isthat an entire industry has developed to reprocessthese devices, but the legality of current practicesis ambiguous. The reprocessors should be subjectto the FDC Act, but the FDA's decision to use "reg-ulatory discretion" in enforcing these provisionshas been confusing to physicians and hospitals. Amore cohesive policy is required.

Review of Published Studies Regarding TheReuse of Electrophysiological CathetersThe issues pertaining to the safety and effi-

cacy of reusing catheters focus on the risk oftransmitting an infection from one patient to an-other and the structural and functional integrity ofa catheter that is used more than once. Whileresterilization procedures are well established formost catheter designs, objective measures ofcatheter integrity are not as well documented.Some catheters are subjected to very little stressduring a procedure, while the deflectability or ma-neuverability of others may change considerably.Moreover, the process of resterilization may affectmaterials used in the design of the catheter andcould have an impact on function. A few pub-lished studies have evaluated the safety of reusingcatheters for electrophysiological studies andhave addressed some of these issues.

O'Donoghue and Platia^ surveyed 12 medicalcenters to determine the safety of reusingcatheters. The incidence of infection related to atotal of 14,640 electrophysiological studies involv-ing 48,075 catheter uses was reported. At threecenters, catheters were automatically discarded af-ter a single use. These centers carried out 1,245electrophysiological studies using 3,125 catheters.At the other nine centers, the catheters were steril-ized for reuse. There were 13,395 studies using44,950 catheters in the reuse group. The incidenceof bacteremia (blood borne infection) and superfi-cial skin infection at the site of catheter insertion isshown in Table IL The authors concluded that ster-ilization and reuse of the catheters used in thisstudy did not result in an increase in the risk of in-fection. They felt the catheters were sufficientlydurable to be reused well in excess of five times,and that one-time use of such catheters appeared tobe an unnecessary and expensive policy.

Dunnigan et al.^° obtained similar results in aprospective study that evaluated catheter reuseover a 5-year period during which 178 catheterswere used 1,576 times for 847 electrophysiologi-cal studies. Detailed records of catheter testingand use were maintained. No complications wereencountered during the study period. All reusedcatheters functioned for cardiac pacing and

Table II.

Incidence of Infection During ElectrophysiologicalStudies

Group Bacteremia Superficial Skin

Single use catheters 1 (0.03%) 1 (0.03%)1,245 studies3,125 catheters

Reused catheters 8(0.018%) 1(0.002%)13,395 studies44,950 catheters

recording of cardiac electrical signals. Surveil-lance cultures and biological indicators revealedthat adequate sterilization procedures were used.The authors concluded that electrophysiologicalcatheters may be safely reused provided a thor-ough cleaning, testing, and record keeping systemis instituted. They also concluded that the prac-tice of reusing catheters would result in substan-tial cost savings to hospitals.

The prior studies were conducted in patientsundergoing diagnostic electrophysiological stud-ies before the advent of deflectable catheters andarrhythmia ablation procedures. Avital et a l . "prospectively investigated the time course of elec-trical, physical, and mechanical changes in abla-tion catheters to determine the affect of reuse onsafety and efficacy. They studied 69 ablationcatheters made by a single manufacturer that wereused in 336 procedures. Testing of physical in-tegrity consisted of visual and stereoscopic (X30magnification) examination of handle function,catheter shaft, and the deflectable tip. Specific at-tention was paid to the ablation electrode attach-ment to the catheter shaft, and the ablation tipelectrode was scrutinized for pitting. The electri-cal integrity of the catheters was measured by elec-trical resistance from the handle connector to therecording rings and to the tip electrode. Deflectionand torque measurements were made to assessmechanical integrity.

During the course of this study, 36 (52%)catheters were rejected at some point because ofmechanical or electrical failure. Eighteen catheterswere repeatedly sterilized and 11 of the catheterswere used > 10 times. The most common reasonsfor catheter rejection were tip electrode glue sepa-ration after 4.3 ± 4.3 uses and loss of deflection af-ter 5.0 ± 3.3 uses. The glue that covers the mostproximal portion of the distal electrode is shinyand uniform before any use. The application of ra-diofrequency energy causes a rise in tissue tem-perature and the electrode tip is heated secondar-ily. Small fractions of glue were missing and mayhave been released into the bloodstream. Catheters

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with blood that collected in this space could not beproperly cleaned. There was no evidence that thetip to shaft attachment was affected by the outerglue separation; however, the possibility that theattachment of the tip electrode was weakened bythe glue separation could not be excluded. Electri-cal discontinuity was observed after 10,0 ± 3,7uses. There was no significant decrease in thecatheter torquing ability that determines the steer-ing responsiveness of the catheter. The medicalrecords of 140 patients who had arrhythmia abla-tion procedures in this study revealed only one(0,7%) case of local infection at the insertion sitethat was treated effectively by antibiotics. Therewere no other complications.

Avital et a l , " concluded that the cathetermodel used in this study could be reused an aver-age of five times. They recommended that aftereach use catheters be carefully examined undermagnification with special attention to the tipelectrode. They also recommended that thecatheters be tested for deflection and electrical in-tegrity after each use.

As part of an internal quality review processAton et al,^^ determined the effects of reprocess-ing on mechanical integrity, sterility, and chemi-cal residuals to establish and validate an institu-tional policy for reuse, A total of 12 commerciallyavailable catheters from two manufacturers wereanalyzed. Eleven of the catheters were randomlyselected from the catheter inventory of the clinicaleiectrophysiological laboratory after being usedone to four times. They were manually cleaned,repackaged, and gas sterilized with ethylene ox-ide. To assess the sterility of reused catheters,three were cut into 2-inch segments, placed inbacterial culture media, and incubated for 5 days.Six of the catheters were analyzed for chemicalresiduals after gas sterilization. Two catheterswere examined for evidence of component failure.Visual inspection and microscopy were used todetermine the mechanical integrity of the cathetersurface, and x-ray inspection was performed to as-sess interior structures.

The study results of Aton et al.^^ showed nobacterial growth detected on any of the cultures,which indicated that reprocessed electrodecatheters are effectively sterilized. The chemicalanalysis demonstrated that the concentrations ofethylene oxide detected in extraction liquid ex-ceeded standards established by the FDA, Micro-scopic examination of reprocessed cathetersdemonstrated inconsequential metal and fiberparticulates on the catheter surface and at someelectrode to catheter interfaces. Fluid entrapmentaround the distal pole may occur in catheters withtip electrodes. The shaft of the catheters and theelectrodes remained intact. There was no evi-dence of electrical discontinuity, and the integrity

of the internal structures was confirmed by x-rayinspection. The authors concluded that with thesterilization techniques frequently used by hospi-tals, the potential for chemical residual contami-nation might exist after sterilization with ethyleneoxide.

Limitations of Available Clinical DataThe criticisms that can be made of these stud-

ies are that one was a retrospective survey that de-pended on the memory of those who responded.^Jt is possible that isolated events escaped the at-tention of the participants in the survey or theymay have forgotten complicating events. Theother prospective studies involved smaller num-bers of patients.^°~^^ The methodology of thesestudies varied and is unlikely to meet standardsthat are presently being considered by the FDA.Moreover, the catheters used in each of these stud-ies are older designs. Because changes in materialsor deflection mechanisms might have a significantimpact on the durability of eiectrophysiologicalcatheters, it should not be assumed that priorsafety data is applicable to new catheter designs.

Medical Device ReportsMedical Device Reports contain information

about three catheters that broke with dislodgmentof an electrode in the patient. One of these in-volved a reprocessed catheter and the other twoappear to be new single use catheters.

1. Report #1062310-199-0001, A repro-cessed orthogonal eiectrophysiological catheterwas used without incident until it was removedfrom the heart. The physician felt some resistanceduring removal of the catheter, A subsequent Xray showed a small electrode fragment lodged inthe wall of the right atrium. It was presumed thata single platinum electrode mounted on the sur-face of the catheter might have been compromisedduring reprocessing. The surgical consultant de-cided that removal of the fragment was not indi-cated and the patient remained free of symptoms,

2. Report #4501350000-1995-0088, A newdeflectable ablation catheter was being positionedin the right atrium when the catheter tip wasnoted to be detached and wedged in the coronarysinus. The patient was observed overnight anddischarged the following day without any re-ported symptoms,

3. Report #6000087-1998-00002. A smallfragment of the distal tip in proximity to the elec-trode side of a new catheter broke away, and thefragment could not be located. Further details arenot available.

There is concern that physicians do not con-sistently report complications and that the limitednumber of Medical Device Reports underesti-

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mates the problem. Moreover, it is difficult toevaluate Medical Device Reports because the sys-tem for indexing the complications is cumber-some and it is not always clear whether the re-ported device was reprocessed or new. Despitethese limitations, the Medical Device Reportshave drawn attention to defects in new products.The question is if the handful of cases involvingreused devices are representative. In his testimonyto the Subcommittee on Oversight and Investiga-tions, Mr. Vern Feltner, President of AllianceMedical Corporation and a member of the Associ-ation of Medical Device Reprocessors, testifiedthat from January 1997 to March 1999 three medi-cal device reports were filed concerning devicesreprocessed by AMDR companies. In the same re-porting period Boston Scientific, Johnson & John-son, Mallinckrodt, and Tyco had in excess of16,000 Medical Device reports associated with11,827 device malfunctions, 2,509 patient in-juries, and 163 deaths." Dr. David Feigal, repre-senting the FDA, testified that from August 1996through December 1999, the Medical Device Re-ports revealed that out of 300,000 adverse events,464 could possibly be attributed to reuse of anSUD. These reports spanned approximately 70different types of products and showed no dis-cernable pattern of failure with reused SUDs,which differed from patterns observed with theinitial use of SUDs.^^ Based on these data it ap-pears that significant complications are being re-ported to the FDA, but there are no disproportion-ate complications resulting from the reuse ofSUDs.

Transmissible Spongiform Encephalopathies: ADilemma for Reprocessors

Human spongiform encephalopathies are de-generative diseases of the central nervous systemthat include Kuru, Gershmann-Staussler-Sheikersyndrome, fatal familial insomnia, andCreutzfeldt-Jakob disease. There is no immuniza-tion or known treatment for any of these diseases.The nature of the infectious agent is still understudy. Prions, which appear to be the infectiousagent, are proteins that contain no DNA or RNA.These unique pathogens, which are smaller thanviruses, have incubation periods from months toas long as 40 years. The pathogenic forms of pri-ons replicate by transforming normal cellularprion proteins into aberrant proteins that accumu-late in the central nervous system.^^

Fortunately, human spongiform encephalo-pathies are rare. The incidence is estimated to beonly 1 per million, but the incidence of new vari-ant Cruetzfeldt-Jakob disease is rising at a rate of23% in the United Kingdom, presumably due toconsumption of meat contaminated with bovinespongioform encephalopathy.^'''^^ There is con-

cern that unrecognized carriers might contaminatesurgical instruments or blood products becausethere are no effective screening tests. The infec-tious agents are quite resistant to inactivation andcan survive autoclaving regimens used to sterilizesurgical instruments.^''•^^ They are also resistant toethylene oxide, formalin, iodofor, and many othercommon agents used to decontaminate surgicalsupplies.^** Nondisposable surgical instrumentsshould be decontaminated by soaking in INsodium hydroxide or undiluted sodium hypochlo-rite for 1 hour and then autoclaved for 1 hour at134°C.̂ ^ These methods are not applicable to elec-trophysiological catheters.

As of 1998, 103 documented cases of iatro-genically transmitted Cruetzfeldt-Jakob diseasewere attributable to transplantation of brain, pitu-itary, or ocular tissue.^° This is almost certainlydue to the high levels of an infectious agent in thecentral nervous system, but lymphatic tissue isalso highly infective, and the infectious agent iswidespread throughout the body. The risk oftransmission through human blood products isnot resolved. No epidemiological studies have in-criminated blood transfusions, and transfusion ofhuman blood has not transmitted the disease insusceptible animal hosts.^^ Nonetheless, there areanecdotal reports that patients have developedCruetzfeldt-Jakob disease after transfusions ofcontaminated blood.^^ Based on these data,NASPE recommends that laboratories shouldnever reprocess catheters that have been used inpatients with known prion disease or unexplaineddementia.

How can we be certain that prion diseases arenot transmitted from unrecognized carriers? Thisquestion has much broader implications than theFDA's current focus. It would affect the reuse ofclamps, retractors, and other expensive items thatare exempted from the new regulations. It couldalso affect transfusion of blood products or organtransplants. There are probably about 300 patientswith prion disease in the United States (incidence1 per million). According to the Centers for Dis-ease Control, the incidence in the United Stateshas not changed over the past decade and in peo-ple < 30 years of age it remains < 5 per billion.^^In essence, a policy banning all reusable surgicalsupplies would be based on a low risk. In the caseof electrophysiological studies, the risk of a fatalcomplication is about 0.1%. The risk of contract-ing prion disease from reused catheters adds anadditional risk that is probably in the range of 1 inseveral million. Is this an acceptable risk? Shouldit alter clinical practices? To date, neither the FDAnor the Centers for Disease Control and Prevention(CDC) has taken a formal position on this issue. Ifthey do, any standards they develop for resteril-ization of electrophysiological catheters would be

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made in the broader context of if any surgical in-struments should be reused,

GAO ReportThe GAO report submitted during the Senate

hearing on June 20, 2000 was entitled Single-UseMedical Devices: Little Available Evidence ofHarm from Reuse, but Oversight Warranted.^* TheGAO reviewed the relevant scientific literature,met with FDA officials, examined FDA documentsand documents submitted to the FDA by inter-ested parties, interviewed officials at the GDG andthe Health Gare Financing Administration, gath-ered information from other experts in govern-ment and industry, contacted third party repro-cessing companies, and interviewed physicians,hospital administrators, and other health careproviders. They concluded that neither the FDAnor any other organization has accurate informa-tion about the number of facilities that use repro-cessed SUDs or the types of these devices that arereprocessed. They point out that it is difficult toassess the validity of surveys because the responserates are low and some hospitals are unwilling toacknowledge that they reuse devices.

Many health care personnel advised the GAOthat some SUDs can safely be reused,^* The GAOfound mistrust over the single use label becausethe FDA does not require manufacturers to sup-port the designation of single use, there is a per-ception that financial incentives influence thedesignation of single use, and the FDA's require-ments for SUDs are thought to be less extensivethan those for reusable devices. The GAO alsofound contradictions within the manufacturers'practices that contribute to widespread skepti-cism. Some companies have programs to "reman-ufacture" SUDs and others provide guidelines forhospitals to reprocess the devices. Moreover, in a1998 United States District Gourt case, the judgefound that the manufacturer's only purposes in la-beling a device for single use were to comply withthe FDA's requirements and to limit its own lia-bility from reuse, not to prevent a hospital fromusing the device more than once,^^

The GAO report concluded that some SUDscan be safely reprocessed and reused on other pa-tients, and notes that some patient adverse eventsallegedly related to SUDs are inaccurate. Theyspecifically cited the clinical literature supportingthe safety of reprocessing eiectrophysiologicalcatheters. The GAO was advised by hospital in-fection control practitioners, risk management ex-ecutives, and patient safety experts that careful re-processing of SUDs that can be properly cleanedand sterilized does not pose a risk to patienthealth. The report quotes experts from the GDGwho said that they were not aware of any infec-

tions caused by reuse in the last decade. The GDGexpressed confidence that hospital infectionsurveillance systems would detect a significantrisk associated with this practice.

Although the GAO report found little evi-dence of harm arising from reprocessing, it foundinstances where standard procedures were not al-ways followed correctly. It notes reports by the de-vice manufacturers who found damaged, unclean,or unsterile devices taken from hospital stocksthat had been reprocessed by the hospitals or thirdparty reprocessing firms. The GAO is concernedthat surveillance programs may underreport prob-lems, and that it is difficult to trace infections backto the use of a specific device. The GAO reportconcludes that some SUDs can be safely repro-cessed; however, the practice is not invariably safeand further oversight by the FDA is needed to pro-tect the public safety.

Informed GonsentOne of the concerns raised during the United

States House of Representatives subcommitteehearing is that patients are not informed when re-processed catheters are used. The analogy to "truthin advertising" requirements is that patients have aright to know, and that physicians should not bereluctant to disclose this information to the pa-tient. It was clear that the subcommittee is particu-larly concerned about any perception of duplicitywhen informed consent is obtained. The testimonyfrom two ethicists focused on the perspective thatpatients should be informed of substantive risks.One ethicist concluded that patients should be ad-vised when reused SUDs are used because therisks have not been adequately studied,^^ The sec-ond ethicist concluded that the need to obtain in-formed consent for reused SUDs depends on if thephysician believes there is an appreciable risk topatient.^^ He maintained that use of a reprocessedSUD should be disclosed to the patient if it poses asignificant risk; however, if it is determined thatthe risks are minimal, the process of trying to dis-close these risks could actually hinder the integrityof informed consent by promoting irrational con-cerns.

To put this issue in perspective, physiciansdo not routinely obtain consent for the second useof a device that is labeled "reusable" because thisis not associated with substantive risk. Moreover,physicians are not compelled to inform patientsbefore using devices that have been the subject ofa Medical Device Report or Warning Letter fromthe FDA, Physicians do not generally advise pa-tients that medical devices are subject to recalls,nor can they exclude the possibility that devicesused in the procedure could be recalled in the fu-ture. In these cases informed consent is influenced



by the physician's judgement about the level ofrisk relative to the inherent risk of the procedure.

In the case of electrophysiological studies, therisk of a life-threatening or fatal complication is inthe range of 1:1,000.̂ "̂ Certain other risks may behigher depending on the nature of the procedure.The risk of reusing electrophysiological cathetersappears to be so low that no reasonable estimatehas been identified. Relative to the overall risk ofthe procedure, the risk of reusing electrophysio-logical catheters is insignificant. If the use of re-processed devices is not associated with materialrisk, then there is no ethical reason why this issuemust be added to the long list of risks known to beassociated with the procedure. Patients should beinformed if they ask about the hospital's policy,and they have the right to request that reprocessedcatheters not be used. The decision to include thisdiscussion when informed consent is obtainedshould be determined by the attending physician.

FDA Guidance DocumentThe FDA issued a document August 2, 2000

entitled Enforcement Priorities for Single Use De-vices Reprocessed by Third Parties and Hospi-tals.^^ This document provides guidance to thirdparty and hospital reprocessors about their re-sponsibility as manufacturers engaged in repro-cessing devices labeled for single use. The FDAhas made it clear that third party and hospital re-processors are subject to all the regulatory re-quirements currently applicable to original equip-ment manufacturers. This document evolved froma proposed strategy that was published in Novem-ber 1999. In addition to publishing the proposedstrategy for public comment, the FDA also spon-sored a teleconference on November 10,1999, andconvened an open public meeting on December14, 1999. Representatives from NASPE partici-pated in these discussions. As a result of com-ments and discussion about the proposed strategy,the FDA revised its regulatory strategy as follows:

1. Devices will be classified according to theCode of Federal Regulations (Class I, II, or III) toset enforcement priorities for premarket submis-sion requirements.

2. The FDA intends to enforce premarketsubmission requirements within 6 months for allClass III devices (ablation catheters) and within 12months for Class II (diagnostic electrophysiologi-cal catheters) devices.

3. For hospital reprocessors, the FDA will es-tablish a 12-month phase in for active enforce-ment of non-premarket requirements (registration,listing, medical device reporting, tracking, correc-tions and removals, quality system regulations, la-

beling). The agency will use this period to educatehospitals about their regulatory obligations.

The FDA's objective is to ensure a regulatoryprogram based on science that protects publichealth with requirements that are equitable to allparties.

The new regulations require third party andhospital reprocessors to register with the FDA as areprocessor and list the devices they intend to re-process. Reprocessors will not be subject to Medi-cal Device Tracking regulations unless the FDA is-sues an order for the specific device beingreprocessed. The reprocessors will be required tonotify the FDA if they have any reason to suspectthat a device or batch of devices was defective andrequired removal from its point of use to someother location for repair, modification, adjust-ment, relabeling, destruction, or inspection. Allreprocessors will be required to adhere to currentgood manufacturing practice requirements setforth in the Quality System Regulations. These re-quirements include design controls, correctiveand preventive actions, and validation proce-dures. The FDA's general labeling requirementsmust also be met.

Premarket requirements for reprocessed de-vices are still under review and may be particu-larly controversial. Class III devices require eithera premarket notification (510k) submission or aPMA application. The classification regulation foreach type of Class III device indicates if a PMA ap-plication is required. The FDA has indicated thatablation catheters will require PMA applications.These applications must include valid scientificevidence that demonstrates the safety and effec-tiveness of the reprocessed device. It is not yetclear if clinical data will be required to reprocessablation catheters. The requirements for diagnos-tic electrophysiological catheters will generallyfall into the category of a premarket notification(510k), which must contain enough informationfor the FDA to determine if the device is substan-tially equivalent to a legally marketed predicatedevice. Premarket (510k) submissions and PMAapplications are device specific, so the FDA willrequire a 510k or PMA for each device unless theyare convinced that closely related variations of thesame type of device should be grouped in one sub-mission or application. The FDA intends to takeimmediate enforcement action against third partyand hospital reprocessors that fail to make anysubmissions or submit incomplete applicationsfollowing the end of the phase in periods.

Impact of Reuse Policies on Physicians,Hospitals, Manufacturers, and Reprocessors

Most electrophysiological laboratories arestaffed and administered by hospital employees.


LINDSAY, ET AL,

The cost of supplies and maintenance for eiectro-physiological laboratories is also paid from hospi-tal budgets. Most physicians who perform eiectro-physiological studies have no direct or indirectpersonnel financial gain from cost saving mea-sures that are targeted by the hospital. In caseswhere physicians do have a financial incentive toreuse catheters, such as a freestanding laboratoryowned by the physician or his group, there may bea conflict of interest when catheters are reused.

The cost savings realized by hospitals thatreuse eiectrophysiological catheters depend onthe volume of procedures and whether cathetersare reprocessed internally or through a commer-cial reprocessing company. As a general rule, re-processing companies charge 50% of the originalcost of the catheter each time the catheter is re-processed,^^ Allowing for an 85%-90% pass ratefor each reprocessing cycle for a maximum of sixuses per catheter (resterilized a maximum of fivetimes), hospitals can reduce their catheter costs byabout 35%, According to the GAO report, hospi-tals may save from $200,000 to $1,000,000 annu-ally by reprocessing catheters,^* The total savingsat smaller medical centers would be substantiallyless, but for large and small hospitals this practiceis a significant cost reducing measure at a time ofescalating costs and declining reimbursement. Anindirect financial benefit is that the competitionfrom reprocessors probably forces manufacturersto hold their costs down.

One impact of the proposed FDA regulationsfor reuse of eiectrophysiological catheters is thathospitals will almost certainly be forced out of re-processing the catheters themselves. The FDA'snew regulatory requirements^^ will exceed the ad-ministrative or technical resources of most hospi-tals. This might shift reprocessing of catheters tocommercial vendors, or hospitals may simplyabandon reuse of eiectrophysiological catheters.Whether commercial venders can meet the regula-tory standards and remain profitable will dependon the standards that are developed.

The impact of reuse of SUDs on manufactur-ers is obvious. It can be assumed that widespreadresterilization practices have a significant impacton the sales of new products. This must adverselyaffect the manufacturers' profit margins and themoney available for research and development.The manufacturers are also exposed to potentialliability if their products are reused and the pa-tient suffers harm due to a component failure for adevice that was labeled "single use only," Finally,while manufacturers and reprocessors are subjectto regulatory standards, manufacturers claim thatthey are held to a different set of standards thanthe reprocessors. The FDA's proposed policywould bring a uniform set of standards that shouldaddress this concern.

Senate Bill 1542 and House of RepresentativesBill 3148

In response to public concern over reprocess-ing of medical devices, legislation has been intro-duced by Senator Richard Durbin (S,1542) andRepresentatives Anna Eshoo and Fred Upton (H.R,3148) that would require any person who repro-cesses a medical device to comply with certainsafety requirements. These nearly identical propos-als are based on the perception that some repro-cessed medical devices labeled for single use havebeen associated with serious injury and that repro-cessed medical devices labeled for single use havethe potential to cause injury. They also take the po-sition that reprocessed medical devices labeled forsingle use are being used on patients without theirknowledge, against original manufacturers warn-ing, and without a determination by the FDA thatsuch devices are safe and effective. The purpose ofthese bills is to require the FDA to implement allprovisions of the FDG Act, including premarketsafety controls, and to require the informed consentof patients prior to using reprocessed devices suchas eiectrophysiological catheters, Reprocessorswould be required to demonstrate that a repro-cessed device is safe and effective or substantiallyequivalent to a device already deemed to be safeand effective. The bills also contain provisions forall reprocessors to register with the governmentand tighten documentation requirements.

The full impact of these well-intendedamendments is difficult to assess. They wouldclearly increase the documentation required forreprocessing SUDs and might set the standards forPMA at levels that would discourage reprocessingof eiectrophysiological catheters altogether. Theydo not address the fact that some devices appear tobe designated for single use because of marketingas opposed to safety decisions, nor do they recog-nize the role of existing guidelines specified in theQuality System Regulation. Moreover, the FDA al-ready has the authority to regulate reprocessingand is working with NASPE, the American Gol-lege of Gardiology (AGG), manufacturers, and re-processors to implement policies that would ad-dress the stipulations outlined in these proposals.NASPE has expressed concern over the bills be-cause of their potential to add new and unneces-sary regulatory requirements,

ConclusionNASPE's Position on Reuse ofEiectrophysiological Catheters

1, NASPE adheres to the principle that reuseof eiectrophysiological catheters is a safe and costeffective practice provided that they are meticu-lously cleaned, sterilized, and inspected in accor-dance with accepted standards of practice as spec-



ified by the FDA. The exception is when cathetershave been used in patients with human spongi-form encephalopathies such as Cruetzfeldt-Jakobdisease. In these cases, no catheters should bereused because conventional reprocessing meth-ods that are applicable to electrophysiologicalcatheters cannot eliminate contamination that istransmissible to other patients.

2. NASPE recognizes the FDA's responsibil-ity to provide regulatory oversight so that uniformquality control standards are applied and the pub-lic welfare is protected when electrophysiologicalcatheters are reprocessed.

3. NASPE supports the FDA's initiative toprovide a framework for the safe reuse of electro-physiological catheters. NASPE will work withthe ACC, the FDA, original manufacturers, and re-processors to refine standards that can be appliedto reprocessing medical devices.

References1. Reuse of single-use devices. Hearing before the Subcommittee on

Oversight and Investigations of the Committee on Commerce,House of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, pp. 13.

2. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Committee on CommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, pp. 1-184.

3. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Committee on CommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, AttachmentC, p. 138.

4. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Committee on CommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, p. 15.

5. Medical devices: Current Good Manufacturing Practice (CGMP).Final rule: Quality system regulation. Federal Register 1996;61:52601-52662.




9. O'Donoghue S, Platia EV. Reuse of pacing catheters: A survey ofsafety and efficacy. PACE 1988; 11:1279-1280.

10. Dunnigan A., Roberts G, McNamara M, et al. Success of re-use ofcardiac electrode catheters. Am J Gardiol 1987; 60:807-810.

11. Avital B, Khan M, Krum D, et al. Repeated use of ablationcatheters: A prospective study. J Am Goll Gardiol 1993;22:1367-1372.

12. Aton EA, Murray P, Frasier V, et al. Safety of reusing cardiac elec-trophysiology catheters. Am J Gardiol 1994; 74:1173-1175.

13. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Gommittee on GommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, p. 129.

4. In the opinion of this task force there is noethical or legal obligation to include discussion ofreused catheters in the informed consent becauseit does not pose a significant risk. When informedconsent is obtained for electrophysiological stud-ies, the need to discuss the use of reprocessedcatheters should be left to the discretion of the at-tending physician.

5. NASPE seeks clarification of the legal am-biguity that clouds the reprocessing of electro-physiological catheters, and urges strict guide-lines for single use labels.

6. NASPE urges the United States Congress todefer to the FDA as it perfects a regulatory strategyfor the reuse of medical devices that is based onscience and emphasizes public safety as the firstpriority. The FDA is best qualified to address thisissue, and NASPE does not feel that legislative ac-tion is required.

14. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Gommittee on GommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, p. 13.

15. Manson JG. Understanding transmission of the prion diseases.Trends Microbiol 1999; 7:465-467.

16. Baiter M. Spongiform disease. Experts dovirnplay nevir vGJD fears.Science 2000; 289:1663-1666.

17. Haywood AM. Transmissible spongiform encephalopathies. NEngl J Med 1997; 337:1821-1828.

18. Steelman VM. Prion disease - An evidence-based protocol for in-fection control. AORN J1999; 69:946-954.

19. Taylor DM, Fraser JR. The potential risk of transmitting vGJDthrough surgery, (letter) J Hosp Infect 2000; 44:318-321.

20. Brown P. Transmission of spongiform encephalopathy through bi-ological products. Dev Biol Stand 1998; 93:73-78.

21. Johnson RT, Gibbs GJ. Greutzfeldt-Jakob disease and relatedspongiform encephalopathies. N Engl J Med 1998; 339:1994-2004.

22. Klein R, Dumble LJ. Transmission of Greutzfeldt-Jakob disease byblood transfusion. Lancet 1993; 341:768.

23. Centers of Disease Gontrol. http://www.cdc.gov/health/dis-eases.htm

24. Single-Use Medical Devices. Little available evidence of harmfrom reuse, but oversight warranted. United States General Ac-counting Office. Report to Gongressional Requestors, June 2000.http://www.gao.gov/cgi-bin/ordtab.pl

25. United States Surgical Gorp v. Orris, Inc 5F. Supple 2d 1201 at1207.

26. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Gommittee on GommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, pp. 113-116.

27. Reuse of single-use devices. Hearing before the Subcommittee onOversight and Investigations of the Gommittee on CommerceHouse of Representatives, February 10, 2000. Serial No. 106-89,U.S. Government Printing Office, Washington, 2000, pp. 155-159.

28. Horowitz, LN. Safety of electrophysiology studies. Girculation1986; 73(Suppl. II):II-28-II-31.

29. Guidance for industry and for FDA staff. Enforcement priorities forsingle-use devices reprocessed by third parties and hospitals. Au-gust 2, 2000. U.S. Department of Health and Human Services, Foodand Drug Administration, Genter for Devices and RadiologicHealth, Division of Enforcement II, Office of Gompliance. http://www.senate.gov/~labor/hearings/juneOOhrg/juneOOhrg.htm


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Reprocessing of Electrophysiology Catheters: Clinical ... · Pacing and Electrophysiology (NASPE) policy statement is to examine the basis of concerns about reprocessing catheters