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FDA Continues its Scrutiny of Premarket Submissions as HealthcareProfessionals Debate Patient-Safety Issues
By Kelly M. Pyrek
Editor's note: Log onto www.infectioncontroltoday.comfor our virtual roundtable on reprocessing, where three of the leadingreprocessing companies answer questions posed to them. You'll also find moreinformation about the official positions being taken by various organizations onthe reprocessing issue.
Even though certain medical devices have been reprocessed for more than twodecades, it is only within the past several years that this practice has spurredfears about patient safety, hospital liability, and manufacturer integrity. Thefederal government has stepped up its oversight of this controversial practiceamidst charges from device manufacturers that the FDA should set the sameregulatory expectations for reprocessors and original equipment manufacturers(OEMs).
The Food and Drug Administration (FDA) of the US Department of Health andHuman Services is attempting to level the playing field for hospitals,third-party reprocessors and OEMs by introducing in several phases stringentrequirements including registration and listing, tracking, adverse eventreporting, corrections and removals, labeling, quality system regulation, andpremarket submission requirements. This article will review various aspects ofthe reprocessing issue and address changes in the FDA's phasing schedule sincethe final SUD policy was published in 2000.
The Origins of Reprocessing
Reuse became an accepted practice in the 1970s when hospitals discovered itwould be more cost-effective to sterilize single-use devices (SUDS) rather thanpurchase new devices for each surgical procedure. A cottage industry was createdsoon after, when third-party reprocessing companies handled devices that weretoo problematic to sterilize onsite. Approximately 80,000 to 100,000 models ofmedical devices are currently in use in the US, and the domestic market forthese devices totals about $56 billion in 1999.1 The Medical DeviceManufacturers Association (MDMA) reports that 6,000 medical device manufacturersproduce almost $70 billion worth of medical products.2
The Bottom Line and Reprocessing
Managed care has forced many hospitals to scrutinize their profit-and-lossstatements and trim what many administrators feel is an already lean budget.According to the US General Accounting Office (GAO), third-party reprocessorscharge hospitals approximately one-half of the price of a new medical device foreach reprocessed SUD. Although there is debate over how true costs arecalculated, hospitals that use reprocessed devices have reported to the GAO thatthey save money. One group of hospitals that uses reprocessed SUDs estimatedtheir annual savings per hospital were $44,000 for sequential compressiondevices, $17,000 for pulse oximeter sensors, and $115,000 for electrophysiologycatheters, while other hospital groups estimated their cost savings ranged from$200,000 to $1 million annually.3
The GAO has found that purchasers and manufacturers can often negotiate theprice of new SUDs, since some OEMs lower their prices due to increasedcompetition from SUD reprocessing. GAO personnel discovered that somemanufacturers had offered lower prices to hospitals that agreed not to reprocessthe devices.4 Hospitals charge the same whether or not the device hasbeen reprocessed, and it comes down to informed consent. Hospitals are not eagerto make a correlation between a reprocessed device and a sentinel event due tofinancial and legal liability.
The FDA Intervenes
In 1999, the Food and Drug Administration (FDA) solicited feedback fromhealthcare professionals, medical device manufacturers, and reprocessing firmsto determine if federal oversight was needed to address the issue, since allparties involved in the debate could not find common ground. Some hospitals andreprocessors allege that OEMs may be labeling reusable devices"single-use" since designating a device as such could enhancecompanies' bottom lines. At the same time, the number of SUDs currently in themarketplace has increased, including many devices that were once consideredmultiple-use. Some believe the high price of medical devices and instrumentationhas forced hospitals to resort to reprocessing--an avoidable situation if OEMshad more reasonable pricing standards, some say. To investigate the matterfurther, Congress commissioned the GAO to investigate the practice ofreprocessing and reusing SUDs in US hospitals.
The GAO Weighs in on the Issue
In June 2000 the GAO compiled a report whose name might indicate the heart ofthe debate: "Single-Use Medical Devices: Little Available Evidence of HarmFrom Reuse, but Oversight Warranted." The report reviewed the practice ofSUD reprocessing in the US and focused on the extent of reprocessing, the healthrisks associated with it, the cost savings involved, and the degree of the FDA'soversight required.
The GAO reported that various surveys conducted by other organizations found20-30% of US hospitals say they reuse at least one type of SUD and that at leastone-third of the hospitals that do so have contracted with third-partyreprocessors. The GAO also learned that many hospitals believe manufacturersmarket devices with a single-use label because of the economic benefits of doingso, and that they therefore believe many SUDs can be reprocessed.5
While the report could not quantify the exact size of the reprocessingindustry, it said the FDA has identified only 13 third-party reprocessors,although the agency suspects more are in operation. The report stated that in1999, a trade association representing major third-party firms said its memberscollectively received about $20 million annually for their services. There issome evidence pointing to the fact that a minority of the country's 6,000-plushospitals and roughly 2,700 ambulatory surgery centers reprocess SUDs in-house.6The GAO is aware that many healthcare facilities do not report theirreprocessing activity; in fact, manufacturer representatives have informed theGAO that their examination of SUDs that malfunctioned indicated that devicesfrom some hospitals showed clear signs of being reprocessed, yet theinstitutions denied reusing SUDs.7
While this evidence exists, it's apparent that healthcare personnel havemixed feelings about SUDs, believing that some of them can be reused. The GAOreported that healthcare workers (HCWs) said they do not trust the single-uselabel on some devices because the FDA cannot require manufacturers to supportthe designation of a device as single-use; they perceive that manufacturers havean economic incentive to market devices as single-use that could just as well besold as reusable. For example, SUD manufacturers are not required to providedata to validate that their cleaning, disinfection, and/or sterilization methodsand instructions are effective and do not alter the safety or function of thedevice is not intended to be reused. However, a manufacturer of a reusabledevice must provide this additional information to the FDA if they intend fortheir devices to be reused again.
Most notably, the GAO learned that the application of the single-use label tonon-critical medical devices erodes its meaning for some HCWs.8
The report revealed that on some occasions, OEMs "have contributed tothe sense that compliance with the single-use label is not alwaysnecessary."9 In a 1998 US District Court case, a judgediscovered that the OEM's only purpose in labeling a device for single use wasto comply with the FDA's requirements as well as to limit its own liability fromreuse, not to prevent a hospital from using it more than once.10Other contradictions spring up in the letters sent by OEMs to hospitals thatcaution against the re-sterilization of SUDs, yet still give detailedsterilization instructions for their single-use device(s). This may beespecially troubling if--as in the case of one hospital GAO personnel spokewith--a facility uses the OEM's letter as its official in-house reprocessingguidelines.11
Is New Always Better?
The challenge is perception on the part of patients and consumers that new isalways better, and that newness is a guarantee of a device's sterility. Whileempirical evidence still is lacking, science is sometimes clouded by emotionwhen the subject of patient safety is discussed. The argument has no conclusiveevidence either way, the GAO decided, stating, "While SUD reprocessing doespose some theoretical health risks, the available evidence indicates that someSUDs can be safely reprocessed and reused on other patients." 12
The Centers for Disease Control and Prevention (CDC) guidelines state that ingeneral, "reusable medical devices or patient-care equipment that enternormally sterile tissue or the vascular system, or through which blood flows,should be sterilized before each use."13 Under the strictestterms, sterilization means the use of a physical or chemical procedure todestroy all microbial life--including highly resistant endospores--and involvesthe use of steam autoclaving, ethylene oxide gas, and dry heat.
In its report, the GAO states, "To successfully reprocess a device thathas been used on a patient, institutions must be able to clean it thoroughly,sterilize it to acceptable standards, and ensure that reprocessing and reusewill not degrade its functioning." 14 From conversations GAOpersonnel had with reprocessors, it can be ascertained that they are followingsimilar reprocessing procedures, including:
The GAO says reprocessors told them they or their client hospital establishlimits on the maximum number of times a device can be reused and the device isdiscarded when that threshold is reached.
In its guidance statement on the reuse of single-use devices, the Associationof periOperative Registered Nurses (AORN) states the foremost concern is patientsafety, therefore, if a device cannot be cleaned, it cannot be reprocessed andreused; if sterility of a post-processed device cannot be demonstrated, thedevice cannot be reprocessed and reused; and the integrity and functionality ofa reprocessed SUD cannot be demonstrated and documented as safe for patient careand/or equal to the original device specifications, the device cannot bereprocessed and reused.15
The GAO admits that comprehensive data about the frequency of adverse patientevents related to reprocessing of SUDs is limited. The office recognizes thateven new SUDs can contribute to injuries or infections if theymalfunction, thus clouding the distinction between new and reprocessed devicesin sentinel-event data. The GAO report refers to clinical studies that haveestablished the relative safety of reprocessed SUDs, in that medical proceduresinvolving reprocessed SUDs can be accomplished safely and without negativepatient outcomes. Several studies on the reprocessing of single-use endoscopicinstruments revealed that SUDs could be reused at least several times withoutincreasing patient risk.16
Healthcare personnel themselves, including infection control practitioners,risk managers and patient safety experts interviewed by the GAO saidreprocessing the kinds of SUDs that can be properly cleaned and sterilized doesnot pose a risk to patients, a viewpoint shared by infection control experts atthe CDC. With the exception of device manufacturers, all groups contacted by theGAO, including the Association for Professionals in Infection Control andEpidemiology (APIC), the American Hospital Association (AHA), and the AmericanSociety for Healthcare Central Service Professionals (ASHCSP), supportedreprocessing with closer FDA oversight.
Jennifer Thompson, director of government and public affairs for APIC, says,"APIC does not have an official position per se, but believes thatreprocessing must be done on a case-by-case basis to ensure that all qualitystandards are met and that the device is as safe and effective as when firstmanufactured. We want to preserve the option to reuse devices in certain cases,while ensuring that the practice is safe. It's been a very sensitive issue forus, since as users, we are in the middle of the debate between the originaldevice manufacturers and the reprocessors."
The challenge lies in identifying, documenting and tracking adverse patientoutcomes associated with reprocessed SUDs. Although the FDA has an establishedMedical Device Reporting (MDR) program,17 the data can bemisinterpreted or under-reported. Out of approximately 125,000 reports ofpatient injuries and device malfunctions, 49 cases were for SUDs included on theFDA's list of frequently reprocessed devices.18 In addition, the GAOidentified several reports of adverse events that were either inaccurate ordifficult to interpret, such as a patient death attributed to infectiontransmitted by a reprocessed cardiac catheter when in actuality, the infectionwas traced to an improperly sterilized glass medicine cup.19
In its report the GAO is quick to point out that the lack of conclusiveinformation about reprocessing, however, is a strong enough argument for theneed of additional monitoring and regulation of this practice. It also foundthat many types of SUDs cannot be reprocessed safely. In fact, devicemanufacturers have sent to the FDA reports of allegedly damaged, unclean, andnon-sterile devices taken from a hospital's inventory that had been reprocessedby a third-party firm. The manufacturers say that even those devices that can bereprocessed safely can be dangerous to patients if they have not been cleanedand sterilized correctly. The CDC has reported five infectious outbreaksstemming from the failure of automatic cleaning machines to properly cleanbronchoscopes and endoscopes.20
So, while there is no clear evidence that reprocessed SUDs have harmedpatients, there is the possibility that sterilization of these devices accordingto current protocol does not ensure the absence of bacterial contamination. TheGAO recognizes that surveillance systems in US hospitals are affected byunder-reporting, incomplete reports, and loopholes that prevent totalidentification of infections and injuries related to reprocessed SUDs.
Lily Ng, policy analyst in the Office of Surveillance and Biometrics in theFDA's Center for Devices and Radiological Health (CDRH), says the agency hasconducted its own laboratory studies on SUDs that were used once and evaluatedthe effects of various cleaning, disinfection, and sterilization methods on thesafety and function of the device. "Our experts looked at EP catheters andbiopsy forceps and found some devices probably could be adequately cleaned. Sawblades and stainless steel equipment that are not very complex are probably safeto reprocess and reuse. Other devices that have a lot of lumens or a lot ofbells and whistles may be very cumbersome and are probably more difficult toclean. There may even be no way to truly sterilize some of the very complexdevices to the level that healthcare workers are comfortable using them onanother patient."
Ng continues, "We have examined our medical device reporting database tosee if there have been any incidents where a reprocessed SUD caused an adverseevent. Unfortunately, our database is only as good as the information we get. Asfar as I am aware there is no incidence of adverse events that we couldconclusively determine was the result of a reprocessed SUD. We are aware thatthere could be under-reporting of adverse events because hospitals are notlikely to report that they reused a device that was intended by the OEM forone-time use. We know that our database doesn't capture everything--we may haveincidents where there probably could be a causal effect but we can't prove it.The incidents we have seen that involved reprocessed devices involved a failuremode that was no different than what we have seen with brand-new devices. Wehave reports where the reprocessed device used in a procedure wound up leadingto an adverse patient event, but we can't prove that the reprocessing was whatcaused the device to malfunction. We have seen incidents where the tips ofcatheters fell off, but that's also the kind of incident we see with brand-newdevices that just came out of the box. From our perspective, there are noincidences where we can draw the conclusion that injuries or deaths have beencaused by reprocessed devices. Depending on who you listen to--either those whosupport reuse, or the OEMs--you may hear all about the benefits of reusingreprocessed SUDs or you may hear about horrendous events, such as babies whohave died from reused SUDs. We have looked at every one of those adversereports, investigated them, and we still draw the conclusion that you can't saythat the incident was related to a reprocessed device."
FDA's New Framework
Last year, hospitals, manufacturers, and third-party reprocessors had theirfirst real taste of the FDA's involvement in regulating the reprocessingindustry. The agency will ensure that hospitals and third-party reprocessorscomply with all requirements currently faced by OEMs, and ensure that hospitalsthat reprocess SUDs as well as third-party reprocessors meet all applicablepremarket requirements as listed in the Aug. 14, 2000 reuse SUD guidancedocument.
Essentially what has changed in the past year is that hospitals andthird-party reprocessors of SUDs are subject to the same regulations as OEMs,according to the FDA's Lily Ng. She explains that all SUD reprocessors mustattend to requirements for registration and listing, tracking, reporting,corrections and removals, device labeling, quality system regulation, andpremarket submission requirements:
According to Ng, entities must meet premarket submission requirements foreach listed device--either a premarket notification, or (510k), or a premarketapplication, or PMA, based on the device classification. A (510k) is requiredfor all Class I and Class II devices that pose minimal or moderate levels ofrisk to patients unless the device has been specifically exempted by regulation.A PMA is required for Class III devices, classified as the highest risk.
"For a (510k), a manufacturer needs to say in its documentation about adevice, 'I look like, I act like, I have the same intended use as something thatis already legally marketed,'" Ng explains. "The documentationinvolved in a (510k) is less because usually we don't require them to conductclinical trials. What they need to prove to the FDA is that their device issubstantially equivalent to a legally marketed device. The higher of the twothresholds is the PMA. PMAs are generally required for new technology, however,PMAs may also be required for an old technology, but if a manufacturer ispromoting it for a new use, they must demonstrate its safety and effectivenessthrough clinical trials." In other words, a PMA must include validscientific evidence demonstrating the safety and effectiveness of the originaland/or reprocessed medical device. The premarket requirements are new to allreprocessors.
In 2000 the FDA established a phase-in timeline for enforcement of theseregulatory requirements based on device risk classifications; however, Ng saysthe FDA has revised this timeline at the request of several healthcareorganizations, including the American Hospital Association (AHA), Ng reports.She says US Health and Human Services Secretary Tommy Thompson was petitioned byhospitals requesting exemption from submitting the premarket requirement fornon-exempt Class I devices. Instead, Thompson agreed to delay the enforcement ofthe non-premarket requirement for a year, with the exception of registration andlisting.
"If a hospital or third-party reprocessor is reprocessing a Class IIIdevice, the submissions should have come in by now," Ng says. "Back inFeb. 14, 2001, they should have come in with a PMA; we didn't receive PMAs fromhospitals, so our interpretation is there are no hospitals that are legallyusing or distributing Class III devices that they are reprocessing in house.They could be contracting with a commercial reprocessor and that's OK. As ofAug. 14, 2001, if a hospital is reprocessing non-exempt Class II devices, theyshould have come in with a (510k). We don't believe we have any in-house fromhospitals; however, we did get approximately 90 (510k)s from commercialreprocessors. We assume--and that's a big assumption--that no hospital iscurrently reprocessing in-house non-exempt Class II devices. Because SecretaryThompson agreed to that one-year extension, we're not penalizing hospitals ifthey aren't reporting adverse events or are not yet in compliance with the otherpost-market requirements except for registration and listing that are related todevices they are reprocessing in-house. On the other hand, we don't have anyindication that any hospital is reprocessing in-house. With that said,the (510k)s for the non-exempt Class I devices are not due until Feb 14, 2002.Hospitals can legally still reprocess non-exempt Class I devices in-house untilFeb. 14, 2002."
Ng reports the FDA has four PMAs for cardiac ablation catheters under review."If everything went according to the timeline identified in the Aug. 14,2000 guidance document, these PMAs should have been approved or disapproved backin August 2001," she says. "Those PMAs came to the FDA in February2001. We allowed 6 months of review time for the agency, and we should haverendered a decision on Aug. 14, 2001. The reprocessors that submitted theseapplications are telling us they haven't had sufficient time to conduct clinicaltrials. They had a hard time recruiting patients into their studies and it tooklonger than envisioned. The clinical data didn't come in time for us to make adecision, so the FDA allowed them 6 more months to collect clinical data tosupport their PMAs. We have four reprocessors who are legally still in themarket of reprocessing Class III ablation catheters. These reprocessors maycontinue to distribute cardiac ablation catheters until Feb. 14, 2002; then theycan only continue if their PMA receives the FDA's approval. That's the onlycategory of Class III devices for which we have applications. At the time wewere developing the reuse policy, we learned that approximately 207 devices thatwere being reprocessed in the US. This list is included in the Aug. 14, 2000guidance document. That may look very different a year from now. If amanufacturer, hospital, or reprocessor doesn't have FDA approval or clearance,they can't continue to reprocess SUDs for reuse legally."
Who's Doing What?
Ng admits there is an urgent need for the FDA to get a grasp on the number ofhealthcare facilities that are reprocessing medical devices in-house, and saysthe agency has contracted with an outside firm to conduct a phone survey tocontact every hospital in the US to ask if they are reprocessing SUDs.
"We did the best we could to ensure every hospital was notified of ournew SUD policy," Ng says, "but there still could be some hospitalsthat are not aware of our requirements. We also contracted with the JointCommission on Accreditation of Health Organizations (JCAHO) to share informationabout reprocessing they garnered from hospitals they inspected. At the time theJoint Commission conducted their study, some hospitals reported they wereactively reprocessing in house. In an agreement with the agency, JCAHO did nothave to provide the names of these facilities to the FDA. The trend is thathospitals are getting out of the reprocessing business and going to third-partyreprocessors because meeting the quality systems and premarket submissionrequirements is not economically feasible. We still hear about some hospitalsreprocessing medical devices, but we don't know if it's an exempted Class Idevice or a Class III device. We have made some informal visits to randomlyselected hospitals and so far it's all come up negative."
Ng continues, "One of the criticisms that motivated this is that OEMscomplained there wasn't a level playing field. They had to go through the (510k)and/or PMA process before they could market their devices, which is neitherinexpensive nor easy to do, then they said the reprocessors took theirtechnology and benefited from it. One way the FDA could level the playing fieldwas to apply the premarket requirement across the board, and unfortunately, thisrequirement also applied to hospitals. The good news is that hospitals haveuntil Aug. 14, 2002 to come into compliance with the non-premarket requirementswith the exception of registration and listing. Any hospital that is currentlyreprocessing, must be registered and listed with the agency. We are aware thathospitals are not medical device manufacturers. They are in the patient carearena. Their primary interest is not manufacturing and selling medical eqipment,so the FDA has agreed to extend the enforcement deadline for hospitals. When theFDA first decided to examine its reuse policy, I talked to many risk managersand found many were unaware that their hospitals were engaged in in-housereprocessing. I don't think that is true today. I believe that risk managershave done a terrific job in finding out whether reprocessing of SUDs occurs intheir facilities, and if so, educating their facilities about the agency'sregulatory requirements."
Under the current framework, the FDA has the authority under theInvestigational Device Exemption (IDE) regulation to require manufacturers toobtain informed patient consent for the use of specific medical devices. Outsideof the IDE regulation, informed consent is an issue between the hospital and thepatient. Ng adds the FDA is hearing conflicting stories about informed-consentissues.
"We hear from HCWs that some doctors aren't aware that a particulardevice has been used before," Ng says. "The American MedicalAssociation (AMA) told us doctors don't always know if the devices have beenreused because by the time they use it in the OR field, all the packaging hasbeen removed so they can't tell it's not the original packaging. They'reconfused because sometimes if devices are open but not used, the hospital willre-sterilize them and use them. When the reprocessing debate surfaced in late1999, the media actively reported on this practice, so we know that some segmentof the public is aware of it. It's interesting to learn that that few patientsquestion their doctors about whether the device has been used previously. I'vebeen told of a few incidents where patients have requested on their operativepermits that they do not want to use reprocessed SUDs."
Ng confirms the GAO's observations that the contingencies screaming theloudest in the debate over reprocessing are the OEMs and the reprocessors, aruckus Ng adds the FDA is trying to overlook for the sake of patient safety."The agency makes its decisions based on public health. We take thepolitics out of it and we don't look at the economics of this issue. Whether ornot OEMs are losing money because they are not selling as many devices andbecause reprocessors are inching in on their technology, that doesn't concernus. Three principles underline our reuse policy: we are trying to create a levelplaying field for everyone; we're trying to base our decisions on good scienceand solid data; and most importantly, we are protecting public health."
A hot topic related to the reprocessing issue is the open-but-unused debateplaguing OR personnel. Many hospitals are sterilizing and reusing surgicaldevices and instruments that have been unwrapped but not used in the OR, andrisk managers and infection control practitioners are questioning the safety ofsuch a practice.
"A lot of hospitals apparently are re-sterilizing those instrumentsin-house, although some facilities are sending them to third-party reprocessors,"says Lily Ng, policy analyst for the FDA. "I don't know how extensive thispractice is but some of the OEMs are also taking these devices back andcrediting the hospitals, or re-sterilizing them or trading them in for unopened,unused devices. We are getting ready to look at this practice and see if the FDAneeds to address it. I understand some hospitals that open devices and not usethem either discard them or ship them off to less-developed countries. We'reconcerned because these devices can range from low risk to high risk. Thefeedback we received from OR personnel is that they are concerned about whattheir administrators consider to be open but unused. It may never touch thepatient, it may never be inserted into a patient's body cavity, but sometimesthey're not sure it didn't get sprayed with bodily fluids. Is it contaminated ornot? Is it gross contamination? We're looking to healthcare communities to helpus identify what their current practices are."
In its guidance statement on the reuse of single-use devices, the Associationof periOperative Registered Nurses (AORN) states, "Unless so stipulated bythe OEM, it is unknown what effect reprocessing may have on the safety andefficacy of any SUD. AORN believes that unless the OEM provides specific,written reprocessing instructions for the SUD, an opened but unused device(e.g., compromised package integrity, accidental contamination upon opening,etc.) should be subject to the same rigorous reprocessing protocols, includingquality system regulations, as the used device."
-- Kelly M. Pyrek