FDA Continues its Scrutiny of Premarket Submissions as Healthcare
Professionals Debate Patient-Safety Issues
By Kelly M. Pyrek
Editor's note: Log onto www.infectioncontroltoday.com for our virtual roundtable on reprocessing, where three of the leading reprocessing companies answer questions posed to them. You'll also find more information about the official positions being taken by various organizations on the reprocessing issue.
Even though certain medical devices have been reprocessed for more than two decades, it is only within the past several years that this practice has spurred fears about patient safety, hospital liability, and manufacturer integrity. The federal government has stepped up its oversight of this controversial practice amidst charges from device manufacturers that the FDA should set the same regulatory expectations for reprocessors and original equipment manufacturers (OEMs).
The Food and Drug Administration (FDA) of the US Department of Health and Human Services is attempting to level the playing field for hospitals, third-party reprocessors and OEMs by introducing in several phases stringent requirements including registration and listing, tracking, adverse event reporting, corrections and removals, labeling, quality system regulation, and premarket submission requirements. This article will review various aspects of the reprocessing issue and address changes in the FDA's phasing schedule since the final SUD policy was published in 2000.
The Origins of Reprocessing
Reuse became an accepted practice in the 1970s when hospitals discovered it would be more cost-effective to sterilize single-use devices (SUDS) rather than purchase new devices for each surgical procedure. A cottage industry was created soon after, when third-party reprocessing companies handled devices that were too problematic to sterilize onsite. Approximately 80,000 to 100,000 models of medical devices are currently in use in the US, and the domestic market for these devices totals about $56 billion in 1999.1 The Medical Device Manufacturers Association (MDMA) reports that 6,000 medical device manufacturers produce almost $70 billion worth of medical products.2
The Bottom Line and Reprocessing
Managed care has forced many hospitals to scrutinize their profit-and-loss statements and trim what many administrators feel is an already lean budget. According to the US General Accounting Office (GAO), third-party reprocessors charge hospitals approximately one-half of the price of a new medical device for each reprocessed SUD. Although there is debate over how true costs are calculated, hospitals that use reprocessed devices have reported to the GAO that they save money. One group of hospitals that uses reprocessed SUDs estimated their annual savings per hospital were $44,000 for sequential compression devices, $17,000 for pulse oximeter sensors, and $115,000 for electrophysiology catheters, 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 the price of new SUDs, since some OEMs lower their prices due to increased competition from SUD reprocessing. GAO personnel discovered that some manufacturers had offered lower prices to hospitals that agreed not to reprocess the devices.4 Hospitals charge the same whether or not the device has been reprocessed, and it comes down to informed consent. Hospitals are not eager to make a correlation between a reprocessed device and a sentinel event due to financial and legal liability.
The FDA Intervenes
In 1999, the Food and Drug Administration (FDA) solicited feedback from healthcare professionals, medical device manufacturers, and reprocessing firms to determine if federal oversight was needed to address the issue, since all parties involved in the debate could not find common ground. Some hospitals and reprocessors allege that OEMs may be labeling reusable devices "single-use" since designating a device as such could enhance companies' bottom lines. At the same time, the number of SUDs currently in the marketplace has increased, including many devices that were once considered multiple-use. Some believe the high price of medical devices and instrumentation has forced hospitals to resort to reprocessing--an avoidable situation if OEMs had more reasonable pricing standards, some say. To investigate the matter further, Congress commissioned the GAO to investigate the practice of reprocessing 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 of the debate: "Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted." The report reviewed the practice of SUD reprocessing in the US and focused on the extent of reprocessing, the health risks associated with it, the cost savings involved, and the degree of the FDA's oversight required.
The GAO reported that various surveys conducted by other organizations found 20-30% of US hospitals say they reuse at least one type of SUD and that at least one-third of the hospitals that do so have contracted with third-party reprocessors. The GAO also learned that many hospitals believe manufacturers market devices with a single-use label because of the economic benefits of doing so, and that they therefore believe many SUDs can be reprocessed.5
While the report could not quantify the exact size of the reprocessing industry, it said the FDA has identified only 13 third-party reprocessors, although the agency suspects more are in operation. The report stated that in 1999, a trade association representing major third-party firms said its members collectively received about $20 million annually for their services. There is some evidence pointing to the fact that a minority of the country's 6,000-plus hospitals and roughly 2,700 ambulatory surgery centers reprocess SUDs in-house.6 The GAO is aware that many healthcare facilities do not report their reprocessing activity; in fact, manufacturer representatives have informed the GAO that their examination of SUDs that malfunctioned indicated that devices from some hospitals showed clear signs of being reprocessed, yet the institutions denied reusing SUDs.7
While this evidence exists, it's apparent that healthcare personnel have mixed feelings about SUDs, believing that some of them can be reused. The GAO reported that healthcare workers (HCWs) said they do not trust the single-use label on some devices because the FDA cannot require manufacturers to support the designation of a device as single-use; they perceive that manufacturers have an economic incentive to market devices as single-use that could just as well be sold as reusable. For example, SUD manufacturers are not required to provide data to validate that their cleaning, disinfection, and/or sterilization methods and instructions are effective and do not alter the safety or function of the device is not intended to be reused. However, a manufacturer of a reusable device must provide this additional information to the FDA if they intend for their devices to be reused again.
Most notably, the GAO learned that the application of the single-use label to non-critical medical devices erodes its meaning for some HCWs.8
The report revealed that on some occasions, OEMs "have contributed to the sense that compliance with the single-use label is not always necessary."9 In a 1998 US District Court case, a judge discovered that the OEM's only purpose in labeling a device for single use was to comply with the FDA's requirements as well as to limit its own liability from reuse, not to prevent a hospital from using it more than once.10 Other contradictions spring up in the letters sent by OEMs to hospitals that caution against the re-sterilization of SUDs, yet still give detailed sterilization instructions for their single-use device(s). This may be especially troubling if--as in the case of one hospital GAO personnel spoke with--a facility uses the OEM's letter as its official in-house reprocessing guidelines.11
Is New Always Better?
The challenge is perception on the part of patients and consumers that new is always better, and that newness is a guarantee of a device's sterility. While empirical evidence still is lacking, science is sometimes clouded by emotion when the subject of patient safety is discussed. The argument has no conclusive evidence either way, the GAO decided, stating, "While SUD reprocessing does pose some theoretical health risks, the available evidence indicates that some SUDs can be safely reprocessed and reused on other patients." 12
The Centers for Disease Control and Prevention (CDC) guidelines state that in general, "reusable medical devices or patient-care equipment that enter normally sterile tissue or the vascular system, or through which blood flows, should be sterilized before each use."13 Under the strictest terms, sterilization means the use of a physical or chemical procedure to destroy all microbial life--including highly resistant endospores--and involves the use of steam autoclaving, ethylene oxide gas, and dry heat.
In its report, the GAO states, "To successfully reprocess a device that has been used on a patient, institutions must be able to clean it thoroughly, sterilize it to acceptable standards, and ensure that reprocessing and reuse will not degrade its functioning." 14 From conversations GAO personnel had with reprocessors, it can be ascertained that they are following similar reprocessing procedures, including:
- Devices to be reprocessed are frequently rinsed or otherwise cleaned soon after use, before they are sent to the reprocessing facility.
- The steps in standard reprocessing procedure are: cleaning, refurbishing, inspection, and sterilization.
- The function of all devices is checked before sterilization and before the device is returned to the hospital.
The GAO says reprocessors told them they or their client hospital establish limits on the maximum number of times a device can be reused and the device is discarded when that threshold is reached.
In its guidance statement on the reuse of single-use devices, the Association of periOperative Registered Nurses (AORN) states the foremost concern is patient safety, therefore, if a device cannot be cleaned, it cannot be reprocessed and reused; if sterility of a post-processed device cannot be demonstrated, the device cannot be reprocessed and reused; and the integrity and functionality of a reprocessed SUD cannot be demonstrated and documented as safe for patient care and/or equal to the original device specifications, the device cannot be reprocessed and reused.15
The GAO admits that comprehensive data about the frequency of adverse patient events related to reprocessing of SUDs is limited. The office recognizes that even new SUDs can contribute to injuries or infections if they malfunction, thus clouding the distinction between new and reprocessed devices in sentinel-event data. The GAO report refers to clinical studies that have established the relative safety of reprocessed SUDs, in that medical procedures involving reprocessed SUDs can be accomplished safely and without negative patient outcomes. Several studies on the reprocessing of single-use endoscopic instruments revealed that SUDs could be reused at least several times without increasing patient risk.16
Healthcare personnel themselves, including infection control practitioners, risk managers and patient safety experts interviewed by the GAO said reprocessing the kinds of SUDs that can be properly cleaned and sterilized does not pose a risk to patients, a viewpoint shared by infection control experts at the CDC. With the exception of device manufacturers, all groups contacted by the GAO, including the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and the American Society for Healthcare Central Service Professionals (ASHCSP), supported reprocessing 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 that reprocessing must be done on a case-by-case basis to ensure that all quality standards are met and that the device is as safe and effective as when first manufactured. 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 for us, since as users, we are in the middle of the debate between the original device manufacturers and the reprocessors."
The challenge lies in identifying, documenting and tracking adverse patient outcomes associated with reprocessed SUDs. Although the FDA has an established Medical Device Reporting (MDR) program,17 the data can be misinterpreted or under-reported. Out of approximately 125,000 reports of patient injuries and device malfunctions, 49 cases were for SUDs included on the FDA's list of frequently reprocessed devices.18 In addition, the GAO identified several reports of adverse events that were either inaccurate or difficult to interpret, such as a patient death attributed to infection transmitted by a reprocessed cardiac catheter when in actuality, the infection was traced to an improperly sterilized glass medicine cup.19
In its report the GAO is quick to point out that the lack of conclusive information about reprocessing, however, is a strong enough argument for the need of additional monitoring and regulation of this practice. It also found that many types of SUDs cannot be reprocessed safely. In fact, device manufacturers have sent to the FDA reports of allegedly damaged, unclean, and non-sterile devices taken from a hospital's inventory that had been reprocessed by a third-party firm. The manufacturers say that even those devices that can be reprocessed safely can be dangerous to patients if they have not been cleaned and sterilized correctly. The CDC has reported five infectious outbreaks stemming from the failure of automatic cleaning machines to properly clean bronchoscopes and endoscopes.20
So, while there is no clear evidence that reprocessed SUDs have harmed patients, there is the possibility that sterilization of these devices according to current protocol does not ensure the absence of bacterial contamination. The GAO recognizes that surveillance systems in US hospitals are affected by under-reporting, incomplete reports, and loopholes that prevent total identification of infections and injuries related to reprocessed SUDs.
Lily Ng, policy analyst in the Office of Surveillance and Biometrics in the FDA's Center for Devices and Radiological Health (CDRH), says the agency has conducted its own laboratory studies on SUDs that were used once and evaluated the effects of various cleaning, disinfection, and sterilization methods on the safety and function of the device. "Our experts looked at EP catheters and biopsy forceps and found some devices probably could be adequately cleaned. Saw blades and stainless steel equipment that are not very complex are probably safe to reprocess and reuse. Other devices that have a lot of lumens or a lot of bells and whistles may be very cumbersome and are probably more difficult to clean. There may even be no way to truly sterilize some of the very complex devices to the level that healthcare workers are comfortable using them on another patient."
Ng continues, "We have examined our medical device reporting database to see if there have been any incidents where a reprocessed SUD caused an adverse event. Unfortunately, our database is only as good as the information we get. As far as I am aware there is no incidence of adverse events that we could conclusively determine was the result of a reprocessed SUD. We are aware that there could be under-reporting of adverse events because hospitals are not likely to report that they reused a device that was intended by the OEM for one-time use. We know that our database doesn't capture everything--we may have incidents 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 failure mode that was no different than what we have seen with brand-new devices. We have reports where the reprocessed device used in a procedure wound up leading to an adverse patient event, but we can't prove that the reprocessing was what caused the device to malfunction. We have seen incidents where the tips of catheters fell off, but that's also the kind of incident we see with brand-new devices that just came out of the box. From our perspective, there are no incidences where we can draw the conclusion that injuries or deaths have been caused by reprocessed devices. Depending on who you listen to--either those who support reuse, or the OEMs--you may hear all about the benefits of reusing reprocessed SUDs or you may hear about horrendous events, such as babies who have died from reused SUDs. We have looked at every one of those adverse reports, investigated them, and we still draw the conclusion that you can't say that the incident was related to a reprocessed device."
FDA's New Framework
Last year, hospitals, manufacturers, and third-party reprocessors had their first real taste of the FDA's involvement in regulating the reprocessing industry. The agency will ensure that hospitals and third-party reprocessors comply with all requirements currently faced by OEMs, and ensure that hospitals that reprocess SUDs as well as third-party reprocessors meet all applicable premarket requirements as listed in the Aug. 14, 2000 reuse SUD guidance document.
Essentially what has changed in the past year is that hospitals and third-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 must attend to requirements for registration and listing, tracking, reporting, corrections and removals, device labeling, quality system regulation, and premarket submission requirements:
- All entities that manufacture or process medical devices must register with the FDA for inspection purposes, as well as provide a list of the devices these entities intend to reprocess.
- Manufacturers and reprocessors must be able to locate their devices should notification or corrective action need to be taken. OEMs and reprocessors are subject to tracking regulation when the FDA issues a particular tracking order for a specific device. "There is a short list of devices--usually used in life-supporting or life-sustaining procedures -- whose failure could lead to serious injury or death-that must be tracked," Ng says.
- Under MEDWATCH, the FDA's medical device reporting program, OEMs and users must report serious injuries or deaths to the agency if it can be reasonably determined that a medical device may have contributed to or directly caused the incident. Hospitals that reprocess SUDs must obey both facility reporting and manufacturer reporting requirements.
- Corrections to a medical device and/or removal of the device from use must be reported to the FDA when such action is initiated by the manufacturer/reprocessor to correct a violation of the Food, Drug and Cosmetic Act or to reduce a health risk to a user.
- Labeling requirements includes providing the name and location of the manufacturer/reprocessor as well as sufficient directions for the device's use.
- Quality system regulation requires that manufacturers, third-party reprocessors and hospitals follow the FDA's Good Manufacturing Practices that govern the design, manufacturing, packaging, labeling, storage, installation and servicing of medical devices.
According to Ng, entities must meet premarket submission requirements for each listed device--either a premarket notification, or (510k), or a premarket application, or PMA, based on the device classification. A (510k) is required for all Class I and Class II devices that pose minimal or moderate levels of risk 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 a device, 'I look like, I act like, I have the same intended use as something that is already legally marketed,'" Ng explains. "The documentation involved in a (510k) is less because usually we don't require them to conduct clinical trials. What they need to prove to the FDA is that their device is substantially equivalent to a legally marketed device. The higher of the two thresholds is the PMA. PMAs are generally required for new technology, however, PMAs may also be required for an old technology, but if a manufacturer is promoting it for a new use, they must demonstrate its safety and effectiveness through clinical trials." In other words, a PMA must include valid scientific evidence demonstrating the safety and effectiveness of the original and/or reprocessed medical device. The premarket requirements are new to all reprocessors.
In 2000 the FDA established a phase-in timeline for enforcement of these regulatory requirements based on device risk classifications; however, Ng says the FDA has revised this timeline at the request of several healthcare organizations, including the American Hospital Association (AHA), Ng reports. She says US Health and Human Services Secretary Tommy Thompson was petitioned by hospitals requesting exemption from submitting the premarket requirement for non-exempt Class I devices. Instead, Thompson agreed to delay the enforcement of the non-premarket requirement for a year, with the exception of registration and listing.
"If a hospital or third-party reprocessor is reprocessing a Class III device, the submissions should have come in by now," Ng says. "Back in Feb. 14, 2001, they should have come in with a PMA; we didn't receive PMAs from hospitals, so our interpretation is there are no hospitals that are legally using or distributing Class III devices that they are reprocessing in house. They could be contracting with a commercial reprocessor and that's OK. As of Aug. 14, 2001, if a hospital is reprocessing non-exempt Class II devices, they should have come in with a (510k). We don't believe we have any in-house from hospitals; however, we did get approximately 90 (510k)s from commercial reprocessors. We assume--and that's a big assumption--that no hospital is currently reprocessing in-house non-exempt Class II devices. Because Secretary Thompson agreed to that one-year extension, we're not penalizing hospitals if they aren't reporting adverse events or are not yet in compliance with the other post-market requirements except for registration and listing that are related to devices they are reprocessing in-house. On the other hand, we don't have any indication 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 until Feb. 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 back in August 2001," she says. "Those PMAs came to the FDA in February 2001. We allowed 6 months of review time for the agency, and we should have rendered a decision on Aug. 14, 2001. The reprocessors that submitted these applications are telling us they haven't had sufficient time to conduct clinical trials. They had a hard time recruiting patients into their studies and it took longer than envisioned. The clinical data didn't come in time for us to make a decision, so the FDA allowed them 6 more months to collect clinical data to support their PMAs. We have four reprocessors who are legally still in the market of reprocessing Class III ablation catheters. These reprocessors may continue to distribute cardiac ablation catheters until Feb. 14, 2002; then they can only continue if their PMA receives the FDA's approval. That's the only category of Class III devices for which we have applications. At the time we were developing the reuse policy, we learned that approximately 207 devices that were being reprocessed in the US. This list is included in the Aug. 14, 2000 guidance document. That may look very different a year from now. If a manufacturer, 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 of healthcare facilities that are reprocessing medical devices in-house, and says the agency has contracted with an outside firm to conduct a phone survey to contact 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 our new SUD policy," Ng says, "but there still could be some hospitals that are not aware of our requirements. We also contracted with the Joint Commission on Accreditation of Health Organizations (JCAHO) to share information about reprocessing they garnered from hospitals they inspected. At the time the Joint Commission conducted their study, some hospitals reported they were actively reprocessing in house. In an agreement with the agency, JCAHO did not have to provide the names of these facilities to the FDA. The trend is that hospitals are getting out of the reprocessing business and going to third-party reprocessors because meeting the quality systems and premarket submission requirements is not economically feasible. We still hear about some hospitals reprocessing medical devices, but we don't know if it's an exempted Class I device or a Class III device. We have made some informal visits to randomly selected hospitals and so far it's all come up negative."
Ng continues, "One of the criticisms that motivated this is that OEMs complained 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 neither inexpensive nor easy to do, then they said the reprocessors took their technology and benefited from it. One way the FDA could level the playing field was to apply the premarket requirement across the board, and unfortunately, this requirement also applied to hospitals. The good news is that hospitals have until Aug. 14, 2002 to come into compliance with the non-premarket requirements with the exception of registration and listing. Any hospital that is currently reprocessing, must be registered and listed with the agency. We are aware that hospitals are not medical device manufacturers. They are in the patient care arena. Their primary interest is not manufacturing and selling medical eqipment, so the FDA has agreed to extend the enforcement deadline for hospitals. When the FDA first decided to examine its reuse policy, I talked to many risk managers and found many were unaware that their hospitals were engaged in in-house reprocessing. I don't think that is true today. I believe that risk managers have done a terrific job in finding out whether reprocessing of SUDs occurs in their facilities, and if so, educating their facilities about the agency's regulatory requirements."
Under the current framework, the FDA has the authority under the Investigational Device Exemption (IDE) regulation to require manufacturers to obtain informed patient consent for the use of specific medical devices. Outside of the IDE regulation, informed consent is an issue between the hospital and the patient. Ng adds the FDA is hearing conflicting stories about informed-consent issues.
"We hear from HCWs that some doctors aren't aware that a particular device has been used before," Ng says. "The American Medical Association (AMA) told us doctors don't always know if the devices have been reused because by the time they use it in the OR field, all the packaging has been removed so they can't tell it's not the original packaging. They're confused because sometimes if devices are open but not used, the hospital will re-sterilize them and use them. When the reprocessing debate surfaced in late 1999, the media actively reported on this practice, so we know that some segment of the public is aware of it. It's interesting to learn that that few patients question their doctors about whether the device has been used previously. I've been told of a few incidents where patients have requested on their operative permits that they do not want to use reprocessed SUDs."
Ng confirms the GAO's observations that the contingencies screaming the loudest in the debate over reprocessing are the OEMs and the reprocessors, a ruckus 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 the politics out of it and we don't look at the economics of this issue. Whether or not OEMs are losing money because they are not selling as many devices and because reprocessors are inching in on their technology, that doesn't concern us. Three principles underline our reuse policy: we are trying to create a level playing field for everyone; we're trying to base our decisions on good science and solid data; and most importantly, we are protecting public health."
FDA to Examine "Open-But-Unused" Issue
A hot topic related to the reprocessing issue is the open-but-unused debate plaguing OR personnel. Many hospitals are sterilizing and reusing surgical devices and instruments that have been unwrapped but not used in the OR, and risk managers and infection control practitioners are questioning the safety of such a practice.
"A lot of hospitals apparently are re-sterilizing those instruments in-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 this practice is but some of the OEMs are also taking these devices back and crediting 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 FDA needs to address it. I understand some hospitals that open devices and not use them either discard them or ship them off to less-developed countries. We're concerned because these devices can range from low risk to high risk. The feedback we received from OR personnel is that they are concerned about what their administrators consider to be open but unused. It may never touch the patient, it may never be inserted into a patient's body cavity, but sometimes they're not sure it didn't get sprayed with bodily fluids. Is it contaminated or not? Is it gross contamination? We're looking to healthcare communities to help us identify what their current practices are."
In its guidance statement on the reuse of single-use devices, the Association of periOperative Registered Nurses (AORN) states, "Unless so stipulated by the OEM, it is unknown what effect reprocessing may have on the safety and efficacy 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, including quality system regulations, as the used device."
-- Kelly M. Pyrek