REPROCESSING OF MEDICAL DEVICES:

REPROCESSING OF MEDICAL DEVICES:
GOVERNMENT INTENSIFIES ITS SCRUTINY AS CLINICIANS DEBATE PATIENT-SAFETY ISSUES

By Kelly M. Pyrek

With the increasing degree of acuity of procedures performed in ambulatory surgery centers (ASCs) dictating the need for more complex surgical instrumentation and medical devices, owner/operators must be knowledgeable about refurbishing and reprocessing issues. Reprocessing is generally regarded as the cleaning, disinfection, sterilization, repair, reconditioning and refurbishing of medical devices, both items labeled as reusable and single use. Reprocessing can be done inhouse by hospitals or by third-party reprocessors, and each reprocessor is heavily regulated by the government with oversight by the Food and Drug Administration (FDA).

Within the reprocessing industry, many terms are used, but what's in a name? Everything, if you're a company that is in the business of reprocessing medical devices and equipment. As the FDA continues to grapple with the oversight and regulation of reprocessors, those in the business are working to differentiate themselves in the used medical devices marketplace. As documented in the Federal Register (Vol. 62, No. 246), the FDA acknowledges that medical device marketing has always involved a certain amount of remarketing of used medical devices that were refurbished, rebuilt, serviced, conditioned, cosmetically enhanced or marketed "as is" for further use.

The FDA's concern has been that remarketing used medical devices may consist of activities that significantly change the finished device's performance, safety specifications or intended use. As defined by the FDA's Quality System regulation, these activities constitute "remanufacturing." Remarketing also can consist of activities that do not change the device's performance or safety, and include refurbishing, reconditioning, rebuilding or servicing the device. In another Federal Registerdocument, the FDA stated that refurbishing relates to activities and entities outside the control of the original equipment manufacturer (OEM) and believes that entities performing such functions meet the definition of a manufacturer. Issues have been raised relating to the applicability of other regulatory requirements to remarketers, so the FDA has been working with the International Association of Medical Equipment Remarketers (IAMER) to define the concerns of the medical equipment refurbishing community.

Hospital closures and mergers have created a glut of repairable used medical equipment that is being reconditioned and sold back into the healthcare marketplace. Depending upon its condition, this refurbished equipment can save healthcare facilities as much as 30 percent to 70 percent over the cost of new equipment, according to the IAMER. However, some refurbishers warn healthcare administrators not to trade small price tags for large problems related to patient safety and legal liability.

Tom Green, president of Michigan-based Paragon Service -- the refurbishers and servicers of anesthesia machines and equipment -- is a vocal member of the healthcare equipment refurbishing industry.

"What really concerns me are businesses that call themselves reconditioners or refurbishers yet it many cases their equipment is merely cleaned up or repainted," Green says. "They ship it to the end user, telling them it has been refurbished when in some cases no mechanical rebuilding was done. "Some companies think the most important aspect is the cosmetic refurbishing, but I believe the mechanical refurbishing is more important because it's not the paint that keeps people alive, it's the medical device. Yet that's the part of the process that is being neglected the most. It dumbfounds me."

Green asserts that registration by the FDA as a refurbisher doesn't ensure the quality of the work done. "Companies can say they're FDA registered and that's paramount to the quality of the equipment, but in reality that means nothing. It means you fill out a one-page form every year and you have to put a sticker on the back of the machine saying that you refurbished this machine, supplying your name, address and phone number. Then you have to track from whom you bought it, who you sold it to and you follow the manufacturers' guidelines when you do the work. That doesn't seem real stringent to me."

Green says the most important aspect of a refurbisher is his qualifications. Green says Paragon is an authorized service organization and authorized refurbisher for the manufacturers who make the machines, and believes this is the way to establish credibility in the industry. "We know how to provide the service and how to do the mechanical work," Green says, "because we get our training and parts directly from the manufacturer. It means we have been chosen as a recognized refurbisher to represent their equipment. Without those qualifications, how can you say you're (legitimate)? In order to refurbish it properly you must know how to service it. Otherwise you only know how to paint it and clean it."

Green explains proper refurbishing -- especially of life-support equipment -- is a time- and labor-intensive process encompassing cosmetic and mechanical reconditioning. For example, four anesthesia machines he recently purchased from another refurbisher required an "astounding" amount of time to recondition and will cost the potential client a fair amount of money, but Green says that when a machine leaves his door, he knows it is worthy of use by clinicians because of his rigorous expectations. He worries, however, that an unscrupulous refurbisher won't share his high standards. "The danger is, what if a machine was reconditioned and set up by someone who didn't care as much as we did about the end user and patient safety?"

Green says refurbishers have three responsibilities to which they must adhere: following the moral responsibility of patient safety, avoiding lawsuit-related bankruptcy and answering to government mandates. "Even though we talk about patient harm and it scares the hell out of us, I'm not aware of any refurbished medical equipment that's ever harmed anybody," Green says. "There are just a handful of instances involving refurbished equipment that wasn't handled properly and caused harm. You don't want to minimize that because people still got hurt, but it's a percentage that's no greater than the number of injuries created by brand-new equipment out of the box. Let's not run from refurbishers because most of them do a great job; it's the (small minority) that worries me because I don't want to see patients harmed."

Although there are no limits on the number of times a medical device can be reconditioned, a certain level of protection is offered, in that refurbishers must recondition the device or equipment equal to or greater than the OEM's specifications, Green says. "You can never go backward, but some companies do. They'll put in cheaper bellows than when it was manufactured originally, for example. But because we are a service organization, we have to meet or exceed the OEM's specifications."

Green also says refurbishers must not sell refurbished equipment or devices that are no longer supported by the manufacturer; doing otherwise he says would be "unconscionable."

Pitfalls aside, Green reports that future demand for refurbished devices and equipment will be "huge."

"Our business is up 50 percent this year from last year," Green says. "I understand that the number of outpatient ORs will surpass the number of inpatient ORs, and the industry will keep growing. In the last 10 years the surgery center market has grown and the future remains in surgery centers."

While the kind of reprocessor or refurbisher an ASC might use is a simple choice of free-market options, the regulation of the reprocessing industry is anything but simple. In an attempt to level the playing field for hospitals, third-party reprocessors and OEMs, the FDA has introduced in phases stringent requirements including registration and listing, tracking, adverse event reporting, corrections and removals, labeling, quality system regulation and premarket submission requirements. On Oct. 26, 2002, Congress passed the Medical Device User Fee and Modernization Act (MDUFMA), public law 107-250, amending the Federal Food, Drug and Cosmetic Act and equipping the FDA with new resources, responsibilities and challenges.

The three significant provisions of the act include:

• User fees for premarket reviews that will fund FDA goals to provide patients with earlier access to safe and effective technology and will provide more interactive and rapid review to the medical device industry.

• Establishment inspections may be conducted by accredited third parties under carefully prescribed conditions.

• New regulatory requirements for reprocessed single-use devices (SUDs), including provisions requiring the submission of additional data on devices now being reprocessed, plus a new category of premarket submission, the premarket report.

Before enactment of the new law, the regulatory requirements for manufacturers of reprocessed SUDs depended upon the class of the device. Manufacturers of reprocessed Class I and II (representing the lower-risk medical devices) SUDs were required to have a 510(k) unless the device was exempt, while reprocessors of Class III devices (higher-risk devices) were required to obtain premarket approval. Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but will need to submit 510(k)s that include validation data. This validation data also will be required for many reprocessors of SUDs that are currently the subject of cleared 510(k)s. Reprocessors of Class III devices will need to submit a premarket report.

At the core of the reprocessing issue are concerns about safety and effectiveness of refurbished medical devices and surgical instrumentation, particularly devices deemed by its manufacturers to be single use only. An improperly reprocessed device can harbor bacteria that trigger infections that can lead to serious illness or death. To create better accountability, the FDA is requiring that all reprocessed SUDs introduced into interstate commerce after Jan. 25, 2004 must "prominently and conspicuously" bear the statement: "Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device]." This provision is designed to make it easier for healthcare professionals and patients to know when a reprocessed device is being used.

While the jury is still out on reprocessing as a whole, reprocessing of SUDs in particular has come under fire. In June 2000 the Government Accounting Office (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 GAO reported that various surveys conducted by other organizations found 20 to 30 percent of U.S. healthcare facilities say they reuse at least one type of SUD and that at least one-third of the facilities that do so have contracted with third-party reprocessors. The GAO also learned many hospitals believe manufacturers market devices with a single-use label because of the economic benefits of doing so, and therefore believe many SUDs can be reprocessed.

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 that a minority of the country's 6,000-plus hospitals and roughly 2,700 ambulatory surgery centers reprocess SUDs in-house.

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 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.

Patients' and consumers' perception that new is always better and is a guarantee of a device's sterility is a challenge. While empirical evidence is lacking, science is sometimes clouded by emotion when patient safety is discussed. The GAO decided the argument has no conclusive evidence either way, 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."

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.

It can be ascertained that reprocessors 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.

In its guidance statement on the reuse of SUDs, 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 if 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.

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 several times without increasing patient risk.

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, 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. The GAO is quick to point out that the lack of conclusive information about reprocessing is a strong enough argument for additional monitoring and regulation of this practice.

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 U.S. 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 could be adequately cleaned. Saw blades and stainless steel equipment that are not complex are probably safe to reprocess and reuse. Other devices that have a lot of lumens or bells and whistles may be very cumbersome and are probably more difficult to clean. There may be no way to truly sterilize some of the 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 for any incidents where a reprocessed SUD caused an adverse event, but 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. 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 led to an adverse patient event, but we can't prove it was the reprocessing that caused the malfunction."

In December 2002, The Center for Patient Advocacy released a survey of surgeons, operating room nurses and consumers revealing that health care professionals have grave concerns about the reuse of SUDs. The survey showed the majority of those surveyed oppose the use of reprocessed SUDs and that most consumers are unaware of the practice of reprocessing. According to the survey, 3 out of 4 surgeons believe that reprocessed SUDs pose a risk to patients. The survey also found that 74 percent of surgeons thought SUDs should not be reprocessed and 79 percent of nurses believe that the use of reprocessed SUDs should be discontinued.

"Clearly, this is a safety issue for patients," says Neil Kahanovitz, MD, president and founder of the Center for Patient Advocacy. "The fact that surgeons and nurses are overwhelmingly concerned that the reuse of SUDs poses a threat to product quality as well as risk of infection and the spread of disease should raise red flags with the public."

The survey, which interviewed 401 surgeons, 401 surgical nurses and 1,004 consumers, was paid for by the Endoscopy Division of Smith & Nephew Inc.

The survey also found that 82 percent of nurses and 71 percent of surgeons surveyed say they would be uncomfortable if a reprocessed single use device were used on themselves or a family member.

"How can we expect patients to feel safe with these reused devices, if surgeons and nurses clearly would not want the devices used on them?" Kahanovitz asks.

Sixty-five percent of consumers are unaware that these surgical devices may have previously been used, often multiple times, in other patients. "It is unacceptable that hospitals do not routinely inform patients that these devices will be used in their surgery," Kahanovitz says. By a 2-to-1 ratio, patients surveyed said they would expect to be informed about the practice before surgery. And of those aware of this practice, nearly 70 percent were unaware they had the right to request that such devices not be used in their surgery.

Medical device reprocessors say they support a clear, rational regulatory scheme that is based on demonstrated public safety risks and not on what they call "hypothetical risks designed to provoke public alarm." Reprocessors are represented by the Association of Medical Device Reprocessors (AMDR), whose members perform approximately 80 percent of third-party reprocessing of devices labeled for single use. The AMDR says that the reprocessing of SUDs has occurred for more than 20 years and when done properly, reprocessing does not endanger public health and allows healthcare facilities to conserve limited dollars. What it comes down to in the reprocessing debate is the overriding economic factor involved. The AMDR charges that medical device manufacturers seek to establish economic and regulatory barriers designed to thwart competition, and that they attempt to persuade healthcare facilities that reprocessed devices are more affordable than new devices and that market competition from reprocessing exerts downward pressure on the price of new medical devices. The AMDR also says medical device manufacturers try to emphasize that SUD labels provide little indication of the product's useful life, and that if an SUD can be properly cleaned, sterilized and packaged without negatively impacting its functionality, it can and should be used again.

"It's important to note that not every device should be reprocessed," emphasizes Mark Salomon, senior vice president of corporate development for Vanguard Medical Concepts. "One of the guiding principles of the AMDR reprocessors is that a device should only be reprocessed if it can be scientifically proven and validated that the device can be cleaned, functionally tested, sterilized and reused without harm to the patient. The FDA's new regulatory framework eliminates many of the questions that have been raised about the safety and efficacy of reprocessing SUDs. Reprocessed devices now are put through the same processes and are treated in exactly the same way as new devices coming straight from the manufacturer. Although hospitals have long regarded reprocessing as a safe alternative to the wasteful single use of durable medical devices, the guidance announced by the FDA in August 2000 eliminates any doubt that a reprocessed device is just as safe and works exactly the same as a new one. For that reason, patients and healthcare personnel can expect the same margin of safety from a reprocessed device that they expect from a new one."

While hospitals try to cut costs by reprocessing, OEMs are lobbying hard against this practice. In this battle over dollars and sense, reprocessing firms like Alliance Medical Corporation say patient safety can be safeguarded while free enterprise is protected.

"The FDA has leveled the playing field by applying the same rules to reprocessors and medical device manufacturers," says Don Selvey, vice president of regulatory affairs and quality assurance at Alliance. "Not only does this entail the submission of 510(k)s and PMAs, but third-party reprocessors undergo the same FDA inspection as that performed at an OEM. Healthcare facilities should ask to review a reprocessor's FDA inspection report called an Establishment Inspection Report, which is only issued when a reprocessor or device manufacturer is in compliance with the FDA's regulations. It's also important to remember that device manufacturers, not the FDA, designate a device as "single-use." In many cases, this is done by the manufacturer to limit liability and increase sales, not because the device warrants such a label. In some instances, reusable devices have been reclassified as single-use without significant changes in design or materials. Reprocessing drives efficiency in healthcare by offering hospitals a way to save significant sums of money without changing device preferences or practice patterns. For financially strapped hospitals, which include most hospitals in the United States, these savings can be used to bolster patient care."

"Balancing patient safety with free enterprise is not an either/or proposition; both can be accomplished," Solomon says. "Today's rapidly advancing technology has incredible benefits for patients, but it also carries a cost for the hospital and the OEM. Each year, the healthcare industry discards millions of dollars in otherwise functional medical devices after a single use. There is no question that medical device reprocessing offers a safe, scientific alternative that can help medical facilities realize as much as a 50 percent savings over the purchase price of new medical devices without affecting the quality of patient care."

"We are firm believers in the safety of our reprocessed devices. It's important to note that reprocessing is not just about saving hospitals money; additional benefits of the practice are becoming widely apparent," says Kevin Kelley, vice president of business development for ClearMedical. "In addition to creating considerable savings for the hospital, other benefits of reprocessing include the outsourcing of regulatory compliance and reporting issues, acquiring scientific expertise, reducing risk and realizing efficiencies by using the focused expertise of a specialist in medical device reprocessing, and reducing medical waste."