Reprocessing of Medical Devices:

Reprocessing of Medical Devices:
Government Intensifies Scrutiny as Clinicians DebatePatient-Safety Issues

By Kelly M. Pyrek

Reprocessingis generally regarded as the cleaning, disinfection, sterilization, repair,reconditioning and refurbishing of medical devices, both items labeled asreusable and single use. Reprocessing can be done inhouse by hospitals or bythird-party reprocessors, and each reprocessor is heavily regulated by thegovernment with oversight by the Food and Drug Administration (FDA).

While the kind of reprocessor a hospital might use is a simple choice offree-market options, the regulation of the reprocessing industry is anything butsimple. In an attempt to level the playing field for hospitals, third-partyreprocessors and original equipment manufacturers (OEMs), the FDA has introducedin phases stringent requirements including registration and listing, tracking,adverse event reporting, corrections and removals, labeling, quality systemregulation and premarket submission requirements. On Oct. 26, 2002, Congresspassed the Medical Device User Fee and Modernization Act (MDUFMA), public law107-250 amending the Federal Food, Drug and Cosmetic Act and equipping the FDAwith 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 formanufacturers of reprocessed SUDs depended upon the class of the device.Manufacturers of reprocessed class I and II (representing the lower-risk medicaldevices) SUDs were required to have a 510(k) unless the device was exempt, whilereprocessors of class III devices (higher-risk devices) were required to obtainpremarket approval. Under the new law, reprocessors of some exempt devices willno longer be exempt from the 510(k) submission requirements but will need tosubmit 510(k)s that include validation data. This validation data also will berequired for many reprocessors of SUDs that are currently the subject of cleared510(k)s. Reprocessors of class III devices will need to submit a premarketreport.

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

While the jury is still out on reprocessing as a whole, reprocessing of SUDsin 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 conductedby other organizations found 20 to 30 percent of U.S. healthcare facilities saythey reuse at least one type of SUD and that at least one-third of thefacilities that do so have contracted with third-party reprocessors. The GAOalso learned many hospitals believe manufacturers market devices with asingle-use label because of the economic benefits of doing so, and thereforebelieve many SUDs can be reprocessed.

Patients' and consumers' perception that new is always better and is aguarantee of a device's sterility is a challenge. While empirical evidence islacking, science is sometimes clouded by emotion when patient safety isdiscussed. 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 andreused on other patients."

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."

It can be ascertained that reprocessors are following similar reprocessingprocedures, 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 ofperiOperative 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 if the integrity and functionalityof a reprocessed SUD cannot be demonstrated and documented as safe for patientcare and/or equal to the original device specifications, the device cannot bereprocessed and reused.

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 several times without increasingpatient risk.

The challenge lies in identifying, documenting and tracking adverse patientoutcomes associated with reprocessed SUDs. Although the FDA has an establishedMedical Device Reporting (MDR) program, the data can be misinterpreted orunder-reported. Out of approximately 125,000 reports of patient injuries anddevice malfunctions, 49 cases were for SUDs included on the FDA's list offrequently reprocessed devices. The GAO is quick to point out that the lack ofconclusive information about reprocessing is a strong enough argument foradditional monitoring and regulation of this practice.

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 could be adequately cleaned. Saw bladesand stainless steel equipment that are not complex are probably safe toreprocess and reuse. Other devices that have a lot of lumens or bells andwhistles may be very cumbersome and are probably more difficult to clean. Theremay be no way to truly sterilize some of the complex devices to the level thathealthcare workers are comfortable using them on another patient."

In December 2002, The Center for Patient Advocacy released a survey ofsurgeons, operating room nurses and consumers revealing that healthcareprofessionals have grave concerns about the reuse of SUDs. The survey showed themajority of those surveyed oppose the use of reprocessed SUDs and that mostconsumers 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. Thesurvey also found that 74 percent of surgeons thought SUDs should not bereprocessed and 79 percent of nurses believe that the use of reprocessed SUDsshould be discontinued.

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

The survey, which interviewed 401 surgeons, 401 surgical nurses and 1,004consumers, was paid for by the endoscopy division of Smith & Nephew Inc. Thesurvey also found that 82 percent of nurses and 71 percent of surgeons surveyedsay they would be uncomfortable if a reprocessed single use device were used onthemselves or a family member.

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

Medical device reprocessors say they support a clear, rational regulatoryscheme that is based on demonstrated public safety risks and not on what theycall "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 ofdevices labeled for single use. The AMDR says that the reprocessing of SUDs hasoccurred for more than 20 years and when done properly, reprocessing does notendanger public health and allows healthcare facilities to conserve limiteddollars. The AMDR also says if an SUD can be properly cleaned, sterilized andpackaged without negatively impacting its functionality, it can and should beused again.

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

While hospitals try to cut costs by reprocessing, OEMs are lobbying hardagainst this practice. In this battle over dollars and cents, reprocessing firmslike Alliance Medical Corporation say patient safety can be safeguarded whilefree enterprise is protected.

"The FDA has leveled the playing field by applying the same rules toreprocessors and medical device manufacturers," says Don Selvey, vicepresident of regulatory affairs and quality assurance at Alliance. "Notonly does this entail the submission of 510(k)s and PMAs, but third-partyreprocessors undergo the same FDA inspection as that performed at an OEM.Healthcare facilities should ask to review a reprocessor's FDA inspection reportcalled an Establishment Inspection Report, which is only issued when areprocessor 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 themanufacturer to limit liability and increase sales, not because the devicewarrants such a label. In some instances, reusable devices have beenreclassified as single-use without significant changes in design or materials.Reprocessing drives efficiency in healthcare by offering hospitals a way to savesignificant sums of money without changing device preferences or practicepatterns. For financially strapped hospitals, which include most hospitals inthe United States, these savings can be used to bolster patient care."

"Balancing patient safety with free enterprise is not an either/orproposition; both can be accomplished," Solomon says. "Today's rapidlyadvancing technology has incredible benefits for patients, but it also carries acost for the hospital and the OEM. Each year, the healthcare industry discardsmillions of dollars in otherwise functional medical devices after a single use.There is no question that medical device reprocessing offers a safe, scientificalternative that can help medical facilities realize as much as a 50 percentsavings over the purchase price of new medical devices without affecting thequality of patient care."