Medical device reprocessing—an alternative - Opinion
The US Food and Drug Administration's (FDA's) updated guidance for reprocessing devices marketed as single-use devices (SUDs) was unveiled Aug 14, 2000. Based on this guidance, hospitals and third-party reprocessors now must follow the same premarket submission requirements as original equipment manufacturers (OEMs). Although it has been almost two years since the guidance was released, there still are many misconceptions and erroneous notions regarding the current state and practice of reprocessing.
THE STATE OF REPROCESSING
Reprocessing offers health care providers a patient-safe, economic alternative with a proven safety record. (1) Medical devices represent the highest recurring expense to hospitals after staffing. Reusing rather than disposing of these expensive devices translates into cost savings that can be reinvested in resources (eg, more nurses, new technology) health care providers may need to better serve patients.
Reprocessing is not a secret. Hospitals have reprocessed devices safely for two decades, and third-party reprocessing has become a $40 million-a-year industry. (2) Even before the FDA's updated guidance was issued, third-party reprocessing was regulated by the FDA. Regulations governing reprocessing have existed for as long as there have been regulations for medical devices. The Federal Food, Drug, and Cosmetic Act, established in 1938 and amended in 1976 to include medical devices, regulates the sale of devices intended for use on humans in the United States. Reprocessed SUDs are not excluded from these regulations. In fact, the FDA/ORA Compliance Policy Guides Manuals, issued in 1987, assigns responsibility for the safety and effectiveness of a reprocessed SUD to the party performing the reprocessing. (3)
Third-party reprocessors must comply with a host of regulatory requirements, the most significant of which is the Quality System Regulation (QSR), which includes extensive controls over all manufacturing operations (eg, cleaning, disinfecting, packaging, labeling, sterilizing, distributing). The FDA's QSR requirements apply to both third-party reprocessors and OEMs, as do the premarket submission requirements in the FDA's guidance. Reprocessors take exhaustive measures to ensure the quality and effectiveness of reprocessed SUDs for physicians, hospitals, and patients.
When the FDA was formulating its guidance for reprocessing SUDs, one major issue was whether hospitals that reprocess their own SUDs would be considered manufacturers. If they were, the FDA would have regulatory oversight of their reprocessing activities. A secondary issue was whether third-party reprocessors and hospitals would have to submit premarket notifications for reprocessed SUDs, either through the 510(k) premarket notification process or the premarket approval (PMA) process. This point was debated because reprocessors essentially would be submitting a device for premarket clearance that already had received premarket clearance when first introduced by the OEM. Ultimately, the FDA decided that hospitals and third-party reprocessors would be regulated in the same way as manufacturers. There was never a question as to the regulatory status of third-party reprocessors, however, because the FDA always has regulated them.
THE LABELING QUESTION
A three-tiered classification system for devices listed in the Code of Federal Regulations (CFR) forms the basis for determining what type of premarket clearance is required of any new medical device. This system applies to all devices, not just reprocessed SUDs. For a time, the FDA looked at a special classification scheme for reprocessed SUDs, but it ultimately decided to use the existing system. In August 2000, the FDA issued a guidance document titled "Enforcement priorities for single-use devices reprocessed by third parties and hospitals." This document identifies the existing system as the one under which SUDs would be classified because it made more sense than a new system, was subject to less misinterpretation, and would
ensure a reprocessing and reuse regulatory program based on good science
that protects public health, while ensuring that our regulatory
requirements are equitable to all parties. (4)
The FDA has studied labeling issues surrounding reprocessed devices to determine how SUDs should be labeled to comply with FDA labeling requirements. To satisfy the FDA's general device labeling requirements, the label on a reprocessed SUD must include several pieces of information, most of which are fairly simple and straightforward. There are certain labeling requirements, however, that raised questions as to exactly what labeling information would be considered acceptable. For example, should the OEM or the reprocessor be designated as the manufacturer? Can the OEM's labeling be used for a reprocessed device? How should devices being sent by a hospital to a company for reprocessing be labeled? Must these devices include adequate directions for use or have prescription labeling, even though they are going to be reprocessed? If a third-party reprocessor ships a device back to the hospital that used it originally, does it need to be labeled as that hospital is familiar with the device? These and other questions were dealt with in the FDA's Labeling Recommendations for Single-use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA, issued on July 30, 2001. (5)
After issuing draft guidance and receiving responses from key stakeholders, the FDA ultimately decided that premarket requirements would have to be met by those engaged in SUD reprocessing. Reprocessors initially were given six months to comply with PMA requirements for Class III devices and 12 months to meet 510(k) requirements. This was an extremely constrictive timeframe for both reprocessors and the FDA to operate in compared to the 30 months OEMs were given in 1976 when the Medical Device Amendments were enacted--even after US Senate findings reported that faulty new medical devices were responsible for 731 deaths and 10,000 injuries. (6)
Contrary to what OEMs and other critics would have the public believe, the FDA has stated that reprocessed SUDs do not appear to pose a threat to public health. (7) The Government Accounting Office (GAO) conducted a seven-month study of SUD reprocessing at the request of the US Congress, reviewing scientific literature and meeting with officials from the FDA, Centers for Disease Control and Prevention (CDC), and the Health Care Financing Administration (ie, Centers for Medicare and Medicaid Services). The GAO also interviewed government and industry experts, physicians, hospital administrators, and other health care providers, and GAO staff members reviewed FDA documents and documents submitted to the FDA by interested parties. In its report to Congress, "Single-use medical devices: Little available evidence of harm from reuse but oversight warranted," the agency concluded,
The evidence suggests that some kinds of SUDs can be safely reprocessed if
appropriate cleaning, testing, and sterilization procedures are carefully
followed. However, SUD reprocessing is not invariably safe, and little is
known about the practice of SUD reprocessing in health care institutions.
For this reason, FDA has taken steps to increase its oversight of SUD
Interestingly, the last sentence in the GAO's conclusion states that,
... because the demonstrated health risks from SUD reprocessing are small,
[increased FDA oversight] may have only limited impact on public health.
The report also says,
The safety of reprocessing some types of devices, such as some types of
[electrophysiology] catheters, is supported by well-developed clinical
Hospital infection experts at the CDC told GAO auditors that "the evidence showed that SUD reprocessing poses little, if any, public health risk." (11) Even Forbes Magazine, in a highly charged, negative article, had to admit that "no one can point to a surgical complication or an infection known to be a result of unauthorized reuse." (12) The GAO also found that
several reports of patient adverse events allegedly due to SUD reprocessing
that we identified were inaccurate or not relevant to the debate. (13)
It also is important to note that there are numerous examples of new medical devices causing patient injury during their first use.
The GAO states that
only a very small percentage of the reports FDA has received through its
Medical Device Reporting (MDR) program concerned patient adverse outcomes
associated with reprocessed SUD's. (14)