Medical Device & Diagnostic Industry
Magazine

HREF="/mddi/by_issue.html">MDDI Article Index

An MD&DI March 1999 Column

FIRST PERSON

According to a trade organization official, the reuse of medical devices originally designated for single use raises serious concerns about safety, effectiveness, and equitable FDA oversight.

If you were being wheeled into surgery, would you be comfortable knowing that your surgeon
would be reusing a disposable medical device during the procedure without anyone having studied whether that device was still safe and effective?

Assuming that one knew this was going to happen (and the vast majority of patients do not), I doubt many of us would approve. Nevertheless, numerous healthcare facilities are engaging in this practice without fully evaluating whether the devices they are reusing have been compromised or contaminated.

Without question, the reuse of medical devices is increasing as hospitals and other healthcare facilities look to contain costs. However, the reprocessing and subsequent reuse of medical devices intended for a single use raise a variety of concerns for manufacturers.

In ensuring the safety and effectiveness of a medical device, the manufacturer considers whether the device could be safely used on more than one occasion, or whether its sterility or performance would be unacceptably compromised by reuse. Manufacturers who cannot reasonably assure the safety and effectiveness of a medical device for more than one use will label this device "for single use only."

Manufacturers have the duty to protect the public health and the right to avoid unacceptable business liability risks by labeling devices for single use only. The Medical Device Manufacturers Association (MDMA) is concerned that current FDA regulation of the reprocessing of single-use devices is too limited to provide the public with a reasonable assurance of continued safety and effectiveness. We also fear that manufacturers may be unfairly held liable for injuries that result from the unsafe reuse of single-use devices.

On principle, FDA should regulate all similar activities equitably. For example, if an OEM were to collect its own single-use devices from a hospital, reprocess them, and then return the devices to the hospital, FDA undoubtedly would call this an adulteration or misbranding of the devices and would initiate legal or administrative proceedings against the OEM. Why should a commercial third party or a hospital be regulated differently from an OEM if it undertakes a similar activity? After all, FDA has informed OEMs that changing device labeling from single to multiple use generally requires the submission of a premarket notification.

The reprocessing of a single-use device for subsequent reuse changes the intended use of the device and can significantly affect the safety or effectiveness of the device. Therefore, the reprocessor of a single-use device should be subject to the same regulatory requirements as manufacturers. In particular, reprocessors of medical devices must be required to demonstrate to FDA and the public that reused single-use devices are still safe and effective for their intended use.

Many manufacturers have submitted information to FDA on patient injuries and infections caused by reused disposable devices. The federal Centers for Disease Control (CDC) has also investigated the reuse of single-use devices and recognizes that this practice can contribute to hospital-based infections, which cost the American healthcare system nearly $3.5 billion annually. In fact, the CDC's guidelines on hospital environmental controls recommend that "items or devices that cannot be cleaned and sterilized or disinfected without altering their physical integrity and function should not be reprocessed" (CDC, Morbidity and Mortality Weekly Report 36, no. 2 [1987]: supplement). The guidelines also suggest that "reprocessing procedures that result in residual toxicity or compromise the overall safety or effectiveness of the items or devices should be avoided."

Nevertheless, FDA has so far refused to enforce regulations that would protect the public against unsafe reuse of single-use medical devices. Although the agency requires commercial reprocessors to register and comply with its quality system regulation, reprocessors currently are not required to submit any studies to FDA in support of their claims that reprocessed single-use devices are indeed safe and effective for multiple use. For their part, hospitals are not even required to register with FDA, much less comply with any standards or protocols for reuse. How, then, can we ensure that patients are not harmed by reused single-use devices?

At the very least, FDA should fulfill its mission of protecting and promoting the public health by requiring healthcare facilities and commercial reprocessors to demonstrate that the single-use devices they reprocess and reuse are still safe and effective. The agency should also require all reprocessed and reused single-use devices distributed by third parties to be labeled as "used and reprocessed," so that practitioners and patients are aware of the nature of the devices they are using or being treated with.

This shouldn't be too much to ask of FDA. After all, many commercial reprocessors suggest that the used devices they attempt to clean and sterilize are indeed safe and effective for further use. For instance, one leading reprocessor claims on its Web site that it can reprocess medical devices with "total safety" for patients. Furthermore, the firm maintains that "each device is 100% performance tested using thorough visual and functional cross-inspections."

If commercial reprocessors can market their remanufacturing operations this way, then FDA should require these companies to prove their claims by submitting premarket notifications with supporting clinical data. No manufacturer of a medical device would be allowed to make statements about the safety and effectiveness of a device for its intended use without receiving the appropriate clearance or approval. Why should commercial reprocessors be permitted to evade this standard?

MDMA and its member manufacturers will continue educating healthcare facilities and consumers about the dangers involved in the reuse of single-use devices. However, manufacturers can only do so much to protect patients against unsafe reuse.

It's up to FDA to step in and enforce its regulations. The risks inherent in any surgical procedure, for example, are real enough. Should patients also have to worry about whether the very devices used in that procedure could injure or infect them?

Stephen J. Northrup is executive director of the Medical Device Manufacturers Association (MDMA), a national trade organization based in Washington, DC, that represents approximately 130 independent manufacturers of medical devices, diagnostic products, and healthcare information systems.

Copyright ©1999 Medical Device & Diagnostic Industry