FDA to regulate reuse of ‘high-risk’ devices
January 1, 2000 3 minutes read
FDA to regulate reuse of high-risk’ devices
In response to growing concerns over the safety of single-use medical devices that are reprocessed for reuse, the Food and Drug Administration (FDA) has taken an initial step to more strictly regulate the practice.
The FDA has proposed a three-tiered system that would apply the greatest restrictions to high-risk devices. The agency did not specifically identify which devices fall into that category, but has scheduled a Dec. 14, 1999, open meeting in Rockville, MD, to discuss the current practice of reprocessing and reusing devices that are labeled or otherwise intended for only one use.
Larry Kessler, FDA’s chief of device surveillance, anticipates that the number of high-risk devices will be small. "Right now, there’s a lot of emotion about this," he says. "We need good, credible science to make the decision."
According to recent estimates, about 1 million disposable devices are reprocessed every year in the United States. Critics of the practice argue that recycled products put patients at risk, despite conflicting reports from the Centers for Disease Control and Prevention (CDC) stating that potential problems are "rare."
In response to a congressional urge to crack down on unregulated reprocessing, the FDA recently announced that it will take the first step towards regulation. Under the proposed strategy, disposable medical devices would be categorized into three groups:
I. High-risk: The FDA will stop the sale of those products that will not work after repeated resterilization or show potential safety hazards.
II. Moderate-risk: Products that raise concern, but lack actual evidence of harm, will have safety standards established as additional data is collected by reprocessors.
III. Extremely low-risk: The FDA will permit sales to continue, and require hospitals that reuse products to register for continued monitoring.
"A single-use device’s risk category may depend on such factors as the complexity of the procedures needed to reprocess the device, the risk of infection from reusing the reprocessed device, any risk of performance failure with respect to reprocessing, and the scientific information available on reprocessing the specific device," the FDA reported in a position paper on the proposal. "For single-use devices in the high risk category, i.e., products that may pose a significant public health risk to patients and users after reprocessing, FDA is considering enforcing all the agency’s regulatory requirements, including premarket applications."
While the FDA did not specify devices by risk category, high-risk devices that are currently being reprocessed by some facilities would presumably include items that enter sterile tissue like angioplasty balloon catheters. The Association for Professionals in Infection Control and Epidemiology has previously advised the agency that heightened regulation and oversight may be warranted for reprocessing single-use critical care items that come into contact with sterile tissue or the vascular system. Under its current policy, the FDA has exercised discretion in letting reprocessors operate without submitting premarket product information.
Under the proposed strategy, FDA would consider regulating third-party processors and health care facilities that engage in the reprocessing of single-use devices the same way the agency has regulated original equipment manufacturers. That includes registration and listing of firms, premarket notification and approval requirements, submission of adverse event reports, and labeling requirements.
Although this is only the first step, the FDA needs to ensure "that reprocessed devices be as safe as new devices," says Melissa Merz, spokeswoman for Sen. Richard Durbin (D-IL), who pushed for FDA action. "The fact remains that Congress needs to go further to ensure patients are informed before a recycled device is used on them."
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