FDA may restrict reuse of high-risk’ devices

But agency says strategy not set in stone

The Food and Drug Administration has taken an initial step to more strictly regulate the reuse of single-use medical devices, outlining a three-tiered system that would apply the greatest restrictions to high-risk devices. However, the FDA did not specifically define which devices fall into that category, instead seeking input on the proposal at a Dec. 14, 1999, open meeting in Rockville, MD.

"We are looking for comment from all of the people involved in the issue," an FDA spokes woman tells Hospital Infection Control. "Based on the feedback — the comments we get on this strategy that we are considering — then we will be making final decisions. But it is going to be a while, because we want to give every interested party a chance to have input."

The proposals calls for placing reprocessed single-use devices into categories of low, moderate, or high risk, and applying tougher regulatory measures as risk increases. "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."

APIC: Heightened regulation may be warranted

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 Associa tion 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. (See Hospital Infection Control, October 1999, pp. 133-136.)

Under the proposed strategy, FDA would consider regulating third-party processors and health care facilities that engage in 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.

Indeed, it is hoped the process will lead to clear FDA labeling regarding appropriate use and reuse of medical products, notes Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas. Otherwise, hospitals still could be open to liability for reprocessing items that are labeled for single use and disposal. "The problem is the labeling," Grant says. "That’s why I am not doing it, because it says right on the label, single use only.’ I’m not going to go against the label."

[Editor’s note: Full details on the FDA proposal and more information on the December meeting are available on the Internet at www.fda.gov/cdrh/reuse/index. html.]