FDA Ponders Limits on Reprocessing of Single-Use Devices
September 1, 2000 5 minutes read
FDA Ponders Limits on Reprocessing of Single-Use Devices
By Julie Crawshaw
Lawmakers and food & drug administration (FDA) regulators in Washington, DC, are attempting to iron out changes in procedures for reusing medical devices, but find themselves caught between manufacturers of single-use devices and multiple-use devices.
A subcommittee of the U.S. Senate has held hearings on an FDA pledge that it will more fully implement current law to ensure that reprocessed devices are safe. While hospitals that reprocess devices labeled for single use have been allowed to do so as long as they assume all liability, the FDA is proposing the change to a system that would phase in requirements based on the risk of reprocessing the device. Reused devices are classified as low risk (e.g., sharps containers), moderate risk (e.g., anesthesia breathing circuits), or high risk (e.g., angioplasty balloon catheters).
However, Josephine Torrente, president of the Association of Disposable Device Manufacturers (ADDM), an organization that represents manufacturers of single-use devices, said the FDA’s new guidance plan is "fundamentally flawed." She points out that, while they require full compliance with the law for some devices, the FDA’s guidances leave two enormous gaps in patient protection. "First, they allow high-risk devices to be reprocessed without FDA approval, and second, they stamp FDA approved’ on products that are not safe for use in multiple patients," Torrente said. "These practices do not adequately protect patients." She objected to the FDA finalizing its new guidelines unless they close the gaps that allow patients to be put at risk.
The FDA’s move to "level the playing field" among single-use device manufacturers and reprocessors could ultimately result in more infection control professionals recommending the controversial practice to save their hospitals money. "I see this [FDA draft] as extremely valuable guidance, and [normally] I am antiregulation," says Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial and Trinity Medical Center, both in Dallas, Texas. "This actually for the first time gives me a tangible tool that I can envision using with my financial people while protecting the health and welfare of my patients."
In a plan to phase in the requirements, the FDA would enforce premarket notification and premarket application requirements within six months of issuance of final guidance if the reprocessed device is categorized as high risk, and within 12 months if the device is categorized as moderate risk. Some low-risk devices will be exempt from the requirements, but premarket information would have to be submitted within 18 months for those that are not.
After receiving public comment on the draft guidance, FDA will issue final guidance and begin implementation of an enforcement strategy that would regulate original equipment manufacturers, third-party reprocessors, and hospital reprocessors in the same manner. Hospitals will be given an additional six months after the finalization of the guidelines before having to make any changes.
Accountability Will be Required at all Levels
"The FDA is proposing a strategy to level the playing field, and instead of having three levels of care, we will have one," says Grant. "Whether you are a hospital, a third-party reprocessor, or the original manufacturer, you are going to be held accountable eventually." Grant does not currently use reprocessed single-use devices in either of her work sites, but she may recommend using a third-party reprocessor for low- and moderate-risk devices after all the FDA changes are finalized and the phase-in periods are over.
"I would probably use single-use reprocessed devices because now the FDA has put in controls and checks and balances," she says. "If there is reprocessing involved in a single-use item, the third-party [company] is now going to be giving a similar guarantee [of safety to what the original manufacturer gives] because they jumped through all of the hoops. So from a liability standpoint, I am in clear conscience using a vendor that has met all of the criteria—the same criteria as an original vendor."
While the FDA has included similar guidance for assessing the resiliency of materials in reused devices, the key point is that if a device is classified as high risk in either category, it is high risk across the board, she notes. "If it is high risk for infection and low risk for integrity upon reprocessing, it doesn’t matter; it is still a high-risk device," Grant says. "That makes it very easy to try to determine what it is you are looking at reprocessing."
Similarly, a moderate risk classification for infection remains at that level, even if it is deemed low risk for materials integrity problems, she adds. Grant observes that few things are going to be classified as low risk. "It’s got to be classed as low risk for infection and low risk for the integrity of the product," she says. Some of the low-risk devices are going to be totally exempt from even a premarket analysis. "I am actually looking forward to this, because there are low-risk devices that I would love to reuse (i.e., drill bits in orthopedic surgery)," Grant says. "I won’t right now because I would be [reprocessing] in a hospital or using a reprocessor. And neither of those two is [currently] held to the same standard as the original manufacturer. Eventually, this will allow me to save my hospital some money."
Some of the larger facilities that have the resources for central sterile processing may consider meeting all of the requirements to begin or continue in-house reprocessing, Grant notes. But many other facilities may consider contracting the service out to third-party vendors, she adds. Indeed, there has been speculation that the FDA action could spur more hospitals to use third-party reprocessors so they won’t have to worry about compliance issues while reprocessing in-house.
"That’s a scenario I have heard discussed," says Pamela J. Furman, JD, executive director of the Association of Medical Device Reprocessors (AMDR) in Washington, DC. "But it’s a long time between point A and point B, and we need to focus on point A." Furman says that AMDR continues to be in favor of strong but "reasonable" FDA regulations. "It shouldn’t be so burdensome and expensive that it makes reprocessing go away as an option for hospitals. That would really hurt hospitals, patients, and our industry. The bottom line here is that the reprocessing should be done properly. An entity that is capable of reprocessing properly should be permitted to do so."
Grant notes that the FDA action may eventually result in device manufacturers developing more products labeled reusable rather than single-use only. "In some respects, I think this will help urge health care into a new era," she says. (Editor’s note: Copies of the FDA draft proposals are available on the Internet at http://www.fda.gov/cdrh/ reuse/1029.pdf. You can also contact CDRH Facts on Demand at (800) 899-0381 or (301) 827-0111. Specify No. 1029 when prompted for the document shelf number.)
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