Originally Published MDDI February 2005
Despite Complaints, FDA Shows Progress on SUD Reprocessing
Erik Swain and James G. Dickinson
|Alliance Medical Corp. received FDA clearance for reprocessed diamond-burr drill bits.|
As expected, there was much sound and fury about the reprocessing of single-use devices (SUDs) at FDA's second annual Medical Device User Fee and Modernization Act of 2002 (MDUFMA) stakeholders meeting. At the November 2004 event, the device and the reprocessing industries continued to disagree on whether such procedures are safe. Each accused the other of putting profit ahead of safety or cost-efficiency. Less obvious amid the hubbub was FDA's real progress in deciding which reprocessed SUDs are safe and which are not.
FDA has met its MDUFMA requirement to review 510(k) applications of “critical” reprocessed SUDs that require supplemental validation data, said Office of Device Evaluation (ODE) medical officer Ginette Michaud.
The agency required the reprocessing industry to turn in 53 submissions that covered 1800 device models. Nine were not received. Thus, their products were declared “not substantially equivalent” (NSE) and forced off the market. Of the rest, 19 were declared “substantially equivalent” (SE) and 12 were declared SE for certain models. Eleven were declared NSE or were withdrawn before a decision. Two were still under review at the time of the meeting. Broken down by device models, 52% were found SE, 33% were found NSE and therefore can no longer be marketed, and 15% were withdrawn before a decision.
CDRH staff worked hard to complete the reviews, putting in some 11,000 hours, Michaud said. “CDRH addressed complex scientific issues, conducted careful and thorough reviews, and made timely and scientifically grounded regulatory decisions,” she added.
One of the toughest tasks was deciding on the review parameters, said Steven Turtil of ODE's infection control branch. Particularly challenging was that the agency had to devise standards for cleaning validation from scratch, since none existed previously.
FDA decided to define clean as allowing for successful sterilization, limiting organic soil transfer from one patient to another, and preventing accumulation of residual soil after multiple cycles.
From there, Turtil said, the agency devised a guide to what an SUD's cleaning instructions should specify. But the toughest part, he said, was determining cleaning-process validation protocols. “We spent a lot of time on that,” he said. “It was very elaborate and device-specific.”
In general, FDA decided, protocols should consider use of actual clinical contamination as well as simulations that represent intended clinical exposure. There should be simulation of worst-case clinical-use conditions and worst-case cleaning conditions. End points must be specified and the data should meet them. And, he said, “extraction methods and test methods should be validated. We can't stress that enough.”
CDRH deputy director of compliance Larry Spears noted that progress has also been made in getting reprocessing firms to follow GMPs properly. In the 1990s, he said, 15 to 20 reprocessing firms were doing business. Inspections at a number of them turned up GMP violations. Now, those unwilling to comply have exited the business, and only six reprocessing firms are registered with FDA. All have been found to be in “substantial compliance” during recent plant inspections, he said. In addition, he noted, all have complied with notices to withdraw products declared NSE.
None of these developments have tempered the positions of the device and reprocessing industries, however. Speaking for AdvaMed, Johnson & Johnson's Robert O'Holla objected strongly to FDA regulatory policies governing SUDs and to certain MDUFMA provisions. He said FDA should issue a recall of all reprocessed devices found to be NSE that are now in hospital inventories. He noted that the agency would take that step for any OEM device determined to be unsafe. He also said MDUFMA's SUD labeling provisions have not been adequately implemented.
Association of Medical Device Reprocessors regulatory counsel Naomi Halpern defended the safety record of reprocessed devices. “Despite enormous efforts to eliminate reprocessed devices as an option for hospitals, the third-party reprocessing industry is growing and is continuing to provide hospitals with a safe, effective way to achieve cost savings,” she said.
Work is continuing to further determine which SUDs are safe to reuse and which are not. Validation data for “semicritical” SUDs requiring a 510(k) are due to FDA by July 24, 2005. And in December 2004, Alliance Medical Corp. (Phoenix) received what it said was the first clearance for an SUD that did not require a supplemental validation submission. The approval was for reprocessed diamond-burr drill bits.
For more on the MDUFMA stakeholders meeting, see Washington Wrap-Up, p. 34.
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