Memo to the Medical Device Industry: You’ve Got Problems

FDA News, a purveyor of U. S. Food and Drug Administration regulatory and international standards compliance newsletters, books, special reports and conferences, gathered the medical devices industry to a come-to-Jesus meeting last week and the warnings were stern: quality has been low and the number of U.S. Food and Drug Administration warnings and recalls is high. Medical device manufacturers haven’t met the bar for quality control and the regulations are about to get a whole lot tighter.

Presenters at the three-day conference on risk management and post-market surveillance reeled off a list of unhappy statistics:

Adverse events are growing faster than the market. Infusion pumps, automated external defibrillators and catheters produced 65 percent of the serious adverse events from 2005-2009, according to FDA data.

In 2010, the FDA issued 89 warning letters for Quality Systems deficiencies.

Nearly one-third of all medical device recalls occur as a result of design and/or manufacturing defects and root cause analyses shows that there are wide gaps in product design, manufacturing process control, and supplier management. (The FDA can also require a recall based on a wide variety of non-conformance issues including bad record-keeping, failing to report death and injuries associated with a device and failure to establish a corrective action plan.)

Experts noted that good adverse outcome data are hard to come by. While the FDA operates a web-accessible complaint database, the Manufacturer and User Facility Device Experience (MAUDE) database, it is hardly complete. MAUDE data consist of voluntary reports made to the FDA since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. (Manufacturers are required to report within 30 days to the FDA any deaths or injuries associated with a medical device they market, regardless of the source.) MAUDE likely only represents a fraction of the complaints actually filed. Most manufacturers still send paper reports, and receive no confirmation from the FDA that the complaint was read or processed, so there’s little confidence that the paper reports get entered into the database.

Nor do the recall numbers give the full picture. Manufacturers are making corrections in the field, without notifying the agency or the consumer. Those silent recalls aren’t accounted for presenters said.

The second take-away from the Eighth Annual Medical Device Quality Congress: Manufacturers must step up their own surveillance of suppliers, because increasingly, the recalls reflect problems created by suppliers, but owned by the manufacturers. The FDA’s Center for Devices and Radiological Health does not inspect or regulate suppliers – the manufacturer is responsible and legally liable for anything their supplier does. Like many industries, medical device manufacturers who look to contain costs by using Asian suppliers are taking risks right now. The standards in that part of the world are antiquated by Western standards, with little oversight.

These factors are combining to hasten the end of the era of the quickie approval. Pre-Market Notification or 510k was established to streamline the process for new medical devices that were “substantially equivalent” to devices – called “predicates” in the approval process – that were already on the market by 1976. In 2002, the aggressive deregulation of the George W. Bush presidency resulted in a further loosening of the 510k process. The FDA was directed to take “the least burdensome approach to medical device regulation,” and the definition of “substantially equivalent” now included products made using different materials and mechanics than the predicate device. Predicates no longer had to be in the marketplace in 1976; any device already cleared – either by 510k or PMA – applied. In result, 510k became the de facto route to FDA approval, with 99 percent of all devices approved under this scheme. The regulations now allowed patients to be exposed to devices that had never been subjected to clinical trials, testing or any standards.

But the system has been under fire for the last few years. Everyone from manufacturers, to FDA staffers to consumer advocates has been airing complaint at Congressional hearings and in Government Accounting Office reports.  Late this summer, at the request of the FDA, the Institute of Medicine will issue its assessment of whether the 510 (k) process sufficiently protects patients and promotes public health.