inspected, restored and sterilized, the industry has argued the products are still unsafe.
“The reprocessing of medical devices designed to be used once is inherently risky,” said Stephen Ubl, then president of the trade group AdvaMed, in testimony to the House Government Reform Committee in 2006. “These extremely small and/or structurally complex devices are difficult to properly clean and sterilize. In addition, the cleaning process can have a debilitating effect on the durability of materials in these devices.”
Ubl also urged Congress to ask the Food and Drug Administration to hold reprocessed devices to the same safety and efficacy standards as original devices.
Over the past decade, the FDA has increased its oversight of the reprocessing industry.
Following legislation passed in 2002, FDA imposed additional requirements for about 70 types of reprocessed devices. The agency also required labels so that users would recognize such devices. FDA now inspects reprocessors and monitors reports of adverse events involving reprocessed devices.
With some reprocessed devices that were originally cleared through the 510(k) process, the FDA requires companies submit additional “validation” data regarding cleaning, sterilization, and device performance. The typical 510(k) process is simpler, in which medical device companies just need to show their new product is substantially equivalent to an older one.
Cynics here could say that by raising the regulatory bar on reprocessors, AdvaMed and its members were doing what they could to snuff out their low-cost competitors. Ironically, the original device makers’ push for more FDA oversight of reprocessed devices has helped reprocessors gain credibility among customers, says Laura Schrader, a former medical device consultant who’s now CEO of 3D Biomatrix in Ann Arbor, MI.
With all of the testing and regulatory hurdles now in place, “you know you’re going to get a device that works,” Schrader says.
Big medical device companies aren’t the only ones wondering whether reprocessing is the way to go. In 2008, the Government Accountability Office (GAO), the investigatory arm of Congress, released a report that said it lacked enough data to compare the safety of reprocessed devices versus original devices.
However, the agency concluded: “given that the available data, while limited, do not indicate that reprocessed [ devices] present an elevated health risk.”
Reprocessed devices, however, still face a “bleak future,” GlobalData says. Original medical device makers’
