NEWS: No Consensus Near on Coding Mandate for Devices
An April meeting revealed that FDA is nowhere near a decision on whether to impose requirements for automatic identification of medical devices.
FDA has set up such a system for prescription pharmaceuticals, in hopes of reducing medication errors. Ever since that rule making process began, there has been much speculation on whether something similar would be set up for devices. But so far, about the only point of consensus is that any system put in place would be voluntary.
Bob Hankin, president of the Health Industry Business Communications Council (HIBCC; Phoenix), said that HIBCC representatives who attended the meeting deemed it “very preliminary” and “fact-finding.” HIBCC develops standards for healthcare information exchange.
Another sign that no decision is near was the absence of any hospital or other end-user organization at the meeting. It is those organizations that would bear much of the cost if something were implemented. No code can work without end-user investment in reading equipment.
There was much discussion of whether to make RFID part of the requirement. “The general consensus is that we are a long way from that,” said Hankin. “There are uncertainties about cost and error rates. And do we know what flavor of RFID is even appropriate for devices?”
Also, he said, automatic medical device identification isn’t likely to have a major impact on reducing medical errors. Rather, its main benefits would be making devices more traceable and facilitating recalls. FDA has yet to decide whether those benefits are significant enough to justify any kind of mandate from the agency.
AdvaMed (Washington, DC), the largest trade association for the device industry, also sent representatives to the meeting. Whether it will prompt any changes in the group’s position has not yet been worked out, said spokesman Mark Brager.
AdvaMed supports the voluntary use of automatic identifiers for devices if an industry-approved standard is used. It is not in favor of imposing the requirements for pharmaceuticals and biologics on devices. It also opposes including reimbursement-classification system coding in any automatic identifier. And it calls for reprocessed devices to be treated the same way as OEM devices.