Originally Published MDDI June 2005
No Consensus Near on Coding Mandate for Devices
|Hankin says RFID is too far away to be part of the requirements.|
An April meeting revealed that CDRH is nowhere near a decision on whether to impose requirements for automatic identification of medical devices.
FDA set up such a system for prescription pharmaceuticals more than a year ago, in hopes of reducing medication errors. 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. Those organizations would bear much of the cost if a coding system were implemented. No code can work unless the end-user purchases something that can read it.
There was much discussion of whether to make radio-frequency identification (RFID) part of the requirement, “but 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 identification of devices isn't likely to have a major effect 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 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. In addition, it calls for reprocessed devices to be treated the same way as OEM devices.
Copyright ©2005 Medical Device & Diagnostic Industry