Labeling system picks up speed

WASHINGTON - The Food and Drug Administration (FDA) must weigh carefully the benefits and burdens of a proposed rule that most medical devices include a unique device identification (UDI), according to AAHomecare.

In comments submitted recently, the association stated that it supports the FDA's goal of improving patient safety, but it worries the system could put an administrative and financial burden on manufacturers and providers.

“The manufacturers have the issue of bringing everything up to speed and providers have the issue of possible delays to reimbursement,” said Jay Witter, senior director of government affairs for AAHomecare.

Congress passed legislation in 2007 directing the FDA to develop a UDI system, with an eye toward improving the process of identifying product problems and targeting recalls. A UDI is an alphanumeric code that includes a device identifier; a product identifier; a serial number; and an expiration date.

To ease these burdens, AAHomecare recommends, among other things, that the FDA “harmonize” the UDI requirements with those of other standards-issuing bodies; include a grace period during which providers can continue to use the applicable national drug code (NDC); and exempt low-risk Class I and II medical devices.

“If they're low-risk, the safety concerns don't justify the costs of meeting the requirements,” Witter said.

AAHomecare also asked the FDA to clarify the responsibility of manufacturers of component and repair parts that are incorporated into other products (i.e. the rubber tips on the legs of walkers, and a replacement motor for an electric bed).

“It's a complicated issue,” Witter said.

The FDA proposes phasing in compliance with the UDI requirements over a seven-year period, starting with riskier Class III devices.