For many in the healthcare profession, this will be old news. Others, particularly those not yet fully acclimated to government acronyms, may read this note with a growing sense of alarm.
On September 24, 2013, the U.S. Food and Drug Administration (FDA) issued a directive establishing the Global Unique Device Identification Database (GUDID). The purpose of the database is to create a public, searchable catalog of every covered medical device. The FDA has also issued a 59-page GUDID Draft Guidance to help the medical device industry achieve compliance with the new rule.
Central to this labeling scheme is the Unique Device Identifier (UDI), a standardized labeling format. The UDI is, in turn, composed of a Device identifier (DI) and a Production Identifier (PI). The DI identifies the labeler and the version or model of the device. The PI is the variable portion of the UDI and identifies:
- The lot or batch number of the device;
- The device serial number;
- The device expiration date; and
- The device date of manufacture.
The scope of this directive begins to hit home when it is realized that it will eventually cover medical devices as numerous as reusable catheters.
As to that, compliance with the directive is being staged in five periods:
- By September 24, 2014, packages of Class III medical devices must be labeled in compliance, including Class III stand-alone software.
- By September 24, 2015, all “implantable, life-supporting and life-sustaining” medical devices must comply.
- By September 24, 2016, all individual Class III devices must be labeled.
- By September 24, 2018, all Class II devices must carry a UDI.
- By September 24, 2020, a UDI must be affixed to all reusable Class I devices.
Guidance to these medical device classifications can be found in an FDA information sheet titled Frequently Asked Questions About Medical Devices. To summarize, Class I devices include such things as “bandages, examination gloves, and hand-held surgical instruments.” Class II devices include “powered wheelchairs, infusion pumps, and surgical drapes.” Class III devices include “replacement heart valves, silicone gel-filled breast implants, and implanted cerebellar stimulators.”
While the traceability goals of the GUDID are laudable, many in the medical-device industry find implementation of this sweeping regulation overwhelming. Fortunately, Zebra Technologies, an industry leader in medical product identification technology, has years of experience and a proven record of innovative solutions to call upon in helping you navigate GUDID as straightforwardly and painlessly as possible.