Medical Device Assembly: Medical Device Assemblers Make Their Mark
May 20, 2011
The FDA's Unique Device Identification system is expected to be finalized this month.
In one of my favorite Far Side cartoons, an irate king glares at a servant who has just brought him a cranking mechanism. “I said, ‘Bring me the wench,’ you idiot!” he scolds.
Such a mix-up is amusing in the funny pages, but it can be deadly serious in a health care setting. Imagine a hospital ordering a box of cardioplegia needles, which are used during heart surgery, and receiving instead a supply of belts for applying traction to patients suffering from back pain. It’s not so far-fetched. Although the needle and belt are made by different companies, they have the same five-digit part number. Also carrying that part number are a device for stunning livestock and a kit for testing water quality.
Preventing such mistakes is the goal of the Food and Drug Administration’s Unique Device Identification (UDI) system. Mandated by Congress in September 2007, the UDI system requires every medical device to bear a unique, globally recognized identifier so it can be tracked from the point of manufacture, through distribution, to final use. The FDA hopes the system will facilitate medical device recalls; aid adverse event reporting; improve supply chain security; and prevent medical errors.
The agency has spent the past several years developing UDI in conjunction with medical device manufacturers, trade associations, health care providers, distributors and GS1, the international nonprofit association dedicated to implementing tracking standards for the global supply chain. Public comment on the system concluded this year in April, and UDI is expected to be finalized by June 30. It’s scheduled to be fully implemented by Sept. 30, 2013.
Under the program, every medical device would get a Global Trade Item Number (GTIN). Depending on space, the GTIN must appear as a human-readable number, an automatic identification code, or both. The code could be a bar code (GS1-128), a DataBar or a Data Matrix code. It can also be written to a radio frequency identification tag.
The GTIN identifies a specific product and package. A GTIN plus a lot number identifies a product within a defined group. A GTIN plus a serial number identifies a specific product or packaging size. If applicable, an expiration date would also be included in the GTIN. The GTIN must be placed at all levels of device packaging (box, carton and individual sterile package). In some cases, it may also have to be marked directly on the device itself.
Medical device assemblers will be required to share information about products in a standardized way, and they may have to change their internal product identification and packaging to comply with the new standards. Once the system is up and running, medical device assemblers will need to submit UDI data to a centralized FDA repository.
The FDA will take a phased-in approach to implementing the UDI system. Once it’s finalized, assemblers of Class III medical devices will have 12 months to comply with the standard. Assemblers of Class II devices will need to comply within 36 months, and assemblers of Class I devices will have 60 months. UDI will not apply to medical devices sold strictly in retail settings.
The new regulation could be a boon to suppliers of laser marking equipment. Lasers can quickly and accurately mark a small 2D code on a variety of substrates, including stainless steel, titanium and ceramics. Better still, the laser won’t indent the material, creating a reservoir for bacteria, says Tony Osborne, business application manager for Technifor Inc., a supplier of laser- and stylus-based marking equipment.