THE BLOG

FDA's UDI Rule will Make Device Tracing Simpler and Open'

03/01/2014 11:14 GMT | Updated 04/03/2014 10:59 GMT

In early Septemper this year, the healthcare-battered USA, took a significant step towards better patient-care. The Food and Drug Administration department of US government made it mandatory for health-related devices to be identified by a specific number, which will make its tracking easy with all vital details relating to the devices/implants and their embedding into a patient.

Which means, implants or medical tools such as valves or a pacemakers -- which can be termed as 'life supporting and sustaining' -- will have to carry FDA specified label with required details. These devices are called class III devices, with class II being equipments used for surgery and support, and class I devices categorized as disposables and hand-held surgical instruments.

All the categories of devices and instruments will have to carry specifically barcoded (termed as GS1 and or HIBCC DataMatrix barcode) to carry large amounts of data in a relatively small space. While the manufacturing industry is still working on ways of creating such information-laden instruments without compromising on the quality of the devices, the details that would require to be engraved will include a unique number assigned by the device manufacturer to the version or model of the device, called the unique device identifier. This identifier will also include production-specific information such as the lot of batch number through which the product was sent into manufacturing line, expiry date of the product, preceded by the manufacturing of the specific piece of device/tool or implant.

While all this would serve as the details of the very product, patient care comes in during the second part, which though has already turned into a rule, is still being discussed in various circles and citizens groups which are for high-confidentiality of products and health related information of patients.

That component is a publicly searchable database, administered by FDA, called the Global Unique Device Identification Database (GUDID) which will serve the role of a reference catalogue for every device with an identifier. While the FDA has made it clear that no identifying patient information would be stored in this device information center, the fact that it is still open to a closed group of professionals has got the voices debating the veracity of this information being sacrosanct or altered subject to usage.

FDA has plans to phase in the UDI system with primary focus being on high-risk medical devices with several low-risk devices being exempt from part or all of the requirements of the final rule.

The US government insists that once fully implemented, the UDI will have many benefits for patients, improving the healthcare system by folds and make the device industry more accountable than before. In its objective, the rule is aimed at 'quickly enhancing the ability to effectively identify marketed devices when recalled to improve the accuracy and specificity of adverse event reports to provide a global and secure administration chain helping to address the counterfeiting and diversions'.

With the United States of America losing out on a chunk of patients travelling to countries with efficient and economic health care systems for the matter of cost alone, UDI rule hopes to check these instances by providing safety and accountability on their own homeland.