Tag: FDA’s final rule requiring most medical devices

GUDID Proves EHRs Aren’t ‘GUD’ Enough

Mohan Ponnudurai
Mohan Ponnudurai

Guest post by Mohan Ponnudurai, director at Sparta Systems

The release of the FDA’s final rule requiring most medical devices to carry a unique device identifier (UDI) will allow regulators to track goods and expedite necessary recalls in order to manage quality and promote patient safety. This process will be streamlined with the population of the global unique device identification database (GUDID, pronounced good-I.D.), which will include a standard set of identifying elements for each device given a UDI. The system will allow healthcare providers to look up information about a medical device, then amend the electronic health record of a patient as needed.

GUDID has no mandate in terms of automatic connectivity to EHR; no matter what device is implanted into a patient, his/her healthcare professional must manually input that information cross-referencing the UDI record with his/her EHR. Without this data entry, the point-of-use component leading to better patient safety and monitoring becomes a moot point. Just like manufacturing and design are inexplicably linked, and quality is an essential part of both for safer products, GUDID and EHR must be connected for better patient safety.

According to the FDA, most of the information contained within the GUDID will be made available to the public, meaning individuals can easily look up information about their medical device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.[1] While the GUDID is a step in the right direction to promoting patient safety, healthcare providers should look to the database as a model for keeping all EHRs.

Continue Reading