AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)

November 21, 2013 | Content Areas: Leadership | Tags: Asset Management, Data Standards, UDI | Formats: Comment/Letter/Statement
Authors: AHRMM

On November 21, 2013, AHRMM submitted electronically comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, Department of Health and Human Services, regarding the Draft Guidance for Industry on the global unique device identification database (GUDID), which was issued on September 24, 2013.

 
In the comment letter, AHRMM supports all of the outlined attributes identified for the GUDID system; however, AHRMM’s comments pertain to three specific GUDID attributes that we strongly recommended be included in the GUDID database requirements In AHRMM’s November 6, 2012, response to the UDI proposed rule:

  • Labeled as hazardous: End-users should always be aware of devices that may pose hazards in order to ensure safe handling as well as product integrity.
  • Contains radioactive isotopes (e.g., radioactive element and atomic number) This information is important for environmentally-safe disposal and end-user handling.
  • Has Safety Data Sheet (SDS) This information provides end-users with a reliable and readily-available source of information should an urgent need arise.

These three attributes no longer appear in the Draft Guidance Document. AHRMM reiterates that the above attributes should be added to the database requirements. These attributes provide critical information that can be the difference between whether a device contributes to or detracts from quality patient care.