For FDA, Pleasing Everyone with UDI Guidance No ‘Party’
Former teen heart throb Rick Nelson had a hit with a song called “Garden Party” way back when. A key line in the song is something that the FDA may take to heart, “You can’t please everyone, so you’ve got to please yourself.” Judging from the steady stream and granularity of the the comments already posted on the FDA’s UDI Guidance, it’s going to be tough for the FDA to make everyone happy.
As FDA explains it, a UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
The guidance comments, which are due by Nov. 7 for the guidance posted in July, generally applaud the idea of UDI, but many make strong cases for flexibility in its implementation.
A good example comes from CeloNova BioScience Inc. in a comment posted October 2 this year. They are a US-based medical device manufacturer who distributes its products around the world.
“We recognize the need to enhance patient safety through correctly communicating necessary data in an unambiguous manner but fundamentally disagree with the alpha-numeric date format proposed in 801.18.,” Celo writes in its comment.
“Acceptance of alpha data fields (JAN, FEB etc) will inevitably result in demand from many countries for their specific translations of the month to be incorporated on their labels whether in addition to or instead of the proposed format (contrary to 801.18(a)). Mandating inclusion of day as well as year and month (801.18 (b)) is not always relevant and in itself could be the potential cause of the current ambiguity (10.07.2012 being either 7th Oct or 10th Jul). Simply requiring Month and Year would eliminate this ambiguity and should be pursued through the International Standards Organization that has generated internationally accepted “symbols” for many aspects of device information and would be open to standardizing wholly numeric fields such as four digit year YYYY and two digit MM or MM-YYYY.”
Finally, Celo asks the agency to withdraw the alpha numeric date format and instead pursue a “wholly numeric field for month and year only.”
From the hospital perspective, X-Ray Associates of Louisville commented, “it is time consuming and sometimes impossible to determine if an implanted device is ‘safe’ to go into the MRI machine. This delays and hinders patient care. It would be very helpful if, 1) implanted devices came with a statement that they are safe, unsafe, or conditional for exposure to the MRI environment, and if conditional, what are the conditions, and 2) if this data was given to the patient in the form of a card they can carry with them.”
Baystate Health Inc., in a comment posted Oct. 17, asks the agency to “incorporate all currently existing major medical device naming conventions, such as ECRI’s UMDNS and the UN’s UNSPSC.”
In a comment posted October 23, Frank G. Shellock, Ph.D., FISMRM, FACC, FACSM Adjunct Clinical Professor of Radiology and Medicine Keck School of Medicine, University of Southern California Director for MRI Studies of Biomimetic MicroElectronic Systems National Science Foundation, Engineering Research, simply says to the FDA, “if you believe that additional information should be required to assure the adequate identification of a medical device, please identify the information you believe is necessary and provide an explanation of your views.”
Another comment letter worth reviewing is an extensive one from Alere Inc., posted October 16, 2012. Imploring the FDA to “avoid reinventing the wheel, Alere makes a detailed and generally strong case for improving the UDI guidance.
• The manufacturer to enter data for as many jurisdictions as it wants
• Each jurisdiction (including FDA) to pull just whatever data it wants
Possibly request FDA to permit company to have controlled authority to edit some fields in GUDID. (E.g. company contact details) and permit optional inclusion of same data for ex US countries.
Everyone’s an angel when it comes to backing UDI, but as is often the case, the devil is in the details.