By Julie Suko, PharmD
It was my great privilege to participate in the SMART Medical Device Informatics Think Tank Meeting held recently in Rockville, MD. This conference, which was organized by the Medical Device Epidemiology Network Initiative (MDEpiNet) public-private partnership, brought together a variety of healthcare professionals to examine the issues and opportunities arising with the advent of unique device identifiers (UDIs) for medical devices.
By sharing a pharmacist’s view on how electronic information has helped improve drug safety with a room full of doctors and other clinicians, I was able to bring a valuable and relevant perspective to the discussion. Given my responsibilities as the Director of Editorial Content at FDB, I tapped into our company’s 30-plus years of experience with the acquisition and dissemination of a variety of drug data, and drew some clear parallels to medical device data.
More specifically, I shared what we have learned through our work at FDB with National Drug Codes (NDCs) by making relevant connections between our experience and current UDI development challenges. More specifically, I described how we identify and incorporate large amounts of data from different sources; assist in the integration of usable data into electronic health records; manage and maintain the data over time; and structure our output to meet the needs of various constituents, from clinicians to billing professionals to patients.
Our experience enabled me to offer encouragement to the conference participants who are just commencing their use and deployment of normalized device data. Since the real use of UDIs is only just beginning and there are no legacy issues at present, there is ample opportunity to make the right decisions – to learn from what worked and what didn’t with drug data.
In my brief remarks, I offered insights drawn from specific experiences FDB has encountered in the deployment of the NDC identifier, such as the headaches that ensue when NDCs are reused for different products. If I had had more time, I would also have shared these additional guidelines:
- Unique identifiers should be applied on each package level, i.e. the same identifier should not be permitted to be assigned to both the outer and inner package.
- Well-defined rules and guidance should identify when, and under what circumstances, a new identifier is required.
- A core set of product attributes should be defined, such that any change would necessitate the application of a new identifier.
It was encouraging to see the keen interest of the participants attending this meeting, and it is clear that everyone understands and appreciates the benefits the UDI initiative will bring. I have signed on to participate in one of the projects identified at the close of the conference, where we will be exploring issues related to the needs of manufacturers and healthcare providers in the device arena. I look forward to making a contribution to the growth and maturation of UDIs, which hold the promise of promoting medical device innovation, enhancing device workflow efficiency and, most importantly, improving device safety and care quality.
All in all, it’s both a challenging and encouraging effort, and it’s exciting to participate in such an important initiative. I welcome your thoughts on the implementation of UDIs – how will it impact you and what would you advise policy makers if you had the chance?
Julie Suko is director of editorial content services for FDB where she is responsible for overseeing the identification and acquisition of relevant drug and drug‐related data from identified primary sources, development and maintenance of drug pricing information, coordination with manufacturers and regulatory agencies and supervision of editorial and data structure modules within FDB MedKnowledge. Connect with Julie on LinkedIn.