MX Magazine quotes me on this issue that won't go away. Here's my top 5 list on “what is it about unique identifiers and medical devices?”

  1. Post market surveillance of medical devices will improve patient safety (and is a good thing)
  2. Unique identifiers for medical devices won't improve patient safety
  3. Medical devices already have unique identifiers, they're called serial numbers
  4. To improve post market surveillance, health care providers must be legally compelled to report adverse and sentinel events to the FDA
  5. Only after providers are compelled to report and the processes are in place to receive, process and report on events, will the question of unique identifiers for medical devices be a reasonable question

When providers and vendors currently do post-event investigations, they have little or no problem identifying the involved devices (unless it's something like tubing), and when necessary, tracing back to the devices Device History File - which is already required by FDA regulations. So perhaps someone can explain to me why politicians, GPOs, and non-profit associations are so hot for unique identifiers for medical devices?

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