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?”
- Post market surveillance of medical devices will improve patient safety (and is a good thing)
- Unique identifiers for medical devices won't improve patient safety
- Medical devices already have unique identifiers, they're called serial numbers
- To improve post market surveillance, health care providers must be legally compelled to report adverse and sentinel events to the FDA
- 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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