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This week the FDA issued a call for comments on how the use of a
unique identifier system for medical devices may reduce medical errors, facilitate
device recalls and improve medical device adverse event reporting. You can read the press release here, and the Federal Register text here.

“Much like the bar code rule for drugs and biological products, unique
identifiers for medical devices could have many potential benefits for improving
the quality of care for patients,” said Daniel Schultz, M.D., Director,
Center for Devices and Radiological Health, FDA. “A unique device
identifier system could have broad applications in reducing medical errors,
facilitating device recalls, improving medical device adverse event reporting
and encouraging cost effectiveness by improving delivery and supply chain efficiency.”

You may recall that just last August the FDA published a white paper by ECRI stating that there is no research demonstrating that patient safety would be improved by giving each medical device a unique identifier. Yet, the quote above sounds like the FDA's position has shifted to one that is looking justification to mandate unique identifiers. It seems that certain “stakeholders” have been stirring the pot…

Over the past year, FDA met with various stakeholders and found that most
supported the development of a UDI system as a way to improve patient safety. FDA
also learned from the meetings that stakeholders recognize that such a system
could provide supportive benefits, such as better management of the purchase,
distribution and use of medical devices.

Those stakeholders would be the politicians, GPOs (who probably see another way to extort extract revenue from vendors and maybe providers), and nonprofit associations. All of this unique identifier talk flys in the face of the fact that vendors are already required to track the device history of every product and/or lot they manufacture. Unlike meds and some implants, medical devices already have a unique identifier called a serial number.

Certainly, postmarket surveillance could (and probably should) be improved dramatically. Assuming postmarket surveillance is increased, creating a system of unique identification for medical devices is an implementation detail when compared to what would be required to actually improve patient safety.

The FDA's current regulatory framework begins and ends with the design, manufacture and sale of medical devices – it does not “pierce the veil of commerce” – i.e., FDA's regulatory oversight ends with the sale of the device and does not extend to medical device users. While device vendors must track individual device history, there are minimal requirements for tracking product performance once it is sold and in use. And hospitals have no legal mandate to report medical device problems to anyone. Efforts to get hospitals to voluntarily report adverse events related to medical devices have failed – most hospitals actually have policies restricting such disclosures.

A robust postmarket surveillance regimen should start with reporting requirements for medical device users and include more postmarket surveillance requirements for vendor's CAPA systems. Vendors could be charged with the responsibility of tracking postmarket data, with oversight from the FDA. An alternative approach (which seems to be what the “stakeholders” are aiming for) would entail a common repository of some or all of this postmarket data – this would take postmarket surveillance out of the hands of vendors and place it with a third party. Even this third party approach doesn't require another unique identifier beyond the device serial number; what it requires is a new postmarket regulatory mandate on the health care industry, but no one seems to want to talk about that.

“It is essential that we monitor the performance of medical products
after they are approved and make sure that we quickly discover any potential
problems that might arise,” said Andrew C. von Eschenbach, M.D., Acting
Commissioner, FDA. “To improve our postmarket data collection at FDA,
we are using a total product lifecycle approach to how we look at medical devices
and focusing more attention on the kinds of systems and processes we need to
have in place to monitor products after they are approved.”