by
Carol Ko, Staff Writer | May 06, 2013
The FDA released an update to its plan to develop a comprehensive system to track medical devices.
The original plan, otherwise known as the the unique device identifier, or UDI, rule,
was released in September 2012 and addressed concerns around a series of medical device malfunctions, most notably Medtronic Inc.'s Sprint Fidelis defibrillator leads, whose fractures led to deaths in 2007.
Current reporting standards for medical devices are fraught with inconsistencies. For example, though companies and hospitals are required to report certain events to the FDA, reporting is optional for doctors.
In the past, it took months, sometimes even years, for authorities to ascertain whether the adverse events were unrelated or indicated that the device posed a public health hazard.
To create a more comprehensive device surveillance system, the FDA plans to create a unique identification number (UDI) for each device. These numbers, stored in a publicly available database, will also be incorporated into patient EHRs, insurance forms and billing records.
Under this new system, if a device malfunctions or needs to be replaced more often than other devices, the FDA will be able to track these events. When hospitals incorporate UDIs into EHRs, eventually these injuries and deaths will be automatically reported to the FDA.
To facilitate quicker reporting, the agency has also created a cell phone app encouraging more doctors to report device malfunctions more often.
The FDA also hopes that UDIs will enable the agency to gather more robust clinical data to better assess risks and benefits around certain devices.
The agency expects to issue a final rule this year creating UDIs. However, a group of House Democrats drafted a letter that questioned whether the FDA will be able to finalize UDI regulations by its statutory deadline on May 7.
