FDA Emphasizing Component Acceptance Procedures

Instituting adequate component acceptance procedures should be part of the strategy device manufacturers employ to reduce their number of product recalls, Michael Verdi, senior recall coordinator for the Center for Devices and Radiological Health, recommended.

“You need to make sure that the component acceptance procedures that you have actually catch a component that doesn’t meet specifications,” Verdi said last month at the Food and Drug Law Institute’s Surviving Medical Device Recalls eConference.

He explained that even simple observations made by staff during the receiving process can tip off companies to changes in specifications for incoming components. For example, if employees notice that receiving addresses are wrong or if the components are packaged differently, that might be an indicator that their specifications have changed.

“These are the things that quality assurance should be tipping off to upper management that this component might have changed,” Verdi said.

Verdi also highlighted other areas that firms can focus on to reduce recalls, including taking user functionality into account when designing medical devices and making sure that product specifications are tight enough to detect defects before their release.

Product validation should be conducted from product, manufacturing and testing perspectives, Verdi recommended, and it should include a worst-case scenario evaluation of the device under conditions where multiple specifications fall outside of their optimal ranges, not just if one specification falls out of range.

In addition, firms should closely examine their in-process controls, according to Verdi. If reworks are necessary, the root cause should be determined. Lots and batches that fall in the upper- or lower-end of specifications should also be assessed.