Study says FDA's 'fast-track' approval process may put patients in danger — 6 findings

From 2007 through 2017, 98.1 percent of recalled foot and ankle devices had approved through the FDA 510(k) premarket approval, according to a study published in the Cureus Journal of Medical Science.

Researchers studied 161 products from 33 different companies.

Here are six key findings:

1. Of all recalled devices, 158 were approved through the 510(k) premarket notification process.

2. Only one recalled product was authorized through the premarket approval process. Researchers were unable to identify the approval process for the remaining two devices, the Symbionic Leg and Centurion Sterile Rubber Bands.

3. Intraoperative and postoperative device breakage accounted for 39 of the 161 medical device product recalls, the most common cause of recalls.

4. Sterility concerns were the second-most common reason for recalls. Labeling and device design issues were also common rationales behind recalls.

5. The largest number of recalled products were Synthes screws, with 19,497,844 screws recalled because of labeling issues.

6. The study's limitations included focusing only on implants within foot and ankle orthopedic surgery, which were identified by searching within the FDA's database. The reasons for recall listed in the FDA's database might not correlate with the manufacturer's reason for initiating a recall.

"This study further supports the idea that products approved through the PMA process are less likely to be recalled. There is a lack of clinical data with products approved through the 510(k) process that may cause the devices to carry a greater risk to patients," authors concluded.

More articles on supply chain:
EyePoint Pharmaceuticals appoints new SVP of regulatory affairs & quality: 3 things to know
Supply chain tip of the day: Standardize products
How many hats does a surgery center materials manager wear every day?  

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Featured Webinars

Featured Whitepapers