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2014 Hot Spots: Top 4 Device Quality & Regulatory Topics

This article was originally published in The Silver Sheet

Executive Summary

Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to "Silver Sheet" readership data. From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities. Further, FDA is "looking at whether information presented on FDA-483s can be organized in a way that better reflects what we consider to be highest priority quality system deviations that require the most significant attention,” CDRH compliance chief Steven Silverman said. Rounding out the top industry issues last year were device recalls, Unique Device Identification, warning letters and CAPA. A recap of in-depth "Silver Sheet" coverage from the year, including updated expert commentary, follows.

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From Suppliers To Sloppiness, Experts Offer 5 Theories Why Aging Devices Are Recalled Most

A CDRH report recently showed that a majority of recalled devices are older, yet the center has provided little insight into how it came to its conclusion. FDA’s relative silence on the matter has left several industry insiders to deduce for themselves why aging product types struggle more with recalls than younger ones. One such expert believes a failure by manufacturers to understand their own products and evolving international standards play a role in the substantial number of older-device recalls. “I don’t think there’s any one thing you can say is causing this problem,” said Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Labs. But in a time of increased global manufacturing and troubles keeping an eye on supply chains, it’s a safe bet that poor supplier control is a culprit.

‘Paradoxical’ FDA Recalls Report Credits Industry Collaboration For Improved Quality, But Uncovers Troubling Data About Older Devices

Medical devices on the market for more than five years are recalled more often than younger ones, according to a recent FDA 10-year retrospective report on corrections and removals. “There is an intuitive appeal to the argument that devices that come to the market in an early point in their lifespan – say, the first year – are more likely to be subject to recalls, but that is simply not true,” CDRH Office of Compliance Director Steven Silverman says. Other notable report findings: troubles with components and software are the leading causes for most recalls; problems with AEDs, ventilators and infusion pumps have triggered an increase in high-risk class I recalls; and domestic manufacturers recall products at a much greater volume than those outside the United States.

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