Quality Control & Compliance
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019
A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.
Latest From Quality Control
The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.
FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events
The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.
US Regulatory Roundup, January 2020: Recalled Surgical Gowns; Coronavirus News; FDA Inspection Tips; And More
News that device giant Cardinal Health recalled millions of potentially unsafe, unsterile surgical gowns – and a message out of the US FDA for customers to “immediately discontinue” using the gowns – was of most interest to our online readers last month. Meanwhile, the FDA’s plans to hasten emergency-use approvals of coronavirus test kits and a set of 10 tips for dealing with agency investigators also garnered significant attention. Here are January’s 10 most popular US policy and regulation stories from Medtech Insight.
A loose cable found in certain models of GE anesthesia machines has resulted in the highest recall alert from the US FDA. Regulators are warning the mechanical problem could result in organ failure and even death.
Exports of components and finished medical devices coming from coronavirus-stricken China will continue to flow to the US and other countries for now, but there could be trouble soon if government quarantines and international travel bans remain in place, an industry expert in Shanghai tells Medtech Insight.
Fool Me Twice: Chinese Supplier Of Recalled Cardinal Health Surgical Gowns Sparked Quality Concerns Back In 2018
Cardinal Health continued using Siyang HolyMed to supply the firm with so-called Level 3 surgical gowns despite the Chinese contract manufacturer’s track record of quality worries dating back a few years. Meanwhile, the device maker has announced a second recall, this time related to its PreSource Kits that contain the recalled gowns. Cardinal Health says it will likely lose $96m in the second quarter of fiscal year 2020 because of the recalls.
Some models of GE Healthcare’s CARESCAPE respiratory modules are being recalled because they may incorrectly display a patient’s blood oxygen level. The US FDA has labeled the action a high-risk class I recall.
A Korean manufacturer of a compression limb therapy system was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by the US FDA this week.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.