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Quality Control & Compliance

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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.

FDA Device Warning Letters Enforcement

Latest From Quality Control

Coronavirus: All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

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.

FDA Enforcement

US FDA Deems MiniMed Safety Issues Class I Recall

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.

Recalls Safety

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.

FDA Quality

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.

Regulation Policy

Loose Cable Leads To Class I Recall For GE Ventilator

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.

Recalls Safety

Chinese Device Exports, Supply Chains Holding Up In The Face Of Coronavirus – For Now

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.

China Manufacturing

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.

Recalls Quality

GE Healthcare Recalls Respiratory Monitors Over Display Issue

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.

Recalls Quality Control

Warning Letter Roundup & Recap – 4 February 2020

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.

Device Warning Letters FDA
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