‘War Room’ Death Knell? Edwards Lifesciences Expert Predicts Inspectional Front, Back Rooms Will Be Pandemic Victim
Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.
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From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish
Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warning that things "can easily become out of control. You need to find a good ringmaster." Yet a back room isn't the only place manufacturers should be careful about using the right people. Present in the front room – where investigators traditionally work when onsite at a firm – should be helpful, reliable facilitators that aid investigators with requests and answer an array of questions.
The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.
The US agency on 3 August said the webform should be used by manufacturers to report shortages of products deemed critical to fighting the ongoing COVID-19 pandemic.