Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals […]
CDRH gives medtech manufacturers employee coronavirus safety tips
As certain medtech companies continue ramping up production of devices and components to fight the coronavirus, the FDA’s Center for Devices and Radiological Health (CDRH) on Sunday announced several tips to help protect medtech manufacturing employees from contracting COVID-19. In addition to frequent and thorough hand-washing, maintaining social distancing and avoiding face-touching, the agency urged […]
Nortech, Minnetronix may start building ventilators
Two Minnesota medtech contract manufacturers are taking a hard look at producing ventilators, including one from the plans that Medtronic made public last week to address the coronavirus outbreak. Maple Grove-based Nortech Systems (NSDQ:NSYS) told Medical Design & Outsourcing it is seriously considering starting to produce the machines based on the design specifications of Medtronic’s Puritan Bennett 560 (PB 560) […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. Get the full […]
Trump uses DPA to boost supplies to certain ventilator manufacturers
President Donald Trump yesterday invoked the Defense Production Act to reduce supply-chain problems for certain manufacturers to produce ventilators. In the executive order, the president gave the secretaries of the departments of Health & Human Services and Homeland Security the power to secure materials for General Electric (NYSE:GE), Hillrom (NYSE:HRC) , Medtronic (NYSE:MDT), ResMed (NYSE:RMD), Philips (NYSE:PHG) and Vyaire Medical. Ventilator […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency […]
Trump slams 3M over foreign respirator sales, invokes DPA
President Donald Trump last evening blasted 3M (NYSE:MMM) for selling some of its N95 masks to other countries, hours after invoking the Defense Production Act to prioritize orders from the Federal Emergency Management Agency. “We hit 3M hard today after we saw what they were doing with their masks,” Trump tweeted Thursday night. “‘P Act’ all […]
Judge refuses to delay Elizabeth Holmes trial
Ex-Theranos CEO Elizabeth Holmes lost a bid to have the trial in her criminal fraud case delayed, despite pleas of hardship due to the COVIDd-19 outbreak. According to published reports, Holmes’ defense attorneys argued yesterday that travel and other restrictions related to the pandemic would hamper their client’s trial preparation efforts. They had filed motions […]
CDC weighs DIY facemasks for the general public. Here’s the science behind mask materials.
Lee Teschler, Executive Editor, DesignWorld It looks as though the U.S. Centers for Disease Control and Prevention (CDC) may end up strongly suggesting that Americans cover their faces in public until the coronavirus pandemic plays out. The Washington Post reports the recommendations now being floated would call for the use of cloth coverings instead of hard-to-find […]
BD to launch point-of-care COVID-19 antibody test
Becton Dickinson (NYSE:BDX) yesterday announced a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics (Morrisville, N.C.), will be available through BD and distributed exclusively by Henry Schein (NSDQ:HSIC) to healthcare providers throughout the […]
FDA to authorize single-laboratory COVID-19 tests
The FDA said yesterday it will consider emergency use authorization (EUA) for molecular COVID-19 diagnostic tests to be used solely in the laboratories that developed them. The laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests. The tests must either be new or represent a significant deviation […]