The Advanced Medical Technology Association (Advamed) said it has joined several other organizations in publishing a re-entry guidance for health care facilities to address concerns about the COVID-19 pandemic. The framework was co-authored by the American Hospital Association (AHA) and the Association of periOperative Registered Nurses (AORN). It builds on an April statement by AORN and AHA, along with several other groups, that provided a roadmap for resumption of elective surgery. The framework puts the onus on hospitals to be the primary source of personal protective equipment, although representatives of medical device firms would be allowed to serve as back-up providers. Scott Whitaker, president/CEO of Advamed, said, “lives are being irreparably lost or ruined” due to the pause in noncritical care, adding that this document shows how a resumption of care “can be done safely and responsibly.”
Health Canada said it has teamed up with med-tech regulators across the globe to advance the regulatory science needed to support rapid development of tests for the COVID-19 pandemic, which consists in part of a commitment to share information on product safety and performance. Regulators in Australia, Singapore and Switzerland are participating, as is the ACSS Consortium, which will collaborate on vaccines as well as tests. The members vowed to reduce regulatory redundancy and increase each member agency’s ability to address the pandemic.
Australia’s Therapeutic Goods Administration (TGA) said it has received several applications from makers of thermometers and other temperature-measuring devices for the COVID-19 pandemic for inclusion in the Australian Register, adding that sponsors should establish the risk category of that device prior to contacting the agency. Clinical thermometers that are not battery-powered are deemed class I articles, while the class IIa designation is applied to battery-powered digital thermometers, such as those that rely on infrared or electrical energy for temperature detection. The same class designation would hold for infrared instruments used to screen people in public places. The TGA noted that while Australia has not signed on to an international push to eliminate the use of mercury, the nation is intent on phasing out the use of the element in all products, including medical devices.