The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) posted a policy addressing the minimal standards for the use of continuous positive airway pressure (CPAP) devices for initial care of patients requiring urgent respiratory support during the COVID-19 pandemic. The agency said the policy sets out the requirements for achievement of a “minimally acceptable performance” for CPAP machines, based on the expectations of anesthesiologists and intensive care health care professionals, although MHRA said “this is a fast-moving situation” and that the policy may be frequently updated. The document, titled “rapidly manufactured CPAP systems,” requires that any units manufactured under this policy be capable of running continuously for 14 days, and should be able to sustain a drop from the height of a bed to the floor. Among the standards cited in the policy is ISO 18562-1:2017 for biocompatibility and IEC 60601 for safety and performance of electrical equipment.

U.S. Senator Lamar Alexander (R-Tenn.) said in a May 5 statement that the increasing availability of diagnostic testing should allow each member of Congress to be tested for the SARS-CoV-2 virus once a week, prior to that individual’s return home from Washington. Alexander, who chairs the Senate Health, Education, Labor and Pensions Committee, said sending every member of the House and Senate home each week without testing would be a “highly efficient virus spreading machine,” adding that the expected total volume of testing in the U.S. of 2 million per week should suffice to allow testing for each member of Congress on a weekly basis.

The Advanced Medical Technology Association (Advamed) said it has launched a new online platform at Ventconnect.org in an effort to connect patient ventilator manufacturers with companies that manufacture components used in those devices. The website is intended to aid manufacturers in their efforts to increase output of ventilators to address the COVID-19 pandemic, and was set up by an alliance of business groups, such as the Aerospace Industry Association and individual companies, such as Google Inc., of Mountain View, Calif. Scott Whitaker, president and CEO of Advamed, said ventilator manufacturers have accelerated production, but need a “steady stream of key components from beyond the normal supply chain” in order to meet global demand.

No Comments