The Advanced Medical Technology Association (Advamed) said it will expand the capacity of the association’s Vent Connect platform to add other complex medical technologies needed for the COVID-19 pandemic. Up to now, the platform has served primarily to connect suppliers and manufacturers of ventilators in an effort to boost production specifically for those products, but the newly rebranded platform will offer the same connecting service for other goods and materials, such as patient monitors, dialysis machines and diagnostic tests, that have been strained by the demands of the pandemic. The new platform allows manufacturers to develop spreadsheets that identify parts and components that are in short supply. Advamed said suppliers interesting in helping to boost production can fill out a brief application describing their production capacities and materials. Manufacturers will review these applications and decide whether to disclose their supply list needs, and the two sides “can then separately choose whether to enter an agreement to provide the needed materials,” Advamed said. Scott Whitaker, Advamed’s president and CEO, said Vent Connect “has been very effective in connecting suppliers and manufacturers to boost ventilator production,” adding that this new platform will build on that success “to meet current patient and caregiver needs and to prepare for any future waves of COVID, natural disasters or other crises.” Whitaker acknowledged the assistance of other organizations that were involved in launching the ventilator-only platform, a list that includes Google Inc., of Mountain View, Calif., and the Aerospace Industries Association (AIA), although this new platform will be managed solely by Advamed.
Legislation has been introduced into the U.S. Senate pertaining to ethylene oxide (EtO), the controversial gas used to sterilize a large volume of medical devices. Sen. Tammy Duckworth announced the Public Health Air Quality Act in a July 29 statement, noting that the legislation would require that the Environmental Protection Agency (EPA) engage in fence-line monitoring for any agents suspected of carrying an elevated risk of carcinogenicity, although the list of toxins includes non-EtO substances such as formaldehyde. The EPA would also have to deploy 1,000 air sensors at a minimum in communities affected by pollutants and the COVID-19 pandemic, and Duckworth said, “Black Americans and other communities of color are dying at disproportionate rates during this pandemic, in part because of the long-term, cumulative health consequences and complications associated with toxic air pollution from facilities located in their neighborhoods.” A companion bill has been introduced in the House of Representatives by Rep. Lisa Blunt Rochester (D-De./at large).
The U.S. National Institutes of Health (NIH) said it is investing $249 million in novel technologies under the Rapid Acceleration of Diagnostics (RADx) program for diagnostics that can detect the SARS-CoV-2 virus. The agency has awarded contracts to seven companies that will go toward development of both point-of-care (POC) and lab-based tests that could “significantly increase the number, type and availability of tests by millions per week” as early as September 2020. NIH said the demand for tests exceeds current capacity by more than one million per day, adding that four of the awards are for testing using CRISPR, next-generation sequencing and integrated microfluidics. The remaining three awards are for POC tests that detect nucleic acids and viral antigens that can be deployed in a variety of settings, and some of the tests can use saliva as a medium for patient samples.
The European Commission’s Compliance and Enforcement Group (CEG) posted a guidance for checklists to be used by sponsors of re-sterilizable medical devices, a response to what the CEG said is a series of major non-conformities for instructions for use picked up by national competent authorities. The notice states that the regulation calls for instructions for use to make reference to EN ISO 17664, but notes also that those involved in re-sterilization activities need “user-friendly guidance” to assist in assessment of devices for re-sterilization. The document states also that surveillance activities indicate that “a vast number” of re-sterilizable devices are going to market without an instruction-for-use manual, and that interested parties can make suggestions on how to improve the checklist by emailing those suggestions to email@example.com.