Coronavirus company news summary – Medtronic modifies cardiopulmonary product indications – UK MHRA temporarily bans fingerprick Covid-19 antibody testing kits

1 June 2020 (Last Updated June 1st, 2020 09:13)

NASA has selected eight manufacturers in the US for the NASA JPL – VITAL Ventilator for Covid-19 patients. The prototype was developed by JPL engineers in 37 days and was given Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on 30 April. The design uses one-seventh of the parts in a conventional ventilator and uses parts that are readily available in supply chains, and can also be changed for field hospital use.

SwabTek has introduced a ‘Buy One, Give One’ (BOGO) programme where the company will donate one mask to a law enforcement agency, for each mask that is bought by individuals and companies. This move follows the partnership with National Sheriffs' Association to supply over 200,000 masks to Sheriffs' offices. SwabTek is protective gear and test kits provider in the US for law enforcement and first responders.

Medtronic has changed the indications of some of its cardiopulmonary devices that are cleared or approved by the FDA. These modifications will permit them to be used for Extracorporeal Membrane Oxygenation (ECMO) therapy for over six hours. The modifications are permitted when they do not pose an undue risk, amid the Covid-19 health crisis.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice to companies to temporarily stop using the Covid-19 antibody testing services that use capillary blood from a fingerprick. The temporary ban will be in effect until the home collection of such samples is properly assessed and validated for use in lab tests. However, the ban does not apply to rapid, point of care tests or laboratory tests that use blood from a vein.