There is currently a shortage of ventilators to help patients with severe respiratory distress due to COVID-19.

Many DIY designs are thus popping up on the Internet showing how mechanisms to pump a bag valve mask (BVM, AKA by the proprietary name “Ambu bag”) could be used as a makeshift ventilator.

Unfortunately, these can do a lot more harm than good.  I would like to point anyone thinking about constructing such mechanism to first watch the following video:

In the US, even under these emergency circumstances, these quickly-built “Ventilators for Emergency Mass Use” (VEMU) or “Emergency Use Ventilators” (EUV) MUST receive authorization by FDA before they can be used to ventilate patients.

FDA has issued an Emergency Use Authorization (“EUA”) that allows certain ventilators – as well as anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories – to be distributed in the U.S., notwithstanding the fact that the devices have not obtained the FDA marketing authorizations that would otherwise be required prior to marketing the products.

To be authorized under the EUA, a device must meet certain requirements, and must be added by FDA to a list of authorized products .  Detailed information about the EUA, including regarding the criteria that must be satisfied for a product to be authorized was issued by FDA on March 24, 2020 and is available here.

In this letter you will see that the requirements are not simple at all, and that the vast majority of DIY designs that simply pump an ambu bag don’t even start to scratch the surface of what would be needed to fulfill even the most basic requirements for safety and performance set by FDA under this emergency.

AAMI published a DRAFT Emergency Use Ventilator (EUV) Design Guidance which describes the minimum requirements of ISO 80601-2-80 that must be fulfilled by an EUV.

If you are considering the design of a VEMU, please start by learning about the requirements for safety and performance rather than by building yet another contraption that can do much more harm than good in this emergency.

Image Credit: Abbott

Abbott announced that it received FDA’s approval for the treatment  of Parkinson’s, Essential Tremor, and some other movement disorders by stimulating the Internal Globus Pallidus (GPi) with its Infinity™ Deep Brain Stimulation (DBS) system.

This is the first approval by FDA using the Internal Globus Pallidus (GPi) as an alternative target to the subthalamic nucleus (STN) and ventral intermediate nucleus (VIM) for the treatment of these movement disorders.

Image Credit: Medtronic

Back in November 2019 Medtronic announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an investigational set of algorithms in the Micra™ leadless pacemaker improves synchrony and cardiac function in patients with  atrioventricular (AV) block.  At the time, Medtronic submitted to FDA for approval of the Micra AV pacemaker, to expand the indicated population to AV block and normal sinus rhythm.

Medtronic announced this week that it received FDA’s approval for its Micra AV™ leadless pacemaker to treat AV block.

According to this week’s announcement:

“Micra AV is unique in the history of pacemakers. Until now, pacemakers sensed the heart’s electrical signals and used that information to provide pacing. But Medtronic scientists figured out how to re-purpose sensors, already inside the original Micra pacemaker, to recognize certain physical, or mechanical movements, within the heart – an approach to pacing that’s never been done before. Micra AV can detect the mechanical movement of a beat in one chamber of the heart – the atrium – and then pace another chamber where Micra is implanted – the ventricle – so the atrium and ventricle beat in synchrony.”