In this special release episode, our hosts are joined by Dr. Phil Smiraldo, Toxicologist at NAMSA.During this episode the team discusses the current pandemic situation of Covid 19 and the production of ventilators and respirators to help treat and prevent spread of this virus. With companies like Dyson, Ford, GMC and others discussing the design and/or manufacture of ventilators to meet the growing need of infected patients, how do we insure biological safety on a very short term?Hosts will discuss some guidance put in place by the UK and USFDA alike that address these needs and offer some guidance and solutions.This is a great example of the evaluation of risk/benefit and how using risk as your guide for biological safety is so critical. These documents go through risk mitigation through various means, which may address evaluation endpoints outlined in ISO 18562, the document that guides the evaluation of air pathway devices.“Respirator is a protection piece of equipment… technically in the US may not even be a medical device – although a surgical mask is a medical device,” – Don Pohl“This (ventilator) is an actual instrument that is helping you breathe - whether it’s provided a positive pressure situation or its doing your inhaling and exhaling for you. So these are very different than respirators.” -Dr. Phil Smiraldo“Biocompatibility associated with all these different guidance (documents) as they pertain to ventilators, masks, respirators - it’s certainly interesting to at least ponder where biocompatibility falls in the grand scheme of things.” – Don Pohl“The lungs are quite efficient at absorbing chemicals and putting those chemicals into systemic circulation.” – Dr. Phil Smiraldo“It’s a risk evaluation. Is the short term solution more critical than any long term risks of exposure?” - Sheri Krajewski-BibinsDiscussion points include:Difference between respirators and ventilators and their evaluation processOverview of the US and UK guidance documents for ventilatorsSelecting materials to help control the chemical possibly releasedParticles – and how to produce in a “relatively clean” environmentThe use of these short term ventilators for acute, life-saving care until a CE Mark device could be usedOpinions are their own and do not reflect that of their current or former employers.

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