Startseite
Podcasts
BiocompCHATibility Podcast
Covid 19 Topic: Biocompatibility of Ventilators and Other Respiratory Devices

Covid 19 Topic: Biocompatibility of Ventilators and Other Respiratory Devices

BiocompCHATibility vor 6 Jahren

0:00

43:27

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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-Bibins

Discussion points include:

Difference between respirators and ventilators and their
evaluation process

Overview of the US and UK guidance documents for ventilators

Selecting materials to help control the chemical possibly
released

Particles – and how to produce in a “relatively clean”
environment

The use of these short term ventilators for acute,
life-saving care until a CE Mark device could be used

Opinions are their own and do not reflect that of their current
or former employers.