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Covid 19: Biocompatibility of Ventilators and Respiratory Devices


In this special-release episode, our hosts are joined by Dr. Phil Smiraldo, NAMSA Toxicologist, to discuss the COVID-19 Pandemic and the production of ventilators and respirators to help treat the virus. With companies like Dyson, Ford, GMC and others tackling the design and/or manufacture of ventilators to meet the growing need of infected patients, how do we ensure biological safety in the very short term?

Guidance was put in place by the UK and the U.S. FDA alike that addresses pandemic needs and provides some solutions. This is a great example of the evaluation of risk/benefit and how using risk as your guide to biological safety is so critical. These documents discuss 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 U.S., it 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 U.S. and UK guidance documents for ventilators
  • Selecting materials to help control the potential release of chemicals
  • Particles and how to produce devices in a “relatively clean” environment
  • The use of short-term ventilators for acute, life-saving care until a CE Mark device can be obtained

Also be sure to check out our Biocompatibility Strategy Navigator.