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.

Host Information


Phillip G. Smiraldo, PhDDABT; Toxicologist, NAMSA

Dr. Smiraldo holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications and has provided several oral presentations.

Dr. Smiraldo’s timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies. Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.

Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.