Rick Schrenker

I may have commented previously, but I’ll add/update my thoughts here.

Years ago I wrote an article in BIT that highlighted the contribution of Henry Petroski to learning from failures. Within the article I included the question as tio whether 20th century medical device regulations would be adequate for 21st century technologies. It has been 50 years since the Medical Device Amendments were adopted into law. 510k regulations came soon thereafter. Are they adequate for 2026? I can’t answer that question, but those of you still in practice must.

I worked as a clinical engineer for 40+ years and experienced the accelerating rate of change of technology at the pointy end of the stick. I still don’t know how physicians, nurses, clinical engineers, BMETS, and others adapt as rapidly as the technology changed, and now the technology can change itself. How will practitioners verify changes? Will they know about them? What are the requirements that drove the changes? How are they validated?

Do these questions even make sense in the changed and rapidly changing context? What do they mean for patients?

Who is considering the impact at the pointy end of the stick? How can a caregiver know with as much certainty as possible that they are not violating "First, do no harm"?

Bottom line: How can V&V at the pointy end of the stick be done in an era when technology undergoes fundamental changes on a month-to-month basis? Unti you can answer that, you should not be introducing this technology into clinical practice.