COVID-19 PANDEMIC TRIGGERS DEVELOPMENT OF NEW STANDARD FOR VENTILATORS
iso.org - 12 Januari 2021
Helping manufacturers meet the demand with devices that are safe, reliable and of high quality.
When the COVID-19 pandemic took hold, so too did the demand for ventilators. With patient safety at its heart, ISO’s committee for respiratory devices rapidly got to work on a new standard to support the manufacture of new, high-quality medical equipment that could help.
Now, as publication of this standard draws near, we talk to two experts about the role of this and other related standards in the current crisis and what difference they could make.
Bob Kopotic is a Critical Care Manager of Clinical and Medical Affairs for Edwards Lifesciences. He is a licensed critical care registered nurse and respiratory therapist.
Dr Sandy Weininger is a Senior Regulatory Engineer in the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA).
Both are members [1] of ISO’s subcommittee ISO/TC 121/SC 3 on respiratory equipment.