PLYMOUTH MEETING, Pa., March 30 Big changes have been implemented in the way medical devices are being rated by ECRI Institute®, an independent, nonprofit organization that researches the best approaches to patient care. The organization, which has been guiding hospitals and other healthcare organizations on medical devices and procedures since 1971, has revamped its rating system to follow a five-star approach. This month’s issue of Health Devices features an evaluation of portable/transport ventilators, the first technology to be rated using the new five-star scale.
This new rating system offers a more updated perspective on product evaluations than the organization’s previous system, which rated products as Preferred, Acceptable and Not Recommended.
“When the original rating system was devised four decades ago, it was not uncommon for us to test devices that failed to meet even the most minimum safety standards,” says James Keller, Jr., Vice President, Health Technology and Safety, ECRI Institute. “Thankfully, product safety has come a long way, and we rarely find a device that just plain works badly. Our new rating system better reflects the caliber of today’s medical devices.”
Now, an easier-to-understand rating scale, with five gradations of rating instead of three, will allow analysts to better convey the products’ advantages and disadvantages, giving a more accurate picture of which devices will be more suitable for a particular organization.
“Our objective is not only to determine which product is best, but also to provide the right amount of analysis to help organizations decide what is best for their specific needs,” says Keller. “For example, the most appropriate ventilator for a long-term care use may not be the best one for mass-casualty critical care.”
ECRI Institute analysts employed the new rating system in this month’s evaluation of portable/transport ventilators. It was featured in the March issue of Health Devices, ECRI Institute’s monthly journal featuring independent, comparative evaluations of medical devices and systems, as well as in-depth technology guidance.
Five ventilators were tested for their use in internal hospital transportation, long-term care, or mass-casualty critical care. Ventilators included the CareFusion Pulmonetic Systems LTV 1200; Draeger Carina; Draeger Oxylog 3000; GE Healthcare/VersaMed iVent201; and Hamilton Medical C2.
Analysts rated the products primarily on their overall capabilities, their portability, and their battery life.
Of the five units tested, one received four stars for in-hospital transport. It was hailed for offering “functionality comparable to advanced intensive care unit ventilators.” In long-term and mass-casualty care, one ventilator received just two stars, due to its cost and performance in those settings.
One additional unit, marketed as a “supplemental mass-casualty ventilator,” was evaluated separately. The Allied Healthcare Products MCV100 was reviewed based upon its intended use for mass-casualty situations, such as a pandemic or biological attack.