“During my internship a four-year old boy died in the E.R. of ventricular fibrillation secondary to airway obstruction and I was furious because the defibrillator failed to work—and I’d reported it broken several times over the previous week. Anger is a great source of energy and I focused it on improving resuscitation technology and organization. That’s how we started.”
Joel J. Nobel, MD, Founder and President Emeritus, ECRI Institute
Resusitators rated "unacceptable"
ECRI Institute’s first evaluation of manually-operated resuscitators, published in the 1971 launch of our Health Devices journal, found 9 of the 18 brands of resuscitators tested to be ineffective and rated them “unacceptable.”
As a result of our Evaluation, eight of the Unacceptable models were removed from the market by their manufacturers; the ninth was later seized by FDA. Also, several products were improved by their manufacturers to address our concerns. Because of this one study, tens of thousands of ineffective “life-saving” products—devices that were supposed to save someone’s life but that would not—were removed from the market.
In the decades since that first Evaluation, significant improvements in technology, new regulatory oversight, and the use of quality-systems processes by manufacturers have changed the medical device landscape for the better.
Does it work? Is it safe?
Joel J. Nobel, MD (1934-2014), founded the independent evaluation organization by asking: “Does it work? Is it safe? Is it reliable?” Using Consumers’ Union as his model for the Health Devices publication, Dr. Nobel predicted that a “highly educated and informed marketplace combined with the physician’s fear of culpability will be more effective in doing away with defective and hazardous devices than any generalized law that might be passed.” To help ensure the publication of unbiased information, the monthly journal accepted no advertising from any source.
We still test medical devices in our onsite research laboratory, but beyond that, we help hospitals procure and save money on the right capital equipment and medical/surgical supplies. Always on call, our Accident and Forensic Investigation Group performs thousands of investigations, ranging from accidents with needles and syringes to linear accelerators. And, we advise healthcare leaders around the globe on how to make sound technology decisions.