Does Anyone Have Info on ECRI Institute?

[Quality96 - 2011]

My company recently received a letter from the ECRI Institute asking for information regarding a minor medical device recall that was completed almost 1 year ago.

From their web site I gather that they are a non-governmental organization that generates revenue through consulting. However, the letter they sent reads more like it came from the FDA. I understand they have no legal authority; So my questions are:
1. Do they have ANY regulatory authority at all?
2. Are they just duplicating device recall information that is already available on the FDA web site?
3. Are they just masquerading as a non-profit while the top C-Level guys take home 7 figure salaries?

Thanks

[Jim Wynne]

I'm out of my depth when it comes to medical devices, but it sounds a bit shady from your description. What did they say when you called and asked about the letter?

[Quality96 - 2011]

They do not list a phone number. I sent an email yesterday and still waiting for a response.

[Jim Wynne]

In Reply to Parent Post by Quality96

They do not list a phone number. I sent an email yesterday and still waiting for a response.

There's a phone number here. Please post back and let us know what you find out.

[Quality96 - 2011]

I did call that number and got thru on the second try. They answered all of my questions. They provide a service to their clients (mostly hospitals) where they compile all sorts of medical device and drug information from several sources. I was able to resolve all of the issues I had with them.

[Jim Wynne]

In Reply to Parent Post by Quality96

I did call that number and got thru on the second try. They answered all of my questions. They provide a service to their clients (mostly hospitals) where they compile all sorts of medical device and drug information from several sources. I was able to resolve all of the issues I had with them.

Thanks for letting us know. It still sounds like something shady might be going on with their methods if after reading their letter you were left with the impression that something official was going on. Is there any chance you could scan and post the letter here (after appropriate redactions to conceal your confidential information)? It might be helpful for others.

[Quality96 - 2011]

Hi Jim, I can probably do that after I remove some of device and company information. I'll try to get to that over the next couple of days.

[esacks5200]

For more than 40 years, ECRI Institute, a nonprofit organization, has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, all to enable you to improve patient care. As pioneers in this science, we pride ourselves in having the unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research. We are one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality.

ECRI Institute’s Healthcare Product Alerts information service was founded in 1977 as Health Devices Alerts and is subscribed to by thousands of hospitals and other healthcare provider organizations worldwide. The program aggregates safety alert information on medical devices, supplies, pharmaceuticals, blood products, and food products. Our sources include our own exclusive research, multiple international regulatory agencies including FDA, and our member hospitals. In addition to collecting the information into a single e-mail notification and Web-based search resource, ECRI Institute verifies the accuracy of publicly available information, provides expert clarification and perspective on the significance of each alert, and presents a plan of action for healthcare providers affected by each alert.

To learn more, visit our Web site at ecri.org or contact me directly.

Eric S. Sacks
Director, Healthcare Product Alerts
ECRI Institute
5200 Butler Pike
Plymouth Meeting, PA 19462-1298, USA
Tel +1 (610) 825-6000, ext. 5317