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Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

September 2008

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ECRI Institute: Spanning 40 years of product, process exploration

by Jeffrey C. Lerner, PhD, president & CEO, ECRI Institute

Four decades ago a small group of young, idealistic people joined together with a shared desire—more like an obsession—to seek meaningful improvements in patient care. And so, ECRI Institute was born. Forty years later we are a lot bigger and some of us are a tad older, but what remains constant is our commitment to continue to search for ways to help our members and clients help their patients.

This search has led to the explorations of many paths. And in this journey we have grown, significantly expanding our services and our knowledge base. But through it all, we have insisted on being fully dedicated to the discipline of science while remaining completely independent—just as we were when we began. It’s part of our DNA now.

ECRI Institute’s first issue of Health Devices found 9 of the 18 manually operated resuscitators to be ineffective and rated them "unacceptable"; half of the unacceptable models were later removed from the market.

We believe that accurate, reliable research does not live in environments where conflicts of interest are present. Our conflict-of-interest rules are the strictest in the healthcare industry. That’s why ECRI Institute can always be depended upon to deliver unbiased, thorough and reliable evidence-based research that has literally saved thousands of lives.

To say the least, we’ve been pretty busy these last four decades. So busy working to improve care and reduce harm that we have neglected to "tell our story." Many organizations that can significantly benefit from our services still do not know us. Even ECRI Institute’s members and clients may be only aware of a small fraction of what we can do for them.

That’s why we’re taking advantage of our 40th Anniversary in two ways. One is to celebrate! The second is to give you the opportunity to get to know us.

This is who we are

ECRI Institute is a nonprofit organization, 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.

This is what we do

While not an easy question to answer briefly, here are a few stories that illustrate what we have accomplished:

u "Does it work? Is it safe? Is it reliable?"

ECRI Institute’s first evaluation of manually operated resuscitators, published in the 1971 launch of our Health Devices journal, found nine 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.

Joel Nobel (standing) and project engineer Eugene LeBoy use a vibrating machine to test whether a defibrillator will stand up under rough use in the hospital setting.

Joel J. Nobel, M.D., founded our 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."1 To help ensure the publication of unbiased information, the monthly journal accepts no advertising from any source. [Editor’s Note: Healthcare Purchasing News recognized Joel Nobel, M.D., as one of the 30 Most Influential Professionals in Supply Chain Management, in its July 2007 edition.]

We still test medical devices in our onsite research laboratories, but beyond that, we help hospitals procure and save money on appropriate capital equipment and medical/surgical supplies. Always on call, our Accident and Forensic Information (AFIG) 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.

u Standing firm on evidence that disputed a widely held belief

In the early 1990s, conventional medical wisdom held that high dose chemotherapy, in conjunction with bone marrow transplant, extended the lifespan of women with metastatic breast cancer. Our systematic review of the evidence disputed this widely held belief. Our research showed that this therapy did shrink tumors initially, but the response did not last and the cancer progressed. In fact, there was evidence that the best available standard-dose chemotherapy regimens offered patients with metastatic breast cancer a longer response time and an increased overall survival time. This was a highly unpopular stance to take at the time, but we believed in our findings and stood by them. Our recommendations to discontinue bone marrow transplants for this type of cancer were proven correct, and women were saved an unnecessary, painful, expensive and potentially harmful procedure.

Today, hundreds of hospitals, health insurers, and Ministries of Health get evidence-based guidance and vital insight on the ever-changing healthcare landscape from our Health Technology Assessment Information Service. Every day they turn to us for answers to these questions: "Is a ‘new’ drug, device, or procedure actually new? Is it safe and effective? Is it better than what is currently used? And do you expect it to be used widely?"

And we continue to set new standards for patient-driven information, such as our most recent resource, Bulimia Nervosa: Resource Guide for Family and Friends. Most patient information is created from the top down. Scientific or medical reports are put into lay language and called ‘patient information’ without ever really asking patients and families what their questions are. We built this resource from the bottom up.

Urgent Hazard Bulletins, originally called Pink Sheets, cautioned hospitals about unsafe medical devices.

u From Pink Sheets to PSO

Getting pink slips from ECRI Institute during the last four decades meant bad news, but maybe not the kind you’d expect. ECRI Institute’s Pink Sheets weren’t job termination notices, but Urgent Hazard Bulletins intended to alert hospitals about potential critical issues with medical devices. ECRI Institute often issued the bulletins after being asked to research the problems reported by our member hospitals. We continue to investigate hazardous issues, but these days the alerts are about pharmaceuticals, blood, devices, biologics and food, and are issued electronically—marked with a critical priority status in weekly Health Devices Alerts e-newsletters. We even have software so that hospitals can tell if they’ve acted to actually fix the problems.

Our advisories now extend to patient safety events and medical error. Under contract with the Pennsylvania Patient Safety Authority, ECRI Institute collects 200,000 adverse event and near miss reports each year, analyzes them and makes recommendations for improvement as part of the statewide Pennsylvania Patient Safety Reporting System.

Later this fall, ECRI Institute expects to become a federally-certified Patient Safety Organization (PSO) with programs to help hospitals and healthcare systems improve patient safety through learning gleaned from reporting of adverse events.

What can ECRI Institute’s unbiased, evidence-based healthcare research, information and advice enable your organization to do? 

u Assess and address your patient safety, quality and risk management challenges

u Select the safest, most effective medical devices, procedures and drugs

u Procure healthcare technology in the most cost-effective manner

u Develop evidence-based health coverage policies

u Align hospital and health facility capital investments with your strategic technology needs

We invite you to get to know us — to really know us. It’ll do your organization, your heart, your peace of mind and your patients a world of good. For more stories, history, and photos, visit https://www.ecri.org/40years.


Reference:

1. Modern Hospital, November 1973

Joel Nobel (left) testifies before congress in 1973
on pending medical device legislation.

Congressional Hearings on the Medical Device Amendment

By 1973, when Dr. Nobel presented testimony before the Senate Health Subcommittee on the Medical Device Amendments Act, ECRI Institute was ‘directly responsible for bringing over 100 hazardous devices to broader attention…and directly responsible for removal of at least 25 items from market." Upon conclusion of Dr. Nobel’s statement, Sen. Edward M. Kennedy (D-MA) said, "Yours is a unique organization that has done an extraordinary amount of work…It is the only one of its kind, I believe, and you are one of the pioneers in this area."