Dr. Yadin David, Foundation President Emirates and Director of Biomedical Engineering at Texas Children's Hospital, together with Professor William Hyman of Texas A&M University and also a Foundation Board member, recently brought together a diverse group of some 65 stakeholders including biomedical engineers, risk managers, medical technology manufacturers, physicians, nursing leadership and industry regulators to discuss medical-device safety issues at the Responding to Medical Devices Failures Colloquium.

The group met at M. D. Anderson Cancer Center in Houston to hear about different incident reporting strategies and to develop an integrated action plan for improving patient safety through an effective — and fair — system for reporting device-related failures and other mishaps. The one-day event was sponsored by the American College of Clinical Engineering Healthcare Technology Foundation, Texas Children's Hospital, Texas A&M University and the U.S. Food and Drug Administration (FDA) Medical Device Industry Coalition.

"As an adviser to the FDA and an active member of the Clinical Engineering profession, I am often called upon to help interpret regulations and to investigate devices-related incidents," David said. "I was searching for a way I could help by promoting more open dialogue, a better-educated workforce and better-designed equipment. When I started talking to people in the industry, they encouraged me to bring together this colloquium to generate discussion and concrete proposals."

Over the past 20 years, the average number of medical devices at the patient's bedside has increased on the average from just a few to over 20. Due in part to several high-profile recalls, the public is becoming increasingly concerned about device safety. In response, the FDA is moving rapidly to ramp up it's mechanisms for additional post market device monitoring.

Achieving a higher safety level will require a concerted effort to bridge the gaps between manufacturers, regulators, maintainers, end-users and patients, David said. All segments of the industry will have to more openly share information in a way that will reduce problems and improve patient safety.

In a 2006 editorial in an industry magazine, David set the wheels in motion for the colloquium by calling on leaders across industries and communities to join to improve device safety.

"Unquestionably, consumer safety is diminished when there is limited communication among the engineers who design devices, the clinicians who deploy them, the clinical engineers who support them, the regulators who monitor them, and the patients and care givers who experience them," he wrote.

At the colloquium, David proposed a system to reduce errors and other incidents that is similar to the "black box" successfully used by airlines to collect contemporaneous system data.

"If we are able to capture data at the point of care in the hospital, so we know what conditions existed that allowed the error to be committed, or the failure to occur, and thereby learn how to avoid repetition, we will make health care safer and better for our patients."