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Mark Bruley, who has been with ECRI Institute for 38 of the organization’s 45-year history, has investigated more medical device failures and accidents in healthcare facilities than anyone else in the world.

Part Sherlock Holmes

As an ECRI Institute vice president, Bruley is responsible for the organization’s accident and forensic investigation programs, which he began to develop in 1978. Additionally, he has overseen ECRI Institute’s Problem Reporting Network (PRN), a database of medical-device-related incidents and hazards reported to ECRI Institute healthcare providers and others, since 1978. 

“I had never thought of my experience as the leading investigator of device-related failures and accidents until Dr. Joel Nobel [a physician and ECRI Institute’s founder and president emeritus] described me as such to a foreign minister of health in the mid-1990s,” Bruley recalls.

As the person in charge of ECRI Institute’s Accident and Forensics Investigation Group, he has performed and overseen thousands of investigations, ranging from accidents with needles and syringes to linear accelerators. And given that ECRI Institute’s PRN database now contains tens of thousands of reports, Bruley realized that Nobel’s description was likely true.

How it All Began

Bruley, a certified clinical engineer, started at ECRI Institute in 1975, just after obtaining his BS in biomedical engineering technology from Temple University in Philadelphia. Although he considered jobs in biomedical engineering at hospitals, his contacts kept referring him “to a laboratory in Philadelphia that does marvelous work evaluating medical devices and technology.” He was offered a job as a project engineer at ECRI Institute while he was still completing his last semester at Temple. At the time, there were 27 people working at the organization.

As project engineer, Bruley’s first assignments involved evaluations of traction and air splint devices, emergency stretchers, and antishock trousers. And because he had previous experience in hospital settings as a nurse’s aide and autopsy assistant, he was quickly enlisted to assist with ECRI Institute’s consulting work for hospitals.

Part Fire Fighter

Bruley’s first solo accident investigation was in 1978 to determine the cause of a surgical fire during eye surgery at a New Jersey hospital. The patient’s face was badly burned. Bruley met with all individuals involved in the incident and observed a subsequent case to watch the surgeon’s technique. He recognized that the buildup of oxygen under the surgical drape created an oxygen-enriched atmosphere that caused the cotton surgical towels to burst into flames when the surgeon’s battery-powered, hotwire cautery pencil accidentally contacted them. ECRI Institute has since published many recommendations for the prevention of surgical fires based on hundreds of such investigations.

The Accident and Forensics Investigation Group continues to investigate surgical fires. Bruley is extremely proud of ECRI Institute’s work in “understanding why fires happen and creating awareness,” and he is encouraged that in the last few years groups such as the Joint Commission and medical professional societies have joined with ECRI Institute in promoting surgical fire prevention. He is also proud of many other safety issues raised by ECRI Institute to which he has contributed his expertise, including prevention of intraoperative skin injuries and burns and the need to scavenge nitrous oxide from cryosurgical equipment.

When asked to conduct an investigation of a device-related accident at a healthcare facility, Bruley is often told that the device failed. Nevertheless, his work on countless device-related investigations has led ECRI Institute to conclude that nearly 70% of medical device failures are due to the technique of use of the device. To conduct an investigation, Bruley considers four interfaces with the device—the user, the patient, the device accessories, and the environment such as electricity and gases supplied by the facility. “A common mistake made when investigating a device-related event is simply inspecting the device or equipment without regard to all the applicable interfaces,” says Bruley.

Part Houdini

Bruley’s encyclopedic memory of past investigations as well as his training as a magician—he has been a member of the Philadelphia chapter of the International Brotherhood of Magicians for 35 years—helps inform his work. Understanding the cause of a medical accident often involves looking for clues that others ignore because they are convinced the incident occurred a certain way, Bruley explains.

“My experience as a magician has served me well in understanding how people ‘see’ and remember the details with devices and physical items.” Overall, Bruley says, “There’s rarely the case that we do not solve.”