Mark E. Bruley, CCE
Vice President, Accident and Forensic Investigation
Mark E. Bruley, CCE, is Vice President for Accident and Forensic Investigation. Since 1982, he has been responsible for ECRI Institute’s health technology accident and forensic investigation programs, which provide consultation services worldwide, and has supervised ECRI Institute’s medical device problem reporting and hazard reporting systems since 1978.
Mr. Bruley has been an issues group leader on the U.S. Food and Drug Administration (FDA)-sponsored Hospital Bed Safety Workgroup since its inception in 1999. In 2004 he was appointed to the Institute of Medicine (IOM) Committee on Postmarket Surveillance of Pediatric Medical Devices. The Committee will examine the FDA’s postmarket surveillance system for medical devices to assess whether the system provides adequate safeguards for the use of devices in children.
Mr. Bruley has been a chief liaison between ECRI Institute and FDA regarding each agency’s medical device problem reporting system and for ECRI Institute/FDA collaboration on a number of critical patient safety initiatives, including reuse of single-use medical devices, electrocution hazards from unprotected patient electrocardiograph lead wires, and patient safety risks from repair, refurbishment, and reconditioning of medical devices. He had primary responsibility for hazard analysis of many critical health technologies, including those used in intensive care, surgery, dialysis, and the prehospital setting. He began at ECRI Institute in 1975 as a project engineer responsible for clinical and laboratory evaluation of medical devices.
Mr. Bruley earned a B.S. degree in biomedical engineering technology from Temple University and holds EIT certification from the Pennsylvania State Board of Professional Engineers.
Recent news coverage:
- Fatal Flaw: When Medical Devices Fail, Investigators Connect the Dots, SmartPlanet, 4/19/2012 (article)
- Pennsylvania Biomedical Engineer is World's Expert on Medical Accidents, The Philadelphia Inquirer,