Mark E. Bruley has been inducted into the Clinical Engineering Hall of Fame in recognition of his significant contributions to Clinical Engineering. He is a distinguished clinical engineering consultant and renowned internationally for his expertise in accident and forensic investigation. Patient safety with medical devices has been the focus of Mr. Bruley's work since beginning at ECRI in 1975. His initial work as a project engineer focused on the clinical and laboratory evaluation of medical devices. During his career he frequently consulted and lectured on medical device safety, medical technology accident investigation, and recall and problem reporting programs. The Joint Commission, state departments of health, the FDA, standards committees, professional societies, and foreign governments have all relied on Mr. Bruley for his expertise for decades.

With over four decades of experience at ECRI, Mr. Bruley specializes in accident and forensic investigation of medical devices, particularly within the realm of health technology and patient safety management. His comprehensive background includes proficiency in medical device accident investigation and prevention, risk management, forensic investigation, and ensuring compliance with governmental regulations.

Throughout his career, Mr. Bruley has conducted numerous investigations globally, covering a wide spectrum of healthcare technologies, ranging from anesthesia machines to surgical tools. His contributions to understanding the causes and prevention of surgical fires have been particularly notable. Moreover, he has collaborated with esteemed organizations such as the Association of Perioperative Registered Nurses (AORN), the American Society of Anesthesiologists (ASA), and the Anesthesia Patient Safety Foundation (APSF) to develop practice advisories, videos, and fire safety toolkits aimed at preventing and managing operating room fires.

Mr. Bruley has actively engaged in collaborative efforts with regulatory bodies like the FDA, serving as the chief liaison between ECRI and the U.S. FDA Center for Devices and Radiological Health (CDRH). He has contributed significantly to critical FDA patient safety initiatives, including those addressing the re-use of single-use medical devices, electrocution hazards from unprotected patient electrocardiograph (ECG) lead wires, and patient safety risks associated with repaired, refurbished, and reconditioned medical devices. Additionally, he directed ECRI’s consultation to FDA CDRH for the development of educational and training materials on medical device problem recognition and reporting for healthcare facilities participating in the FDA MedSun medical device surveillance network.

Education, Certification, Registration & Peer Recognition:

• B.S., Biomedical Engineering Technology, Temple University, Philadelphia, PA 1975. 
• EIT, Pennsylvania State Registration Board for Professional Engineers, 1975 
• Certified Clinical Engineer, Healthcare Technology Certification Commission (2007) 
• Fellow of the American College of Clinical Engineering (2018) 
• American College of Clinical Engineering Devteq Patient Safety Award, 2003 
• Institute of Electrical/Electronics Engineers, Phila. Chapter, Benjamin Franklin Key Award, 2007, 2013 
• AAMI & Becton Dickinson Patient Safety Award 2014 Lifetime Achievement Award from American College of Clinical Engineering (2018)

Mr. Bruley's commitment to patient safety is further evidenced by his involvement in the FDA-sponsored Hospital Bed Safety Workgroup (HBSW), where he served as an Issues Group Leader. This voluntary partnership aims to reduce bed entrapment incidents through technical and risk management initiatives. The work resulted in published guidance for hospitals on safer use of bedrails and, for manufacturers, significant changes in bedrail design.

In 1997, Mr. Bruley's voluntary efforts led to the amendment of the FDA Safe Medical Devices Act (SMDA) to remove obstacles hindering hospital and healthcare facility reporting of medical device problems and errors. Furthermore, he provided oral and written testimony on the research agenda for errors with healthcare technology at the First National Summit on Medical Errors and Patient Safety, sponsored by the U.S. Quality Interagency Coordination Task Force (QuIC) and the Agency for Healthcare Research and Quality (AHRQ). From 2003 to 2004, Mr. Bruley served as a consultant to the University of Chicago's Developing Center for Patient Safety, contributing his expertise to the AHRQ contract for "Creating High Reliability Healthcare Organizations." His involvement focused on the pilot project "Coping with medical device hazards: a study of organizational practices."  

Mr. Bruley's impact extends beyond investigations and consultations to education and advocacy. He has lectured or taught courses on healthcare technology topics at over 300 domestic and international venues, spanning countries such as Australia, Cameroon, Canada, Chengdu China, France, Hong Kong, Malaysia, The Netherlands, Turkey, Saudi Arabia, United Kingdom, and Singapore. His presentations cover a wide range of subjects, including medical device hazards, accident recognition, investigation and prevention, risk management, and the selection and management of medical equipment. Furthermore, Mr. Bruley has actively contributed to professional organizations such as the Association for the Advancement of Medical Instrumentation (AAMI), where he served as Co-Chairman of the Patient Safety Track for several annual conferences​

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Below are some extracts from the material provided for his nomination:

"The work Mark performed and his subsequent publications and presentations in industry venues during his entire time at ECRI had a major and lasting impact on and influenced the clinical engineering and health care community. This includes his early work on accident victim rescue and helping to demonstrate the impact of good ambulance design and the proper use of tools like the "jaws of life." Mark also was a leading advocate for fire and burn prevention including proper surgical techniques and the importance of the use of flame-retardant materials in surgery and oxygen-rich environments, and the proper and safe use of electrosurgical units on patients who were under anesthesia. Using data from the FDA, Mark demonstrated that the hospital bed was the medical device responsible for many serious patient accidents and worked to developed tools and standards adopted by the industry to help to significantly reduce this issue."

"Mark’s ability to bring evidence and facts to the most challenging issues of patient safety has been making patients safer and promoting the field of clinical engineering for almost 50 years"

Mr. Bruley lecturing on the causes and prevention of surgical fires at the nursing OR Excellence conference in San Antonio, TX, 2015.​