Tobey Clark, Director*, Burlington USA Vigilance on medical devices in hospitals workshop: Adverse event notification, investigation and regulatory reporting in the United States Tobey Clark, Director*, Burlington USA * WHO Collaborating Center for Health Technology Management Presentation #161 Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Disclosure The presenter declares no conflict of interest with the materials provided. Fourth WHO Global Forum on Medical Devices

Why Surveillance of Medical Devices Is Important: US Experience Medical device failures account for 13% of all type of adverse events in medicine (Frost & Sullivan) Deaths from hospital errors which is a primary cause of adverse events is estimated to be 98,000 – 440,000 per year (IOM 1999 and Journal of Patient Safety 2014) The total national costs from preventable adverse events range between $20 billion to $75 billion annually. (IOM) The annual number of medical device recalls increased by 97 percent from FY 2003 to FY 2012 (Food & Drug Administration (FDA) Medical Device Recall Report) Software failures number 1 reason for recalls (FDA 2018) Fourth WHO Global Forum on Medical Devices

USA Food and Drug Administration (FDA) The FDA is the USA consumer protection and health agency Under the Department of Health & Human Services Consumers spent about $1 trillion on hundreds of thousands of products whose safety and effectiveness is the FDA’s responsibility The FDA covers food, drugs, and medical devices Sub-agency Center for Devices and Radiological Health (CDRH) specifically responsible for medical devices DHHS FDA CDRH Fourth WHO Global Forum on Medical Devices

CDRH Post-Market Surveillance Safe Medical Devices Act of 1990 (SMDA) Required reporting by all users of device related incidents that caused injury, death or required the plan of care for the patient to be altered Fourth WHO Global Forum on Medical Devices

CDRH Post-Market Surveillance Medical device adverse event reports of device-associated deaths, serious injuries and malfunctions Reports used to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. MAUDE database – adverse event reports submitted by manufacturers, importers, device user facilities, health care professionals, patients and consumers. Over 600,000 reports submitted to the CDRH to date in 2018 Over 5000 deaths and 175,000 plus injuries Primary reporter - manufacturers Fourth WHO Global Forum on Medical Devices

CDRH Post-Market Surveillance: Best Practices MedSun Pilot program involving a network of approximately 300 hospitals Sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. Utilizes a secure, on-line system for reporting problems with the use of medical devices High quality data Proactive surveillance Incentives for Hospitals Recognition for submitting voluntary reports related to potential problems Near miss events Product quality issues Design issues Instructions for use problems Fourth WHO Global Forum on Medical Devices

CDRH Post-Market Surveillance: Future Plans Medical Device Safety Action Plan Current post-market surveillance system: Passive, relies on device users to report problems resulting in underreporting Moving to an active surveillance system Prioritized this area for regulatory reform efforts National independently-run public-private coordinating center for gathering real-time evidence on medical device safety National Evaluation System for Health Technology Women’s Health Technologies Coordinated Registry Networks Events related to cyber attacks and security events a primary focus Fourth WHO Global Forum on Medical Devices

Example Issue: Impact of Clinical Alarms on Patient Safety Alarm fatigue results from staff being overwhelmed by non-actionable alarms which do not lead to changes in patient management or treatment. Large volumes of non-actionable alarms often lead to the following: a delayed response, alarms being silenced, ignored or simply turned off. FDA/CDRH – 100-150 deaths each year ECRI Institute – Alarm hazards #1 Health Technology Hazard 5 years in a row Healthcare Technology Foundation surveys over the past ten years guidance documents most recent survey responses of 4000+ clinicians showed 20% reported adverse events related to alarm hazards Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Hospital Efforts to Reduce Adverse Events from Alarms: Clinical engineering’s lead role Joint Commission instituted National Patient Safety Goal – Improve the Safety of Clinical Alarm Systems University of Vermont Medical Center adverse event review Review of three years of adverse event reports involving alarms Most common devices involved: Bed/chair exit alarms Hemodialysis units Infusion pumps Ventilators Nurse call Physiological monitors Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Hospital Efforts to Reduce Adverse Events from Alarms: Clinical engineering’s lead role Actions: Usability assessments, training, unit design changes, & awareness Fourth WHO Global Forum on Medical Devices