1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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 – deaths each year
ECRI Institute – Alarm hazards #1 Health Technology Hazard years in a row
Healthcare Technology Foundation
surveys over the past ten years
guidance documents
most recent survey responses of clinicians showed 20% reported adverse events related to alarm hazards
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10. 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

11. 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