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
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 Disclosure

• The presenter declares no conflict of interest with the materials

provided.

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

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

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 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

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 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
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 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
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 Hospital Efforts to Reduce Adverse Events from Alarms:
Clinical engineering’s lead role

Actions: Usability assessments, training, unit design changes, & awareness

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