Vigilance on medical devices in hospitals workshop: - PowerPoint Presentation

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Vigilance on medical devices in hospitals workshop: Adverse event notification, investigation and regulatory reporting in the United States

Tobey Clark, Director*, Burlington USA

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* WHO Collaborating Center for Health Technology Management

Presentation #161

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

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Why Surveillance of Medical Devices Is Important: US ExperienceMedical 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 ServicesConsumers 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 devicesSub-agency

Center for Devices and Radiological Health (CDRH) specifically responsible for medical devices

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CDRH Post-Market SurveillanceSafe 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 SurveillanceMedical device adverse event reports of device-associated deaths, serious injuries and malfunctionsReports 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 2018Over 5000 deaths and 175,000 plus injuries

Primary reporter - manufacturers

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CDRH Post-Market Surveillance: Best PracticesMedSun

Pilot program involving a network of approximately 300 hospitalsSites 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 dataProactive surveillance

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Incentives for Hospitals

Recognition for submitting voluntary reports related to potential problems

Near miss events

Product quality issues

Design issues

Instructions for use problems

CDRH Post-Market Surveillance: Future PlansMedical 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 systemPrioritized this area for regulatory reform effortsNational 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 focusFourth WHO Global Forum on Medical Devices

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Example Issue: Impact of Clinical Alarms on Patient SafetyAlarm 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 yearECRI Institute – Alarm hazards #1 Health Technology Hazard 5 years in a row

Healthcare Technology Foundation

surveys over the past ten years guidance documentsmost 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 SystemsUniversity 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 unitsInfusion pumpsVentilatorsNurse call

Physiological monitorsFourth WHO Global Forum on Medical Devices

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Actions

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

Hospital Efforts to Reduce Adverse Events from Alarms:

Clinical engineering’s lead role