Medical Technology and Patient Safety

James P. Keller, M.S.Vice PresidentHealth Technology Evaluation and Safety

May 21, 2007

New York State Department of HealthPatient Safety Conference

Re-Introducing

Company Overview Who is ECRI Institute?

ECRI Institute is a nonprofit healthcare research organizationOur mission is to enable our members to improve patient care For 40 years we have dedicated ourselves to applied scientific research to discover which technologies and patient care approaches are best

Health Devices Journal

Typical guidance article on patientsafety

Survey of the LandscapeWide variety of technologies (disposables to multi-parameter interconnected instruments)Increasing complexity of technologyPoor planning for new technology, which results in poor implementation of technologyInadequately trained usersLack of standardization

Common Problem – Close to Home

User Error50 - 70% of Device Accidents

Pre-use inspectionsLabelingMisassemblyMisconnectionImproper (“bad”) connectionIncorrect clinical useIncorrect control settings

Incorrect programmingSpillsAbuseInappropriate reliance on automated featuresFailure to monitorMaintenance or incoming inspectionFailure to follow or have preventive procedures

Is This User

Qualified?

Key Concerns - “Top Ten List”Infusion technologyVentilators and anesthesia systemsPatient monitors DefibrillatorsCutting and coagulating surgical devices (e.g., electrosurgical units)Heart-lung bypass and circulatory assist devices

Catheters andneedlestick prevention devicesTrocars and staplersReprocessing ofendoscopy instrumentsMagnetic resonance imaging

A Scary User-Related Problem

Spermatic Cord Damage from Electrosurgery

11

A Serious and

High-Profile Problem

An Accident Waiting to Happen!

13

Dose Error Reduction SystemsNew technology in 2002Establishes limits on setting flow rates for infusion pumpsSignificantly reduces risk from overdoseIn 2002 ECRI rated products without dose error reduction as Not-RecommendedAt the end of 2006 all major infusion and PCA pump vendors offered products with dose error reduction features

Management of Hazards and Recalls

March 31, 2005

This Issue Has Been Covered Before

February 28, 2003 – Two Years Earlier!

Same Problem

Best Practices for Management of Hazards and Recalls

Clearly defined roles and responsibilitiesConsistent naming conventions for devices and systemsApproved and comprehensive sources for informationReliable and consistent dissemination of informationAccountability and follow-through

General Recommendations

Pay close attention to appropriate technology selection and useEstablish safety-related device selection criteriaPlan for user training during technology acquisitionsConduct regular ongoing training and check for proficiencyPlan for new technology at the right time and for the right reasons

Thank you

Questions?