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
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
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
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
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
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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
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