Medical Technology and
Patient Safety
New York State Department of Health
Patient Safety Conference
James P. Keller, M.S.
Vice President
Health Technology Evaluation and Safety
May 21, 2007
Re-Introducing
Company Overview
Who is ECRI Institute?
X ECRI Institute is a nonprofit healthcare research organization
X Our mission is to enable our members to improve patient care
X 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 patient
safety
Survey of the Landscape
XWide variety of technologies (disposables to
multi-parameter interconnected instruments)
XIncreasing complexity of technology
XPoor planning for new technology, which
results in poor implementation of technology
XInadequately trained users
XLack of standardization
Common Problem – Close to Home
User Error
50 - 70% of Device Accidents
X Pre-use inspections
X Labeling
X Misassembly
X Misconnection
X Improper (“bad”)
connection
X Incorrect clinical use
X Incorrect control settings
X Incorrect programming
X Spills
X Abuse
X Inappropriate reliance on
automated features
X Failure to monitor
X Maintenance or incoming
inspection
X Failure to follow or have
preventive procedures
Is This
User
Qualified?
Key Concerns - “Top Ten List”
X Infusion technology
X Ventilators and
anesthesia systems
X Patient monitors
X Defibrillators
X Cutting and coagulating
surgical devices (e.g.,
electrosurgical units)
X Heart-lung bypass and
circulatory assist devices
X Catheters and
needlestick prevention
devices
X Trocars and staplers
X Reprocessing of
endoscopy instruments
X Magnetic resonance
imaging
A Scary User-Related Problem
Spermatic Cord Damage from Electrosurgery
A Serious
and
High-Profile
Problem
11
An Accident Waiting to Happen!
Dose Error Reduction Systems
XNew technology in 2002
XEstablishes limits on setting flow rates for
infusion pumps
XSignificantly reduces risk from overdose
XIn 2002 ECRI rated products without dose error
reduction as Not-Recommended
XAt the end of 2006 all major infusion and PCA
pump vendors offered products with dose error
reduction features
13
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
X Clearly defined roles and responsibilities
X Consistent naming conventions for devices
and systems
X Approved and comprehensive sources for
information
X Reliable and consistent dissemination of
information
X Accountability and follow-through
General Recommendations
XPay close attention to appropriate
technology selection and use
XEstablish safety-related device selection
criteria
XPlan for user training during technology
acquisitions
XConduct regular ongoing training and
check for proficiency
XPlan for new technology at the right time
and for the right reasons
Thank you
Questions?