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© 2012 ECRI Institute
Safety Surveillance for
Medical Devices
May 10, 2012
James P. Keller, M.S.
Vice President, Health Technology Evaluation and Safety
jkeller@ecri.org
(610) 825-6000, ext. 5279
© 2012 ECRI Institute
Presentation Overview
ECRI Institute background
Issues surrounding regulatory monitoring for medical device
safety
Product recalls
Incident reporting
Problem reporting systems
Hospital use of recall information
Upcoming regulations for device identification
Device approvals/clearance process as it relates to safety
General discussion
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© 2012 ECRI Institute
ECRI Institute
Nonprofit healthcare research organization
Mission: Enable healthcare organizations to improve patient
care
The Discipline of Science
Multidisciplinary staff
Proven methods & review processes
The Integrity of Independence
Unmatched conflict-of-interest rules
Serving providers to help patients
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© 2012 ECRI Institute
Medical Device-Related Safety Analyses
Health Devices Consumer Reports-like comparative
evaluations
International problem reporting system
Accident and forensic investigation program
Consultation and advisory services
Standards development and other research
General experience
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© 2012 ECRI Institute
Top Ten List of Hazards
Historical analysis
Health technology-related hazards that should be on every
hospital’s “to-do” list to address
Focus on prevalence and severity of reported events
Similar in concept to widely reported “Never Events”
Get the word out about important and preventable safety
problems
Published in Health Devices (November 2007 - 2011)
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© 2012 ECRI Institute
Top Ten List of Hazards
Historical analysis
Health technology-related hazards that should be on every
hospital’s “to-do” list to address
Focus on prevalence and severity of reported events
Similar in concept to widely reported “Never Events”
Get the word out about important and preventable safety
problems
Published in Health Devices (November 2007 - 2011)
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© 2012 ECRI Institute
Multi-Media Promotions
Top Ten Hazard Video 11
© 2012 ECRI Institute
A Pennsylvania Story
New Olympus colonoscope –
Looks similar to another model used
by the hospital
New model requires independent
rinsing of water-jet channel with
liquid chemical germicide
Hospital mistakenly reprocessed
like older model for four months!
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© 2012 ECRI Institute
March 2005
Headline: Monroeville Hospital urges 200 colonoscopy patients to get
checked for hepatitis, HIV
Headline: Callers flood hospital over colon tests
April 2005
Headline: Suit claims negligence in hospital’s colonoscopies
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© 2012 ECRI Institute
This Issue Has Been Covered Before
February 28,
2003 – Two
Years Earlier!
Same
Problem
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© 2012 ECRI Institute
Factors Impacting the Growing Numbers
Major increase in the number of devices
Increasing complexity of medical devices
Higher level of regulatory attention
Widespread coverage of recalls in the press
More cautious approach by medical device manufacturers
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© 2012 ECRI Institute
ECRI Institute Sources
FDA
Manufacturers
Hospitals
MHRA (United Kingdom)
BfArM Medical Devices (Germany)
Australia TGA
Canada
ECRI Institute research
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© 2012 ECRI Institute
High Profile Recalls
DePuy ASR metal-on-metal hip implants
Saint Jude Riata implantable defibrillator
Poly Implants Prosthese breast implants
STERIS System 1/1E
Surgical Mesh
Baxter COLLEAGUE infusion pumps
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© 2012 ECRI Institute
Classification Confusion
FDA’s high risk medical devices (e.g., deep-brain stimulators
and implantable cardioverter defibrillators) – Class III
FDA’s low risk devices (e.g., stethoscopes) – Class I
For recalls – Class I means there is a reasonable probability
that use of or exposure to a violative product will cause serious
adverse health consequences or death
Class III recalls occur when use of or exposure to a violative
product is not likely to cause adverse health consequences
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© 2012 ECRI Institute
Safety Surveillance
FDA
MAUDE database
Voluntary vs. mandatory recalls
Medical Device Surveillance Network (MedSun) program
Field inspections
Europe
Reporting to member state Competent Authorities (e.g., MHRA)
Less coordinated system
New Eudamed database will improve coordination but currently is not
fully utilized and has limited access
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© 2012 ECRI Institute
A New Regulatory Agency’s Challenge
Chinese “examination” gloves
Snuck on the market through kitchen appliance stores
Used for medical applications
Limited product labeling (e.g., no OEM name, manufacturing
date, lot number, or expiration dates)
Can we “allow” them on the market?
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© 2012 ECRI Institute
Perspectives from Recent Analysis on
Clinical Alarms
Underreporting
Some estimates suggest that the actual number of alarm-related deaths
is ten-fold higher or more than what problem data shows
Ability to do analytics on data is very limited
I literally had to read every report (hundreds) in a recent problem
reporting analysis
Actual reports often don’t have much information
Typical language (paraphrased) - During use of device alarm did not
sound and patient died
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© 2012 ECRI Institute
Other Reporting Systems and Channels
Various Ministries of Health and regulatory agencies
State problem reporting systems (e.g., Pennsylvania Patient
Safety Reporting System)
Patient Safety Organizations
Device registries (e.g., Kaiser Permanente Implant Registries)
Voluntary systems (e.g., ECRI Institute)
NY Times, Boston Globe, etc.
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© 2012 ECRI Institute
Ideal Hospital Processes for Managing
Hazards and Recalls
Capture complete and timely information
Not always model specific
Not limited to recalls
Interpretation of alert contents (including recommendations)
Information dissemination to relevant stakeholders
Inventory matching
Follow-through and reporting
Analysis and oversight
Did we miss anything?
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© 2012 ECRI Institute
Upcoming Unique Device Identification
Coming soon from FDA – for years (was required in FDA
Amendments Act of 2007)
New heavy pressure from US Congress
Will require unique identifier for all devices – likely in a phased
approach starting with implants
Potential for cost savings and safety improvements (e.g., from
better identification of recalled products)
Uncertain cost implications and nomenclature concerns
Many implementation challenges
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© 2012 ECRI Institute
Device Approvals/Clearance Roles in
Assuring Safety
PMA vs. 510(k)
Manufacturer testing
Transparency and availability of data
Rigor or lack thereof for clinical testing
Product update challenges and delays (i.e., in getting a “safer”
product to market)
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© 2012 ECRI Institute
Useful References
Top 10 Hazard Resource Center – www.ecri.org
Top 10 Technology Hazards for 2012: Key Technology Risks to
Keep in Check. Health Devices, November 2011
Regulation of Medical Devices in the United States and
European Union. New England Journal of Medicine, March
2012
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