Safety Surveillance for Medical Devices

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

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 2

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 3

Health Devices Evaluations and Guidance 4

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 5

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) 6

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) 7

Top Ten Health Technology Hazards 8

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Downloadable poster from our Top Ten Hazard Online Resource Center 10

Multi-Media Promotions Top Ten Hazard Video 11

Widespread Press Pick-up 12

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! 13

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 14

This Issue Has Been Covered Before February 28, 2003 Two Years Earlier! Same Problem 15

Safety Alerts Management: An Escalating Burden 16

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 17

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ECRI Institute Sources FDA Manufacturers Hospitals MHRA (United Kingdom) BfArM Medical Devices (Germany) Australia TGA Canada ECRI Institute research 19

Source: Health Devices Alerts Special Report S0209, March 2011 20

Source: Health Devices Alerts Special Report S0209, March 2011 21

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 22

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 23

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 24

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? 25

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 26

The New Technology Paradigm MDDS a new factor 27

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. 28

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? 29

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 30

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) 31

Thank You 32

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 33