safety surveillance for medical devices - center for ...€™s high risk medical devices (e.g.,...

© 2012 ECRI Institute

Safety Surveillance for

Medical Devices

May 10, 2012

James P. Keller, M.S.

Vice President, Health Technology Evaluation and Safety

[email protected]

(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

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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

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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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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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Top Ten Health Technology Hazards

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Downloadable

poster from our

Top Ten Hazard

Online Resource

Center

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Multi-Media Promotions

Top Ten Hazard Video 11

https://www.ecri.org/Video/Top_Ten_Hazards_Presentation_2011/Default.html


Widespread Press Pick-up

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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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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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This Issue Has Been Covered Before

February 28,

2003 – Two

Years Earlier!

Same

Problem

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Safety Alerts Management: An Escalating Burden

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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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ECRI Institute Sources

FDA

Manufacturers

Hospitals

MHRA (United Kingdom)

BfArM Medical Devices (Germany)

Australia TGA

Canada

ECRI Institute research

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Source: Health Devices Alerts Special Report S0209, March 2011

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Source: Health Devices Alerts Special Report S0209, March 2011

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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

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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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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

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The New Technology Paradigm

27

MDDS

a new

factor


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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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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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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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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Thank You

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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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http://www.ecri.org/

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