Hazard and Recall Management

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Hazard and Recall Management Best Practices and
Professional Development Opportunities presented
to CABMET January 22, 2009
Maria Garrity Group Leader, Alerts Tracker
Product Support mfoster_at_ecri.org (610) 825
6000, ext 5111
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This Evenings Presentation Topics

• Scope of the Problem
• Best Practices
• Use Alerts Program to Take a Leadership Role

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Scope of the Problem

• Quality of Information Available
• Distribution of Essential Knowledge
• Escalating Numbers of Alerts

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A Growing Challenge for Hospitals
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A Growing Challenge for Hospitals (contd)

• Half of the 4,157 healthcare product safety
  alerts that ECRI Institute issued during 2008
  were regarding medical devices.
• Half of the device alerts were related to capital
  medical equipment.

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Best Practices for An Effective Safety Alerts
Program

• Ensure Complete Alerts Information
• Challenges
• Ensuring Alerts Are Not Missed
• Getting the Information You Need
• Support Staff Involvement
• Individualized Alert Distribution
• Communication and Information Sharing
• Closed Loop Process
• Report to Support Management of Alerts Program
• Overall Program Benefits
• Specific and Current Alert Examples
• Areas of Vulnerability

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Best Practices Ensuring Complete Alerts
Information

• Challenges
• Recall Lost in the Mail
• Incomplete Information
• Confusing Information
• Difficult to Match to Inventory

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Best Practices Ensuring Complete Alerts
Information (contd)

• Ensuring Alerts Are Not Missed
• Reevaluate Policies and Procedures
• Insist that hospital personnel be trained to
  funnel hazard and recall notices to hospitals
  alerts program coordinator.
• Write into purchase/lease agreements requirements
  for the reporting of recalls to the hospitals
  alerts program coordinator.
• Have a safety net
• By subscribing to a comprehensive source of
  alerts like ECRI Institutes Healthcare Product
  Alerts you are collaborating with us, and with
  hundreds of member hospitals on a definitive
  source of hazard and recall notices.

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Best Practices Ensuring Complete Alert
Information (contd)

• Getting the Information You Need
• Product ID Information
• Unique Product Identifiers
• Manufacturers Contact Information
• Geographic Distribution of Affected Product
• Clinical settings for usage
• Clear Explanation of the Problem
• Objective Advice

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Best Practices Support Staff Involvement

• The Need
• Enlist clinical users for their help and
  expertise.
• Collaboration
• Collaboration is beneficial in several ways
• Helps prevent someone from missing an item that
  is under recall.
• Helps get that item on record, inspected, and
  configured according to hospital protocol.
• Helps identify the gap in the program that
  allowed the device into service without
  notification of engineering.
• Record and Share Information to Close the Loop

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Best Practices Supporting Staff Involvement
(contd)

• Communication
• and Information
• Sharing

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Best Practices Reporting to Support Management
of Alerts Program

• Overall Program Benefits
• Illustrate magnitude of problems program is
  successfully avoiding.
• Specific and Current Alert Examples
• Show which alerts do, or recently did, affect
  your hospital.
• Areas of Vulnerability
• Point out departments that are not contributing
  as evidence that alerts could be missed in those
  areas.

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Using Alerts Program to Take a Leadership Role

• Demonstrate Project Management Skills
• Successful alert management programs often
  include you.
• Encourage Clinical Engineering/IT Convergence
• Goal is to effectively synthesize an approach
  that works for everyone based on local expertise
  related to
• Clinical Technology
• Information Technology
• User Needs in Clinical Setting (i.e., Workflow)
• Demonstrate Effective Information Presentation in
  Administrative Circles
• Communicate the impact of the program to garner
  support from clinical users and attract the
  attention of executive leadership.

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Process Management and Accountability
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Identifying Areas of Risk
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Detailed Documentation
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Summary

• Effectively Managing Hazards and Recalls is
  Challenging
• Incorporate Use of Best Practices to Ensure
• You are not missing alerts.
• You are getting all the information and objective
  advice you need.
• You are enlisting the support of your clinical
  partners.
• You are communicating the impact of the alerts
  program to garner support.
• Use Your Alerts Program to Take a Leadership Role
  Through
• Project Management
• Effective Information Presentation

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Questions Discussion
Maria Garrity Group Leader, Alerts Tracker
Product Support mfoster_at_ecri.org (610) 825
6000, ext 5111