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Using Risk Information in Product Using Risk Information in Product Recall DeterminationsRecall Determinations
Edward J. Heiden, PhDPresident
Heiden Associates, Inc.
International Bar Association2006 Conference
September 18, 2006
Core Areas of ExpertiseCore Areas of Expertise
Product Safety and Risk Analysis– Risk and hazard
pattern evaluation– Product population/
incident projections– Comparative risk
assessment– Brand-specific fire risk
analysis
Baseball Injuries
Hit with bat29%
Other injury pattern25%
Hit with ball15%
Collision w/ player
6%
Fell/ sliding25%
Core Areas of ExpertiseCore Areas of Expertise
Product Recalls– Program design and
management support– Outreach analysis and
options– Effectiveness
evaluations– Program audit and
close-out
Possible Corrective ActionsPossible Corrective Actions
Changing product design Withdrawing products from the distribution chain Sending information and warnings about use of
products to consumers Modifying products at customers’ premises or
elsewhere Recalling products from consumers for
replacement or refund
Risk-Based Decisions about Risk-Based Decisions about Corrective ActionsCorrective Actions
Identify hazards with actual or potentially serious risks and respond quickly
Avoid recalls of products with marginal or non-existent risks of harm
Need to use all available data to make informed, defensible decisions
Data RequirementsData Requirementsfor Recall Determinationsfor Recall Determinations
Representative of product sales, use and incident profiles
Documented incident data collection and reporting procedures
Adequate detail to identify specific types of products or hazards
Few sources meet all 3 tests!
Useful Types of DataUseful Types of Data
Company/Proprietary– Warranty returns, consumer complaints– Claims, lawsuits– Company/consultant testing
Public Databases– Product-related Injuries, fatalities– Fire, poisoning incidents– Accident investigations, special studies
Public Data Available (CPSC)Public Data Available (CPSC)
National Electronic Injury Surveillance System (NEISS)– Statistically
representative sample– Demographic and
injury-characteristics– Brief narrative
descriptions of incidents
Sample Narrative:
“Pressure cooker opened. Diagnosis: shoulder burn”
Public Data Available (CPSC)Public Data Available (CPSC)
Other Databases: Accident Investigations, Incident Reports– Not statistically
representative– Varied sources of
referral/reporting– More detailed incident
descriptions
Sample Narrative:
While a brand new pressure cooker was in use on an electric range at the consumer's home, the lid to it blew-off & struck the light & hood above the range, causing the light and its cover to shatter. While the 37 year old wife was cleaning up the debris, she cut the middle finger to her right hand on some broken glass from the light bulb.
Other U.S. Public Data SourcesOther U.S. Public Data Sources
Fire Incidents (NFIRS) Workplace Injuries (BLS, OSHA) Transportation Accidents (FARS, GES) Poisoning/Chemical Ingestion (TESS) Medical Device Problems (MDRs)
Varied levels of statistical reliability and detail
Injury Database (IDB) - EUInjury Database (IDB) - EU
EHLASS (European Home and Leisure Accident Surveillance System)– Place of Occurrence– Time of Injury– Mechanism of Injury– Activity– Type of Sports– Type of Injury– Product causing the Injury– Accident description
Next Steps for the IDBNext Steps for the IDB
Extend data collection to include road transport, workplace and violence
Gain more information on products and services Involve new Member States in injury surveillance Develop statistical procedures for the estimation
of population-based injury rates
How Best to Use these Data?How Best to Use these Data?
Precautionary PrincipleStructured Risk AnalysisBaseline/Comparative Risk
Assessment
1) Precautionary Principle1) Precautionary Principle
If the potential consequences of an action are severe or irreversible, in the absence of full scientific certainty the
burden of proof falls on those who would advocate taking the action.
Application to RecallsApplication to Recalls
“Scientific proof” means appropriate economic/statistical methodology
“Action” means “decision not to recall a product” with some potential hazard
The EU GPSDThe EU GPSD
A safe product "does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons."
Benefits of Using the PrincipleBenefits of Using the Principle
Effectiveness of recall diminishes if product is in consumers’ hands for long time
Addresses serious or frequent hazards that might not be apparent at the time of the determination
Reduces potential for criticism due to inaction
Costs of Using the PrincipleCosts of Using the Principle
Source of hazard is not always well understood, so the remedial action must be validated before initiating the recall
Misdirects resources to hazards that do not represent meaningful risks to consumers
Causes recall notification “clutter” that makes it harder to reach consumers when there is a serious problem
2) Structured Risk Analysis2) Structured Risk Analysis
Attempt to develop qualitative, and if at all possible, quantitative measures of the risk associated with consumer use of the product
Address specific criteria, such at those set forth in– Consumer Product Safety Act (US)– GPSD Risk Assessment Procedure (EU)
CPSA FactorsCPSA Factors
Pattern of Defect Number in Commerce Severity of Risk Likelihood of Injury
No formal specification of how factors contribute to overall recall decision
GPSD FrameworkGPSD Framework
Evaluate Overall Gravity of Outcome– Probability of hazard– Severity of potential damage
Exposure of Vulnerable Populations– Children– Elderly
Adequacy of Warnings/Obviousness of Hazard
RAPEX: Probability and SeverityRAPEX: Probability and Severity
RAPEX: Risk RAPEX: Risk Action Required Action Required
Application: Yo-Yo BallsApplication: Yo-Yo Balls
Potential suffocation hazard if wrapped around child’s neck
186 incidents, 11-15 million balls made, no actual suffocation incidents
US: CPSC issues warning and advises to exercise caution
Canada: immediate prohibition on advertising, sale or importation
Benefits of Statistical AnalysisBenefits of Statistical Analysis
Meets need for “scientific determination”Responds to regulatory requirementsProvides verifiable basis for making a
decisionAllows for revision as new data become
available
Problems with Statistical AnalysisProblems with Statistical Analysis
No single way to do it “right” – can get different results from same data
Relevant information may not be available, may be of variable quality, or may be difficult to interpret
Lack of familiarity with data sources and methods – particularly their strengths and weaknesses
3) Baseline / Comparative3) Baseline / ComparativeRisk AssessmentRisk Assessment
Determine whether hazard represents a meaningful increment of the ordinary (“baseline”) risk associated with use of the product
Compare risks on a usage- or exposure-adjusted basis with those from comparable products and/or activities
Application: Electric Shock Application: Electric Shock HazardsHazards
Assignment:– Determine
whether a toaster with a low potential for shock incidents should be recalled
Assessment Conclusions:– Risk of shock was low
compared to overall level of shock risk from using toasters
– Risk of shock from using toasters and other small kitchen appliances is low compared to many other common household electrical products
# of ER-Treated Shock Injuries# of ER-Treated Shock InjuriesRequiring HospitalizationRequiring Hospitalization
Avg./
Product Group Year Share
Home Furnishings & Fixtures 124 24%
Home Structures & Construction Materials 82 16%
Home Workshop Apparatus, Tools & Attachments 60 12%
General Household Appliances 50 10%
Yard & Garden Equipment 46 9%
Home Communication, Entertainment & Hobby Equip. 40 8%
Small Kitchen Appliances 0 0%
Benefits of Comparative Risk Benefits of Comparative Risk AssessmentAssessment
Shares benefits of structured risk analysisFocuses attention and effort on meaningful
risksPlaces risks in the context of consumer
expectations and experience with similar types of products
Costs of Comparative Risk Costs of Comparative Risk AssessmentAssessment
Responsibility to ensure that “apples to apples” comparisons are made:– product comparability– proper adjustment for sales/use– nature and severity of injuries taken into account
In some cases, gaining regulatory acceptance of analysis may be more difficult
Looking ForwardLooking Forward
Data available to inform recall decisions is improving and becoming more readily available
Expanding acceptance of, and more demanding expectations for, analysis used to make risk-based recall determinations