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