KEVIN BEDALLISA CARLIN

MATT CARROLLERIN NICHOLS

Product Safety & Failure Analysis

Introduction

Safety Standards Designed to ensure the safety of products, activities, or

processes, etc Enforced by an advisory or regulatory body

Safety Organizations◦ International Organization of Standardization (ISO)◦ Consumer Product Safety Commission◦ Environmental Protection Agency (EPA)◦ Food and Drug Administration (FDA)◦ Occupational Safety and Health Administration (OSHA)◦ Underwriters Laboratories (UL)◦ British Standards Institution (BSI)

History

Medical Device Reporting Regulation (MDR rule) 1984 requires manufacturer to submit a report to FDA whenever

a device they marketed might have caused an adverse event resulting in death or serious injury

must file a report whenever 1 device was known to have failed and a repeat occurrence would be likely to lead to death or serious injury

FDA Plan of Action (second) 1987◦ FDA would focus on risk assessment for informed

judgments on device safety◦ emphasize post-market surveillance of devices◦ FDA focus on user education

Product Safety

Definition of Safety: Freedom from accidents or loss

Argued that absolute safety does NOT exist; more correct to define in terms of acceptable risk A judgment of the acceptability of risk is a measure of

the probability and severity of harm to human health Product is safe if risks are ruled acceptable

Risk Assessment

To ensure a safe product risk assessment is required CFR Title 21- Part820

What failure could cause harm to patient?

How could the device be misused to cause harm?

Fault Tree Analysis

Failure Mode Analysis

Risk Management

Activity directed towards assessing, mitigating, and monitoring of risks.

In businesses, risk management entails organized activity to manage uncertainty and threats, which involves people following procedures and using tools in order to ensure conformance

The strategies include transferring the risk to another party, avoiding the risk, reducing the negative effect of the risk, and accepting some or all of the consequences of a particular risk.

Effective Risk Management Program

Includes: Internal hazard analysis procedures (Hazard ID

worksheet, DFMEA/PFMEA, CAPA) Regulatory standards (FDA CFR,EU Med Dev, ISO and

ASTM) Awareness of current industry best practices Costs a lot but are worthwhile investment in company

reputation and financial liability

Product safety begins with project conception and continues through development and production, as well as post market surveillance

Post Market Surveillance

Complaints to company (Product Experience Reports) Most helpful with referral to detailed database

Complaints to FDA (MAUDE database & MedSUN) Useful for competitive products

Product Recalls Voluntary FDA Requested FDA Mandated

Internal Review/Audit Initiated by any of the above and new product design

Failure Analysis

A vital tool used in the development of new products and for the improvement of existing products.

Process of collecting and analyzing data to determine the cause of a failure and how to prevent it from recurring.

Failure Modes & Effects Analysis (FMEA)

Methodology for analyzing potential problems early in the development cycle

Used to identify potential failure modes Determine their effect on the operation of the

productIdentify actions to mitigate the failures. A crucial step is anticipating what might go

wrong with a product - potential failure modes

FMEA Procedure

Identify failure modes A failure mode is defined as the manner in which a

component, subsystem, system, process, etc. could potentially fail to meet the design intent.

Describe effects of each specific failure modeEstablish a numerical ranking for the severity of

the effectIdentify the causes for each failure modeProbability of the cause occurringCalculate Risk Priority Number and Determine

Recommended Action(s) to address potential failures that have a high RPN

FMEA Example

Engineer Responsibilities in Post Market Engineering

Engineer analysis on returned products Calculate complaint rates/ identify trends Update risk analysis documentation

Product investigations Health Hazard analysis forms Research/ Testing

Common tools to identify root cause of failure Fishbone diagrams Is/Is Not worksheets

Summary

Safety involves both risk assessment and liability assessment No product is completely safe in all situations

Product safety is an area of concern for medical device manufacturers from conception through the life of the product

Product safety is monitored by numerous regulatory agencies

Ultimately company is responsible for product on market

Effective risk assessment programs are key to quality products

Questions?