Product Safety & Failure Analysis

Jeff Beegle

Michael Jordan

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

Internation Organization of Standardization (ISO) Founded in 1947 and focuses on providing worldwide

standards in industry and manufacturing Publish technical reports, technical specifications, guides,

etc. ISO 13485 (2003) – represents requirements for quality

management system for the design and manufacture of medical devices Regulatory requirements Work environment and product safety Inspection and Traceability requirements Documentation and validation processes Preventative Actions

History (Cont.)

Food and Drug Administration Formed 1906 and goal is to protect and promote public health

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 riskA 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 acceptableWhat steps to take to ensure Product Safety?

Hazard Analysis

Want to identify all types of risk (very broad and usually done during early phases of project)BiocompatibilitySterilizationShippingFailure of deviceProcedural Error

Misuse on instruments Misuse of implants

Risk Assessment More precise prediction of risks and occurs when project is more defined

Ask same questions, just more specific

Note risks that were eliminated from Hazard Analysis and why

Entire product development team (marketing, regulatory, manufacturing, etc.)

Keep asking yourself What failure could cause harm to patient?

How could the device be misused to cause harm?

How will this device be sterilized?

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 practicesAffective Sterilization and Shipping validationCosts 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

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.Non-destructive testing is widely used during

inspection.

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 product

Identify 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 mode

Establish a numerical ranking for the severity of the effect

Identify the causes for each failure mode

Probability of the cause occurring

Calculate Risk Priority Number and Determine Recommended Action(s) to address potential failures that have a high RPN

FMEA Example

FMEA Risk Level Table

Probability/Severity

I II III IV V VI

A Low Low Low Low Moderate High

B Low Low Low Moderate High

Unaccept-able

C Low Low Moderate

Moderate High

Unaccept-able

D Low Moderate

Moderate High Unaccep

t-able

Unaccept-able

E Moderate

Moderate High Unaccep

t-ableUnaccept-able

Unaccept-able

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

Engineer Responsibilities in Post Market Engineering

Engineer analysis on returned productsCalculate complaint rates/ identify trendsUpdate risk analysis documentation

Product investigationsHealth Hazard analysis formsResearch/ Testing

Common tools to identify root cause of failureFishbone 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?