Product Safety & Failure Analysis

1. Product Safety & Failure Analysis Jeff Beegle Michael Jordan

2. 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)

3. 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

4. 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

5. 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 • What steps to take to ensure Product Safety?

6. Hazard Analysis • Want to identify all types of risk (very broad and usually done during early phases of project) • Biocompatibility • Sterilization • Shipping • Failure of device • Procedural Error • Misuse on instruments • Misuse of implants

7. 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

8. 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.

9. 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 • Affective Sterilization and Shipping validation • 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

10. 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.

11. 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

12. 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

13. FMEA Example

14. FMEA Risk Level Table

15. 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

16. 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

17. 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

18. Questions?