1. KEVIN BEDAL LISA CARLIN MATT CARROLL ERIN NICHOLS Product Safety & Failure Analysis

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 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

4. 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

5. 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

6. 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.

7. 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

8. Post Market Surveillance Complaints to company (Product Experience Reports)  Most helpful with referral to detailed database Complaints to FDA (MAUDE database & MedSUN)MAUDE  Useful for competitive products Product Recalls  Voluntary  FDA Requested  FDA Mandated Internal Review/Audit  Initiated by any of the above and new product design

9. 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.

10. 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

11. 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

12. FMEA Example

13. 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

14. 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

15. Questions?