Blaine Best David Mette Katie Kodrich Allie Pitchler Kyle Killam “An error doesn’t become a mistake until you refuse to correct it.” - Orlando A. Battista

 Safety standards ◦ Designed to ensure the safety of products, activities or processes, etc. ◦ Enforced by an advisory or regulatory body  Safety Organizations in the US ◦ 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)

 Definition of Safety: Freedom from accidents or loss  Argued that absolute safety does NOT exist; more acceptable to define in terms of acceptable losses ◦ A judgment of the acceptability of risk, with risk, in turn, as a measure of the probability and severity of harm to human health ◦ Product is safe if risks are ruled as acceptable

 Reliability is not the same as safety  Reliability defined: Probability of device to not meet its design specification  System can fail in a safe way  Product can be safe but not reliable

 Product safety laws and regulations serve purpose of compensating users for injury  Laws serve to ensure safe products  Biotech companies aim to avoid lawsuits  Product safety effects both a company’s financial success and its reputation.

 Common types of liability:  Negligence:  Company pays for injuries caused by acting below reasonable standard of conduct  Focus is on conduct of company rather than product  Strict Liability:  Focuses on deficiencies of product itself  Company is liable if product is defective and unreasonably dangerous  Breach of Warranty:  Manufacturer is liable if injury is caused due to the product not functioning as warranted- as explicitly stated (oral or written).  By introducing a product into the market, the manufacturer implicitly warrants that the product is fit for intended purpose, as compared to competition.  Warranties typically not the source of monetary compensation for injury. Usually negligence and strict liability claimed.  A few cases have resulted in extensive and well publicized punitive recoveries by injured users. Hence, the cost of product liability insurance has increased.

 Risk Assessment  What failure could cause harm to patient?  How could device be misused to cause harm  These aspects can be investigated using processes designed with device such as fault tree analysis and failure mode analysis  Liability Assessment  Have all failure modes been explored and designed out?  Have all possible misuse situations been addressed?  Must make sure that all knowledge of unsafe conditions are fully explored and corrected

◦ Activity directed towards the assessing, mitigating (to an acceptable level) and monitoring of risks.  In some cases the acceptable risk may be near zero. Risks can come from accidents, natural causes and disasters ◦ In businesses, risk management entails organized activity to manage uncertainty and threats and 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.

◦ Process of collecting and analyzing data to determine the cause of a failure and how to prevent it from recurring. ◦ A vital tool used in the development of new products and for the improvement of existing products.

 Operational/Industrial safety ◦ Examine product during operational life ◦ Fixing problems posing unacceptable risk  Accidents identified and examined ◦ Causes determined ◦ Corrective actions initiated  Goal: Design acceptable safety level in system/product before production

Proof of Safety: Show that fault cannot occur (no unsafe state) If fault occurs, it is not dangerous Use of fault tree analysis Used to work backward to see the source of a problem Use proof by contradiction Ex. Show that unsafe action is not possible Much more efficient than proof of correctness and infallibility

 Effective safety program includes:  Internal hazard analysis procedures  Regulatory standards  Awareness of current industry best practices  Cost a lot but are worthwhile investment in company reputation and financial liability  Product safety begins with project conception and continues through development and production  Safety analysis program includes:  Well educated personnel  Effective reporting protocol  Checklist of product  i.e. Circuit breakers, environmental specs, ergonomical specs

 Example Safety System ◦ Internal Review  Company staff review products during and after development ◦ Peer Review  Scientists look to one another for input ◦ Government Safeguards  Adhere to government agency regulations ◦ Ongoing Oversight  Company aftermarket monitoring, public hearings, advisory committees

 Methodology for analyzing potential reliability 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

 System - focuses on global system functions  Design - focuses on components and subsystems  Process - focuses on manufacturing and assembly processes  Service - focuses on service functions  Software - focuses on software functions

◦ 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

 A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues  The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity.  Initiation of a Recall ◦ Voluntary ◦ FDA requested ◦ FDA mandated

 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  Safety programs are important for both financial needs and company reputation  Product safety is monitored by numerous regulatory agencies that serve separate sectors  Ultimately company is responsible for product on market  Effective safety programs are key to quality products