Blaine BestDavid Mette

Katie KodrichAllie 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 wayProduct 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

analysisUsed to work backward

to see the source of a problem

Use proof by contradictionEx. Show that unsafe

action is not possibleMuch 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