Blaine Best David Mette Katie Kodrich Allie Pitchler Kyle Killam “An error doesn’t become a...
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Transcript of Blaine Best David Mette Katie Kodrich Allie Pitchler Kyle Killam “An error doesn’t become a...
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