Failure Modes Effects Analysis (FMEA), also called as potential failure modes and effects analysis; failure modes, effects and criticality analysis (FMECA).Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in the design, manufacturing or assembly process, or a product or service.
“Failure modes” mean the ways or the modes, in which something might fail. Failures are any errors or defects especially the ones that affect the customer and can be potential or actual.
“Effects analysis” refers to the study of consequences of those failures.
Failures are prioritized according to how serious their consequences are, how frequently they occur & how easily they can be detected. The purpose of FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. Failure modes and the effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is used during design to prevent failures. Later it’s used to control, before and during ongoing operation of the process. Ideally, The FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
Begun in the 1940s by the U.S. military, FMEA was further developed by aerospace and automotive industries. Several industries maintain formal FMEA standards. What follows is an overview and reference. Before undertaking an FMEA process learn more about standards and specific methods in your organization and industry through other references and training.
When to Use FMEA
- When any process, product or service is being designed or redesigned after quality function deployment.
- When an existing process, product or service is being applied in a new way.
- Before developing control the plans for a new or modified process.
- When the improvement goals are planned for an existing process, product or service.
- When analyzing the failures of an existing process, product or service.
- Periodically throughout the life of a process, product or service.
Steps in Failure Modes Effects Analysis (FMEA)
- FMEA Pre-Work and Assemble the FMEA Team
- Path 1 Development (Requirements through Severity Ranking)
- Path 2 Development (Potential Causes and the Prevention Controls through Occurrence Ranking)
- Path 3 Development (Testing and Detection Controls through Detection Ranking)
- Action Priority & Assignment
- Actions Taken / Design Review
- Re-ranking RPN & Closure
Healthcare Application of FMEA
- Specimen identification
- Hospital-acquired conditions- pressure ulcers, patient falls, wrong site surgery etc.
- Medication safety and dispensing
- Fall prevention
- Test delays and results
- Infection control
- Facility or new process design
FMEA Of Needle Stick Injuries Prevention
Needle stick injuries (NSIs) are puncture wounds, cuts, or scratches inflicted by medical instruments intended for cutting or puncturing (cannula, lancets, scalpels, etc.) that may be contaminated with a patient’s blood or other bodily fluids. Contact of blood with non-intact skin and contact with mucous membranes (eye, mouth, and nose) are also subsumed under the term “needle stick injury.”
Healthcare workers susceptible to Needle stick injuries-
- Housekeeping Staff
Steps Taken After Needle Stick Injury
- Wash the wound with soap and water.
- Alert the supervisor and initiate the injury reporting system used in your workplace.
- Identify the source patient, who should be tested for the HIV, hepatitis B and hepatitis C infections. Your workplace will begin the process to test the patient by seeking consent.
- Report to the employee health services, the emergency department, or other designated treatment facility.
- Get tested immediately and confidentially for HIV, hepatitis B, and hepatitis C infections.
- Get PEP in accordance with CDC guidelines when the source patient is unknown or tests positive for a disease.
The risk of becoming infected with a blood-borne virus after NSI is highest for hepatitis B, followed by hepatitis C, and then HIV. For every 1,000 NSIs from the infected patient, 300 HCWs will become infected with HBV. For HCV and HIV, seroconversion rates are 30 per 1,000 and 3 per 1,000, respectively. Since the prevalence of blood-borne pathogens such as HBV, HCV and HIV is higher in hospitalized patients, there is a greater risk after NSI in this setting.
Economic Burden Of Needle Stick Injuries
After a NSI occurs, there is substantial cost, which includes:-
1) testing for infection in an injured worker and, if known the patient on whom the needle/sharp had been used
2) post-exposure prophylaxis to prevent or manage potential blood-borne virus transmission
3) short- and long-term treatment of chronic blood-borne viral infections that are transmitted to injured workers
4) staff absence and replacement
5) counseling for injured workers
6) legal consequences (litigation and compensation claims).
As soon as a needle stick injury occurs, the employee reports the incident to the respected incharge of the department. The employee is then made to fill the following form which states the details of time, date and site of injury. Also the source and description of how the injury occurred. The source could be known or unknown and the prophylaxis is done accordingly. Follow up is done every 0 months, 3 months and 6 months.
Elimination of Hazard – Substitute injections by administering medications through another route, such as the tablet, inhaler, or transdermal patches, for example. Remove sharps, needles and eliminate all unnecessary injections. Jet injectors may substitute for syringes and needles. Other examples include the elimination of unnecessary sharps like towel clips and using needleless intravenous (IV) systems.
Engineering Controls – Such as the needles that retract, sheathe, or blunt immediately after use.
Administrative Controls – Policies aimed to limit exposure to hazards. Examples include the allocation of resources demonstrating a commitment to health care worker safety, a needle stick prevention committee, an exposure control plan, removing all unsafe devices, and consistent training on the use of safety devices.
Work Practice Controls – The examples include no re-capping, placing sharps containers at eye-level and at arm’s reach, remember that most nurses are women, and some of the placement practices of disposal containers have not taken that into consideration), emptying sharps containers before they’re full, and establishing the means for safe handling and disposing of sharps devices before beginning a procedure.
Personal Protective Equipment (PPE) – barriers and filters between the worker and the hazard. Examples include eye goggles, face shields, gloves, masks, and gowns.