With the advancement of technology in the design and integration of medical devices, health care personnel have obtained the needed resources to better patient care. With this advancement, new vulnerabilities have been brought to light making it necessary for the clinical engineering profession to evolve and develop new techniques and assessment. The introduction of Failure Mode and Effects Analysis (FEMA) to Medical Equipment Management Plan at Methodist Hospital of Southern California has helped the Clinical Engineering Department identify these new vulnerabilities. FEMA is conducted by examining the history of the device and providing a qualitative analysis of its function, design, and reliability allowing for better servicing of these medical devices.
The Joint Commission has added the usage of Alternate Equipment Management (AEM) programs for 2015 and requiring Clinical Engineering departments to identify any failure modes. AEM programs review incident histories on medical devices and determine how serious and/or prevalent is harm from the equipment should it fail or malfunction (Commision, 2014). The Joint Commission recognizes the need to go beyond manufacturer specifications and develop alternative maintenance strategies to better service the technology of today. As a part of the FEMA process at Methodist Hospital of Southern California, these concerns are addressed. FEMA identifies potential design inadequacies that may adversely affect safety and performance (Whitemore, 2012). It also allows for the analysis of past failures that compromised patient safety and the development of failure trends, resulting in establishing medical equipment service plans for the future.
Failure Mode and Effects Analysis has been utilized by reliability engineers since the late 1940s and is applicable to help establish a more thorough service plan for the technology of today. The Methodist Hospital of Southern California Biomedical Engineering Department has utilized Failure Mode and Effects Analysis on major medical device purchases and has developed service plans and performance improvement goals based on the outcomes of the assessment. The goals of the FEMA are to look at failure modes based on global incident history, recalls, and alerts. Utilizing resources from agencies like the FDA, ECRI Institute and manufacturers, an alternative risk-based maintenance strategy can be developed.
At Methodist Hospital of Southern California, the process of risk analysis starts with a completed FEMA worksheet consisting of a chronological detailed assessment of all incidents, recalls and alerts for a particular medical device. Each event is then assessed and evaluated for trends. The worksheet is also accompanied by an executive summary that identifies any significant failure modes and mitigation that are needed. By evaluating the failure modes of the past, preventive maintenance procedures can be fined tuned and performance improvement goals can be catered towards increasing patient safety. With a focus on the function failures, a clinical engineer can determine how serious the harm can be from the medical devices if the function is compromised. An educational plan can be established by evaluating all past incidents, the service plan and performance improvement goals
Another aspect of failure mode analysis focuses on the design of medical devices. By examining recalls, design errors can be identified and service plans can be developed with the intent to ensure that these errors have been eliminated and avoided. For example, a battery recall can establish a targeted preventive maintenance procedure that will focus on battery operation. Another example would be the constant physical damage and cracking of a device’s casing can help develop a focus on clinical education of handling of a particular device. In addition, technology of today consists of integration and wireless connectivity as part of their design. This advancement in technology can develop failure modes that can jeopardize electronic patient information and create new threats to patient safety. Establishing a FEMA for equipment design can help a health care organizations address new vulnerabilities like integration and cybersecurity for medical devices.
Another area of focus with FEMA involves evaluating the Probability of Failure. With a FEMA, all the potential causes of failure mode are identified and documented. Some examples of failure are operator error, manufacturing induced faults, wear and tear, training deficiency, software related or due to faulty accessories. A “Probability Ranking” is then developed using the information attained. Using the probability ranking, a “Severity of Failure” is then used to determine the worst-case scenario. By determining the Probability and Severity of Failure, not only are vulnerabilities identified, but preventive measures of failure can be established. Also, identification of these vulnerabilities can help develop a complete risk management program.
At Methodist Hospital of Southern California, the Clinical Engineering Department has utilized FEMA on capital equipment purchases such as Carefusion Infusion Devices, Karl Storz Integrated Operating Equipment, Hill-Rom Critical Care Beds and others. Health care personnel are dedicated to identifying risks associated with medical devices and patient safety. The addition of Failure Mode and Effects Analysis can strengthen a program and help promote patient safety. With the combination of function, design, and reliability assessments, an alternate equipment management plan can be established and a clinical engineering department can be better prepared for technology of the future.