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Is the equipment performing according to specifications submitted by the manufacturer and approved by the FDA?
Is the equipment safe (for both users and patients)? Is the equipment reliable? Does and when the equipment needs to be serviced? Where is the equipment if it needs to be serviced (routine or
subject to a recall)? Is there enough quantity and variety of equipment for adequate
Clinical leaders have requested equipment that well exceed available budget (US$30 M)
Your group was asked to evaluate the requests and recommend the final list to hospital executives.
Requested equipment Combination PET/MRI: $10M Gamma knife: $8 M Full integration of equipment with electronic health records
(EHR): $7 M Fully automated clinical lab system: $5 M Fully integrated, robotic surgical system: $4 M Wireless telemetry system for ICUs: $3 M Replacement of all infusion pumps: $2 M Miscellaneous equipment replacement: $5 M
PET+MRI Gamma knife EHR Clinical Lab None of above
There is no right (or wrong) answer! It all depends on other variables not specified in the exercise, i.e., • Institution’s mission & vision• Needs versus desires• Resources availableThe only right answer is having a good PROCESS for technology incorporation.
Many contributors, each with a different role, taking turns serving the process
A good team Enlists all key stakeholders Uncovers the real issues Gathers the right information Identifies all the options Puts everything on the table
Reminder: Joint Commission International (JCI) has requirements for the selection and acquisition of laboratory and radiology equipment (but not for biomedical)
Plan: Design scheduled maintenance strategies. Do: Test the strategies in small-scale if possible. Check: Evaluate the results (safety & effectiveness) Act: Keep the strategies if they improved safety or
effectiveness. Otherwise, revise them. If you have new ideas, start the cycle again.
A continual improvement process that analyzes the effectiveness of maintenance resources deployed in comparison to outcomes achieved previously or elsewhere, and makes necessary adjustments to maintenance planning and implementation.
Fishing = Process Catching = OutcomeTackle = Structure
Primary goals of equipment maintenance (including SM) Safety: equipment is safe for patients and clinical users Reliability: equipment is available for use whenever needed
Therefore: Safety Evaluation: determine if the maintenance strategy is enhancing
the safety of patients and clinical users (i.e., reduce equipment malfunctions that negatively affect patients and clinical users)
Reliability Evaluation: determine if the maintenance strategy is enhancing the reliability of equipment and, thus, the care of patients (i.e., making equipment more available for use when needed)
NPF No problem found (or the reported problem was not duplicated). both
UPF Unpreventable failure, typically caused by normal wear and tear but is unpredictable. CM
ACC Accessory failure, excluding batteries, typically caused by normal wear and tear. both
BATT Battery failure, i.e., battery(ies) failed before the scheduled replacement time. Does not include scheduled replacement of batteries.
both
NET Failure in or caused by network, while the equipment itself is working without problems. Applicable only to networked equipment.
both
USE Failures induced by use, e.g., abuse, abnormal wear & tear, accident, or environment issues. CM
EF Evident failure, i.e., a problem that can be detected, but was not reported by the user, without running any special tests or using specialized tester.
SM
SIF Service-induced failure, i.e., caused by CM or SM that was not properly completed or a part that was replaced and failed prematurely (“infant mortality”).
CM
HF Hidden failure, i.e., a problem that could not be detected by the user under normal circumstances, unless running a special test or using specialized tester.
SM
PF Potential failure, i.e., failure is either about to occur or in the process of occurring but has not yet caused equipment to stop working or problems to patients or users.
SM
PPF Preventable and predictable failure, typically caused by wear and tear that can be predicted or detected.
Develop an Evidence-Based CM method to keep equipment safe and reliable for Diagnostic imaging equipment Radio-therapy equipment Surgical equipment Monitoring equipment Laboratory equipment
How to prioritize repairs by equipment category? When to drop SM in favor of CM and vice-versa? How to ensure the repairs are correctly performed? How to evaluate the safety and effectiveness of your
Thus a full scale inspection (SPI not PM) is required after each (functional) repair to ensure that equipment is safe and performing according to its original specifications.
Mission Criticality (MC) Defined as the equipment’s role or importance within the
organization’s mission Examples Low MC: a particular defibrillator. While critical for the survival
of a particular patient who is having a cardiac arrest, it may not be necessary to give this unit the highest priority in repairs (or SM) when a sufficient number of working defibrillators is currently available within the organization
High MC: the sole lab automated chemistry analyzer system. While not high-severity, it quickly becomes a bottleneck for the hospital as many patients will be left without proper diagnosis and, consequently, proper care
CM Priority = mission criticality, i.e., fix the equipment with the highest MC first!
SPI = safety & performance inspection: a combination of visual inspections, tests, and measurements performed to verify device safety and performance according to specifications.
Assign a “failure cause code” (FCC) for all scheduled maintenance (SM) and repair workorders
Determine the amount of SIF, HF, PF and PPF found Determine within each of these 4 FCCs the number of equipment
groups (i.e., same brand and model, and similar ages, utilization location and intensity, and users)
Look for the equipment groups with “unusually” high #FCCs per group, especially PPFs
For these groups, determine the underlying cause “unsafe acts” (aka “active failures”) committed by individual staff (employed
by hospital, OEM, or third party), e.g., lapses or slips “latent conditions” created by the organization due to oversight or
deliberate violation of regulations, codes or standards. If >50% of the FCCs analyzed is due to “latent conditions,” then
determine whether it is caused by the adoption of AEM strategy, i.e., a maintenance frequency and/or procedure different than those recommended by the respective manufacturer. If so, revise it.