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HTM ComDoc 8

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Contents

Maximizing medical equipment-related reliability and safety (under revision)

(This document was last revised on 9-10-18)

8.1 Introduction

To the best of our knowledge, all of the studies reported to date have shown that only a very small percentage of injuries resulting from failures of medical devices are attributable to poor maintenance. See,for example, reference HTM ComRef 12). As we describe in Section 1.4 of HTM ComDoc 1 the great majority of medical device failures can be attributed to one or other of a fairly wide range of other causes. However, if the cause of each device failure is routinely documented in the manner suggested in that same section of HTM ComDoc 1, this information (on which of those causes is currently contributing the most to device failures in a particular facility) can be very helpful in managing device failure prevention activities other than PM, and in monitoring the effectiveness of those efforts.

8.2 The primary safety enhancing strategies for critical medical devices

According to Table 2 there are 11 device types whose total failure could be life threatening. These can be described as critical life support device types. The primary failure prevention strategy to use with these particular device types should be to use a version of the device that has a high inherent reliability (i.e. a very low inherent failure rate), or a version in which the manufacturer has built into the device one or more automatic protection mechanisms or so-called “fail-safe” features. It is the nature and quality of the device’s design, the quality of the components selected and the quality of construction that determines the device’s inherent failure rate. There are a variety of approaches to so-called fail-safe design features but they are not often seen in medical devices. A measure of each device’s inherent failure rate can be obtained by compiling data on the number of inherent reliability-related failures (IRFs) from each device’s Repair Call Cause Coding records (Section 1.4 of HTM ComDoc 1).

In the case of the device types that are considered critical because they have potential high severity (LOS 3) hidden failures (i.e. the top 16 device types listed in Table 3) that have also been found likely or very likely to occur, the primary safety strategy should be performing the manufacturer-recommended safety verification tasks at the recommended interval. If the critical hidden failures are found to be unlikely to occur - i.e. less than one hidden failure every 75 years (see the PM-related reliability numbers in Table 13 or the relevant section of Table 5) - then this safety measure should be considered much less urgent.

But, for both of these different kinds of critical devices, some additional consideration should be given to safety measures other than planned maintenance.

8.3 Safety measures other than PM for critical life support devices

In addition to giving a high priority to the device’s inherent unreliability, there are, as we noted in HTM ComDoc 1, a number of other possible causes that could lead to a complete loss of device function - including process-related failures (PRFs) and the remaining maintenance-related failures (MRFs). These are listed below in the approximate order in which they are usually found to occur (see HTM ComRef 3, HTM ComRef 8, HTM ComRef 9 as well as Section 1.4 of HTM ComDoc 1):

  • User-related issues such as controls or switches that have been set incorrectly. Although this type of failure may not always lead to a complete loss of function, it can have the same effect as actual failure. For example, an incorrectly set defibrillator can jeopardize patient resuscitation. (These Category PR1 calls typically represent between 13-20% of all of the repair calls).
  • Problems related to a poor rechargeable battery management program. (These Category PR3 calls typically represent between 7-8% of all of the repair calls)
  • Physical damage usually caused by a combination of poor design and user carelessness, such as dropping the device. (These Category PR2 calls typically represent between 6-25% of all of the repair calls).
  • Problems with an accessory, such as patient cables and electrodes. (These Category PR4 calls typically represent between 3-9% of all of the repair calls).
  • Problems resulting from an out-of-specification environmental condition, such as poor control of the ambient temperature. (These Category PR5 calls typically represent between 1-7% of all of the repair calls).
  • Failure to restore (replace or refurbish) a part of the device that requires periodic attention (i.e. lack of timely PM). (These Category MR1 calls typically represent between 1-4% of all of the repair calls).
  • Poor installation or poor initial set-up of the device. (These Category MR2 calls typically represent between 1-3% of all of the repair calls).
  • Tampering with internal switches or other controls that are not intended to be user-accessible. (These Category PR6 calls typically represent <1% of all of the repair calls).
  • Problems due to an issue with a data transmission network connected to the device’s output. (Category PR7 calls)

8.4 Five additional strategies for improving the safety of critical life support devices

Based on information from the facility's Repair Call Cause Coding records, for each type of device with possible outcomes at the most serious level (LOS 3), consideration should be given to implementing the following additional preventive measures:

1. User training . A program emphasizing how to use the equipment properly, how to exercise care in handling the equipment and how to avoid any temptation to tamper with the device’s internal controls (addressing the first, third and eighth items in the list above). Although this may be considered outside the usual scope of the HTM/ Biomed/ clinical engineering program, it is a very important and generally underutilized safety measure. This single measure alone has the potential to reduce the number of repair calls (as well as possible device "failures" by 13-20%. Since Category 1 calls indicate the user’s lack of familiarity with the device, this kind of training should also reduce the potential for the user to misuse the device in a way that might lead to a patient injury.
2. Management of rechargeable batteries. An effort dedicated to minimizing potential problems with rechargeable batteries. Again it is important to be sure that any user responsibilities are addressed. A program of this kind has the potential to reduce the number of failures of battery-powered devices by 7-8%.
3. Accessories. Ensuring that any accessories purchased for any potentially PM-critical devices (classified as capable of adverse outcomes at the highest severity l (LOS 3) are of the appropriate quality. This measure has the potential to reduce the number of device failures by 3-9%.
4. Environmental conditions. Ensuring that careful attention is given to the environmental requirements of the critical life support devices. Tightening up this oversight has the potential to reduce the number of device failures by 1-7%.
5. Backup measures. Every piece of equipment, even the most carefully designed and constructed devices that are also subjected to the most effective set of preventive measures, will eventually fail. For this reason it is prudent to have some measure of last resort for all of the facility’s critical life support devices. The importance of this is recognized in The Joint Commission standards, which call for the hospital to have “written procedures to follow when medical equipment fails, including using emergency clinical interventions and backup equipment” (Standard EC. 02.04.01 EP6 in HTM ComRef 11). This is certainly important for all of the 20 device types at the top of the severity ranking shown in Table 4)

8.5 Monitoring the effectiveness of the additional safety strategies

Progress resulting from the implementation of these additional safety measures can be monitored by tracking changes in the relevant indicators. For example, did the number of calls in Repair Call Category 6 go down after an appropriate battery maintenance program was initiated, or the existing program revamped?

According to Table 2 there are 23 types of device that have the potential to cause some level of patient injury when they fail completely, of which 11 are considered to be capable of creating life-threatening situations, and the hospital should give the highest priority for all of these devices to implementing all of the preventive measures listed above – except, of course, for devices with no non-durable parts. These devices should be exempted from this measure.

A periodic review of the facility’s equipment safety program (see Section 8.11 below) should include documenting the actual failure rates of each of the top 23 device types in Table 2 and analyzing the relative contributions to the failures from each of the various Cause Codes - along with research on the clinical consequences of each failure. Did they in fact result in patient injuries? How many were considered near misses and what was learned from each of those incidents?

Consideration should also be given to implementing these same preventive measures for all of the 53 device types (including the additional 30 device types with only LOS 1 level of severity listed in Table 2. While failures of these devices will probably not have an immediate, direct impact on the level of patient safety, eliminating the potential inconvenience resulting from these failures may justify the cost of this additional effort.

8.6 Maximizing the safety of devices that have potentially critical hidden failures

In the case of devices that can develop hidden failures which could be either life-threatening (LOS 3) or which could create the potential for a less serious patient injury (LOS 2), the primary preventive strategy as we stated above, should be subjecting the device to the recommended periodic safety verification testing – specifically, checking all of the hidden failure modes that have been identified as potentially critical and likely to occur.

For example, if the alarm in a device monitoring a critical parameter such as cardiac function fails, then it would be highly desirable to detect that hidden failure as soon as possible – suggesting perhaps that there should be a very short interval between inspections. But, as we described in HTM ComDoc 6., more careful consideration suggests that following this initial impulse would probably not be that much more effective than continuing to use the longer interval – and the longer interval would certainly be more efficient. Performing weekly or even daily checks would provide very little additional assurance of safety when the failure in question occurs on the average very infrequently, say once every 75-100 years.

8.7 Three additional measures for improving the safety of devices that have potentially critical hidden failures

In addition to the primary safety strategy noted above (conducting the recommended periodic safety verification checks), consideration should be given - particularly for the 16 potentially critical device types identified in Table 3 as having hidden failures at severity level LOS 3 - to the following additional safety measures:

1. Built-in self testing. For devices with this level of risk it would be prudent to choose (if it is available) a version of the device that has the built-in capability of self checking the critical features
2. Fail-safe design. Again, for devices with this level of risk, it would be prudent to choose (if it is available) a version of the device that has some kind of built-in fail-safe design, such as component redundancy.
3. Pre-use checks. In certain extreme situations, if the device is found to have one or more potentially high severity hidden failure modes with relatively short MTBFs, it would be prudent to arrange to have the user undertake specific function and/or safety testing immediately before each use.

8.8 Monitoring the effectiveness of the facility’s Equipment Safety Program

Periodic review of the facility’s Equipment Safety Program should include, at least, the following:

Critical life support devices

  • Review, and affirm or reconsider, which of the various device types in the facility's inventory are identified as having failures with outcomes at severity level LOS 3.
  • Document the MTBF or average failure rate during the period of the program being reviewed for each manufacturer-model group of those device types considered to be severity level LOS 3.
  • Provide brief analyses of the nature (e.g. a break down by Cause Code) of the failure history of each device considered to be critical life support device.
  • Generate a statement as to whether or not this analysis supports a conclusion that the various safety measures in use for these devices are adequate and, therefore, that the effectiveness of the current equipment safety program is considered to be acceptable.

Devices that have critical hidden failures

  • Review, and affirm or reconsider, which of the various device types in the facility's inventory are identified as having potential hidden failures with outcomes at severity level LOS 3.
  • Document the discovery of any hidden failures that were judged capable of causing a patient injury, and the subsequent precautionary actions that were implemented.
  • Provide a brief analysis of the testing intervals being used for each manufacturer-model group considered to have potential hidden failures at severity level LOS 3.
  • Generate a statement as to whether or not this analysis supports a conclusion that the various safety measures in use for these devices are adequate and, therefore, that the effectiveness of the current equipment safety program is considered to be acceptable.

Equipment-related incidents

  • Document the occurrence and nature of any reported equipment-related incidents or near misses
  • Attempt to correlate any changes in the level of documented incidents with any recent changes in the equipment safety program




End of revised material ................................................................................................................................................................................................................................................

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Progress Report (November 2017)

To quote from the third paragraph of the statement titled “Background” on the Introductory Materials page of the website created by the Maintenance Practices Task Force (MPTF), one of the primary motivations prompting this project, which AAMI began supporting in November 2015, is to address the huge problem created by the failure of the Healthcare Technology Management (HTM) community to establish a “… generally-agreed way of quantifying current levels of maintenance-related medical equipment safety …”.

Much has been written about medical technology, and virtually all of it states that the ultimate, overriding consideration must always be assuring the very highest levels of patient safety. Maximizing patient safety is, of course, a very worthy goal - with which there can be no quarrel - but to paraphrase one of the better maxims of the business world – if you can’t measure it, you can’t manage it. And since virtually all of the regulations and standards governing the HTM business include a requirement, either direct or indirect, to provide levels of patient safety that are “generally acceptable”, this current lack of an accepted metric for medical device safety – and maintenance-related medical equipment safety in particular - makes it impossible to prove how well (or not) we are satisfying this important obligation. This same lack of the proper tools also makes it very difficult to compare the levels of maintenance-related medical equipment safety achieved by different maintenance strategies.

A current manifestation of this quandary is the requirement in the recently amended medical equipment maintenance regulations of The Centers for Medicare & Medicaid Services (CMS) which implies very strongly that the use of any of the now-permitted alternate equipment management (AEM) strategies for maintaining the facility’s medical equipment must keep the equipment just as safe as it would be if the devices were being maintained according to the manufacturer’s recommendations. This is clearly a very reasonable requirement but it is creating practical difficulties for facilities trying to introduce more cost-effective maintenance practices, as well as for the various survey and inspection teams who are responsible for confirming that maintenance practices other than those recommended by the device manufacturer are not exposing patients to higher levels of risk.

Everyone familiar with the standard texts on risk management knows that safety itself is not directly measurable (see, for example, the third chapter in “ Of Acceptable Risk: Science and the Determination of Safety “ by William Lowrance). The only aspect of safety that is measurable is the actual level of risk created by some specified potential hazard. So when we say that something such as a medical device is safe, what we are really doing is making a judgment relative to some recognized standard that the risk created by one or more particular potential hazards (such as, in this case, the potential for an adverse patient outcome attributable to inadequate device maintenance) is generally acceptable. Devices that are deemed “safe” in this way are really only safe with respect to the specifically identified hazard, or hazards.

While all of the various participants in the HTM business - including the regulating authorities - have cited patient safety as the primary driver within their respective areas of responsibility, there has been a lack of meaningful efforts to establish a rational, scientific basis for making these judgment calls on the level of safety of the patient. This is certainly true of the regulatory framework that is intended to ensure the safety of medical devices in their working lifetime, subsequent to the device having passed through the FDA ‘s initial device approval process. It has already been pointed out in the just-published AEM Program Guide that some of the accreditation standards based on the CMS regulation (referenced above) contain sloppily incorrect or inconsistent terminology as well as a complete lack of direction on how conformance to what are allegedly the “generally acceptable” levels of patient risk should be demonstrated.

By adopting the widely used and very well respected scientific methodology embedded in reliability-centered maintenance (RCM), the Maintenance Practices Task Force (name shortened elsewhere in this report to “the Task Force”, “the MPTF” or just “the TF”) has made significant progress towards solving this fundamental problem. As described in HTM ComDoc 1 and several other related documents on the website, the Task Force has created a useful method for characterizing the level of the PM-related risk associated with the different manufacturer-model versions of the most PM-critical medical devices. Each of the identified levels of maintenance-related risk are combinations of two parameters; one representing an assessment of the worst-case level of severity of the adverse outcome of a PM-preventable failure of the device (the TF has selected three representative levels - either a life-threatening injury, a serious but less than life-threatening injury, or a less serious outcome such as a delayed diagnosis or delayed treatment) and a second parameter quantifying the likelihood of a PM-preventable failure actually occurring (represented by the device’s documented PM-related failure rate).

The Task Force has also proposed a practical method for establishing what level of PM-related risk should be considered acceptable – another notable step forward. In this particular context it seems logical to set the standard for acceptable maintenance-related safety at the typical level of PM-related risk achieved when the devices in question are maintained strictly according to the manufacturer’s recommendations. Just what this level is, can and will be determined (see project Objectives # 3 & 4) by conducting a statistically satisfactory number of tests to determine and document the actual PM-related failure rates demonstrated by a sample drawn from a number of the potentially most critical devices during a time when they are being maintained according to their manufacturer’s recommendations.

Patient safety as it relates to the maintenance of medical devices

Much has been written about medical technology and virtually all that is written cites maximizing patient safety as the ultimate, overriding consideration. This is, of course, a very worthy goal with which there can be no quarrel; it is the motherhood and apple pie of healthcare technology management (HTM) and a cherished icon that we all serve dutifully and enthusiastically. In addition to this, virtually all of the regulations and standards governing the HTM business include either a direct or indirect obligation to provide acceptable levels of patient safety. The rub comes however when we attempt to quantify how well our efforts are measuring up to this rather vague maximize-patient-safety obligation.

A recent piece by …. on the debate over medical device service urging …. is an good example.

Safety itself is not measurable. The only aspect of safety that is measurable is the actual level of risk created by some specified potential hazard. So when we say something is safe, what we are really doing is making a judgment that the level of risk posed by one particular potential hazard is considered to be acceptable. The device is indeed safe but only with respect to this one particular hazard (cite Lowrance).

To illustrate this we will use an example from recent investigations (cite ?) into alternative equipment management (AEM) strategies that would make medical devices just as safe as they would be if the device were being maintained according to the manufacturer’s recommendations – something now permitted by recent revisions to the regulations of the Centers for Medicare & Medicaid Services (CMS) relating to medical equipment (cite ?). In this example the risk that we are concerned with is the risk that the device will fail from a PM-preventable cause.

PM-preventable failures. The key to identifying which device failures can be attributed to a PM-preventable cause (could have been prevented by a more effective or more timely PM activity) is to examine each of the tasks listed in the manufacturer’s PM procedure. This will identify which of the device’s components needs some kind of periodic restoration such as a filter that needs cleaning or a battery that needs to be replaced. If a device is presented for repair and the only thing wrong with it can be traced a component that is scheduled for some kind of restoration during PM, then it is quite likely that this failure can be considered to be a PM-preventable failure. Maybe the restoration performed during the last PM was ineffective or maybe the PM interval is too long. Similarly, the manufacturer’s PM procedure may include testing the performance of the device to detect deteriorations in either its functional performance or in its compliance with certain safety requirements that would not be obvious to the user – so-called hidden failures. While these deteriorations have not caused a complete failure the diminished performance could be putting the patient at risk and these should be considered to be PM-preventable failures. A shorter PM interval would have reduced the length of time that the patient was exposed to some level of risk.

In order to gather reliable information on the frequency with which PM-preventable failures are encountered it is very important to standardize the techniques and criteria for diagnosing when a user-reported failure is legitimately attributable to inadequate or tardy PM. Similarly, we need to standardize the techniques and criteria for diagnosing failures encountered when the actual PM is performed. Obviously a PM finding that the device failed one or more of any critical performance or safety tests included in the PM procedure constitutes a PM-preventable failure (It is an indicator that the PM interval is too short). And the Maintenance Practices Task Force has proposed that discovering a part that was scheduled for some kind of restoration during the PM has already deteriorated to the point where it could have been interfering with the proper operation of the device is also considered to be a PM-preventable failure. This is also an indicator that the PM interval is too short.

Unfortunately there is still some considerable variation in the kind of maintenance data collected throughout the field. While there have been recommendations for standardizing on these particular indicators that the failure was PM-preventable, they are not yet in widespread use.



So even though we are often required to characterize something such as a maintenance practice or maintenance “strategy” as safe or unsafe we generally fail to address the judgment call nature of this requirement. Although we champion data driven decisions – and this is an important and laudable step forward - we need to recognize that with respect to safety there are generally no prescribed boundaries separating acceptable (i.e. safe) levels of risk from unacceptable (i.e. unsafe) levels of risk.

The data driving the decisions are the levels of risk relevant to certain specific hazards.


Monitoring levels of PM-related patient safety

One of the primary expectations for a well executed medical equipment maintenance program is a high level of patient safety.

One of the better ways to generate confidence that the PM program is meeting its safety objective is to routinely code all corrective maintenance (repair) calls that are judged to be “PM-preventable” as such, and periodically report on how many of these involved “potentially high PM risk” devices. A relatively low count would indicate that the devices in question are acceptably safe with respect to PM-preventable failures.

A good supplement to this would be to report on how frequently the “potentially high PM risk” devices failed one or more of its PMs, either because the device failed a performance or safety verification test, or a critical non-durable part was found to be well past the time that it should have been restored. A low count here would similarly indicate that the devices in question are demonstrating high levels of PM-related reliability, with very few PM-preventable hidden failures. For further discussion of these techniques and suggested ways of coding maintenance calls, see HTM ComDoc 15, section 15.3. (Link here?) Of course any routine reporting such as this should include statistics on any device-related patient incidents in which harm was attributed to a PM-preventable device failure.





8.5 Maintenance strategies for PM-critical devices

As noted in the section on remedial measure #7 above, there should be a program of traditional preventive maintenance to rejuvenate the non-durable components of each of the facility’s devices that has been classified as potentially PM-critical at Severity Level 3, that is performed in a competent and reasonably timely manner.

As for the device types that are classified as potentially PM-critical at Level 1 (and possibly even Severity Level 2) and the many other types of devices not listed anywhere in Table 2. there is no reason – from a safety point of view – to implement any of the safety measures described above. From this same safety viewpoint they could all be considered candidates for the most efficient maintenance strategy which is light maintenance also known as corrective maintenance only (i.e. allowing the device to run-to-failure). The relatively minor increase in the device failure rates resulting from the failure of any of their non-durable parts will not increase the level of risk to the patient. It may have some impact on the downtime of these devices and this could result in an identifiable cost to the facility that would justify adding these devices back into the preventive maintenance program. However, this is a purely economic factor that we will be investigating in more detail in HTM ComDoc 9.


8.7 How to document the MTBF of a hidden failure

The mean time between failures (MTBF) is equal to the number of devices tested multiplied by the length of time, in years, over which the testing was performed, divided by the number of hidden failures (of a specified kind) discovered during the testing. For example, suppose that annual PMs were performed on 280 infusion pumps over a period of 3 years and on 7 occasions it was found that the pump’s flow rate was out of specification. Then there were 7 hidden failures among the 280 pumps over a period of 3 years:

MTBF (for an out-of-spec. flow rate) = 280 x 3/ 7 = 120 yrs


8.9 Monitoring the safety levels of hidden-failure-critical devices

Progress resulting from the implementation of these safety measures can be monitored by tracking changes in the relevant quantitative indicators. For example, does the number of hidden failures discovered during the periodic performance verification and safety testing go down after pre-use safety checks have been implemented?

According to Table 3. there are 65 types of device that have a theoretical potential to cause a patient injury when they develop hidden failures, of which 16 device types are considered to be theoretically capable of developing potentially life-threatening hidden failures. The hospital should consider giving a high priority to implementing a comprehensive program of regular performance verification and safety testing for all of these devices – until there is a reasonable body of evidence showing that the likelihood of the hospital’s equipment developing a critical hidden failure is for all practical purposes very close to zero - with, say, an MTBF of more than, say, 75 years. If the testing program should reveal that there is a significant likelihood of a particular hidden failure that is judged capable of causing a patient injury, then further protective measures should be implemented as soon as possible. A report on this finding should also be sent to the manufacturer of the device.

8.10 Maintenance strategies for hidden-failure-critical devices

As noted above, it is very important to subject all of the facility’s devices that have been classified as hidden-failure-critical at severity Level 3 or 2 to periodic performance verification and safety testing – specifically, checking all of the failure modes that have been identified as potentially critical.

While there is, by definition, no tangible safety benefit from implementing this same program of periodic performance and safety testing for the ten device types listed in the Level 3 section of Table 3. it is worth considering whether or not eliminating the potential inconvenience resulting from these failures would justify the cost of this additional effort. As for the many other types of device not listed anywhere in Table 3., there is no reason – from a safety point of view – to implement any of the measures described above. They should all be considered candidates for the most efficient light maintenance (i.e. allowing the device to run-to-failure) strategy. The relatively minor increase in hidden failures (if any) for these non-critical devices will have no effect whatsoever on the level of patient safety.

8.11 Effectiveness of the facility’s Equipment-related Risk Management Program

Periodic review of the facility’s Equipment Safety Program should consist of, at least, the following steps:

Critical devices

  • Review, and affirm or reconsider, which of the various device types in the facility's inventory are identified as having failures with outcomes at Severity Level 3.
  • Document the MTBF or average failure rate during the period of the program being reviewed for each manufacturer-model group of those device types considered to be severity Level 3.
  • Provide brief analyses of the nature (e.g. a break down by Cause Code) of the failure history of each device considered to be reliability-critical at severity Level 3.
  • Generate a statement as to whether or not this analysis supports a conclusion that the various preventive and mitigation measures are adequate and therefore that the effectiveness of the current equipment safety program is acceptable.

Hidden-failure-critical devices

  • Review, and affirm or reconsider, which of the various device types in the facility's inventory are identified as having failures with outcomes at Severity Level 3.
  • Document the discovery of any hidden failures that were judged capable of causing a patient injury (device types considered to be severity Level 3); and the subsequent precautionary actions that were implemented.
  • Provide a brief analysis of the testing intervals being used for each manufacturer-model group considered to be Severity Level 3.
  • Generate a statement as to whether or not this analysis supports a conclusion that the various preventive and mitigation measures are adequate and therefore that the effectiveness of the current equipment safety program is acceptable.

Equipment-related incidents

  • Document the occurrence and nature of any reported equipment-related incidents or near misses
  • Attempt to correlate any changes in the level of documented incidents with any recent changes in the equipment safety program

8.12 Which device types benefit the most from PM – from a patient safety viewpoint?

The analysis in HTM ComDoc 3. showed that from a patient safety viewpoint the facility’s equipment maintenance and safety programs should be focused on a relatively small fraction (about 10%) of the 700 to 800 different kinds of devices on the typical hospital’s inventory. Reducing the failure rate of what are judged to be the most critical of the facility’s PM-critical devices (eleven different types of device) by restoring their non-durable parts in a competent and timely manner has the potential to have the greatest impact on maintaining the highest possible level of patient safety. But the actual contribution of this part of the facility’s equipment maintenance program relative to other potential safety measures can only be determined by analyzing the facility’s Repair Call Cause Coding data. Based on the repair call analyses reported to date (HTM ComRef 3., HTM ComRef 8. and HTM ComRef 9.) the impact of traditional preventive maintenance is not expected to be very large, relative to the other causes of failure. Similarly, the contribution of the facility’s device performance and safety testing is not expected to be very large either. However, this can only be confirmed by documenting the actual incidence rate of any hidden failures discovered when testing the facility’s performance-critical devices. And device maintenance does nothing whatsoever to reduce the primary cause of equipment-related incidents - which is misuse of certain kinds of equipment (HTM ComRef 12.). Use-error data from an ongoing Repair Cause Coding program can, however, shed valuable light on which devices in the facility’s inventory appear to have the greatest potential for misuse that could cause a patient injury.

Widespread adoption of this more focused, risk-based and evidence-based type of equipment maintenance and safety program will allow the commitment of fewer resources to the non-productive preventive maintenance tasks that many hospitals are still performing. This would then create an important opportunity for clinical engineering programs to accept a greater level of responsibility for medical equipment safety by assisting with, or managing, some or all of the non-maintenance preventive measures described above.

8.13 Which device types benefit the most from PM – from a business economics viewpoint?

As noted elsewhere, there are some important business economics factors that should be taken into account when designing the facility’s medical equipment maintenance program. This is the subject of HTM ComDoc 9.. There are probably items that the facility considers to be reputation-critical or that have the potential to generate preventable, expensive repairs. These economic issues certainly need to be considered when optimizing the facility’s medical equipment maintenance program (HTM ComRef 13.).


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