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HTM ComDoc 16

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Contents

Implementing a simple CMS-compliant Alternate Equipment Management (AEM) program

(This document was last revised on 12-10-18)

16.1 AAMI's Maintenance Practices Task Force

After many years of inconclusive discussions about the role of planned maintenance (PM) in keeping medical equipment safe, in October 2015 AAMI announced its support for a new project …”to begin exploring whether an approach known as reliability-centered maintenance (RCM) should be adopted on a wider scale throughout the field of healthcare technology management (HTM).”

The project established an ad-hoc AAMI Maintenance Practices Task Force and charged it with several specific objectives (see Objectives of AAMI's Maintenance Practices Task Force). An immediate, practical goal of the Task Force's project is to provide a solution to the quandary posed by the current medical equipment maintenance requirements in the regulations of the Centers for Medicare and Medicaid (CMS). One approach to compliance is very simple but it is extremely extravagant in terms of technical manpower because it requires that every single piece of medical equipment in the facility be maintained strictly according to the manufacturer’s recommendations. The second approach involves taking advantage of the CMS-permitted Alternate Equipment Maintenance (AEM) program. While this is a much more efficient approach, it poses several quite intimidating challenges.

In May 2016, AAMI posted in the public section of its website the PDF file of an article titled Reliability Centered Maintenance: A Tool for Optimizing Medical Device Maintenance (HTM ComRef 29). The article describes the basic principles of the RCM approach and how they can be used to address each of these challenging issues, including how a device’s demonstrated PM-related reliability (its likelihood of developing a hidden failure or failing from a PM-preventable cause) can be used as a measure of the associated level of PM-related safety.

Publication of this first article (HTM ComRef 29) represented an important milestone for the RCM project. The Task Force has also developed its own website (http://htmcommunitydb.org/wiki/index.php?title=Main_Page) where you can find additional explanatory articles on this same topic, as well as a companion set of tables - some of which will act as the public database around which the entire project is centered.

16.2 The relevant regulations of the Centers for Medicare and Medicaid Services (CMS)

The original legislation that created the Medicare & Medicaid programs in 1965 (The Social Security Amendments of 1965) established minimum requirements that healthcare organizations must meet in order to participate in those programs. The requirements are contained in a document known as the “Conditions of Participation” (CoP). The section of the CoP specifying the requirements relating to medical equipment maintenance is 42 CFR 482.41(c)(2). The broad guiding requirement states that: "Hospital facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality". The original language, in Section A-0724, states that: "... There must be a regular periodical maintenance and testing program for medical devices and equipment. A qualified individual such as a clinical or biomedical engineer, or other qualified maintenance person must monitor, test, calibrate and maintain the equipment periodically in accordance with the manufacturer's recommendations and Federal and State laws and regulations. ..."

16.3 The two “clarification” memos

In 2008 Congress transferred oversight of all accrediting organizations with “deeming” authority, including The Joint Commission (TJC), to CMS. Healthcare organizations that are accredited by TJC, as well as the other accrediting organizations, are “deemed” to be in compliance with the CMS regulations. However, this change gave rise to an important conflict because the JC standards at the time did not require devices that hospitals considered to be “low risk” to be maintained “in accordance with the manufacturers recommendations”. Eventually, in December, 2011, CMS issued a memorandum creating an exception for what they called “non-critical” equipment but requiring that this “non-critical” status be justified by some kind of rigorous risk assessment conducted on the device’s maintenance history, and that there also be credible proof that none of the exceptions resulted in an unacceptable risk to patient health and safety. Even after some negotiations with HTM community representatives and a second “clarification” memo in December 2013 (HTM ComDoc 11), the situation remains stalemated with many hospitals appearing to be somewhat intimidated by the new rules for the risk-based AEM option. Many are instead choosing to adopt the extremely inefficient practice of simply following, for all of their devices, whatever PM recommendations the manufacturers have issued. The relevant TJC standards reflect, as they must, the same basic requirements contained in the “clarified”/ amended CMS regulations.

Reports from meetings between representatives of CMS and AAMI in 2012 suggest that everyone involved on both sides of this issue would like to see a national standard based on some kind of credible risk assessment that surveyors could use as an objective, scientifically-sound method to assess whether or not a hospital's PM program meets some reasonable standard of performance and safety.

16.4 The CMS-permitted Alternate Equipment Management (AEM) option

According to the RCM Task Force’s analysis of the December 2013 “clarification” of the relevant CMS regulations (HTM ComDoc 11), there are three key requirements that facilities must meet in order to take advantage of the AEM program option. The facility must:

  1. Be able to explain the criteria used to select which devices have been moved into an AEM program.
  2. Use a form of risk assessment that is considered to be a generally accepted industry standard.
  3. Provide credible evidence that their AEM program is providing an acceptable level of safety.

16.5 What is "the RCM approach"?

The traditional approach to maintenance used for relatively simple machines (locomotives, autos) has always been periodic scheduled overhauls. However, this was proving to be much too costly for the new jumbo jets that were planned to be introduced by the airlines in the 1970s. Driven by this economic incentive, in the mid-1960s an FAA Task Force had investigated the way more complex machines actually fail. Their findings lead to a more systematic and much less costly way of maintaining these more complex devices – a method that is now known as reliability-centered maintenance (RCM). So, RCM was created and first developed during the decade of the 1960s in the civil aviation industry. It revolutionized the way maintenance is performed on all kinds of aircraft and it has since been adopted in virtually every other segment of industry where the reliable and safe performance of any kind of complex device is important - except for healthcare!

The traditional (pre-1960) idea of how all machines fail is characterized by a reliability curve that shows a dramatic "end-of-life" increase in the likelihood of failing. The traditional picture is that all machines simply wear out and the earlier approach to maintenance in the civil aviation business was based on the idea that every component in the aircraft (which is quite a complex piece of equipment) has a point in time at which it must be completely refurbished. In the locomotive and automobile industries, the machines have always been much less complicated than aircraft and for many years maintenance was focused on simply lubricating the machine’s moving parts. Also reliability is not such a big concern in the railroad and automobile businesses as it is in the aviation industry, primarily (of course) because the consequences of auto and locomotive failures were not as potentially catastrophic as are aircraft failures!

In the aircraft business these periodic refurbishments were called “scheduled overhauls”. However, over time it became apparent that many of the common failures could not be prevented by any kind of “preventive” maintenance, no matter how diligently the PMs or overhauls were performed. Because of this, airplane designers had been increasingly using strategies such as complete redundancy for critical components such as engines, and overdesigning mechanical structures such as wings - to make them more tolerant of accidental damage.

The picture of how complex machines really fail – based on aircraft data collected in the 1960s - is however quite different.

  • Complex devices are made up of many different kinds of components that demonstrate quite different failure characteristics over time.
  • Some show the end-of-life wear out characteristic
  • One type shows a so-called infant mortality type characteristic (an initially high but quickly declining failure rate)and others show gradually rising or falling changes in reliability with time.
  • One characteristic is a simple horizontal line that is characteristic of devices showing only random failures over time.
  • The relative number of components with each of these different characteristics varies according to the type of machine.
  • Other kinds of devices will show different proportions than the findings for airplanes.

The primary conclusion from the work of the FAA’s task force was that the traditional scheduled overhauls did very little to improve the overall reliability of a complex device such as an airplane. However the new RCM methodology proved that it could not only bring down the cost of maintenance but – amazingly - it also had a very dramatic effect on the overall reliability of the aircraft.

  • Under traditional maintenance programs for the conventional DC-8, United Airlines typically expended more than 4 million man-hours on major structural inspections before reaching 20,000 hours of operation. Whereas for the considerably bigger and more complex DC-10 jumbo jet, RCM reduced their manpower expenditures by 94% - to just 66,000 man-hours for the same number of hours of operation.
  • This change similarly reduced the number of items needing to be overhauled by 98% (from 339 items to just 7 items). The million dollar engines were no longer on the must-be-overhauled list. This change alone was a major contributor to a reduction in labor and materials of more than 50%.

Although cost reductions of this magnitude are clearly important to organizations maintaining large fleets of complex equipment, it is equally important to note that these savings were achieved with absolutely no decrease in reliability.

  • On the contrary, the better understanding of the underlying failure processes that this new method brought into play actually improved overall reliability. The “reportable event rate” for the DC-10 dropped by a factor of 200 times relative to the DC-8 (from 60 per million takeoffs for the DC-8 to 0.3 per million takeoffs for the DC-10).

In the 1980s and 1990s, as the news about the benefits of RCM became more widely known, the RCM methods were adopted by the military, by NASA, and by the many segments of the utility industry (most notably for nuclear power plants).

16.6 What is a PM-focused risk assessment?

The basic analytical process used in the RCM approach is the 5-step Failure Modes and Effects Analysis (FMEA)

  1. Map (describe) the process. Describe very precisely how the device produces the desired output.
  2. Identify the device’s failure modes (the ways in which the process can fail) and the possible causes of each failure
  3. Project the severity of the adverse outcome of the device failing (The Task Force defines 3 levels of severity - see Section 1.7 of HTM ComDoc 1)
  4. Project the probability of the device failing (The Task Force defines 3 ranges of probability - see Section 1.11 of HTM ComDoc 1)
  5. List the possible failure prevention strategies (see HTM ComDoc 10)

The middle part of the FMEA process (Steps 2, 3 and 4) makes up what the Task Force calls the RCM-based risk assessment. An RCM-based risk assessment is a modern, scientific alternative to the previously used, and apparently unacceptable, qualitative risk assessment sometimes called the Fennigkoh-Smith method.

With respect to the concept of “risk”; the combination of Steps 3 and 4 is important because, according to modern reliability and risk management theory, the quantification of "risk" is achieved by multiplying together figures representing the magnitude of the two components that are estimated in Steps 3 and 4:

  • The severity of the outcome of the event (in this context a PM-preventable device failure) - specified in Step 3; and
  • The likelihood that the event (the PM-preventable device failure) will actually occur - specified in Step 4.

This combination of two different components making up “risk” explains why traveling on a commercial airliner is considered to be safe. Although there is a theoretical potential for a high-severity outcome (if the plane should crash), the likelihood that this will actually happen is very low. And so, the level of risk when flying on a commercial airliner is also very low - (at least, relative to other ways of traveling).

For more on FMEA, see HTM ComDoc 13, HTM ComRef 7, HTM ComRef 22 and HTM ComRef 24

The three basic causes of device failures

Although there can be a number of different failure modes, there are basically only 3 kinds of causes of device failures:

  1. Inherent causes (such as circuit boards failing, poor construction, poor design, etc.)
  2. Process-related causes (such as the device being dropped, incorrect operation by the user, etc.)
  3. Maintenance-related causes (such as inadequate PM, etc.)

For our purpose here we are concerned only with hidden failures or PM-preventable failures, so we can ignore the inherent and process-related causes (which together, in the case of medical equipment, usually accounts for more than 90% of all failures) and we can perform what the Task Force calls a PM-focused risk assessment. This is much quicker and easier than performing a full FMEA-like RCM-based risk assessment. We need to consider only those device failures caused by inadequate preventive maintenance.

Contrary to a widely held belief, there is absolutely nothing magical about PM, but belief in the traditional device restoration approach to improving reliability (by performing periodic overhauls) continues to this day,

Generally PM consists of device restoration (DR) tasks + safety verification (SV) tasks

  • DR tasks restore parts that need periodic attention
  • SV tasks check that performance and safety are still within the specified limits

It is very important to recognize that not all medical devices can be made safer by traditional preventive maintenance (PM). Unless the device has a component that needs some kind of periodic restoration to stop it from failing, or it exhibits a tendency to deteriorate in a way that is not obvious to the operator, but which could cause some kind of adverse outcome, then periodic PM cannot possibly make the device any safer.

PM is beneficial, of course, if the device has moving parts that are subject to wear (such as bearings, drive belts or pulleys) that need to be cleaned, lubricated, refurbished or replaced, or non-moving parts that are subject to some other kind of deterioration with time (such as gaskets, filters, flexible tubing and electric batteries) that need to be refurbished or replaced during the working lifetime of the device.

However, if intrusive maintenance is performed with unnecessary frequency, it has been found to have an adverse effect on device reliability. There is much wisdom in the phrase - if it ain’t broken don't fix it!

Safety verification tasks are intended to find, what are called in RCM jargon, hidden failures. These are particularly important if the result of these performance or safety deteriorations can cause an injury to either the patient or the device user.

See the two Failure Severity Questionnaires in Section 3.7 of HTM ComDoc 3 or in HTM ComRef 29

16.7 Identifying which devices can be moved into an AEM program.

In the context of trying to improve the economics of the hospital’s medical equipment maintenance program, as many as possible of the facility’s medical devices should be moved into an AEM program. This maximizes the facility’s flexibility to choose the very efficient run-to-failure (RTF) maintenance option (if the equipment users are willing to allow this) and if the RTF option is considered too extreme, it allows the facility freedom to choose maintenance intervals that allow the most efficient use of the available technical manpower – provided, of course, that these changes do not reduce the overall PM-related reliability and safety of the included devices below a level that the hospital deems acceptable.

The device selection process recomended by the MPTF utilizes the following five decision points. (See flowchart for RCM-based risk assessment)

The first decision point ("Is this a medical device?") involves determining whether or not the device meets the two criteria listed below, which qualify it to be considered a legitimate medical device.

  • Has the device been cleared by the FDA as intended for the diagnosis, treatment or monitoring of patients?
  • Has the device been assigned a serial number by its manufacturer?

The second decision point ("Is this device eligible for AEM per CMS ?") asks whether or not the device belongs in any of the four "taboo" categories listed below. According to the current CMS regulations, a device in any of these categories is specifically ineligible for inclusion in an AEM program.

  • Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes).
  • Medical laser devices
  • Equipment subject to federal or state law or Medicare Conditions of Participation in which inspecting, testing, and maintaining must be in accordance with the manufacturer’s recommendations, or otherwise establishes more stringent requirements.
  • New medical equipment with insufficient maintenance history to support the use of alternative maintenance strategies.

In the absence of any existing standard, the Task Force is proposing a tentative threshold of 50 device-years as being sufficient to support the use of alternative maintenance strategies. There will of course be many hospitals that have PM-critical devices for which they do not have this amount of maintenance experience. It is primarily for this reason that the AAMI Task Force has established its database website (www.HTMCommunitydB.org). The CMS regulations explicitly allow individual hospitals to draw on information from “nationally recognized expert associations”

The third and fourth decision points comprise the first two of the Task Force’s four PM-focused risk criteria.

  • Can there be some kind of adverse outcome if the device stops working completely while it is in use? and
  • Does the device have any components that must be restored periodically in order to prevent it from stopping working completely?

Device types for which the answer to the first question is “yes” are listed in rows 1 through 53 of Table 2 Note that only 11 of those 53 are judged to have possible adverse outcomes at the highest level of severity (serious, life-threatening injury). Research into the second question is not yet complete. So far, only 13 of the 53 that are affirmative with respect to the first question have been deemed affirmative with respect to the second question.

The fifth decision point addresses again the question about a significant adverse outcome in the second of the RCM Task Force’s four PM-focused risk criteria:

  • Can the device cause a significant adverse outcome if it develops a hidden failure (one that may not be obvious to the user but is detected when the device fails a critical performance or safety test during a PM)?

Device types for which the answer to this question is “yes” are listed in Table 3 and given a “Y” in column 4. Again, note that only 16 of the 75 device types judged to have the potential to develop a hidden failure have possible adverse outcomes at the highest severity level (serious, life-threatening injury).

The assessments contained in Table 2 and Table 3 take into account the following factors:

  • How the equipment is used
  • Likely consequences of equipment failure
  • The number of patients or staff adversely affected by the failure
  • Mitigating factors such as the availability of alternative or back-up equipment if the device fails.

The sixth decision point addresses the question implicit in the CMS definition of "critical equipment":

  • Could the outcome of the failure be a serious, life-threatening injury?

Device types for which the answer to this question is “yes” are listed in rows 1 through 20 in Table 4 These are devices that have the potential to cause a serious, life-threatening injury if they are not subjected to timely PM. These twenty device types constitute what the current CMS regulations define as “critical equipment” (i.e. “biomedical … equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail”). These devices also meet the definition for “high-risk equipment” contained in the current standards of The Joint Commission (“EC.02.04.03 EP 2 … Note 1: High-risk equipment includes medical equipment for which there is a risk of serious injury or even death to a patent or staff member should it fail, which includes life-support equipment.”).

Recommended two phase implementation

According to the fourth of the Task Force’s four PM-focused risk criteria, devices meeting the CMS definition of “critical equipment” (or the TJC definition of “high-risk medical equipment”) should be permitted to be included in an AEM program unless a PM-preventable or PM-detectable failure of the device with a serious, potentially life-threatening outcome is found to be “quite likely to occur” (tentatively defined as more than one PM-preventable failure every 75 years). Of course, if reliable information on the PM-related reliability of the device is not yet available, then it should default to being still considered a PM Priority 1 device and maintained according to the manufacturer’s recommendations.

However, because the Task Force has chosen to determine the PM-related reliability of each individual manufacturer-model version of each PM-critical device type by accumulating actual maintenance data from real-world documentation rather than project (or guess at) each device's PM-related reliability, it may be some time before all of the data required to incorporate the fourth risk criterion becomes available. For this reason the Task Force is recommending that individual facilities implement their AEM programs in two phases.

In Phase One it is recommended that devices that are projected to have the most severe adverse outcomes (LOS 3) from either hidden failures or PM-preventable failures be defaulted into the "potentially high PM risk" (or PM Priority 1) category and considered ineligible for the AEM program. However, as can be seen from the mapping shown in Figure 16.1 AEM eligibility based on outcome severity of failure this still leaves a very large fraction of the estimated 1500 device types as eligible for the AEM program. Only about 20 of the estimated 1500 device types meet the CMS definition of "critical equipment" and are included in the "potentially high PM risk" (PM Priority 1) category.

When the PM-related reliability data becomes available and it is feasible to implement Phase Two of the MPTF project, it is the position of the AAMI MPTF Task Force that “critical equipment” whose PM-related failure modes have been credibly demonstrated to be "unlikely to occur" (tentatively defined as less than one PM-preventable failure every 75 years) or “very unlikely to occur” (tentatively defined as less than one failure every 150 years) should be considered eligible for addition to the AEM program. This will add a significant number of devices to those already eligible for inclusion in the AEM program, as shown by the mapping shown in Figure 16.2 AEM eligibility based on outcome severity and risk of failing

One important challenge to the ongoing RCM project and the Task Force's intention to collect this data is that there has been no general agreement yet on where to set the threshold, in terms of the MTBF, at which a critical device failure from a PM-preventable cause is considered to be “quite likely to occur”.

In summary, in Phase One

It is the Task Force's recommendation that the following medical devices be considered eligible for inclusion in an AEM program and considered for transition to alternate maintenance strategies (see HTM ComDoc 10.) - provided that they are not specifically designated as ineligible by the CMS regulation (see Figure 16.1 AEM eligibility based on outcome severity of failure):

and in Phase Two (see Figure 16.2 AEM eligibility based on outcome severity and risk of failing)

It is the Task Force's recommendation that the following medical devices be considered eligible for inclusion in an AEM program and considered for transition to alternate maintenance strategies (see HTM ComDoc 10.) - provided that they are not specifically designated as ineligible by the CMS regulation (see Figure 16.1 AEM eligibility based on outcome severity of failure):

  • Devices with potential PM-preventable failures or PM-detectable hidden failures whose adverse outcomes from a PM-preventable failure are at judged to be at severity level LOS 3 but whose likelihood of failing from a PM-preventable cause is documented (in column C12 of Table 5) as being either unlikely or very unlikely. These devices should also be considered eligible for inclusion in the AEM program.

16.8 Monitoring the overall level of PM-related patient safety achieved by an AEM program

It is a primary expectation that a well executed medical equipment maintenance program will result in a high level of patient safety - a level that is at least as high as would be achieved by maintaining the devices according to the manufacturer's recommendations. A very good way to generate confidence that the PM program is meeting its safety objective is to:

  • Routinely document all corrective maintenance (repair) calls that are judged to be “PM-preventable”, and periodically report on how many of these involved “potentially high PM risk” devices (devices that the CMS regulations call "critical equipment"). A low count would indicate that the devices in question are demonstrating that they are acceptably safe with respect to PM-preventable failures. (For more on this see Section 15.3 in HTM ComDoc 15.)
  • Routinely report on how frequently the “potentially high PM risk” devices were reported as failing one or more of their PMs - either because the device failed a performance or safety verification test, or because 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 that they are acceptably safe with respect to PM-preventable device failures.
  • Routinely provide statistics on any device-related patient incidents in which harm was attributed to a PM-preventable device failure.

For further discussion of these techniques and suggested ways of coding maintenance calls, see Section 1.10.5 of HTM ComDoc 1 "What changes to current PM work practices would be beneficial?".

Measuring an individual device's level of PM-related safety (i.e. its level of PM-related risk)

Several members of the Task Force have already proposed using a device’s PM-related reliability in combination with the level of severity of the worst-case outcome of the device failure to represent the device’s PM-related level of safety (HTM ComRef 15, HTM ComRef 16). A device's level of PM-related risk is determined first by the LOS of its worst case failure (see column 6 of Table 4), and then by its level of PM-related reliability (see columns C8 and C9 of Table 13).

The device's PM-related reliability is the lesser (the one representing the lower level of reliability) of the following two MTBFs:

  • The MTBF based on the total of (1) any overt MR1 failures caused by inadequate device restoration (from the repair cause coding) and (2) any PM Code 9 findings (which are immediate precursors of the overt MR1 failures caused by inadequate restoration).
  • The MTBF based on the total of any hidden performance and safety degradations detected by the safety verification tasks (PM Code F findings)

A device's Level of PM-related risk is determined by combining the projected worst case severity of the outcome of a PM-related failure and the projected or demonstrated likelihood that the failure will actually occur. The Task Force has defined the following five levels for a device's level of PM-related risk (i.e. level of priority for timely PM) in Table 12 "Definitions of the different levels of a device's priority for PM".

With respect to what should be considered an acceptable level of PM-related reliability and PM-related safety, the strategy adopted by the Task Force is to determine, through its website-based community database, what level of PM-related reliability is achieved when devices meeting the CMS definition of “critical equipment” are maintained according to their manufacturer’s recommendations. The results of this exercise will provide statistics on the range, weighted average, etc. of typical failure rates (MTBFs) that the manufacturers (and therefore, because they approved the device, the FDA) appear to consider acceptable.

Determining whether or not each of the PM interval/ PM procedure combinations for the various device types (by manufacturer and model) results in MTBFs equal to or greater than the acceptable MTBF will provide a robust, quantitative evaluation of the AEM program’s overall level of safety.

Once the Task Force's research has revealed an apparently acceptable “safe MTBF” this particular MTBF will be used as the border between “unsafe” and “acceptably safe” for all other types of devices with the same level of severity of potential adverse outcome. With this figure as a standard, the Task Force’s plan is to explore how far the manufacturer-recommended intervals can be extended while still achieving MTBFs higher (safer) than the “acceptably safe” benchmark.

16.9 Seven-step implementation plan for creating a simple, basic AEM program

Step 1. Create a comprehensive Medical Equipment Inventory listing all of the medical equipment in use in the facility along with a policy (that should be incorporated into the facility’s Medical Equipment Management Plan) specifying the criteria used for including devices in this listing. See section below on Creating the facility’s Medical Equipment Inventory. Create a modified version of the Medical Equipment Inventory ("AEM-eligible Medical Equipment Inventory") by removing those devices that CMS specifically excludes from eligibility for an AEM program.

Step 2. Use the risk assessment process described in Section 16.7 above (and in Figure 1) to identify which of the facility’s devices should be considered what CMS calls “critical equipment” (what TJC calls “high-risk medical equipment” and what the Task Force calls "potentially high PM risk equipment" or “potential PM Priority 1 equipment") and create (or reference) a document explaining how the process embodied in Figure 16.3 (RCM-based risk assessment) is consistent with established industry standards of practice.

Step 3. Create a policy describing the alternate maintenance strategies that will be considered for devices included in the AEM program. See HTM ComDoc 10 "Alternate Maintenance Strategies and Maintenance Program Optimization".

Step 4. For Phase One, use the process described in Section 16.7 above (and in Figure 16.3 Flow chart for RCM-based risk assessment) to identify which of the facility’s devices are considered to be zero PM risk devices, or PM-critical devices with potential adverse outcome severity levels of LOS 0, 1 or 2, then determine which (if any) of these devices will continue to be maintained according to the manufacturer’s recommendations and which will be maintained according to an alternate maintenance strategy.

Step 5. Create a policy describing the process used to evaluate the levels of PM-related safety achieved by the alternate maintenance methods used for the various devices included in the AEM program. Consider using this model policy as a place to start (HTM ModelDoc 1) See also Section 1.12 in HTM ComDoc 1.

The policy should also include a description of what corrective actions will be taken if the minimum acceptable level of PM-related safety is not met, and how this evaluation provides credible evidence that implementing PM strategies for certain of the hospital’s medical devices that are different from those recommended by the device manufacturer is not reducing patient safety below what the facility deems to be an acceptable level. Note that the Task Force’s tentative threshold of less than one PM-preventable failure every 75 years is subject to revision as more information is collected.

Step 6. Create material that can be used to train the relevant hospital staff on how to explain the decisions made to place equipment in an AEM program and the evidence used to justify using any alternate maintenance strategies. See section below on Training.

Step 7. Create a document describing the qualifications of the personnel managing the AEM program and those performing the AEM maintenance activities. See section below on Personnel qualifications.


Creating the facility’s Medical Equipment Inventory The relevant policy document should list the criteria used for determining which devices are included in the facility’s Medical Equipment Inventory. The most commonly used criteria are:

  • The device is a recognized medical device. This is the case if:
  • The device been cleared by the FDA as intended for the diagnosis, treatment or monitoring of patients; and
  • The device been assigned a serial number by its manufacturer
  • Low risk/ low cost devices. It is acceptable to group low-cost devices, such as sphygmomanometers and electronic thermometers into identified groups, and keep track of the total number of devices in the inventory that way.
  • Not a disposable device. For our purpose here, single use devices - such as tongue depressors - are a special category of medical device and they should not be included in the Medical Equipment Inventory
Note that it is the intent of the Task Force to make available on their website samples of specific, de-identified policies as they come to the attention of the TF (See Page 7 Model documents).

Managing the inventory It is important to keep the inventory “clean” (insert here material “borrowed” from Alan’s article (Reference 5)

Device identification. Depending on the nature of the facility’s computerized maintenance management system (CMMS) there are probably several ways that the tools included in the CMMS can be used to give the following devices some kind of unique identification, as required by the current CMS regulation. Devices that are:

  • Included in the Medical Equipment Inventory
  • Ineligible for inclusion in the AEM Program
  • Considered to be Critical/ High-risk Medical Equipment items
  • Included in the AEM Program and being maintained outside the manufacturer’s recommended parameters
  • Considered to be non-critical devices

There are other ways of physically identifying these subsets of devices. Again, it is the intention of the Task Force to make available on their website other ideas for identifying these various subsets of devices, as they come to the Task Force's attention (See Page 7 Model documents).

Industry Standards of Practice As described in HTM ComRef 1, reliability centered maintenance (RCM) is a well established and widely accepted standard methodology used within virtually all high reliability sectors of modern industry such as civil aviation and nuclear power. Specifically, the design of the two Failure Severity Questionnaires described in Section 3.4 of HTM ComDoc 3 and all of the tables and other materials on the RCM Task Force’s website are consistent with established industry standards of practice. An inquiry consisting of the phrase “reliability-centered maintenance” entered into a common internet search engine such as Google currently returns more than 250,000 results.

Alternate PM strategies HTM ComDoc 10 describes a number of different maintenance strategies. Besides the traditional time dependent method, the most important alternative is the very efficient “light maintenance” or “run-to-failure” strategy. It is the intention of the Task Force to make available on their website samples of specific, de-identified policies as they come to their attention (See Page 7 Model documents).

Training: What the hospital's clinical user staff needs to know about the AEM program (Materials still in preparation)

Personnel qualifications There are some fairly specific directives in the current CMS clarification letter HTM ComRef 28 on the requirements that the staff managing and implementing the facility’s medical equipment maintenance program must meet. It is the intent of the AAMI-sponsored Task Force to request of the CMS that the documents and records made available on its public website be considered an acceptable source of guidance. The Task Force is currently made up of 18 invited members with a combined experience in the Health Technology Management field that is well in excess of 150 years.

16.10 Optimizing the efficiency of the AEM program

While it has very little to do with regulatory compliance, the Task Force has an inherent objective of helping hospitals reduce any unnecessary cost burdens. Presumably this was also the reason why the CMS has provided the AEM option in its current regulations. The Task Force recommends the following action plan for optimizing the efficiency of the program.

1. Investigate the willingness of the device owners to transition those devices categorized in the above exercise as non-critical devices to a light maintenance (“run-to-failure maintenance”) strategy. (Materials still in preparation).
2. Transition those devices approved by the owners for light maintenance from their existing maintenance strategies to a light maintenance strategy.
3. Go through the listing of those devices identified in the above exercise as “critical equipment” (what the Task Force categorizes as potential PM Priority 1 devices) and note the evidence on different levels of PM-related safety at different PM intervals aggregated in Table 5 (the Summary Proof Tables) and in Table 13 (Documented levels of PM-related reliability ... )
4. Note particularly the levels of PM-related safety (the MTBFs) of those devices categorized as PM Priority 3 and identify any with MTBFs greater than, say, 100 years, when maintained at the manufacturer’s recommended PM interval. These are candidates for exploring what level of safety they exhibit when maintained at a PM interval that is modestly longer than those currently recommended by the manufacturer. It is anticipated that Table 5 and Table 13 on the website will have data from institutions that are not constrained by the CMS regulations (such as VA facilities in the US, or facilities in Canada). If there are data showing that any of these lower priority devices are, in fact, apparently safe (with MTBFs greater than, say, 100 years) when maintained at a longer interval, then this should be considered grounds for petitioning the manufacturer to reconsider its current recommendation for the PM interval. (See Table 5 and Table 13).

16.11 Cautionary note (copied over from Section 4.11 of HTM ComDoc 4)

Patient and staff safety has long been the primary justification in medical equipment maintenance programs for performing routine PM on the hospital’s frontline patient care equipment. Regular PM also has become a deeply rooted symbol of institutional caution and caring. After all, if the equipment doesn’t look well cared for, what does that imply about how well the organization takes care of its patients?

The intent of this effort on the part of the AAMI-sponsored Maintenance Practices Task Force is to address longstanding misunderstandings about how much regular PM contributes to keeping modern medical equipment safe. If this effort is accepted as a way to support a reduction in the amount of PM performed on low PM-risk equipment, we urge that careful thought be given to replacing those services with more efficient or less technically intensive alternative routines (e.g., department rounds) to ensure that clinical staff remain confident in the equipment and that it still looks well cared for and ready to do its job.

16.12 Final word

Based on a number of personal observations by the members of the Task Force, it is our belief that a large number of hospital maintenance programs have not yet taken advantage of the AEM option. We are hoping that this material will encourage adoption of this much more efficient approach. Pressure on technical resources has never been greater than it is in hospitals today and there are many places where manpower currently being allocated to unproductive scheduled maintenance could be put to better use.

The analysis recently reported by ECRI (Reference ?) provides timely evidence that not only has the incidence of safety issues attributable to medical equipment maintenance been extremely small for many years, but there was a particularly low incidence of maintenance–related patient safety problems over the period between 1989 and 2011, during which time the vast majority of medical equipment maintenance was performed using some version of a risk-based maintenance program which was very similar in practice to the Alternate Equipment Management program that is now permitted by the current regulations.

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