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HTM ComDoc 11

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Contents

Regulatory Compliance

(This document was last revised on 10-2-18)

11.1 Evolution of the CMS regulations

The original legislation that created the Medicare & Medicaid programs in 1965 (The Social Security Amendments of 1965) established the minimum requirements that healthcare organizations must meet in order to participate in those programs. These requirements are contained in a document known as the “Conditions of Participation” (CoP). The section of the CoP containing the requirements relating to 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".

This same law also has a provision stating that hospitals accredited by The Joint Commission (TJC) and a few other accrediting organizations are deemed to be in compliance with the Medicare CoPs and so they automatically qualify for reimbursement from the Medicare and Medicaid programs which are managed by CMS (The Centers for Medicare and Medicaid Services)

Until 2008, when Congress passed the Medicare Improvements for Patients and Providers Act and transferred responsibility for overseeing all accrediting organizations with "deeming" authority to CMS, TJC had been able to develop its own standards without oversight and consultation from CMS. One important result of this was that the TJC standards differed in one very significant way from the CMS equipment maintenance requirements which are detailed in section A-0724 which is Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals to the State Operations Manual (SOM). It is these requirements that the State agencies use when they survey facilities that are not accredited by TJC or one of the other accrediting organizations, and when they perform "validation" surveys of accredited hospitals. About 5% of accredited hospitals are subjected to these "validation" surveys each year to confirm that the accrediting organizations are performing competent examinations of compliance with the Conditions of Participation.

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. ..." As recently as 2011 the corresponding standards of the Joint Commission contained two key differences;

  1. They allowed equipment that was not considered to present a significant physical risk to be excluded from the medical equipment inventory (and thus from any specific maintenance requirements) and
  2. The statement about what the PM frequency should be was: "The hospital identifies, in writing, frequencies for inspecting, testing, and maintaining medical equipment on the inventory based on criteria such as manufacturer's recommendations, risk levels, or current hospital experience."

Including the phrase "such as" in effect eliminated the absolute mandate in section A-0724 of the Interpretive Guidelines in the State Operations Manual to follow the manufacturer's recommendations. The other deeming agencies also had differing interpretations of the simple statement in the CoP mandating compliance with the manufacturer's maintenance recommendations.

11.2 The first "clarification" memo

This latent conflict came to a head sometime in 2006 when a hospital in the State of Indiana that had been subjected to a validation survey by the State inspectors complained to CMS about the citations that they had received during that survey for not following the manufacturer's recommendations on which PM frequencies to use, while they had not been cited for this by the Joint Commission. This led to a fairly drawn out series of discussions and negotiations between CMS and TJC about the conflict and in October, 2010 CMS said they would agree to approve the approach embodied in the Joint Commission standards. The other deeming organizations received notice of this agreement, and, shortly after this - in December, 2011 - CMS issued what they called a "clarification" memo which is identified as S&C 12-07-Hospital revising Appendix A of the State Operations Manual (SOM).

In the Summary, this "clarification" memo dated December 2, 2011 states:

  • Alternate equipment maintenance schedules permitted in some instances: Hospital may adjust maintenance, inspection, and testing frequencies and for some facility and medical equipment below those recommended by the manufacturer, based on an assessment by qualified personnel of the risk to patient and staff health and safety.
  • Manufacturer‐recommended maintenance frequency is required for:
1. All equipment critical to patient health and safety; and
2. Any new equipment until a sufficient amount of maintenance history has been acquired.
  • Alternative equipment maintenance (AEM) methods are not permitted: Hospitals must continue to follow the manufacturer’s recommended techniques for maintaining equipment, even if the hospitals alter the frequency of maintenance activities.

This "clarification" provided several improvements over the original CoP requirements.

  • The PM frequency is no longer determined by the manufacturer's recommendations - but this concession is only for non-critical equipment, and only when there is a maintenance history-based justification supporting a conclusion that any "adjustment" will not adversely affect patient or staff health and safety
  • A run-to-failure maintenance PM strategy can be used if it can be shown that this represents an acceptable risk to patient health and safety.

It has been reported that CMS was expecting that the concessions in the "clarification" would be widely welcomed by the HTM community. However, they were not. Among the primary complaints were:

  • There was no practical definition for which equipment should be designated as being "critical"
  • It is highly unlikely that a typical hospital will have enough maintenance history data to conduct meaningful risk assessments
  • The mandated level of the required level of PM still represents a very onerous burden that seems out of proportion to the very low level of PM-related equipment failures and reported patient injuries. It is diverting scarce technical resources from other areas where there are known equipment-related problems, such as use errors and system connection problems.

Further discussions between TJC and CMS produced two further concessions.

  • Equipment maintenance histories from other similar facilities can be used for PM frequency assessments
  • There is no obligation to use PM test equipment or software specified by the manufacturers

In June, 2012, representatives from AAMI and ASHE met with CMS and came away with the understanding that CMS would very much like to have "a national standard that their surveyors can use as an objective, scientifically sound method to assess whether or not a hospital's PM program meets some minimum performance standards based on some kind of rational risk assessment".

11.3 The second "clarification" memo

In November, 2013, a letter signed by AdvaMed (the Advanced Medical Technology Association - a trade association formerly known as HIMA – the Health Industry Manufacturers Association) and 29 other professional associations representing a number of technology dependent medical specialties was sent to CMS expressing concern about what they describe as the CMS “approach to hospital equipment maintenance as a Condition of Participation” and urging them to categorize equipment used for radiation therapy or medical imaging as “critical to patient health and safety”. They further urged that any new CMS guidance require maintenance according to what they describe as the manufacturer’s recommended standard for medical imaging and radiation therapy equipment.

In December, 2013, CMS issued a second "clarification" memo addressed to the State Survey Agency Directors, again revising Appendix A of the State Operations Manual (SOM).

In the Summary, this second "clarification" memo which is dated December 20, 2013 and identified as S&C 14-07 states:

  • "S&C 12-07-Hospital Superceded. We are updating previously provided guidance to clarify":
  • "Hospital facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality".
  • "A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk‐based assessment by qualified personnel", unless:
  • "Other Federal or state law; or hospital Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements".
"For example, All imaging/radiologic equipment" must be maintained per manufacturer’s recommendations; or"
  • "The equipment is a medical laser device;" or
  • "New equipment without a sufficient amount of maintenance history has been acquired."
  • "Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish."
  • "Decision to Place Equipment in an AEM Program" "The determination of whether it is safe to perform facility or medical equipment maintenance without following the equipment manufacturer recommendations must be made by qualified personnel, regardless of whether they are hospital employees or contractors".
  • "In determining whether or not it is safe to include equipment in the AEM program, the hospital must take into account the typical health and safety risks associated with the equipment’s use. A hospital is expected to identify any equipment in its AEM program which is “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".
  • "Alternate Equipment Management (AEM) Program A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from those recommended by the manufacturer. Hospitals that choose to employ alternate maintenance activities and/or schedules must develop, implement, and maintain a documented AEM program to minimize risks to patients and others in the hospital associated with the use of facility or medical equipment. The AEM program must be based on generally accepted standards of practice for facility or medical equipment maintenance."

This AEM program option represents a very important concession that The Joint Commission and other accrediting agencies have been recommending very strongly to their healthcare facility clients because it is so much more efficient than the alternative default option of maintaining all of the facility's medical equipment according to the manufacturer's recommendations. However, there are three issues that appear to have been deterring more widespread adoption of the AEM program option:

  1. Deciding which devices to categorize as "critical equipment" (See Section 11.4 below)
  2. Deciding what kind of "risk-based assessment" to use to select the equipment to be included in the AEM program (See Section 11.5 below)
  3. Providing assurance that the AEM program is providing the same level of safety as the default option would provide i.e. "minimizing the risks to patients and others ..." (See Section 11.6 below)

11.4 Deciding which devices to categorize as “critical equipment”

There are many different causes for medical equipment failures. They can be grouped into three general categories (see Section 1.5 of HTM ComDoc 1):

  • Failures attributable to the device’s inherent reliability, including the random failure of its components, as well as poor design or poor construction of the device itself
  • Process-related failures, attributable to causes such as use errors, physical damage, environmental stress, accessory problems, tampering, and connected network issues
  • Maintenance-related failures, attributable to causes such as inadequately restored non-durable parts or delayed re-calibrations as well as intrusive maintenance, and poor initial set-up of the device itself

And there are only four ways in which such failures can become hazardous.(see Section 1.5 of HTM ComDoc 1)

  1. When a device on which a patient’s well-being is dependent experiences an unexpected failure.
  2. When a device on which a patient’s well-being is dependent develops a failure that reduces its performance or safety to an unacceptable level, and the failure is not likely to be obvious to the device user (often called a “hidden” failure)
  3. When a device is damaged in such a way that it presents some kind of direct physical threat to the safety of patients or staff. For example, if the damage leaves an exposed sharp edge.
  4. When the device is used improperly.

Of these four ways of becoming hazardous, only two of the four are PM-preventable (see Section 1.9 of HTM ComDoc 1):

  • Failures that are caused by the premature deterioration of a non-durable part that is usually restored during a periodic PM
  • “Hidden” failures that reduce the device’s performance or safety below a critical level, and that would be detected by performance or safety verification testing during PM as recommended by the manufacturer.

And keep in mind that not all of these failures will necessarily result in outcomes that could result in serious injury or death. The intent in the CMS memo appears to be to disqualify from immediate inclusion in an AEM program, any item of equipment that could present “a risk of serious injury or death to a patient should the equipment fail”- unless the facility can provide specific justification. Further, CMS requires that the facility conduct some kind of credible risk assessment to identify (and label as “critical equipment”) devices whose failure could result in such a serious risk. The CMS surveyors are instructed in the memo to pay particular attention to any items that the facility has labeled as “critical equipment” but that are being maintained other than as recommended by the manufacturer. This implies that when such items are found the facility might be asked to explain why not following the manufacturer's PM recommendations for the items is not reducing the overall level of patient safety.

However, a practical problem emerges: No one has yet created a list of devices, or device types, for which there is a consensus that all of the items meet the CMS definition of “critical equipment”. To the best of our knowledge, no general agreement exists on which particular device types should be considered "critical equipment". The same is true for the similar term -“high-risk medical equipment” - which is used by The Joint Commission (TJC) - see Section 11.9 below. The only examples of “critical equipment” provided in the regulation are ventilators, defibrillators, and robotic surgery devices.

The objective of the AEM option is to avoid making any changes to the default planned maintenance program mandated by CMS (which is following the manufacturer’s PM recommendations for every piece of medical equipment) that will increase the risk to patients or the attending staff. Therefore, a logical place to start would be to determine which devices could result in a serious, life-threatening outcome if they should fail - from any cause, not just a PM-preventable cause. According to the current language in the revised CMS regulation, all such devices would meet the current CMS definition of "critical equipment.

But there is some uncertainty about the extent to which items that (a) demonstrate a relatively high level of inherent unreliability, or (b) are relatively easy to misuse in a way that makes them hazardous, or (c) are unusually prone to becoming damaged in a way that can become dangerous, were intended to be classified as “critical equipment” and thus excluded from the AEM program.

The Task Force has taken the position that this ambiguity in the definition was not intended and that, for this particular purpose, such items should not be labeled as “critical equipment”. To make this interpretation absolutely clear the Task Force has chosen to use the alternative, more specific terms, “potentially PM-critical” to label devices with critical failures that can be prevented by competent and timely planned maintenance, and "PM-critical" for “potentially PM-critical” devices that are "quite likely" to experience PM-preventable failures. (see Table 12 for the tentative definition of the terms "quite likely", "unlikely" and "very unlikely")

If this position is acceptable to CMS, then healthcare facilities will be able to create a completely comprehensive CMS-compliant AEM program using a relatively simple risk assessment that considers only the device's PM-preventable failure modes.

The three AEM program challenges

The Task Force’s analysis of the presumed intention of the December 20, 2013 “clarification” of the relevant CMS regulations (HTM ComRef 28), results in three quite challenging requirements that facilities must address in order to take advantage of the AEM program option. The facility must:

  1. Be able to explain the rationale and process used to decide which devices are eligible to be 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.

With respect to the first challenge, the Task Force has concluded that the agency intends to allow into an AEM program only those devices that meet one, or both, of the following criteria:

  • The device is highly unlikely to cause a serious injury or death to a patient or staff person if it should fail in a way that could have been prevented by the device having been subjected to appropriate PM, and
  • The device is highly unlikely to fail from a PM-preventable cause

Tentative definitions of "highly unlikely to cause a serious injury or death" and "highly unlikely to fail from a PM-preventable cause" can be found in Table 4 and Table 12 respectively.

These two criteria could be used as AEM Program Inclusion Criteria, however the Task Force has instead set up a formal selection process (RCM-based Risk Assessment) using a set of five more explicit RCM-based risk criteria. This process is described more fully in Section 11.5 below.

And, with respect to the second challenge, Reliability Centered Maintenance (RCM) is certainly a generally accepted and widely used industry standard - as detailed in HTM ComRef 1 and HTM ComRef 26 and a number of the other reference materials listed on Page 4 (Reference documents).

As for the third challenge, see Section 11.6 below.

11.5 Risk-based assessment process to identify which devices can be safely moved into an AEM program

In order 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 maintenance option (if the equipment users are willing to allow this) and otherwise 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 recommended device selection process is shown in the graphic titled RCM-based Risk Assessment. It incorporates as decision points the set of RCM-based risk criteria developed specifically for this purpose by the Maintenance Practices Task Force.

The first decision point in the RCM-based Risk Assessment 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 in the RCM-based Risk Assessment asks whether or not the device belongs in any of the four 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 a sufficient amount of maintenance history 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 Task Force has established this database website. The CMS regulations explicitly allow individual hospitals to draw on information from “nationally recognized expert associations” (such as AAMI)

The third and fourth decision points in the RCM-based Risk Assessment incorporate the first two of the Task Force’s RCM-based risk criteria.

  • Can there be some kind of adverse outcome if the device stops working completely while it is in use?
  • 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 in the RCM-based Risk Assessment addresses the third of the Task Force’s RCM-based risk criteria:

  • Can the device cause an 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 Tables 2 and 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 in the RCM-based Risk Assessment addresses the fourth of the Task Force’s RCM-based risk criteria:

  • 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.”).

According to the fifth of the Task Force’s RCM-based risk criteria, devices meeting the CMS definition of “critical equipment” (or the TJC definition of “high-risk equipment”) should be permitted to be included in an AEM program unless a PM-preventable failure of the device is deemed “quite likely" to occur. Of course, if reliable information on the PM-related reliability and safety of the device is not available, then it should default to the device being maintained according to the manufacturer’s recommendations.

Note that, although it is the position of the Task Force that “critical equipment” whose PM-related failure modes have been credibly demonstrated to be reasonably unlikely to occur should be allowed to be included in an AEM program, this position has not yet been approved by CMS. One important complication of the Task Force’s ongoing project to collect this information is that there has been no general agreement yet on where to set the point (MTBF) at which a critical device failure from a PM-preventable cause is considered “quite likely" to occur.

In summary, based on the current CMS regulation, the following medical devices are eligible to be moved into an AEM program and subjected to alternate maintenance strategies (such as run-to-fail/light maintenance) :

  • Devices that are not specifically designated as ineligible by the CMS regulation
  • Devices that do not have any PM-preventable failure modes
  • Devices with PM-preventable failure modes that will not result in a serious, life-threatening injury

Using the Task Force’s RCM-based risk criteria would extend this option to:

  • Devices with PM-preventable failure modes that could result in a serious, life-threatening injury but which are "unlikely" or "very unlikely" to occur”

11.6 Evaluating the level of safety achieved by the AEM program

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)

With respect to what should be considered an acceptable level of PM-related safety, the strategy adopted by the Task Force is to determine, through the database incorporated into this website (Table 5), what level of PM-related reliability is achieved when devices meeting the Task Force's definition of a Potential PM Priority 1 device (equivalent 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 PM-related failure rates (MTBFs) that the manufacturers appear to consider to represent an acceptable level of PM-related reliability (i.e. PM-related safety).

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 this proposed benchmark for an 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 dividing line between “unsafe” and “acceptably safe” for all other types of devices with the same level of severity of potential adverse outcome. With this dividing line as a benchmark, 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 Task Force's proposed threshold for acceptably safe.

  • Note that we have also described a practical methodology for monitoring actual levels of patient safety in Section 3.10 of HTM ComDoc 3.

11.7 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”) strategy.
  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 the Summary Proof Tables (Table 5)
  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 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.

Based on a number of personal observations by several members of the Task Force it is their 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 6) 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 a significant fraction of the entire medical equipment maintenance workload was performed using some version of a risk-based maintenance program which was very similar in effect to the Alternate Equipment Management program currently permitted by the CMS regulations.


11.8 Creating a practical AEM program that satisfies the key CMS requirements

The Task Force recommends the following seven steps for creating a CMS-compliant AEM program.

  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 additional material on Creating the facility’s Medical Equipment Inventory).
  2. Use the process described in Section 11.6 (and in the RCM-based Risk Assessment) to identify which of the facility’s devices should be considered what CMS calls “critical equipment” (what TJC calls “high-risk equipment” and what the TF calls “potential PM Priority 1” devices) and create (or reference) a document explaining how the process embodied in the RCM-based Risk Assessment is consistent with established industry standards of practice. (See additional material on Industry Standards of Practice).
  3. Create a policy describing the alternate maintenance strategies that will be considered for devices included in the AEM program. (See additional material on alternate maintenance strategies).
  4. Use the process described above in Section 11.6 and in the RCM-based Risk Assessment to identify which of the facility’s devices are considered to be non-critical devices, then determine which (if any) of the non-critical devices will continue to be maintained according to the manufacturer’s recommendations and which will be maintained according to an alternate maintenance strategy.
  5. Create a policy describing the process used to evaluate the levels of PM-related safety achieved by the AEM activities for the various devices included in the AEM program. This should 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 current tentative threshold of less than one PM-preventable failure every 75 years is subject to revision as more information is collected.
  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 additional material on Training).
  7. Create a document describing the qualifications of the personnel managing the AEM program and those performing the AEM maintenance activities. (See additional material on Personnel qualifications).

For a more extensive description of this process see HTM ComDoc 16.

11.9 The relevant Joint Commission Standards for hospitals that use JC accreditation for deemed status purposes - as of the January 2017 HAS


Standard EC.02.04.01

The hospital manages medical equipment risks.

EP 2. The hospital maintains a written inventory of all medical equipment
EP 3. The hospital identifies high-risk medical equipment on the inventory for which there is a risk of serious injury or death to a patient or staff member should the equipment fail.

Note: High-risk medical equipment includes life-support equipment.

EP 4. The hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting, and testing all medical equipment on the inventory. These activities and associated frequencies are in accordance with manufacturers’ recommendations or with strategies of an alternative equipment maintenance (AEM) program.

Note 1: The strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice, such as ....

Note 2: Medical equipment with activities and associated frequencies in accordance with manufacturer's recommendations must have a 100% completion rate.

Note 3: Scheduled maintenance activities for high-risk medical equipment in an AEM program inventory must have a 100% completion rate. Scheduled maintenance activities for non-high risk medical equipment in an alternative equipment maintenance (AEM) program inventory are to be completed at 100%. AEM frequency is determined by the hospital AEM program.

EP 5. The hospital’s activities and frequencies for inspecting, testing and maintaining the following items must be in accordance with manufacturers’ recommendations:
  • Equipment subject to federal or state law or Medicare Conditions of Participation in which inspecting, testing, and maintaining must be in accordance with the manufacturers’ recommendations, or otherwise establishes more stringent maintenance requirements
  • Medical laser devices
  • Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes)
  • New medical equipment with insufficient maintenance history to support the use of alternate maintenance strategies

Note: Maintenance history includes any of the following documented evidence:

  • Records provided by the hospital’s contractors
  • Information made public by nationally recognized sources
  • Records of the hospital’s experience over time
EP 6. A qualified individual(s) uses written criteria to support the determination whether it is safe to permit medical equipment to be maintained in an alternate manner that includes the following:
  • How the equipment is used, including the seriousness and prevalence of harm during normal use
  • Likely consequences of equipment failure or malfunction, including seriousness and prevalence of harm
  • Availability of alternative or back-up equipment in the event the equipment fails or malfunctions
  • Incident history of identical or similar equipment
  • Maintenance requirements of the equipment
EP 7. The hospital identifies medical equipment on its inventory that is included in an alternative equipment maintenance program
EP 8. The hospital monitors and reports all incidents in which medical equipment is suspected in or attributed to the death, serious injury, or serious illness of any individual, as required by the Safe Medical Devices Act of 1990.
EP 9. The hospital has written procedures to follow when medical equipment fails, including emergency clinical interventions and backup equipment.
EP 10. The hospital identifies quality control and maintenance activities to maintain the quality of the diagnostic computed tomography (CT), positron emission tomography (PET), magnetic resonance imaging (MRI), and nuclear medicine (NM) images produced. The hospital identifies how often these activities should be conducted.


Standard EC.02.04.03

The hospital inspects, tests, and maintains medical equipment.

EP 2. The hospital inspects, tests, and maintains all high-risk equipment. These activities are documented.

Note 1: High-risk medical equipment includes medical equipment equipment for which there is a risk of serious injury or even death to a patient or staff member should it fail, which includes life-support equipment.

Note 2: Required activities and associated frequencies for maintaining, inspecting, and testing of medical equipment completed in accordance with manufacturer's recommendations must have a 100% completion rate.

Note 3: Scheduled maintenance activities for high-risk equipment in an alternative equipment maintenance (AEM) program inventory must have a 100% completion rate.

EP 3. The hospital inspects, tests, and maintains non-high-risk equipment identified on the medical equipment inventory. These activities are documented.

Note: Scheduled maintenance for non-high risk medical equipment in an alternative equipment maintenance (AEM) program inventory are to be completed at 100%. AEM frequency is determined by the hospital's AEM program.

EP 15. Qualified hospital staff inspect, test, and calibrate nuclear medicine equipment annually. The results and completion date are documented.



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