Table 13

From HTMcommunityDB.org

Documented levels of PM-related reliability for all devices that meet the CMS definition of "critical equipment" (under revision)

• Each of the specific manufacturer-model versions of the device types listed in the table below are considered to be a potentially high PM criticality device because they could have a high severity (LOS 3) adverse outcome - either when they fail unexpectedly because a scheduled device restoration task had not been completed in a timely manner (see Table 2), or when they have been found to have developed a significant (but hidden) performance or safety deterioration during scheduled safety verification testing (see Table 3). Both of these types of failure are considered to be PM-preventable failures.

• Column C2 shows the specific manufacturer-model versions of the top twenty device types listed in Table 4 (those with the highest potential severity adverse outcomes if they should fail). These particular items also meet the definition of what the CMS regulation calls "critical equipment". (Information on the manufacturer's recommended PM interval and procedure quoted directly from the manufacturer's technical literature can be accessed by clicking on the relevant manufacturer-model version name in column C2).

• Column C3 provides a useful "crosswalk" between the HTMC standard name for each manufacturer-model version and other commonly used names for the same manufacturer-model version. Downloading Table 13 into Excel and using the Excel search feature will allow location of alternate common terms in the (AKAs)" column (C3) and determination of the corresponding HTMC standard name for that particular manufacturer-model version.

• This link to the FDA's Global Universal Device Identification (GUDID) website (https://accessgudid.nlm.nih.gov) is provided here for possible use in the future.

• Column C4 brings over from column 4 of Table 4 the broad characterization made by the MPTF in Phase 1 of their project of the worst-case severity of the adverse outcome if this particular device type should fail. For example; a device characterized as high PM criticality could produce a life-threatening (LOS 3) adverse outcome if it should fail.

• Column C5 identifies the amount of data in the experience base for each particular manufacturer-model at each particular PM interval and/or PM procedure. The acceptable minimum currently set by the MPTF is 50 device-years (see Table 11).

• Column C6 provides links to standardized PM procedures reflecting any differences between the manufacturer-recommended generic procedure for this particular device type and the procedure used for this particular testing. For example;

• Columns C7 - C9 identify the levels of PM-related reliability found when the devices were subjected to the periods of real-world maintenance that are fully documented in the various sub-tables of Table 5. For example see the link to Table 5.1 (AEDs) on the second row of column 2. An entry of (M-R) in column C8 indicates that this particular combination of PM interval and PM procedure is consistent with the manufacturer's maintenance recommendation.

• Column C10 shows the likelihood of the device failing from a PM-preventable cause (corresponding to the levels shown in Table 12). Based on this finding an indication whether or the device should be considered eligible (Yes) or not (No) for inclusion in an AED program is shown in Column 11. (Devices that are unlikely to fail from a PM-preventable cause meet the Task Force's second AEM program inclusion criterion - see Section 3.4 of HTM ComDoc 3).

This table was last revised on 10-22-18

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