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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

C2
HTMC device type/
manufacturer-model

and
(links to supporting data in Table 5)
C3
Other possible names (AKAs)
for each mfr-model version
(use Excel keyword
search on document)
C4
Potential
PM criticality
of this
device type

(see Table 4)
C5
Experience
base

(in device-yrs)

(see Table 11)
C6

HTMC
Generic
PM proc.

C7
PM interval
(in months)
C8
= (M-R)
if this is
mfr-rec
PM interval
C9
PM-related reliability

(expressed
as MPTF)
C10
Likelihood
of PM-rel. failure
(see
Table 12)
C11

Eligible for
inclusion in
an AEM program?
1 AEDs High (LOS 3) AED-01 (No)
See Table 5.1 AEDs
1a Philips HeartStart FRx High (LOS 3) 102 AED-02 12m >102 yrs Unlikely Yes
1b Physio-Control Lifepak 1000 High (LOS 3) 166 AED-02 12m 166 yrs Very unlikely Yes
1c Physio-Control Lifepak CR Plus High (LOS 3) 85 AED-02 12m >85 yrs Unlikely Yes
1d Zoll AED Plus High (LOS 3) 322 AED-02 12m >322 yrs Very unlikely Yes
High (LOS 3)
2 Anesthesia units High (LOS 3) ANES-01 (No)
See Table 5.2 Anesthesia units
2a Drager Apollo High (LOS 3) 95 12m ? (M-R) >95 yrs Unlikely Yes
2b Drager Fabius GS High (LOS 3) 114 6m (M-R) >114 yrs Unlikely Yes
2c GE Medical Aestiva 5 High (LOS 3) 186 6m (M-R) about 10 yrs Quite likely No
2d GE Medical S 5 Aespire High (LOS 3) 83 12m (M-R) about 21 yrs Quite likely No
High (LOS 3)
3 Apnea monitors High (LOS 3) APN.M-01 (No)
See Table 5.8 Apnea monitors
3a Medtronic Capnostream 20p Covidien High (LOS 3) 274 12m ? >274 yrs Very unlikely Yes
3b Respironics SmartMonitor2 Respironics is now divn of Philips High (LOS 3) 37 12m ? >37 yrs Undetermined No
High (LOS 3)
4 Cardiac resusitators High (LOS 3) C.RES-01 (No)
See Table 5.10 Cardiac resuscitators
4a Fischer & Paykel Neopuff High (LOS 3) 250 12m (M-R) 125 Unlikely Yes
High (LOS 3)
5 Critical care ventilators High (LOS 3) C.VEN-01 (No)
See Table 5.3 Critical care ventilators
5a Carefusion AVEA Carefusion now divn of Becton Dickinson/ High (LOS 3) 127 12m (M-R) 127 yrs Unlikely Yes
5b Drager Evita Infinity V500 High (LOS 3) 64 12m (M-R) 64 yrs Quite likely No
5c Gettinge Servo 1 Maquet Gettinge Servo 1 High (LOS 3) 263 12m (M-R) 263 yrs Very unlikely Yes
5d Puritan Bennett 840 Medtronics/ Covidien 840 High (LOS 3) 342 6m (M-R) 342 yrs Very unlikely Yes
5e High (LOS 3)
6 Defibrillator/ monitors High (LOS 3) DEF-01 (No)
See Table 5.4 Defibrillator/ monitors
6a Philips HeartStart MRx High (LOS 3) 192 6m No 192 yrs Very unlikely Yes
6b Philips HeartStart XL High (LOS 3) 3m
6c Philips M4735A High (LOS 3) 267 6m non specd. 67 yrs Quite likely No
6d Physio-Control Lifepak 12 Physio-Control is now div of Stryker High (LOS 3) 12m
6e Physio-Control Lifepak 15 Physio-Control is now div of Stryker High (LOS 3) 12m
6f Physio-Control Lifepak 20 Physio-Control is now div of Stryker High (LOS 3) 12m
6g Physio-Control Lifepak 20e Physio-Control is now div of Stryker High (LOS 3) 322 12m 322 yrs Very unlikely Yes
6h Propaq M High (LOS 3)
6i Propaq MD High (LOS 3)
6j Zoll M Series High (LOS 3) 6m
6k Zoll R Series ALS High (LOS 3) 242 6m No 121 yrs Unlikely Yes
6l Zoll R Series Plus High (LOS 3) m
High (LOS 3)
7 External pacemakers High (LOS 3) EX.PA-01 (No)
See Table 5.11 External pacemakers
7a Medtronic 5348 High (LOS 3) 182 12m ? >182 Very unlikely Yes
7b Medtronic 5388 High (LOS 3) 259 12m ? 259 Very unlikely Yes
7c Medtronic 5392 High (LOS 3) 187 12m (M-R) >187 Very unlikely Yes
High (LOS 3)
8 Extracorporeal blood pumps High (LOS 3) BL.P.E-01 (No)
See Table 5.17 Extracorporeal blood pumps
8a BBB High (LOS 3)
High (LOS 3)
9 Heart-lung bypass units High (LOS 3) H.L.BY-01 (No)
See Table 5.12 Heart-lung bypass units
9a High (LOS 3)
10 Infant incubators High (LOS 3) IN.IN-01 (No)
See Table 5.9 Infant incubators
10a Drager C2000 Airshields Isolette High (LOS 3) 46 12m ? >46 Undetermined No
10b GE Medical Care Plus Ohmeda, Ohio High (LOS 3) 69 6m ? >69 Undetermined No
10c GE Medical Giraffe OmniBed Datex Ohmeda High (LOS 3) 395 12m ? 132 Unlikely Yes
High (LOS 3)
11 Intra-aortic balloon pumps High (LOS 3) I.A.B.P-01 (No)
See Table 5.5 Intra-aortic balloon pumps
11a Abiomed Impella High (LOS 3) 42 12m ? 42 yrs Undetermined No
11b Maquet Cardiosave High (LOS 3) 35 12m ? >35 yrs Undetermined No
11c Maquet CS300 High (LOS 3) 128 6m ? 128 yrs Unlikely Yes
High (LOS 3)
12 Linear accelerators High (LOS 3) LN.AC-01 (No)
See Table 5.16 Linear accelerators
12a LLL High (LOS 3)
High (LOS 3)
13 Neonatal monitors High (LOS 3) NEO.M-01 (No)
See Table 5.13 Neonatal monitors
13a NNNN High (LOS 3)
High (LOS 3)
14 Oxygen analyzers High (LOS 3) OXY.A-01 (No)
See Table 5.18 Oxygen analyzers
14a OOO High (LOS 3)
High (LOS 3)
15 Oxygen monitors High (LOS 3) OXY.M-01 (No)
See Table 5.14 Oxygen monitors
15a OOOO High (LOS 3)
High (LOS 3)
16 Patient monitoring systems High (LOS 3) P.M.S-01 (No)
See Table 5.15 Patient monitoring systems
16a PPP High (LOS 3)
High (LOS 3)
17 PCA pumps High (LOS 3) INF.D-03 (No)
See Table 5.19 PCA pumps
17a PPPP High (LOS 3)
High (LOS 3)
18 Syringe pumps High (LOS 3) INF.D-02 (No)
See Table 5.20 Syringe pumps
18a SSS High (LOS 3)
High (LOS 3)
19 Transport incubators High (LOS 3) T.INC-01 (No)
See Table 5.6 Transport incubators
19a Drager TI500 Air-Shields Isolette High (LOS 3) 37 12m ? >37 Undetermined No
19b International Biomed A750i Airborne High (LOS 3) 21 6m ? >21 Undetermined No
High (LOS 3)
20 Transport ventilators High (LOS 3) T.VEN-01 (No)
See Table 5.7 Transport ventilators
20a BIO-MED Devices MVP-10 High (LOS 3) 16 12m ? >16 Undetermined No
20b Viasys LTV 1200 Carefusion High (LOS 3) 96 24m ? >96 Unlikely Yes
High (LOS 3)


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