Log in Article Discussion Edit History Go to the site toolbox

Table 2

From HTMcommunityDB.org

Results from assessment using the wear-out failures questionnaire (preliminary)

By examining the device's HTMC generic PM procedure and using the Task Force's wear-out failures questionnaire , the 11 devices in rows 1-11 below are judged to be potentially PM Priority 1 device because they have one or more critical device restoration (DR) task(s) that if not completed properly or in a timely manner could cause the device to fail unexpectedly - having an adverse outcome at the highest Level of Severity 3 (life-threatening). The 42 devices in rows 12-53 are considered to be of a lower PM Priority level because the adverse outcome of their failure is judged to be at a lower Level of Severity (LOS 2 (having the potential to cause a patient injury) or LOS 1 (having the potential to disrupt patient care).

An entry of "Y" in column 4 (Has NDP(s)?) confirms that the device has at least one non-durable part that is not designed to last the expected lifetime of the device because the manufacturer-recommended PM procedure (see link in column 3) has at least one line-item task that could cause the device to stop working if that task or those tasks were not completed properly, or in a timely manner.

An entry of "Y" in column 5 ("Must work?") confirms that there will be some kind of adverse outcome (summarized briefly in column 6) which is judged to have a potential Level of Severity of 1, 2 or 3 (see column 7) if the device fails unexpectedly while it is in use. Possible mitigating factors and potential scope of adversity are noted in column 8 and have been taken into consideration in assigning the potential Level of Severity in column 7.

  • This table is not necessarily complete but this is a wiki site and members of the Health Technology Management (HTM) Community are invited to review the professional judgments reflected in this analysis and submit any comments, particularly any suggested changes, to the Task Force at: htmc.mptf@gmail.com


(This table was last revised on 5-16-18)

2.

HTMC device type
3.

HTMC Procedure Code
4.

Has NDP(s)?
5.

Must work?
6.
Nature of the most serious potential adverse outcome
if the device fails and stops working while in use,
because a non-durable part (NDP) was not
restored properly or in a timely manner

7.
Potential Level of Severity (LOS)
of potential adverse outcome
if device fails because of inadequate restoration of its non-durable parts
8.

Possible mitigating factors
1 AED AED-01 Y Y Patient will be deprived of cardiac stimulation during time that the device is not operable LOS 3. Serious, life-threatening injury Device is specially designed for high reliability and clinician may be close by during use.
2 anesthesia unit ANES-01 Y Y Patient may be deprived of oxygen if the device stops working LOS 3. Serious, life-threatening injury Clinician usually present during use.
3 blood pump, extracorporeal BL.P.E-01 ? Y Patient's supply of oxygenated blood may be reduced during time the device is not working LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
4 cardiac resuscitator C.RES-01 Y Y Unable to resuscitate patient if device becomes inoperable and there is no alternative unit available close by. LOS 3. Serious, life-threatening injury Alternative manual resuscitation by clinician who is usually present during use.
5 critical care ventilator C.VEN-01 Y Y If the device stops working or a gas filter becomes clogged the patient's oxygen supply may be interrupted for an extended period. LOS 3. Serious, life-threatening injury Device is specially designed for high reliability and clinician usually close by during use.
6 defibrillator/ monitor DEF-01 Y Y May be unable to resuscitate patient if device becomes inoperable and there is no alternative unit available close by. LOS 3. Serious, life-threatening injury Device is subjected to regular operator-level checks by users to assure high reliability.
7 external pacemaker EX.PA-01 ? Y Patient will be deprived of cardiac stimulation during time that the device is not operable LOS 3. Serious, life-threatening injury Clinician usually present during use or close by.
8 heart-lung bypass unit H.L.BY-01 ? Y Patient's supply of oxygenated blood will be reduced during time the device is not operable LOS 3. Serious, life-threatening injury Clinician and trained operator usually present during use.
9 intra-aortic balloon pump I.A.B.P-01 Y Y Patient's supply of oxygenated blood will be reduced during time the device is not operable LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
10 transport incubator T.INC-01 Y Y Vital life-supporting services for the infant will be interrupted for an extended period while the device is inoperable. LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
11 transport ventilator T.VEN-01 Y Y Patient's oxygen supply will be interrupted for an extended period while the device is inoperable. LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
12 apnea monitor APN.M-01 Y Y Potential to miss a critical alarm if the failure is not noticed. LOS 2. Less serious, non life-threatening injury Unlikely that unnoticed device failure will coincide with critical alarm
13 Blood Bank refrigerator ? Y Stored blood could deteriorate if the device is down for an extended period. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Provided with temperature alarm
14 CT scanner ? Y Delay in providing diagnostic information. In ER delay may be serious. Otherwise patients may have to be rescheduled. LOS 2. Less serious, non life-threatening injury Alternative equipment may be available (?)
15 fetal monitor ? Y Potential to miss a critical alarm if the entire system stops functioning while a difficult pregnancy is being monitored. LOS 2. Less serious, non life-threatening injury Alternative equipment may be available (?)
16 infant incubator IN.IN-01 Y Y Patient treatment will be delayed until an alternative is made available. LOS 2. Less serious, non life-threatening injury Unlikely that duration of unnoticed failure will be long enough to result in serious injury
17 neonatal monitor NEO.M-01 ? Y Potential to miss a critical alarm if the entire system stops functioning while a very sick infant is being monitored. LOS 2. Less serious, non life-threatening injury Alternative equipment may be available (?)
18 oxygen monitor OXY.M-01 ? Y Potential to miss a critical alarm if the entire system stops functioning while a seriously ill patient is being monitored. LOS 2. Less serious, non life-threatening injury Alternative equipment may be available (?)
19 patient monitoring system P.M.S-01 ? Y Potential to miss a critical alarm if any part of the system stops functioning while seriously ill patients are being monitored. LOS 2. Less serious, non life-threatening injury Unlikely that unnoticed device failure will coincide with critical alarm
20 surgical guidance unit ? Y Injury may result if unit fails during use (?). Surgery will be delayed until another unit or alternative means of completing surgery is made available. LOS 2. Less serious, non life-threatening injury Clinician usually present during use.
21 surgical robot ? Y Injury may result if unit fails during use (?). Surgery will be delayed until another unit or alternative means of completing surgery is made available. LOS 2. Less serious, non life-threatening injury Clinician usually present during use.
22 telemetry system ? Y Potential to miss a critical alarm if any part of the system stops functioning while patients are being monitored. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Unlikely that unnoticed device failure will coincide with critical alarm
23 transcutaneous O2/ CO2 monitor ? Y Potential to miss a critical alarm while the device is down. LOS 2. Less serious, non life-threatening injury Alternative equipment may be available (?)
24 brachytherapy unit ? Y Patient treatment will be delayed. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
25 C-arm ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
26 cataract extraction unit ? Y Surgery will be delayed until a replacement unit is made available. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
27 cath lab ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
28 clinical lab analyzer ? Y Delay in providing diagnostic information. LOS 1. No injury but possible disruption of care
29 contrast injector ? Y Patient treatment will be delayed until an alternative is made available. . LOS 1. No injury but possible disruption of care Clinician and trained operator usually present during use.
30 ECG recorder ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
31 electrophysiology lab ? Y Delay in providing diagnostic information. LOS 1. No injury but possible disruption of care
32 electrosurgical unit ? Y Surgery will be delayed until a replacement unit is made available. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
33 endoscope, specialty ? Y Diagnostic information/ surgical treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
34 gamma camera ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
35 hemodialysis unit ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
36 hypo/ hyperthermia unit ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
37 infant warmer ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
38 linear accelerator LN.AC-01 ? Y Patient treatment will be delayed until an alternative is made available requiring that patients be rescheduled LOS 1. No injury but possible disruption of care
39 mammo unit ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
40 MRI scanner ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
41 opthalmic laser ? Y Surgery will be delayed until a replacement unit is made available. LOS 1. No injury but possible disruption of care
42 OR light ? Y Surgery will be delayed until a replacement unit is made available. LOS 1. No injury but possible disruption of care Alternative equipment may be available (?)
43 peritoneal dialysis unit ? Y Patient treatment will be delayed until an alternative is made available maybe requiring that patients be rescheduled LOS 1. No injury but possible disruption of care
44 PET scanner ? Y Possible delay in providing diagnostic information LOS 1. No injury but possible disruption of care
45 PET/ CT scanner ? Y Possible delay in providing diagnostic information LOS 1. No injury but possible disruption of care
46 PET/ MRI scanner ? Y Possible delay in providing diagnostic information LOS 1. No injury but possible disruption of care
47 special procedures room ? Y Delay in providing diagnostic information. LOS 1. No injury but possible disruption of care
48 sterilizer Y Y Surgeries and other patient treatments will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
49 surgical laser ? Y Surgery will be delayed until a replacement unit is made available. LOS 1. No injury but possible disruption of care
50 thyroid uptake unit ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
51 tomo room ? Y Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 1. No injury but possible disruption of care
52 ventilator ? Y Patient treatment will be delayed until an alternative is made available. LOS 1. No injury but possible disruption of care
53 xenon scintigraphy system ? Y Possible delay in providing diagnostic information LOS 1. No injury but possible disruption of care
54 autotransfusion unit N Patient treatment will be delayed until an alternative is made available. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
55 blood gas analyzer N Delay in providing diagnostic information. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
56 blood pressure monitor (invasive) N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
57 blood warmer N Patient treatment will be delayed until an alternative is made available. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
58 bone densitometer N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
59 EEG recorder N Delay in providing diagnostic information. Patients may have to be rescheduled. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
60 hemodialysis blood pump N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
61 infant scale IN.SC-01 N Possible minor delay until alternative equipment found LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
62 infusion pump INF.D-01 ? N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
63 lab microscope N Delay in providing diagnostic information. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
64 oxygen analyzer OXY.A-01 N Patient treatment will be delayed until an alternative is made available. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment may be available (?)
65 PCA pump N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
66 phototherapy light N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
67 portable x-ray unit N Patient treatment will be delayed until an alternative is made available. LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
68 pulse oximeter N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
69 R&F room N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
70 rad room N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
71 radiation dosimeter N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
72 radioisotope calibrator N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
73 syringe pump N Possible delay in patient treatment LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably readily available.
74 ultrasound scanner N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
75 vital signs monitor N Possible delay in providing diagnostic information LOS 0. Result of adverse outcome
considered to be negligible
Alternative equipment probably available (?)
76 exercise ergometer EX.ER-01 maybe N No known adverse outcome if device suddenly stops working while in use No critical life support component
if this is a PM-critical device
77 other device maybe N No known adverse outcome if device suddenly stops working while in use No critical life support component
if this is a PM-critical device


Site Toolbox:

Personal tools
This page was last modified 07:02, 6 April 2019. - This page has been accessed 2,114 times. - Disclaimers - About HTMcommunityDB.org