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Table 3

From HTMcommunityDB.org

Results from the assessment using the hidden failures questionnaire (preliminary)

By examining each device type's HTMC generic PM procedure and using the Task Force's hidden failures questionnaire, the sixteen devices in rows 1-16 are judged to be potentially PM Priority 1 because they could have a significant adverse outcome at the highest Level of Severity 3 (life threatening). The fifty devices in rows 17-66 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) when they develop a critical performance or safety deterioration that may not have been obvious to the user (i.e. when they develop a hidden failure).

An entry of "Y" in column 4 ("Has potential hidden failure(s)?") indicates that there will be some kind of adverse consequence (summarized briefly in column 5) which is judged to have a potential Level of Severity of 1, 2 or 3 (see column 6) if the device develops a hidden failure (a failure not obvious to the user) while it is in use. Possible mitigating factors and potential scope of adversity are noted 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 pot. HF(s)?
5.
Most serious potential adverse outcome if the
device develops a worst case hidden failure (HF)
and the potential scope of the resulting adverse outcome
6.
Potential Level of Severity (LOS)
of the adverse outcome if
the device develops a hidden failure
7.
Possible mitigating factors
1 AED AED-01 Y A hidden failure (HF) causes the unit to underdeliver. Patient is not resuscitated LOS 3. Serious, life-threatening injury Device supposedly designed for high reliability. May have built-in self-testing and autocalibration (?).
2 anesthesia unit ANES-01 Y HF causes agent or oxygen level indicator to read incorrectly. Patient is overdosed or deprived of oxygen LOS 3. Serious, life-threatening injury Clinician usually present during use. Pre-use checks. May have built-in self-testing.
3 apnea monitor APN.M-01 Y HF causes the sensor or alarm to read incorrectly. Respiratory arrest goes undetected. LOS 3. Serious, life-threatening injury
4 critical care ventilator C.VEN-01 Y HF causes the unit to underdeliver. Patient deprived of oxygen. LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
5 defibrillator/ monitor DEF-01 Y HF causes the unit to underdeliver. Patient is not resuscitated LOS 3. Serious, life-threatening injury Device supposedly subjected to regular operator-level checks by users to assure correct calibration.
6 infant incubator IN.IN-01 Y HF causes the unit to significantly under perform. LOS 3. Serious, life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
7 intra-aortic balloon pump I.A.B.P-01 Y HF causes the unit to underdeliver. Patient deprived of oxygenated blood. LOS 3. Serious, life-threatening injury Clinician usually present or close by during use.
8 linear accelerator LN.AC-01 Y HF causes the unit to deliver an excessive dose, over-irradiating the patient. Potential to affect multiple patients. LOS 3. Serious, life-threatening injury Regular calibration usually overseen by a physicist.
9 neonatal monitor NEO.M-01 Y HF causes the unit to read/ alarm incorrectly. LOS 3. Serious, life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
10 oxygen analyzer OXY.A-01 Y HF causes the unit to read significantly incorrectly. LOS 3. Serious, life-threatening injury
11 oxygen monitor OXY.M-01 Y HF causes the unit to read significantly incorrectly. LOS 3. Serious, life-threatening injury
12 patient monitoring system P.M.S-01 Y HF causes one or more of the units to read/ alarm incorrectly. Potential to affect multiple patients. LOS 3. Serious, life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
13 PCA pump INF.D-03 Y HF causes the unit to overdeliver a potent drug. Potential to affect multiple patients. LOS 3. Serious, life-threatening injury Clinician usually close by during use. Device may have built-in self testing.
14 syringe pump INF.D-02 Y HF causes the unit to overdeliver a potent drug. Potential to affect multiple patients. LOS 3. Serious, life-threatening injury Clinician usually close by during use. Device may have built-in self testing.
15 transport incubator T.INC-01 Y HF causes the unit to significantly under perform. LOS 3. Serious, life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
16 transport ventilator T.VEN-01 Y HF causes the unit to underdeliver. Patient deprived of oxygen. LOS 3. Serious, life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
17 Blood Bank refrigerator Y HF causes the unit to under-cool and stored blood deteriorates. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Temperature alarm provided
18 blood gas analyzer Y HF causes unit to provide significantly erroneous diagnostic information. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Other frequent operator-level QA checks and balances
19 blood pressure monitor (invasive) Y HF causes the unit to provide significantly erroneous information. LOS 2. Less serious, non life-threatening injury Clinician usually close by during use.
20 blood warmer Y HF causes the unit to over-heat and denature the blood. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Clinician usually close by during use.
21 bone densitometer Y HF reduces the diagnostic resolution to significantly less than it should be. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
22 brachytherapy unit Y HF causes miscalibration of the active agent and the patient is overexposed. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Regular calibration usually overseen by physicist.
23 cardiac resuscitator C.RES-01 Y HF causes the unit to provide significantly inadequate treatment. LOS 2. Less serious, non life-threatening injury Alternative manual resuscitation by clinician who is usually present during use.
24 C-arm Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
25 cath lab Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Pre-use checks (?) Trained clinical technician present during use
26 clinical lab analyzer Y HF causes unit to provide significantly erroneous diagnostic information. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Other frequent operator-level QA checks and balances
27 CT scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
28 ECG recorder Y HF causes unit to provide significantly erroneous diagnostic information. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Other operator-level QA checks and calibration
29 EEG recorder Y HF causes unit to provide significantly erroneous diagnostic information. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Other operator-level QA checks and calibration
30 electrophysiology lab Y HF reduces the validity of the mapping to significantly less than what it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Clinician usually present during use.
31 electrosurgical unit Y HF causes the unit to significantly over or under-perform. LOS 2. Less serious, non life-threatening injury Clinician present during use.
32 endoscope, specialty Y HF causes the unit to significantly under-perform compromising potential diagnosis or treatment. LOS 2. Less serious, non life-threatening injury Trained clinician present during use
33 external pacemaker EX.PA-01 Y HF causes the unit to provide significantly erroneous therapy. LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent patient injury
34 fetal monitor Y HF causes the unit's function to be significantly below what it should be. LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent fetal injury
35 gamma camera Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
36 heart-lung bypass unit H.L.BY-01 Y HF causes the unit to underdeliver. Patient deprived of oxygenated blood. LOS 2. Less serious, non life-threatening injury Clinician and trained operator usually present during use. Pre-use checks
37 hemodialysis unit Y HF causes the unit to significantly under deliver. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
38 hypo/ hyperthermia unit Y HF causes the unit to significantly overheat or overcool the patient. LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent patient injury
39 infusion pump INF.D-01 Y HF causes the unit to overdeliver a potent drug.Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Clinician usually close by during use. Device may have built-in self testing.
40 infant warmer Y HFcauses the unit to significantly overdeliver LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
41 lab microscope Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
42 mammo unit Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Pre-use checks (?) Trained clinical technician present during use
43 MRI scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
44 opthalmic laser Y HF causes the unit to significantly overdeliver LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
45 peritoneal dialysis unit Y HF causes the unit to provide significantly erroneous therapy. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
46 PET scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Pre-use checks (?) Trained clinical technician present during use
47 PET/ CT scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Pre-use checks (?) Trained clinical technician present during use
48 PET/ MRI scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Pre-use checks (?) Trained clinical technician present during use
49 phototherapy light Y HFcauses the unit to significantly overdeliver LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent serious injury
50 portable x-ray unit Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
51 R&F room Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
52 rad room Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
53 radiation dosimeter Y HF causes the unit to read significantly incorrectly. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
54 radioisotope calibrator Y HF causes the unit to provide significantly incorrect calibrations. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
55 special procedures room Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinician or clinical technician present during use
56 sterilizer Y HF causes the unit to significantly under-perform risking serious spread of infection. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Other QA checks and balances (chemical and biological indicators) with each use.
57 surgical guidance unit Y HF causes the unit to significantly under-perform. LOS 2. Less serious, non life-threatening injury Clinician present during use.
58 surgical laser Y HF causes the unit to significantly under-perform. LOS 2. Less serious, non life-threatening injury Clinician present during use.
59 surgical robot Y HF causes the unit to significantly under-perform. LOS 2. Less serious, non life-threatening injury Clinician present during use.
60 telemetry system Y HF causes one or more of the units to read/ alarm incorrectly. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Clinician(s) may be close by but may not observe the malfunction in time to prevent patient injury
61 thyroid uptake unit Y HF causes the unit to significantly under-perform. LOS 2. Less serious, non life-threatening injury Trained clinical technician present during use
62 tomo room Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinician or clinical technician present during use
63 transcutaneous O2/ CO2 monitor Y HF causes the unit to provide significantly erroneous readings. LOS 2. Less serious, non life-threatening injury
64 ultrasound scanner Y HF reduces the diagnostic resolution to significantly less than it should be. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinician or clinical technician present during use
65 xenon scintigraphy system Y HF causes the unit to significantly under-perform. Potential to affect multiple patients. LOS 2. Less serious, non life-threatening injury Trained clinician or clinical technician present during use
66 infant scale IN.SC-01 Y HF causes the unit to read incorrectly and the infant is treated improperly. LOS 1. No injury but possible disruption of care
67 autotransfusion unit Y HF causes the unit to significantly under-perform compromising patient treatment. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician or clinical technician present during use
68 blood pump, extracorporeal BL.P.E-01 Y HF causes the unit to significantly under-perform compromising patient treatment. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician or clinical technician present during use
69 cataract extraction unit Y HF causes the unit to significantly under-perform compromising patient treatment. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician present during use
70 contrast injector Y HF causes the unit to significantly under-perform. LOS 0. Consequence of adverse outcome considered to be negligible Clinician usually present during use.
71 hemodialysis blood pump Y HF causes the unit to significantly under-perform compromising patient treatment. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician or clinical technician present during use
72 OR light Y HF causes the unit to significantly under-perform compromising patient treatment. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician present during use
73 pulse oximeter Y HF causes the unit to read incorrectly and the patient is treated improperly. LOS 0. Consequence of adverse outcome considered to be negligible
74 ventilator Y HF causes the unit to significantly under-perform. LOS 0. Consequence of adverse outcome considered to be negligible Trained clinician or clinical technician present during use
75 vital signs monitor Y HF causes the unit to read incorrectly and the patient is treated improperly. Potential to affect multiple patients. LOS 0. Consequence of adverse outcome considered to be negligible
76 exercise ergometer EX.ER-01 N Device has no known hidden failure modes. No consequent adverse outcomes.
77 other device N Device has no known hidden failure modes. No consequent adverse outcomes.


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