Table 5.
Input parameters categories in medical device reliability studies.
| Category | Subcategory or input parameter | Description | Outcomes | Articles |
|---|---|---|---|---|
| Features | Functionality or performance inspection | Device condition |
|
[50] |
| [32] | ||||
| [60] | ||||
| Age | Device age |
|
[42, 45, 47, 52] | |
| [12, 44] | ||||
| [32] | ||||
| [37] | ||||
| [20] | ||||
| Criticality | Device criticality |
|
[45, 48, 49] | |
| Type of equipment | Device name |
|
[44] | |
| [32] | ||||
| Class | Device classes |
|
[12] | |
| [47] | ||||
| Manufacturer | Device supplier |
|
[32] | |
|
| ||||
| Function | Clinical function or intended function | Device function |
|
[12, 42] |
|
[44, 45, 47–49] | |||
|
[37] | |||
|
[38] | |||
|
| ||||
| Performance | Error codes | Error on device |
|
[50] |
| Failures and frequency | Occurrence of failures |
|
[50] | |
|
[37] | |||
|
[12, 55] | |||
|
[48, 49] | |||
| Root cause of failures | Root cause of failures |
|
[55] | |
| Useful life ratio | The ratio between the age and expected life |
|
[48, 49] | |
| Service status of every failure mode | Status display on the device |
|
[50] | |
| Temperature error | Error on temperature |
|
[29] | |
| Operation and maintenance | Action taken/Repair notes | Tasks during repair work |
|
[50] |
|
[55] | |||
| Time to repair (downtime) | Time is taken during repair |
|
[50] | |
|
[12, 42, 55] | |||
|
[47–49] | |||
|
[60] | |||
| Commission time | Time is taken for commission work |
|
[55] | |
| Missed maintenance | Maintenance not to schedule |
|
[48, 49] | |
| Parts or part usage | Spare parts inventory |
|
[29] | |
|
[42] | |||
|
[35, 36] | |||
| Maintenance interval | Frequency of maintenance |
|
[46] | |
| Maintenance requirement or complexity | Maintenance activity based on device type |
|
[31, 32] | |
|
[2] | |||
|
[34–36] | |||
|
[48] | |||
|
[52] | |||
| Calibration | Calibration work |
|
[31] | |
|
| ||||
| Service availability | Availability of support/alternative devices | Availability of backup device or outsource services |
|
[2, 29] |
|
[32, 34] | |||
|
[52] | |||
| Impact of operation | Operational impact |
|
[29] | |
| Incident history | Incident record |
|
[54] | |
| No. of bed | Total bed | Management system | [55] | |
| Distance to nearest hospital | Measured distance | Management system | [55] | |
| Location | Device location |
|
[31, 35, 36], | |
| Management system | [60] | |||
|
| ||||
| Cost | Maintenance cost | Cost for spare parts and maintenance |
|
[12, 42] |
| Recall and hazards | Recall and hazards | Product recall and hazards |
|
[44, 45, 47, 52] |
|
[12] | |||
| Risk and safety | Risk and safety are associated with devices |
|
[12] | |
|
[45, 47–49] | |||
|
[37] | |||
|
[38] | |||
| Detectability | Ability to detect failures |
|
[37] | |
|
| ||||
| Utilization | Staff preferences | Staff preferences |
|
[42] |
| Utilization coefficient/rate | Average total hours device is used |
|
[29] | |
|
[12] | |||
|
[45, 47–49, 52] | |||
|
[37] | |||
PM: Preventive Maintenance.