A Structured Approach for Investigating the Causes of Medical Device Adverse Events
Table 3
A structured approach for investigating causes of incidents involving medical devices.
(a)
Device
Operator
Infrastructure
Design (i) Technical design
Ergonomics (i) Human factors design Instructions for use (i) Incorrect—faulty (ii) Lack of clarity
Manufacture (i) Faulty manufacture
Device failure (i) Alarm (ii) Device failure (iii) Software failure (iv) Battery (v) Component failure (mechanical, electrical, subassembly) (vi) Wear and tear (vii) Chemical damage (viii) Biocompatibility
System failure (i) Incompatibility between devices (ii) Communication failure between devices
IT-medical device (i) Malware attack (ii) Data protection compromised
User error (i) Misuse by operator (user failure to operate correctly)
Setting up (i) Inappropriate choice of device (ii) Device assembly (iii) Control setting (iv) Alarm setting (v) Preuse checks not carried out
Training from perspective of person providing care (i) Lack of education/training (ii) Knowledge
Procedures (i) Failure to follow protocol (ii) Charting, recording (iii) Communication
User maintenance (i) Failure to clean (ii) Failure to carry out operator maintenance (iii) Distraction/diverted attention (iv) Fatigue
Procurement and commissioning (i) Procurement of inappropriate devices (ii) Commissioning failure (iii) Lack of training on new device(s) (iv) Lack of communication about new device(s) (v) Delayed commissioning (vi) Installation, including mounting, inappropriate, or faulty
Environmental ergonomics (i) Poor ergonomic mounting or layout
Utilities (i) Medical gas (ii) Vacuum (iii) Water, including specialised water for dialysis machines (iv) Mains electrical supply
Devices unavailable (i) Lack (housekeeping, inadequate supply, lost, stolen) (ii) Appropriate devices not available (iii) Maintenance delays (iv) Existing devices no longer appropriate (v) Procurement installation (lack, delays)
Environmental interference (i) Electromagnetic or radiofrequency interference (mobile phone) (ii) Ambient noise
Accessory and Consumable (i) Accessory (ii) Device Consumable
Communicate and concentrate (i) Communicate (ii) Distraction/Diverted attention (iii) Fatigue
Criminal intent (i) Deliberate wilful misuse (ii) Malicious misuse
Operating procedures (design and information content of the procedure is faulty) (i) Procedure fault
Layout and mounting (i) Ergonomics (ii) Strength and robustness
Maintenance (i) Acquisition (ii) Configuration (iii) Inadequate storage (iv) Faulty maintenance (v) Decontamination and cleaning (vi) Failure to upgrade software and/or hardware
Network (i) Network failure
(b)
Tampering
Clinical and patient factors
Unknown
No problem found
(i) Patient (ii) Patient on other patients (iii) Visitor (iv) Other
Where interactions between device and patient (including patient’s pathology/physiology) contributed to the event
Causes why a conclusion could not be reached: (i) Limited data (ii) No investigation
An incident was reported, but investigation revealed no incident had occurred or no fault was found: (i) No incident (ii) No fault found