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