A Structured Approach for Investigating the Causes of Medical Device Adverse Events
Table 2
ECRI classification of medical device incidents [7].
Device
User
External
Support system failures
Tampering or sabotage
(i) Design/labelling error (ii) Device failure (iii) Device interaction (iv) Failure of accessory (v) Improper maintenance/testing (vi) Improper modification (vii) Invalid device foundation (viii) Manufacturing error (ix) Packaging error (x) Random component failure
(i) Abuse of device (ii) Accidental misconnections (iii) Accidental spill (iv) Device misassembly (v) Failure to perform preuse inspections (vi) Failure to read label (vii) Improper connection (viii) Inappropriate reliance on an automated feature (ix) Incorrect clinical use (x) Incorrect control settings
(i) Electromagnetic or radiofrequency interference (ii) Environmental (temperature, humidity) (iii) Medical gas and vacuum supplies (iv) Power supply (including piped medical gas) (v) Water supply
(i) Error in hospital policy (ii) Failure to train and/or credential (iii) Improper storage (iv) Lack of competent accident investigation (v) Lack or failure of incoming and preuse (vi) Poor prepurchase evaluation (vii) Use of inappropriate devices
