Monitoring incidents and accidents related to medical device reprocessing in Quebec, 2016-2017
The frequency of adverse events (incidents and accidents) related to medical device reprocessing (MDR) is a concern for health care services. By definition, an incident means that a medical device breaches a recognized standard for MDR without having been used on a patient. An accident refers to any use on a patient of a medical device which does not meet a recognized standard for MDR, with that use potentially affecting the patient’s health status (INSPQ, 2014).
This report describes the results of monitoring incidents and accidents related to MDR in Quebec between April 1, 2016 and March 31, 2017. Over this year, a total of 3,476 adverse events related to MDR were reported as of June 15, 2017. Of those, 2,933 (84%) were incidents and 543 (16%) were accidents, involving a total of 545 patients. Distribution of these events using the MSSS severity scale (Appendix 1) was:
- 19% (n = 660) were severity A incidents: circumstances or situations which might cause adverse events or affect the patient;
- 65% (n = 2,273) were severity B incidents: adverse events which occurred without affecting the patient;
- 14% (n = 488) were severity C accidents: events with no effect on the patient and not requiring any particular intervention;
- 1.5% (n = 53) were severity D accidents: events which required additional verifications (e.g., physical test or examination, modification of intervention plan, patient support) to assess the presence or onset of consequences;
- 1 event was a severity E1 accident: an event with minor, temporary consequences requiring unspecialized interventions and needing mandatory disclosure to the patient or relatives;
- 1 event was a severity E2 accident: an event with temporary consequences requiring care, services, interventions or specialized treatments;
- No severity F, G, H or I accidents were reported during 2016-2017.
The data analysis showed that two types of medical devices were involved in the majority of the adverse events, namely, the “MD kit” (involved in 60% of events), followed by “medical instruments” (27% of events).
A breach of the reprocessing chain was the main cause of 82% of events. More specifically, in incident cases, failures in assembly and packaging were the cause of nearly 60% of events, whereas in accident cases, failures in sterilization, assembly and cleaning caused nearly 60% of events.
In total, 12 accidents resulted in consequences for the patient, while 190 (6%) of incidents and 90 (17%) accidents produced consequences for the institution. Material or financial consequences were most commonly reported.
Lastly, several measures have been established to prevent recurrence of adverse events, including the recall of poorly reprocessed MDs, staff training, developing or updating procedures and policies, implementing a functional tracing system for the MD involved and assigning qualified staff.