Treatments of Medical Devices

Treatments of Medical Devices


Introduction: The process of sterilization is a complex and invasive procedure performed with insufficiently sterilized Medical Devices (MDs) that have the potential risk to transmit infection.

Therefore, it was crucial to discover sterilization problems and report Adverse Events (AEs) related to the treatment of MDs. The objective of the present study was to analyze a case of AEs related to the treatment of MDs according to the Association of Litigation and Risk Management (ALARM) Method.

Methods: The study was carried out at Sahloul University Hospital (Tunisia). We studied all AEs related to the treatment of MDs over three years (June 2018 to June 2021).

Data were collected using the AEs reporting form, by service quality referents, and medical and paramedical health professionals. Unacceptable AE was analyzed using the ALARM method.

Results: Only one AE was unacceptable risk having a criticality of 10: It occurred during the disinfection step where the battery of a medical device was not removed in the operating room.

These AEs were related to insufficient control before steam sterilization in both the operating room and the central sterilization unit.

It was an unacceptable risk that was analyzed according to the ALARM method: Personal factors (training), teams and organizational factors (Intra and inter-unit communication), and task factors contributed to this AE. We implemented corrective measures and they’re followed up in both the central sterilization unit and operating rooms.

Conclusion: It was the first study describing reported AEs related to the treatment of MDs by reporting systems in our hospital.

Underreporting of AEs and feedback were the main limitations of this reporting system. The notification of incidents must take place with the support of trained and convinced operating room personnel.



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