World J Surg Surg Res | Volume 5, Issue 1 | Research Article | Open Access

Case Analysis of an Adverse Event Related to Treatments of Medical Devices According to ALARM Method

Asma Ben Cheikh1,2, Hela Ghali1,2, Emna Mziou1*, Sana Bhiri1,2, Mariem Ghribi3, Nihel Haddad1, Saloua Trabelsi3, Selwa Khefacha1, Mohamed Ben Rejeb1,2 and Houyem Said Latiri1,2

1Department of Prevention and Security of Care, Sahloul University Hospital, Tunisia
2Department of Medicine, University of Sousse, Tunisia
3Department of Family Medicine, Faculty of Medicine of Sousse, Tunisia

*Correspondance to: Emna Mziou 

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Introduction: The process of sterilization is complex and invasive procedures performed with insufficiently sterilized Medical Devices (MDs) have the potential risk to transmit infection. Therefore, it was crucial to discover sterilization problems and reporting Adverse Events (AEs) related to treatment of MDs. The objective of the present study was to analyze a case of AEs related to treatment of MDs according to Association of Litigation and Risk Management (ALARM) Method. Methods: The study was carried out in 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, medical and paramedical health professionals. Unacceptable AE was analyzed using ALARM method. Results: Only one AE was unacceptable risk having a criticality of 10: It occurred during the predisinfection step where the battery of a medical device was not removed in the operating room. These AEs was related to insufficient control before steam sterilization in both the operating room and the central sterilization unit. It was an unacceptable risk was analyzed according to ALARM method: Personal factors (training), teams and organizational factors (intra and inter unit communication) and task factors were contributed to this AE. We implemented corrective measures and their follow up in both central sterilization unit and operating rooms. Conclusion: It was the first study describing reported AEs related to treatment of MDs by reporting system 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 rooms personnel. 


Sterilization; Medical device; Adverse event; ALARM method


Cheikh AB, Ghali H, Mziou E, Bhiri S, Ghribi M, Haddad N, et al. Case Analysis of an Adverse Event Related to Treatments of Medical Devices According to ALARM Method. World J Surg Surgical Res. 2022; 5: 1393..

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