IntroductionRisk prone events (RPE) related to orthopaedic devices may compromise the achievement and/or the result of a surgical procedure. Their analysis to prevent any further incidents is crucial for orthopaedic surgeons. The aim of this work, based on the analysis of targeted RPE declared to the ORTHORISQ organism over a year, is to analyse the circumstances of their occurrence and their causes.Materials and methodsFor each RPE analysis included the study of the circumstances of the event, the existence of protocols within the institution, and the conditions of recovery. The incidents were classified into three groups: non-available medical devices, non-sterile medical devices and non-functional medical devices.ResultsThe RPE related to medical devices accounted for 35% of all the declarations to Orthorisq (424 cases in 1500). The distribution in the three groups was respectively 55% for non-available medical devices, 29% for non-sterile medical devices 16% for non-functional medical devices. The event “non-available medical devices” concerned primarily casually loaned implantable devices (implants, prostheses). In 20% cases, the device was used occasionally in the institution. In 30% cases, the order was too late with a deadline less than 48 h. In 35% cases, there was no checking procedure of the implants in immediate pre-operative time and 17% of the institutions concerned seem not to have any procedure to deal with expired sterilisation.The event “non-sterile medical devices” mainly concerned cases of perforation of packaging paper and wet sterilisation containers. These events have resulted in recovery periods of about 82 min on average. In 58% cases, the transport containers are used as containers for sterilisation. The existence of a quality manager for the sterilisation department is reported only in 79% of cases. The ‘non-functional medical devices’ group is dominated by the preoperative breakage as well as compatibility problems between the ancillary available and the device to remove.DiscussionPerioperative issues with orthopaedic devices are frequent. They are mainly due to organisation or procedural planning problems, and malpractice is frequently involved. Those issues could be avoided with respect to existing protocols, for example, the use of a minimum deadline in ordering devices before the surgical procedure, checking protocol of ordered devices, and checking conformity of devices to the order. We did not find any link between the distance of sterilisation department to operating room and the occurrence of RPE, but we emphasise and remind that existing sterilisation procedures must be applied. Sterilisation of urgently needed devices is a recovery mode which can significantly increase the operative time, but with increased theoretical risk of infection.ConclusionFollowing this work, five preventive measures can be proposed. We recommend: to develop loan agreements between institutions, to respect minimum deadline order of ancillaries and devices to companies, to have double set of implantable...
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