[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

[Disconnection of arteriovenous fistula: standardize the coverage of the hemorragic risk]. / Débranchement de fistule artérioveineuse : rationaliser la prise en charge du risque hémorragique.

During the disconnection of the arteriovenous fistulas, the nursing staff manages a hemorrhagic risk function of various factors requiring the use of an adapted haemostatic treatment. In front of numerous available references, it seemed interesting to us to standardize the coverage of this risk within the service of hemodialysis. We realized an audit to analyze the practices of disconnections and estimate the context of use of the haemostatic agents. A review of the consumptions as well as a medical economic study were realized on the haemostatic agents used in dialysis. A revaluation of the practices after 6 months was programmed to validate the institution of the protocol. Fifty observed disconnections brought to light numerous critical points. A decision tree was established to direct the choice of the haemostatic method. The importance of the direct compression in first intention was reminded and data sheets were realized. Two absorbable bandages were deleted by the allocation and an alginate of class III was subjected to name specific prescription. The assessment in 6 months proves the support of the teams to this new protocol by the impact on the consumptions and the follow-up of the decision tree during the disconnections. This study allowed us to harmonize a common act and to put at the disposal of the nursing only bandage haemostatics indicated in the disconnection of the arteriovenous fistulas. The spread good use was a major axis of improvement of the practices as well as a help for the integration of the new procedure.