RESUMO
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.
Assuntos
Hospitais , Próteses e Implantes , HumanosRESUMO
OBJECTIVES: Self-administration consists in the administration of medications by the patient himself during his hospitalization. The order of October 10, 2022 (Arrêté du 10 octobre 2022 modifiant l'arrêté du 6 avril 2011) modified the April 6, 2011 regulation to allow and regulate self-administration practices in hospital units. This evolution opens new perspectives for patient autonomy. The objective of this study is, firstly, to evaluate the rate of medication errors from patients under self-administration and secondly, to evaluate the satisfaction of patients and caregivers. MATERIAL AND METHODS: Eligible patients were recruited from a locomotor and polyvalent rehabilitation unit. After verification of eligibility, explanation given to the patient about the hospital self-administration of medication procedure and signature of the compliance agreement, patients started self-administration. Medication errors were reported during seven days. Evaluations of patient and staff satisfaction were also carried out. RESULTS: Of the 83 patients admitted to the care service, 32 were able to experiment self-administered medication procedure during their hospitalization. To assess the safety of this practice, 1235 drug intakes were analyzed. Ninety-four administration errors were noted: 98% of them concerned analgesic drugs. All of these errors were omissions and none of them were rated as serious. The 20 patients questioned were all satisfied with self-administration. The 14 carers interviewed were satisfied with this change in practice. CONCLUSION: The medication self-administration process set up in the rehabilitation unit did not lead to serious medication errors. Patients and caregivers reported being satisfied with this new hospital practice.