RESUMO
BACKGROUND: Health care is shifting toward minimally invasive procedures requiring increasingly complex instruments and sophisticated processing technologies. Effective training methods are needed to ensure sterile processing professionals acquire and retain essential skills. This study aimed to develop and evaluate a new training model that supports mastery and retention of complex key skills. METHODS: The model was pilot-tested with training focused on visual inspection of endoscopes. Pre- and post-training tests were administered to enhance learning during a face-to-face workshop that interspersed lectures and hands-on practice, followed by structured homework, and an online booster session. Surveys assessed satisfaction and confidence levels. RESULTS: Mean test scores for nine certified sterile processing employees increased significantly following the workshop (41% vs 84%, P < .001). After the workshop, all trainees identified actionable visible defects on patient-ready endoscopes in their facilities. Test scores remained high after 2 months (90%), and trainees reported higher technical confidence and satisfaction levels after training. CONCLUSIONS: This study demonstrated effectiveness and clinical relevance of a new, evidence-based model for training sterile processing professionals that incorporated pretesting, lectures, hands-on practice, a training booster, and post-testing to enhance learning. This model may be applicable to other complex skills necessary for infection prevention and patient safety.
Assuntos
Competência Clínica , Relevância Clínica , Humanos , Projetos Piloto , Inquéritos e QuestionáriosRESUMO
Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to apply the Quality by Design (QbD) framework to enhance rapid-response RNA vaccine manufacturing against known and future viral pathogens. This QbD framework aims to support the development and consistent production of safe and efficacious RNA vaccines, integrating a novel qualitative methodology and a quantitative bioprocess model. The qualitative methodology identifies and assesses the direction, magnitude and shape of the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). The mechanistic bioprocess model quantifies and maps the effect of four CPPs on the CQA of effective yield of RNA drug substance. Consequently, the first design space of an RNA vaccine synthesis bioreactor is obtained. The cost-yield optimization together with the probabilistic design space contribute towards automation of rapid-response, high-quality RNA vaccine production.