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基于紫外线染料的洗手和消毒资质认定程序的开发与实施,以提高药房制剂和调配的质量保证,特别是在洁净室:一项试点研究。

Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study.

作者信息

Knol Catharina W J, Stob Paul H, Woerdenbag Herman J

机构信息

Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.

Fagron Sterile Services Nederland, Dieselstraat 3, 7903 AR Hoogeveen, The Netherlands.

出版信息

Pharmacy (Basel). 2024 Apr 25;12(3):73. doi: 10.3390/pharmacy12030073.

DOI:10.3390/pharmacy12030073
PMID:38804465
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11130823/
Abstract

Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations.

摘要

尽管如今大多数药品是工业化生产的,但患者可能有一些医疗需求只能通过定制方法来满足。这就需要有按照良好生产规范(GMP)条件制备的药房制剂。高效的手部卫生操作在此至关重要,特别是涉及在洁净室内制备的无菌产品时。洗手和手部消毒程序的有效性很大程度上依赖于充分的培训。我们开展了一项观察性横断面试点研究,旨在使用紫外线(UV)染料通过客观且可测量的质量评估来优化手部卫生培训。设定并评估了通过这种方法使人员合格的实际验收标准。共有25名具备GMP资质的洁净室操作人员分别使用含UV染料的洗手液和含UV染料的手部酒精进行洗手和手部消毒。为了获得概念验证,根据对世界卫生组织六步规程及相关验收标准的遵守情况来评判结果。找出了常见的遗漏部位,并研究了操作持续时间的影响。基于UV染料的评估在手部消毒方面似乎比在洗手方面更有价值。在这两种操作中,手背和拇指经常被遗漏。这突出了加强和重复洗手及消毒教育的必要性。此外,皮肤干燥带来了额外的清洁挑战。从这项以药品护理为重点的药房实践试点研究可以得出结论,基于UV染料的评估应用为药剂师优化手部卫生提供了有价值的见解,从而提高了定制药品和现场制剂的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/74fa39aaf0ee/pharmacy-12-00073-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/c606b3bcb5c4/pharmacy-12-00073-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/775e2331749b/pharmacy-12-00073-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/e157f7e5daef/pharmacy-12-00073-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/7c2368dd8122/pharmacy-12-00073-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/3bea5973e2c5/pharmacy-12-00073-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/e8f701c9e148/pharmacy-12-00073-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/7d4fd431a827/pharmacy-12-00073-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/74fa39aaf0ee/pharmacy-12-00073-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/c606b3bcb5c4/pharmacy-12-00073-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/775e2331749b/pharmacy-12-00073-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/e157f7e5daef/pharmacy-12-00073-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/7c2368dd8122/pharmacy-12-00073-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/3bea5973e2c5/pharmacy-12-00073-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/e8f701c9e148/pharmacy-12-00073-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/7d4fd431a827/pharmacy-12-00073-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ea/11130823/74fa39aaf0ee/pharmacy-12-00073-g008.jpg

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