Surgical gowns and drapes in the clinical practice: the discrepancies between requirements and reality

Background: Since the law regulating medical devices was introduced, hospit al staff can only use surgical textiles that can guarantee 100% protection against infection. Conventional cotton products have shown themselves to be unsuitable, and must be replaced with barrier textiles. However, the chang eover to innovative barrier textiles has turned out to be more difficult th an expected. There is uncertainty among the qualified staff regarding the c hoice of material because of a lack of legal standardization. The objective of our study was to uncover the existing discrepancies between clinical pr actice and the legal requirements. Methods: Based on a literature review we examined the suitability of the available surgical textiles with regard to the requirements. We then analyzed the situation based on standardized que stionnaires, which were sent out to basic care and maximum care hospitals. Results: According to the currently published data, barrier textiles best f ulfill the requirement criteria. In contrast, the hospital staff questioned in our situation analysis noticeably preferred cotton textiles for the sur gical gowns. The most common reason given was comfort. The laminates were c onsidered most suitable as coverage material. Forty-four percent of those r esponding to the survey proved to have large gaps in their knowledge of the law regulating medical devices. Furthermore, only 41% of the hospital pers onnel were aware of the plan to standardize the requirement criteria. Concl usion: We were able to confirm that there is considerable discrepancy betwe en the requirements and practice. The reasons for this are ignorance and la ck of enforcement of the existing requirements. In this respect we stress t hat a quick introduction of the planned European standards is urgently nece ssary.