Background: Since the law regulating medical devices was introduced, hospital 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 changeover to innovative barrier textiles has turned out to be more difficult than expected. There is uncertainty among the qualified staff regarding the choice of material because of a lack of legal standardization. The objective of our study was to uncover the existing discrepancies between clinical practice 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 questionnaires, which were sent out to basic care and maximum care hospitals.
Results: According to the currently published data, barrier textiles best fulfill the requirement criteria. In contrast, the hospital staff questioned in our situation analysis noticeably preferred cotton textiles for the surgical gowns. The most common reason given was comfort. The laminates were considered most suitable as coverage material. Forty-four percent of those responding to the survey proved to have large gaps in their knowledge of the law regulating medical devices. Furthermore, only 41% of the hospital personnel were aware of the plan to standardize the requirement criteria.
Conclusion: We were able to confirm that there is considerable discrepancy between the requirements and practice. The reasons for this are ignorance and lack of enforcement of the existing requirements. In this respect we stress that a quick introduction of the planned European standards is urgently necessary.