Análise dos colchões hospitalares e superfícies de suporte aprovados pela Anvisa

Abstract

Pressure injury is a significant public health problem present at all levels of care and with repercussions in various areas. This condition is multifactorial and requires healthcare professionals to adopt several prevention measures, especially those aimed at reducing pressure on bony prominences. Among these measures is the use of support surfaces, which are specialized devices for pressure redistribution capable of managing tissue loads and microclimate. There are parameters that aid in the acquisition of a support surface, following guidelines established in resolutions RDC nº 546/2021 and RDC nº 751/2022.Objective: To analyze the hospital mattresses registered with the National Health Surveillance Agency (Anvisa) and their respective characteristics.Method: A descriptive study was conducted, and data collection took place through access to the website https://consultas.anvisa.gov.br/#/saude/ using the term "colchao hospitalar" (hospital mattress) in the "NOME TÉCNICO" (TECHNICAL NAME) field. Initially, 173 records for "colchão hospitalar" were identified. After applying inclusion and exclusion criteria, 32 records were selected, comprising a sample of 741 mattresses/support surfaces. The study did not undergo ethical review by a research committee as it did not involve human subjects.Results: 97.0% of the mattresses were classified as class I, and 98.92% were of low technology. The countries with the highest number of manufactured items were the Czech Republic (25%), France (22%), China (16%), and Brazil (13%). 54.12% of the mattresses were made of polyurethane foam, 22.00% of polyurethane foam + memory foam, and 20.38% memory foam. Regarding dimensions, lengths ranged from 80 to 220cm, widths from 40 to 137cm, and heights from 4 to 22cm. 64.78% had a laminar shape, and 39.41% were multilayered. 73.41% indicated pressure distribution as the product's purpose. The most frequent weight capacity was up to 400kg and was associated with polyurethane foam. Density ranged from 18 to 85kg/m3 in mattresses containing foam. Most mattresses had a PVC cover, with characteristics of air, fluid, and vapor impermeability. 58.70% had a closure system with sewing and concealed zipper. Warranty for mattresses and covers varied from 6 months to 5 years, and product validity/lifespan ranged from 1 to 10 years. Many product details were absent from the manual and usage instructions available on the Anvisa website.Conclusion: The large number of records for "colchao hospitalar" and the wide variety of models and items in the grouping known as families, kits, and systems make it challenging for healthcare professionals to find the most suitable support surface for the hospital setting, considering patients' profiles. There is a diversity of mattress compositions and manufacturing methods. Despite the predominance of polyurethane foam, it can still be found as the sole material or combined with air, memory foam, and gel. In addition to composition, there were cuts and layers arranged in different ways, making standardization for comparison difficult. On the other hand, consumers have more options for acquisition.