26/03/2026
๐ฆ๐๐ฎ๐๐ตยฎ ๐ถ๐ ๐ป๐ผ๐ โ๐ท๐๐๐ ๐ฎ ๐๐ถ๐ฝ๐ฒโ
Last year, an important question came into focus: what defines a Medical Device in daily care?
The Dutch Competent Authority (IGJ) reviewed the classification of Swashยฎ products under Regulation (EU) 2017/745 (MDR). ๐ง๐ต๐ฒ ๐ผ๐๐๐ฐ๐ผ๐บ๐ฒ ๐ฐ๐ผ๐ป๐ณ๐ถ๐ฟ๐บ๐ฒ๐ฑ ๐ฎ๐ป ๐ถ๐บ๐ฝ๐ผ๐ฟ๐๐ฎ๐ป๐ ๐ฝ๐ผ๐ถ๐ป๐: ๐๐ต๐ฒ ๐ฆ๐๐ฎ๐๐ตยฎ ๐ฝ๐ฟ๐ผ๐ฑ๐๐ฐ๐๐ ๐๐ป๐ฑ๐ฒ๐ฟ ๐ฟ๐ฒ๐๐ถ๐ฒ๐ ๐พ๐๐ฎ๐น๐ถ๐ณ๐ถ๐ฒ๐ฑ ๐ฎ๐ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ๐ within the meaning of Article 2 MDR, and the request for enforcement was rejected. One product, Swashยฎ Refreshing Wipes, did not meet the criteria for Medical Device classification and was therefore withdrawn from the market.
๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ ๐ฐ๐น๐ฎ๐๐๐ถ๐ณ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป ๐บ๐ฎ๐๐๐ฒ๐ฟ๐ ๐ฏ๐ฒ๐ฐ๐ฎ๐๐๐ฒ ๐ฑ๐ฎ๐ถ๐น๐ ๐ต๐๐ด๐ถ๐ฒ๐ป๐ฒ ๐ถ๐ป ๐ต๐ฒ๐ฎ๐น๐๐ต๐ฐ๐ฎ๐ฟ๐ฒ ๐ถ๐ ๐ป๐ผ๐ ๐ท๐๐๐ ๐ฎ ๐ฟ๐ผ๐๐๐ถ๐ป๐ฒ ๐๐ฎ๐๐ธ. ๐๐ ๐ถ๐ ๐ฎ ๐ฐ๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ถ๐ป๐๐ฒ๐ฟ๐๐ฒ๐ป๐๐ถ๐ผ๐ป ๐๐ถ๐๐ต ๐ฑ๐ถ๐ฟ๐ฒ๐ฐ๐ ๐ถ๐บ๐ฝ๐ฎ๐ฐ๐ ๐ผ๐ป ๐ฝ๐ฎ๐๐ถ๐ฒ๐ป๐ ๐๐ฎ๐ณ๐ฒ๐๐ [๐ฏ].
Over the course of this campaign, we have shown why:
โข Traditional bathing can compromise skin integrity and act as reservoirs for pathogens [1,2].
โข Daily hygiene in healthcare is not just a routine task, it is a clinical intervention with direct impact on patient safety [3].
โข Swashยฎ was developed as a Medical Device concept to support safe, daily care at the bedside.
Within this Medical Device framework, Swashยฎ brings together bathing, incontinence care and haircare in one integrated, person-bound, single-use concept designed to support infection prevention every day at the bedside.
This concept is supported by ๐ ๐๐ฅ ๐ฐ๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ, ๐๐ฆ๐ข ๐ญ๐ฏ๐ฐ๐ด๐ฑ-๐ฐ๐ฒ๐ฟ๐๐ถ๐ณ๐ถ๐ฒ๐ฑ ๐พ๐๐ฎ๐น๐ถ๐๐ ๐บ๐ฎ๐ป๐ฎ๐ด๐ฒ๐บ๐ฒ๐ป๐, ๐ฐ๐น๐ฒ๐ฎ๐ป-๐ฟ๐ผ๐ผ๐บ ๐ฝ๐ฟ๐ผ๐ฑ๐๐ฐ๐๐ถ๐ผ๐ป, ๐๐๐ฟ๐ถ๐ฐ๐ ๐บ๐ถ๐ฐ๐ฟ๐ผ๐ฏ๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ฎ๐น ๐ฐ๐ผ๐ป๐๐ฟ๐ผ๐น๐, ๐ฏ๐ฎ๐๐ฐ๐ต ๐ฟ๐ฒ๐น๐ฒ๐ฎ๐๐ฒ ๐๐ฒ๐๐๐ถ๐ป๐ด ๐ฎ๐ป๐ฑ ๐ฝ๐ผ๐๐-๐บ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐๐๐ฟ๐๐ฒ๐ถ๐น๐น๐ฎ๐ป๐ฐ๐ฒ.
Today, weโre re-sharing the original video that started this conversation. Because when products are used close to vulnerable patients, classification, quality systems and product control matter.
Swashยฎ MD products fully meet the ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ถ๐ผ๐ป (๐ ๐๐ฅ), ensuring safe, hygienic and high-quality solutions that improve patient safety.
๐ฆ๐๐ฎ๐๐ตยฎ ๐ถ๐ ๐ป๐ผ๐ โ๐ท๐๐๐ ๐ฎ ๐๐ถ๐ฝ๐ฒโ. ๐๐ ๐ถ๐ ๐ฎ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ.
๐๐ป๐ฑ ๐๐ต๐ฎ๐ ๐บ๐ฎ๐ธ๐ฒ๐ ๐ฎ๐น๐น ๐๐ต๐ฒ ๐ฑ๐ถ๐ณ๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ.
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SOURCES:
[1] Skewes, S. M. (1996). Skin care rituals that do more harm than good. American Journal of Nursing
[2] Johnson, D., Lineweaver, L., & Maze, L. M. (2009). Patientsโ bath basins as potential sources of infection: A multicenter sampling study. American Journal of Critical Care
[3] Vollman, K. M. / American Association of Critical-Care Nurses (AACN). Bathing the Adult Patient: Practice Alert (2013).