Introduction of Japanese Regulations for Reprocessing Single-Use Medical Devices

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  • TANISHIRO Hiroyuki
    独立行政法人医薬品医療機器総合機構 医療機器審査第三部

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Other Title
  • 再製造単回使用医療機器の本邦規制導入について
  • 医薬品・医療機器評価をめぐる最近の課題 再製造単回使用医療機器の本邦規制導入について
  • イヤクヒン ・ イリョウ キキ ヒョウカ オ メグル サイキン ノ カダイ サイセイゾウタンカイ シヨウ イリョウ キキ ノ ホンポウ キセイ ドウニュウ ニ ツイテ

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<p>Regulations regarding reprocessed single-use medical devices (R-SUDs) were introduced in Japan in July 2017. R-SUDs are single-use medical devices collected from hospitals by the manufacturer for reuse after cleaning, sterilization, and performance testing. Regulations for R-SUDs have been implemented in some foreign countries already, but the regulations in each country differ. The regulations for R-SUDs in the United States (US) were referred to when drafting the regulations in Japan. Specifically, in the early phase of drafting the regulations, the technical aspects of the US regulations for R-SUDs were investigated regarding the review of medical devices, and the essential requirements were used as guidelines for the Japanese R-SUD regulations. This article describes the perspective of the author, who participated in the planning and drafting of the regulations. The important requirements for reprocessing SUDs are the reverse engineering of the original medical devices and the cleaning and sterilization methods, which were found to be suitable guidelines for the R-SUD regulations in Japan. The manufacturers, users, and patients need to fully understand the principles of R-SUDs, and the author hopes this article helps those seeking to reprocess SUDs or use R-SUDs to implement and follow the R-SUD regulations in Japan reasonably and effectively.</p>

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