| 特集名 | 透析機器の保守と修理 | |
|---|---|---|
| 題名 | 医療機器の「保守点検」および「修理」の今後のあり方 | |
| 発刊年月 | 1997年 04月 | |
| 著者 | 高柳 英夫 | 東レ株式会社医薬・医療部門 |
| 【 要旨 】 | 1．平成6年薬事法の改正により次のことが明確化された．(1) 修理業を新たに認める．(2) 医療機器業界は，保守点検に関する情報を医療機関側に提出すること．(3) 医療機関側は上記情報を受けて，保守点検を実施すること． 2．平成8年医療法の改正により次のことが明確化された．(1) 保守点検は，医療機関側の業務であり，自らが実施すべきこと．(2) 自らができないときは，外部に委託可能であること．(3) 修理業者は保守点検の受託が可能であること． 3．今後の在り方:医療機関側および医療機器業界側は，互いに行うべきことを行いつつ，互いに協調・融合し，安全性の向上，医療技術の発展，医療費抑制等に尽力し，社会的使命を達成すべきである． |
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| Theme | Maintenance and Repair of Dialysis Machines | |
|---|---|---|
| Title | Future trend concerning maintenance and repair services for medical devices in Japan | |
| Author | Hideo Takayanagi | Toray Industries, Inc. Pharmaceuticals and Medical Products Administration Dept |
| [ Summary ] | 1.According to the amendment of the Pharmaceutical Affairs Law in 1994, the following issues were clarified. 1) Repair licensing was authorized. 2) Medical industries should provide medical organizations with information for maintenance operations. 3) Medical organizations must execute maintenance operations in accordance with the above information. 2. According to the amendment of the Medical Law in 1996, the following issues were clarified. 1) Maintenance operations must be executed by the medical organization itself. 2) Maintenance operations can be executed by outside trust companies in the event that medical organization entrusts these tasks to such outside trust companies. 3) Authorized repair-licensing-companies can execute maintenance operations upon request by the medical organization. 3.Future trends in maintenance and repair services for medical devices in Japan. Both medical organizations and medical industry should execute necessary procedures for each task and should also cooperate and work together in order to meet the following goals. - Enhancement of safety - Development of medical technology - Pursuit of minimal medical treatment - Medical expense containment - Contribution to management |
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