The Establishment and the Operation of the Evaluation System for Highly Difficult New Medical Technologies at University of Tsukuba Hospital
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- WADA Tetsuro
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- TAKAHASHI Shinji
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- GOBO Kenta
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- HAMANAKA Hiroyuki
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- IKEDA Masae
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- YASAKI Junko
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- SHIMADA Saori
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- YAMAGUCHI Takeshi
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- TAJIRI Kazuko
- Quality Assurance and Risk Management, University of Tsukuba Hospital
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- HOMMA Satoshi
- Quality Assurance and Risk Management, University of Tsukuba Hospital
Bibliographic Information
- Other Title
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- 筑波大学附属病院における高難度新規医療技術等評価院内制度の創設と運用状況
- ツクバ ダイガク フゾク ビョウイン ニ オケル コウナンド シンキ イリョウ ギジュツ トウ ヒョウカ インナイ セイド ノ ソウセツ ト ウンヨウ ジョウキョウ
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Description
Objectives: The 2016 amendment of the Medical Law Enforcement Regulations requires special functioning hospitals to create and implement regulations regarding the provision of highly difficult new medical technologies. However, detailed reports on such evaluation systems have not been published. In 2015, the University of Tsukuba Hospital launched a medical technology evaluation system. Here, we retrospectively examined the effectiveness of the system’s design and operational performance. Methods: The evaluation committee consisted of four units, each charged with holding its meetings on a weekday suitable for the unit’s members. The evaluation process comprised two steps: evaluation (1) of the new technology and (2) of individual applications for its use. Each department submitted reports of the first five cases in which it performed a new technology. If the Department for Patient Safety noted any adverse effects, it judged whether to continue with the technology. We retrospectively examined the following items: number of applications, time required for review, evaluation of degree of technical difficulty, classification of adverse event level, and decision on continuing with the technology. Results: From May 2015 to August 2019, 70 of 78 technology applications and 246 individual applications have been approved. The median times from technology evaluation application to committee meeting, from committee meeting to approval of the technology, and from individual application to approval of the application were 12, 4, and 4 days, respectively. Level 3b or higher adverse events occurred in 12 cases; in two of those, the Department for Patient Safety requested the evaluation committee’s reexamination of the technology. Conclusions: The unit system was applied to reduce the burden on evaluation committee members and to ensure prompt holding of committee meetings, and the 2-step evaluation system, to ensure both sufficient discussion time and prompt evaluation. To date, 32 technologies have been integrated into the University of Tsukuba Hospital’s care delivery process.
Journal
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- The Japanese Journal of Quality and Safety in Healthcare
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The Japanese Journal of Quality and Safety in Healthcare 15 (3), 227-233, 2020
The Japanese Society for Quality and Safety in Healthcare
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Details 詳細情報について
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- CRID
- 1390854717750462720
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- NII Article ID
- 40022329665
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- NII Book ID
- AA12222118
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- ISSN
- 18823254
- 18813658
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- NDL BIB ID
- 030602707
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- Text Lang
- ja
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- Data Source
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- JaLC
- NDL
- CiNii Articles
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- Abstract License Flag
- Disallowed