The Establishment and the Operation of the Evaluation System for Highly Difficult New Medical Technologies at University of Tsukuba Hospital

  • WADA Tetsuro
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • TAKAHASHI Shinji
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • GOBO Kenta
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • HAMANAKA Hiroyuki
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • IKEDA Masae
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • YASAKI Junko
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • SHIMADA Saori
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • YAMAGUCHI Takeshi
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • TAJIRI Kazuko
    Quality Assurance and Risk Management, University of Tsukuba Hospital
  • HOMMA Satoshi
    Quality Assurance and Risk Management, University of Tsukuba Hospital

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Other Title
  • 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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Abstract

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.

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