医療機器学
Online ISSN : 1884-054X
Print ISSN : 1882-4978
ISSN-L : 1882-4978
88 巻, 1 号
選択された号の論文の12件中1~12を表示しています
原  著
  • 倉島 直樹, 大久保 淳, 瀬島 啓史, 小堺 昭, 佐藤 由利, 星野 春奈, 野田 明里
    2018 年 88 巻 1 号 p. 2-8
    発行日: 2018年
    公開日: 2018/03/27
    ジャーナル フリー

    Utilization of medical electronic equipment management system is essential to meet mandated rules for maintenance and inspection for medical electronic equipments. Also there are some study reports by using location and operation tracking system for more effective management of medical electronic equipments. Tokyo Medical and Dental University Hospital has also introduced location tracking system with active tags. then reported its efficiency. This time we did a field demonstration of location tracking accuracy of IV pump and syringe pump which are integrating wireless LAN function, then compared its accuracy against the active tag which is currently in use in the hospital. The result of comparison showed us no significant differences in location tracking accuracies. We see equivalency of location tracking accuracies which are derived from the wireless LAN and active tag. The above our findings suggest that usefulness of wireless LAN integrated medical electronic equipments which could improve effective management of medical electric equipments..

  • 渡邊 雅俊, 加藤 圭祐, 三澤 哲也
    2018 年 88 巻 1 号 p. 9-16
    発行日: 2018年
    公開日: 2018/03/27
    ジャーナル フリー

    To reduce the risk of medical accidents and litigation, it is required to perform management such that the built-in clocks of ME devices are always accurate. However, there are no laws and guidelines concerning time management of ME devices, and there is concern about the reliability and adequacy of medical manuals in our facility regarding this type of device.

    Therefore, in this study, we performed quantitative analysis with actual time error data using statistical analysis, clarified "to what extent time error is acceptable", and examined how time management should be performed from the viewpoint of a medical device safety management officer.

    Based on the analysis results, considering the balance between benefit and risk regarding medical safety, we propose that tolerance should be within ± 30 seconds per month, and that ME devices exceeding their period of endurance undergo intensive maintenance or equipment updates.

    Further, the effectiveness and safety of ME devices need to be evaluated by scientific risk analysis. The MDIC must collect evidence from both medical institutions and industries and perform safety risk management, and guidelines defining a standard tolerance range should be formulated by the medical industry.

  • 森 信洋, 関根 広介
    2018 年 88 巻 1 号 p. 17-21
    発行日: 2018年
    公開日: 2018/03/27
    ジャーナル フリー

    In order to ensure the safety of medical devices in the intensive care unit, it is necessary to undertake the inspections during use. Therefore, the purpose of this research is to develop and operate the inspection system during use of medical devices to improve medical safety.

    This was a retrospective, observational study conducted in a single hospital. The facility is a tertiary care hospital with a multidisciplinary closed14- bedded ICU. The Failure Mode and Effect Analysis (FMEA) method has been used to study, with period from May 1, 2016 to December 31, 2016. The number of failures in medical devices was 654. Display failures of medical ventilators, which classified as serious failure, have found by the inspections during use. Therefore, development and operation of this system may contribute to improve of medical safety.

特  集〈臨床工学技士制度の30年〉
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