医療機器に関連する有害事象の評価 医療機器に関する有害事象の評価
Sasikasri Veeramani1, Sri Ram Murugesh1, Girish A M1
1Department of Pharmacy Practice, JSS College of Pharmacy, Mysuru, Karnataka, India.
The Indian journal of medical research
|August 29, 2025
まとめ
併発症や多用薬症のリスクが増加する呼吸器疾患の患者では,医療機器の有害事象 (MDAE) が一般的です. これらの患者の早期モニタリングは,より良い患者ケアと結果のために不可欠です.
科学分野:
- 医療機器
- 患者の安全
- 呼吸器のケア
背景:
- 医療機器 (MD) は重症治療において不可欠ですが,有害事象を引き起こす可能性があります.
- 呼吸器系患者のMD関連の有害事象 (MDAE) の評価は,安全性の向上に不可欠です.
研究 の 目的:
- 呼吸器障害のある人のMDAEのパターンを評価する.
- MDに関連する有害事象に関連した予測要因を特定する.
主な方法:
- ICUで1年間に渡って横断的な研究が行われました.
- MDAEはインタビュー,症例レビュー,医療従事者との交流を通じて毎日モニタリングされました.
- MDAEの因果関係,重症度,および処置は,インドのMateriovigilanceプログラムを使用して評価されました.
主要な成果:
- 90人の患者で152件のMDAEが報告され,その22. 2%が61~70歳のグループで発生した.
- 呼吸器関連肺炎 (VAP) は,機械呼吸器使用者の間で一般的であった (38. 8%).
- 併発症と多用薬はMDAEの有意な予測因子であった (P=0. 04).
結論:
- 呼吸器疾患患者のMDAEは予後と治療結果に悪影響を及ぼします.
- 併発症や多用薬症の患者はMDAEのリスクが高くなります.
- これらの高リスクの個体におけるMDAEの強化されたモニタリングは,有害な影響を軽減するために推奨されます.
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