誤使用とユースエラーは異なる

誤使用とユースエラーは異なる

ISOとIECの共通ガイドである「ISO/IEC Guide 51:2014 “Safety aspects - Guidelines for their inclusion in standards”」は、安全規格を策定する際の基準となるガイドラインである。
このガイドに安全の定義である「安全=受容できないリスクがないこと」が定められている。
ISO/IEC Guide 51では、設計者等が想定した使用法(intended use)のみならず、”合理的に予見可能な誤使用”(reasonably foreseeable misuse)も含んだ範囲でリスクを評価し、受け入れ可能なレベルに達するまで、リスク低減を行う反復プロセスを図示している。
ここで「合理的に予見可能な誤使用」をリスクアセスメントの範囲とすることを明記したことが極めて重要である。(その際、使用者の属性を特定する。)
ISO-14971:2019においても、「合理的に予見可能な誤使用」が用語の定義に加わった。

誤使用・不注意事故とヒューマンエラー

注意しなければならないことは、“受容可能なリスクはダイナミックに変化する”ということである。
その理由は以下による。
1.社会通念の変化 (社会環境の変化)
2.製品の歴史
3.使用者の属性
医療機器を上市した後、時間と共に社会通念が変化し、また新たなハザードが発見される。
例えば、米国で少女が猫をリンスした後に寒かろうと思い、電子レンジに入れたという話をご存じだと思う。電子レンジの製造業者はまさか生物を電子レンジに入れるとは想定していなかったのである。
一度、こういった“誤使用”が発生すれば、製造業者は再発防止のために何らかの措置を求められるのである。

「誤使用・不注意」事故の防止は喫緊の課題

「誤使用・不注意」の背景にはヒューマンエラーが存在する。
ヒューマンエラーは一定の確率で必ず発生するものである。
医療機器以外でも、ヒューマンエラーの例としては下記が有名であろう。

  • 航空機事故:
    JL 123便(修理ミス)、テネリフェの地上衝突(思い込み)、エアバスの着陸失敗(自動化の問題)、アロハ航空(点検ミス)
  • 医療事故:
    異型輸血、患者取り違え、薬品取り違え、左右側誤り
  • 個人のエラー:
    株式大量誤発注 (610、000株@1円 と 1株@610、000円、million = 100万 と billion = 10億)
    他社の損失回避コンピュータシステムが暴落に拍車

使用エラーと誤使用は異なる。

医療機器の使用には大きく分けて「正常使用」と「異常使用」がある。(下図参照)
「使用エラー」(Use Error)は「正常使用」に含まれることに注意が必要である。

ここで間違ってはならないことは、使用エラーは必ずしもヒューマンエラーではないことである。
「使用エラー」とは、製造業者が意図するまたは使用者が予期する医療機器の動きと異なる結果を招く行為または行為の省略のことである。
これには、ユーザーがタスクを完了できないことが含まれる。
例えば、老人、子供、妊産婦などが正常使用しようと試みても力が足りずに正常に使用できないケースがある。
また、盲目や色弱である場合などラベルなどの表示を読めない場合も同様である。
つまり、ユーザーの身体的、精神的能力等により、複雑な操作を完遂できないことも「使用エラー」の一つとなるのである。

「使用エラー」は、ユーザー、ユーザインタフェース、タスク、または使用環境の特性の不一致に起因する可能性があり、ユーザビリティエンジニアリングにおいては十分に検証が必要である。
しかも、ユーザーは「使用エラー」が発生したことを認識しない場合がある。
なお、医療機器の誤動作は「使用エラー」ではない。

下図を見てわかるとおり「合理的に予見可能な誤使用(reasonably foreseeable misuse)」には、「使用エラー(use error)」と「異常使用(Abnormal Use)」が含まれる。
つまり「使用エラー」は「誤使用」に包含され「異常使用」を除いたものである。
IEC 62366においては「合理的に予見可能な誤使用」のうち「使用エラー」のみにフォーカスしている。「異常使用」については対象とはしていない。

つまり、ISO 14971とIEC 62366では、適用範囲が異なることにも注意が必要である。
図に示した通り、ISO 14971の適用範囲は水色の四角部分である。
一方で、IEC 62366の適用範囲はオレンジ色で示した四角部分である。

https://www.youtube.com/watch?v=5NaK_4qjMU4&feature=youtu.be

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-154.html” title=”【JIS T 62366-1:2022対応】ユーザビリティエンジニアリング規程・手順書・様式”]

[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]

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