誤使用と使用エラー
ISO/IEC Guide 51: 2014 “Safety aspects - Guidelines for their inclusion in standards”において、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。
つまり「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。(図参照)
医療機器の設計において、リスクマネジメントとユーザビリティエンジニアリングは必須である。
リスクマネジメント(ISO-14971)やユーザビリティエンジニアリング(IEC-62366-1)の適用範囲は、「合理的に予見可能な使用」に限定される。(図の水色の領域)
「合理的に予見可能な使用」には、「合理的に予見可能な誤使用」も含まれている。
さらに「合理的に予見可能な誤使用」には、「使用エラー」(Use Error)と「異常使用」(Misuse)に区別されている。つまり使用エラーは誤使用に含まれている。
ISO-14971においては、「異常使用」を含めた「合理的に予見可能な誤使用」を検討することが要求されている。
一方において、IEC-62366-1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」のみを対象としている。(図のオレンジ色の領域)
その理由は、「異常使用」はユーザビリティエンジニアリングでは制御することができないためである。
ISO-14971においては、「異常使用」を含めた「合理的に予見可能な誤使用」を検討することが要求されている。
一方において、IEC-62366-1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」のみを対象としている。(図のオレンジ色の領域)
その理由は、「異常使用」はユーザビリティエンジニアリングでは制御することができないためである。
使用エラーとは
ユーザビリティエンジニアリングには「使いやすさ」、「ユーザの満足度」および「見栄え」も含めているが、医療機器設計開発で求められているのは「使用エラー」のない「安全」な医療機器である。
「使用エラー」とは、製造業者が意図したことまたはユーザが予想したことと異なる結果を引き起こす、医療機器の使用法中のユーザの行為またはユーザの行為の欠如のことである。
・「使用エラー」は、通常使用で生じることがある。
・「使用エラー」には、ユーザがタスクを完遂できないことが含まれる。
つまり、ユーザは取扱説明書等に従って、医療機器を操作しているのではあるが、
・身体的能力により(例:体力がない)操作が完遂出来ない。
・字が読めない。
・ボタンが識別できない。
などに拠る。
つまり、「使用エラー」と「ヒューマンエラー」を混同すべきではない。
「使用エラー」はヒューマンエラーとは限らないのである。例えば、使用者の属性(例:子供)によっては、正しく使用しようと思っても、力不足や字が読めない、理解ができないなどの理由によって使用できないこともあるのである。
Guide 51によれば、「合理的に予見可能な誤使用」を検討する際に使用者の属性を特定することが要求されている。
身体障害者、色弱、老人、子供、女性(妊産婦)、外国人(言語が異なる)などである。
それぞれユーザがタスクを完遂する能力が問題となる。
また「使用エラー」は医療機器のインターフェースのまずさから発生することもある。分かりにくい、紛らわしい、識別しにくい、間違いやすいなどのインターフェースによって「使用エラー」が発生する。
つまり、ユーザビリティエンジニアリングにおいては、通常の使用において発生する「使用エラー」に注目するのである。
そのため、ユーザビリティエンジニアリングでは、インターフェースに注目してリスクマネジメントを実施することとなる。
インターフェースは、LCD(液晶ディスプレイ)のみではなく、人間の視覚、聴覚、触覚などによって認識されるすべてのものが含まれる。
例えば、取扱説明書、ラベル、ボタン、形状、色、アラーム音などである。
医療機器の事故は「ユーザの意図した利用」と「機器設計者の設計思想」とのギャップによって発生するといわれている。
インターフェースを如何に直感的で分かりやすく間違いのないものとするかは、機器設計者がどれだけ機器の使用され方を理解しているかにかかっている。
さらに詳細に理解されたい方は当社のユーザビリティエンジニアリングセミナービデオをご購入されたい。
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