医療機器設計管理の重要性

医薬品において、回収の原因のほとんどが製造所の問題である。
一方で医療機器の場合、たとえ製造所で適切に製造したとしてもそもそも設計が間違っていては安全な医療機器にはならない。
したがって医療機器の設計管理は非常に重要である。

FDAは1980年代から医療機器の設計管理について厳密な管理を求めてきた、設計管理手順書を完全に文書化することを求めている。

1985年から1987年にかけて、Therac-25と呼ばれる放射線治療装置のソフトウェアのバグにより米国内で6名もの死亡者を出した事故が発生した。
当初は機器の故障であると思われていたが、調査するうちにソフトウェアの問題であることが判明した。
当該医療機器企業が付焼刃的な調査しか行わなかったため3年間にわたり多くの犠牲者を出してしまった経緯がある。
この事故は世界10大ソフトウェア事故の一つに数えられている。

そもそも医療機器の事故は「ユーザの意図した利用」と「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。
したがって要求仕様を適切かつ詳細に文書化することが極めて重要である。

例えば手術を行う際にメスがなかったとしよう、そのため近所の最高級刃物店で最高品質のナイフを買ってきた。
しかしながら例え最高級ナイフであったとしても手術といった「ユーザの意図した利用」には適さないことは自明である。
これでは事故が起きてしまう。

また当該医療機器の設計がユーザ要求を完全に満たしたとしよう。
しかしながら、そもそもユーザ要求が間違っていることもあるのである。
そこで医療機器における設計管理に関する規制要件や国際規格（ISO-13485）では、設計バリデーションの実施を要求している。
設計バリデーションでは、量産初期ロットを使用して、ユーザ環境またはユーザ環境を模擬した環境でユーザまたは同等者がテストを実施しなければならない。

多くの場合、ユーザの要求には安全性に関するものが含まれていない。
そのため要求仕様書にはリスク分析の結果やユーザビリティの報告が引用されていなければならない。

最新の国際規格では、予見できるユーザの誤使用も製造メーカの責任となった。
そのためユーザビリティに関しては特段の注意を払う必要がある。
例えば、駅のコンコースで雑踏の中で取説も読まずに初めて使用するAED、救急車の中で使用する心電図計、家庭で子供が使用する注射器など「誰が」「どのような場で」「そのように使用するか」は重要である。

ユーザビリティというと使いやすさを想像するがそうではない、使いにくくすることもユーザビリティである。
例えば、最近の使い捨てライターはノックが重く火がつけにくい。
これは子供がいたずらで火事を起こさないための方策である。これもユーザビリティに含まれる。

規制要件や国際規格はいわば先人の轍を踏まないためにあるといえる。
規制要件や国際規格を遵守しなければ安全な医療機器は設計製造することができない、けっしてないがしろにしてはならないのである。

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