医療機器設計でFMEAを使用してはならない

医療機器の設計にFMEAは使用してはならない

筆者がコンサルテーションを担当するクライアント企業のうち、少なからず医療機器の設計において FMEA（Failure Mode Effective Analysis：故障モード影響解析）を使用しているケースが見受けられる。

FMEA（IEC-60812）は医療機器規制（本邦における基本要件基準、MDRにおける整合規格）では参照されていない。
FMEAの特徴は、リスクに検出可能性を掛け合わせていることである。これをリスク優先度（RPN：Risk Priority Number）と呼ぶ。

RPN（リスク優先度）＝危害の発生の確率×重大性×検出可能性

医療機器の設計においてFMEAは使用してはならない。正確には、医療機器の設計において、検出可能性を使用してはならないのである。リスク優先度は、患者、ユーザには無関係だからである。
医療機器のリスクマネジメントはISO 14971に従い、リスク（重大性×発生確率）を受容可能なまで低減しなければならない。つまり検出可能性に関係なく、医療機器設計においては、リスクコントロールが必要である。
FMEAは、工程設計において使用すれば良い。

医療機器の設計においてFMEAを使用してはならない根拠をいくつか挙げて説明しよう。

１．FMEAでは検出可能性を掛けている

FMEAの特徴は、危害の発生確率に重大性を掛けたものに、さらに検出可能性を掛けることにある。
ご案内の通り、危害の発生確率に重大性を掛けたものをリスクという。（リスクの定義）
リスクにさらに検出可能性を掛けものを「リスク優先度」（RPN：Risk Priority Number）と呼ぶ。
これは、一般に設計や製造において、コントロールすべきリスクの順位を求めるものである。
これにより、経済性を優先している。リスクによっては、コントロールによって低減することがコスト的に困難なものがあり得る。そのような場合でも、検出可能性が高いリスクの場合、欠陥の発生（ハザードへの暴露）が発見し易いため、優先順位を下げることを目的としている。
しかしながら、医療機器のリスクマネジメントにおいては、検出可能性は使用してはならず（正確には使用しても良いとはどこにも記載がない）、リスクが受容可能か不可かのみがリスクコントロール手段実施の判断となるのである。

例を示そう。重大性（S）、発生確率（P）、検出可能性（D）とする。
【ケース1】S：3、P：5、D：8の場合、RPN：120となる。
【ケース2】S：7、P：3、D：3の場合、RPN：63となる。
もし、自社の基準でRPNが100未満の場合、リスクコントロールが不要と定義しているとしよう。また受容可能範囲は、S×Pが20未満と定義しているとしよう。
この場合、ケース1（RPN：120）はリスクコントロールが必要で、ケース2（RPN：63）はリスクコントロールが不要となる。
しかしながら、ケース1ではS×P＝15であり受容可能である範囲である。一方でケース2ではS×P＝21なので受容不可である。
検出可能性を掛けることによってこういった逆転が生じてしまうのである。
医療機器設計においては、原則としてリスクは受容可能なまで低減しなければならないのである。

２．基本要件基準

医療機器基本要件基準の「第2条リスクマネジメント」について、当局は通知でJIS T 14971またはISO14971に準拠するよう求めている。
けっしてFMEA（IEC 60812）を使用しても良いとは記載がない。

３．ISO 14971:2007 付属書G

ISO 14971:2007の付属書G「リスクマネジメント手法に関する情報」においてはFMEAに関する記載があった。なお、ISO 14971：2019への改定後は、付属書Gは廃止され、ISO/TR 24971 付属書Bに移行された。

G.1 一般

この附属書は，4.3 のリスク分析に利用可能な幾つかの手法についての指針を与える。
（中略）
故障モード影響解析［Failure Mode and Effects Analysis: (FMEA)］及び故障モード影響重大度解析［Failure Mode, Effects and Criticality Analysis: (FMECA)］は，個々の構成要素の影響又は結果を体系的に特定するための手法であり，設計の完成度が高い段階で使うのに適している。

ここで注意が必要なのは、ISO 14971の規定するプロセスのうち4.3「リスク分析」に限って記載されていることである。
つまり4.4 リスク評価（発生確率×重大性）以降は引用されておらず、検出可能性を使用するとは記載されていない。
医療機器設計において、FMEAはリスク分析に関しては一部使用できる場合があるということである。
例えば、故障⇒故障モード⇒機能への影響といったリスクシナリオを検討することに役立つのである。

４．ISO/TR 24971:2020

ISO/TR 24971:2020においても、附属書B（参考）「リスク分析を支援する技法」としてFMEAが紹介されている。やはりリスク分析に限定されており、リスクマネジメントプロセスの一つにすぎない旨の記載がある。

リスク分析は，JIS T 14971:2020 のリスクマネジメントプロセスの一つの段階にすぎないことは強調しておきたい。
さらに，この附属書で説明する技法は，リスク分析の全ての要素について対応するものではなく，補足情報を提供するにすぎない。（中略）
－ 故障モード影響解析［Failure Mode and Effects Analysis（FMEA）］は，個々の構成要素の影響又は結果を体系的に特定するための技法であり，設計の完成度が高く，故障モードがよく理解されている場合により適している。
ここにおいてもFMEAはリスク分析に限って使用可能である旨の記載がある。リスク優先度を使用する旨の記載はされていない。

5．FMEAは工程設計において使用する

上述した通り、FMEAは経済性を優先したリスク分析手法である。企業は製造コストを下げる必要がある。
ISO/TR 24971:2020 附属書B（参考）「リスク分析を支援する技法」に以下の記載がある。

ISO/TR 24971:2020

B.5 故障モード影響解析（FMEA）
FMEA は，個々の故障モードの結果を体系的に特定し評価する技法である。これは“もし…ならば，何が起こるか”という質問を用いた帰納的技法である。構成要素は，一度に一つずつ分析され，一般的に単一故障状態まで検討される。これは，“ボトムアップ”方式で行われる。つまり，手順を進めることで一段ずつ高い機能システムレベルに上がっていく。
FMEA は構成要素の設計における故障に限定せず，構成要素の製造及び組立における故障（プロセスFMEA），及びエンドユーザーによる製品の使用又は誤使用における故障（使用FMEA）を含めることも可能である。
FMEA を拡大し，個々のコンポーネント故障モードの調査結果，それらの発生確率及び検出可能性（JIS T 14971:2020 においては検出によって予防手段が可能となる程度に限る。），及び結果の重大さの程度を統合することが可能である。FMEA を行うには，医療機器の構造をある程度詳細に知ることが必要である。
この技法の弱点は，冗長性の取扱いが困難な場合があること，修理又は予防的保守活動の取込みが困難な場合があること及び単一故障状態に限定されることである。
FMEA の詳細な手順については，IEC 60812 [10]を参照する。

「検出可能性（JIS T 14971:2020 においては検出によって予防手段が可能となる程度に限る。）」とあるように、製造工程などで製品の品質に欠陥が生じた場合、検出可能性が患者やユーザの危害の発生に対して予防手段（未然防止）につながる場合は、検出可能性を使用しても良いとの記載が付け加えられた。
工程設計（製造）においては、FMEAは有効なリスクマネジメント手段となる。

関連商品

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