ISO 14971:2019改定点(その1)

前回も解説した通りISO 14971「医療機器-リスクマネジメントの医療機器への適用」が改定される見込みだ。
今回は、筆者が分析した改定点を紹介したい。

【リスクの定義】
「リスク」の定義が上位規格であるISO 31000 (リスクマネジメント―指針)と異なることが問題であった。そこで適用範囲外として「ビジネスリスク」を除外することを明言している。
これによって、ISO 31000の定義とは異なることの正当性が説明されたものと思われる。

【用語の定義】
用語の定義が更新され、また以下の3つが追加されている。
「ベネフィット」、「合理的に予見可能な誤使用」、「最先端」
ベネフィット/リスク分析において、2007年版では「リスク」の定義はあったが「ベネフィット」の定義がなかった。そこで「ベネフィット」について定義された。
「合理的に予見可能な誤使用」は、ISO/IECガイド51:2014に整合させて定義された。取扱説明書の通り使用した際のリスクのみではなく、予見可能なユーザや患者の誤使用についても製造者責任としたところが大きい。
「最先端」(State of the art)はFDAがしばしば使用する用語である。
一言でいえば、リアルワールドである。医療機器開発中の臨床評価(IVD機器の場合は性能評価)や臨床試験だけではなく、製造販売後の市場からのフィードバックを重要視しなければならない。
また「最先端」は「最新の規制要件、国際規格」なども指している。医療機器の技術は年々進歩するため、当然のことながら最新の国際規格等(例:IEC 60601-1)に従って設計開発され、また設計変更が求められるのである。
さらに、医療機器および類似の医療機器および市場にある類似の他の製品のデータと文献の収集とレビュが含まれる。

【ベネフィット/リスク分析】
2007年版では「リスク/ベネフィット分析」であったものが「ベネフィット/リスク分析」に変更となった。

【ISO/TR 24971】
前回も述べたが、ISO 14971:2007の附属書のほとんどがISO/TR 24971に移動され改定された。
ISO/TR 24971はまだドラフト段階である。リスクマネジメントを適切に実践するためにも、ISO/TR 24971の早期発行が求められる。

【要員の力量】
「3.3 要員の資格認定」が「4.3 要員の力量」となった。
ISO 9000:2015では、力量の定義は「意図した目的を達成するために、知識および技能を適用する能力」とある。
単に講習会に出ただけではリスクマネジメント要員として認定してはならないのである。
自動車運転教習所において、学科教習は「知識」を得るが、「知識」だけで運転することは出来ない。
構内教習や路上教習を経て「訓練」を実施する。しかしながら、それによって免許を得たとしても安全な運転はままならない。「経験」が必要である。
リスクマネジメント要員は、教育、訓練、経験を経て、知識や技能を持った者でなければならないのである。

(つづく)

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