なぜアクセルとブレーキを踏み間違うのか
昨今、アクセルとブレーキを踏み間違えての事故報道を多々目にする。
なぜ、アクセルとブレーキを踏み間違えるのかを不思議に思う読者も多いと思われる。
原因は多く挙げられているが、その一つに運転中に注意をそらすような出来事が起こる場合が考えられる。
運転中に携帯電話の着信などがあると注意力が低下してしまい、アクセルとブレーキを踏み間違えてしまうことがある。
また、人や動物が飛び出してくるなど、突然思いもよらない出来事が起こってブレーキを踏まなければならなくなった場合、判断力が低下してしまい、アクセルとブレーキを踏み間違えてしまうことがある。
では、なぜ注意力が低下したり、判断力が低下した際にアクセルとブレーキを踏み間違えるのかというと、人間は日常においてより多く使用する機能(つまり慣れている機能)の方を選択するという特性があるためである。
運転中にアクセルとブレーキのどちらをより多く踏むかというと、もちろんアクセルである。
したがって、注意力が低下したり、判断力が低下した際に、より慣れているアクセルを無意識に踏んでしまうのである。
本人はブレーキを踏んでいるつもりであるため、力いっぱいアクセルを踏んでしまうことになる。
そのため、思いもよらない加速が起き、ドライバーはパニックとなってしまうのである。
医療機器の設計においても同様で、例えば類似製品や先行製品とは異なる操作性やインターフェース(例:赤と青を逆にするなど)にした場合、ユーザは無意識に慣れた方法によってオペレーションを行い、事故を誘発してしまうことがある。
また別の例として、飛行機のパイロットは、一度に複数の機体の操縦は出来ない。ボーイング787型機の機長は、同時期にボーイング777型機の操縦は出来ないのである。
医療機器のような安全性が求められる製品においては、ヒューマンファクターエンジニアリング(HFE)に基づいた、安全設計(フェイルセーフ設計など)が重要である。
医療機器のユーザビリティエンジニアリングにとって大切なこと
ユーザビリティには「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。
従って、医療機器に適用しているユーザビリティエンジニアリングは使いやすさを評価するものでなく、使用エラーのない安全な医療機器を設計するための分析手法である。
わざと使いにくくすることもユーザビリティなのである。
例えば、使い捨てライターのノックは重くなっている。その理由は、事故(無意識や子供による悪戯など)による予期しない発火を防ぐためである。
FDAは、ユーザビリティという用語は、使いやすさを想像させるため、歴史的にヒューマンファクターエンジニアリングという用語を用いてきた。
しかしながら、国際規格との混乱を招くとして、2016年に発行した『Applying Human Factors and usability Engineering to Optimize Medical Device Design』の用語の定義においてユーザビリティとヒューマンファクターエンジニアリングは同義であることを認めている。
JIS T62366-1の改正
現在は、IEC-62366-1:2015 『医療機器-第1部:医療機器へのユーザビリティエンジニアリングの適用』は、JIS化されているものの、まだ医療機器の申請における基本要件基準にはなっていない。
ところが、厚生労働省は2021年7月27日に「JIS T62366-1 医療機器-第1部:ユーザビリティエンジニアリングの医療機器への適用」の改正案についてのパブリックコメントの募集を開始した。
本改正は、引用規格であるJIS T14971:2020との整合を図るものである。
主な改正点は以下の通りである。
- ユーザーインターフェイス評価計画の確立”における「総括的評価の計画」において、ユーザビリティ試験の場合、試験環境及び使用条件は、現行規格で規定する「実際の使用条件」ではなく、「意図する使用環境」とし、試験の参加者の特性及び参加者数を考慮して、ハザード関連使用シナリオに対する「正しい使用」も明確にするように規定を追加
- 試験における観測対象として、現行規格の「使用エラー(USE ERROR)」に加えて、「使用の困難さ(use difficulty)」を追加
- 「ユーザーインターフェイスのユーザビリティに関する総括的評価の実施」において、総括的評価での分析対象として、現行規格の「使用エラー(USE ERROR)」に加えて、「使用の困難さ(use difficulty)」についての分析を追加
おそらく改正後は、JIS T62366-1への準拠が基本要件基準となることであろう。
詳しくはこちらを参照されたい。
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