The MHRA would like comments on their draft guidance of The Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products. The final day for comments is the 5th August 2016. Could comments be sent to dts@mhra.gsi.gov.uk
NAMDET have had representatives at the MHRA’s Human factors event. This has looked at IEC 63266 and designing out possible user errors in medical devices, prior to manufacture.
The Medicines and Health products Regulatory Agency (MHRA) met with stakeholders to begin to develop guidance on human factors to promote patient safety.
The group decided the guidance will be divided into 4 sections, which are:
•regulatory framework/ pre-market (including settings/ end users)
•regulatory framework/ post-market surveillance (including settings/ end users)
•standards
•simulation/ usablity
The guidance will be mainly aimed at the medical devices industry, although would be useful for clinicians, procurement specialists and all professionals with an interest in patient safety.