The Human Factors Task Group created by the Medicine and Health products Regulatory Agency (MHRA) has held its second meeting of four with external stakeholders to begin to develop guidance on human factors for patient safety.
The group decided the guidance will be divided into four sections:
- 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 could be useful for clinicians, procurement specialists and professionals with an interest in patient safety.
The group includes representatives from notified bodies, academia, NICE, trade bodies and professional associations as well as representatives from the devices, licensing and vigilance, and risk management in medicines divisions at MHRA.
Dr Brian Edwards of the Clinical Human Factors Group commented: “It’s important to work together in particular areas where we have overlapping interests such as drug/ device combinations. We plan to keep the group focused, inviting experts to share their knowledge.”
The group is chaired by Dr Peter Nightingale, who is also the chair of MHRA Devices Expert Advisory Group. MHRA first held the group meeting on 27 February 2015, which was put together as a result of a multi-disciplinary stakeholder day to engage on human factors and the implications for patient safety. There is a plan to follow up on this work by sharing the draft guidance with a wider group of stakeholders in Spring.
Richard Featherstone, Managing Director at Medical Device Usability Ltd, said: “Medical Device Usability is delighted that the MHRA are developing human factors guidance. We welcome the opportunity to be able to work with the MHRA as a stakeholder in the process. Greater clarity about expectations for human factors data will help industry and regulators alike to provide evidence of safe and effective devices.”
