Hello Grace,
Thank you for this information. While it is not understanding why China NMPA might not only harmonise IEC 62366-1 I can understand there is still information and guidance missing which would be at the local country level. FDA has their own guidance on usability and human factors which I often use to supplement IEC 62366-1 since there a quite a few things missing. And considering the standard has not been updated in almost 10 years, this equates more to 50 years in today's fast-moving technology and development.
There is probably too much discussion for a forum post, but some of the differences and variabilities I see impacting usability at local country levels are:
- Understandability by the user as educational levels can be different
- Standard practice of care are different from country to country depending on the maturity of their health care system
- Perception of how products are used can vary significantly between countries especially for more technologically advanced products
- Proper literal translation of text, but also translation of use of text, i.e. left to right/right to left or understanding task processes
As said, there is a lot more and in my experience unfortunately I have seen products designed and instructions developed by scientists, engineers, or development people which are not understandable to the actual user at all (even regardless of the country). Therefore, I can see why regulatory agencies require usability studies more and more these days. There is no such thing as user error - but there is use error which can be addressed.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 11-Apr-2024 22:58
From: Grace Fu
Subject: NMPA Issued Guideline for Medical Device Usability Engineering
On March 19, 2024, the National Medical Products Administration (NMPA) released its latest guideline titled "Medical Devices Usability Engineering Guideline." The guideline aims to enhance the usability and design of medical devices to minimize potential usage errors and the associated harm, thus enabling manufacturers to assess and reduce risks related to medical device usage effectively.
The guideline, referenced by similar FDA directives, emphasizes alignment with international standards to ensure global conformity. It applies to Class III and Class II medical devices, including a range of equipment from cardiac devices to ventilators and infusion pumps.
- Usability Engineering Positioning: Highlighting the integral relationship between usability and safety, stressing the need for comprehensive analysis and control of usage risks based on intended use, scenarios, and core functionalities.
- Risk-Oriented Approach: Identifying usability issues that may lead to usage risks, categorizing them based on severity, and integrating risk management methodologies such as FMEA and FTA to control and mitigate risks.
- Lifecycle Management: Advocating for usability engineering considerations throughout the lifecycle of medical devices, from design and development to post-market analysis, emphasizing iterative improvement and accountability within the quality management framework.
- The Usability Engineering Process involves a comprehensive approach within the quality management system such as requirement analysis, design, validation, and changes, with embedded risk management and traceability analysis.
- User Interface Validation and Confirmation methods include expert reviews, usability testing, and comparative evaluations with similar devices, ensuring compliance with regulatory standards. Special technical considerations are also highlighted by NMPA.
Since usability engineering requirements are required by most of the key countries, I would love to hear your feedback on how you address the variabilities.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.com
Phone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com
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