This is a blog written by Elemed expert guest blogger Claus Rømer Andersen.
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Any member of a team responsible for the development of an electrical medical device, subject to the requirements of the IEC 60601 series of standards, can tell you hair raising stories about the pain and agony associated with demonstrating conformity with these standards. Typically, this is the result of a reactive type testing approach – where the requirements of the standards are only addressed very late in the development project. This approach always leads to costly delays and significant frustrations.
I argue that it does not have to be this way. Over the years I have participated in many projects related to safety for medical devices. I have used these experiences to develop a new approach to manage the requirements of IEC 60601. While it does take some work, it is entirely possible to integrate the safety design activities with other design activities in a value adding meaningful way, which typically results in a better and safer design. Read on and I will introduce you to my approach to Proactive Safety by Design…
Start early – it is cheap to change the design in the concept phase
In my experience, the key to succeed with Proactive Safety by Design is to start early – very early in the planning phase of your design and development project. The effort does not have to be huge, writing a simple plan for how to manage safety by design during the project is an excellent starting point.
This plan should be integrated with or linked to your design and development plan. I recommend you use it to identify key activities and documentation related to safety. The requirements of the IEC 60601 address all aspects related to safety, so it requires a cross-functional team effort to design a device that meets the requirements. Accordingly, a little planning and coordination is not only justified but called for. Remember that the plan does not have to be perfect, it is subject to change as the project progresses.
Also, remember to build on past experiences. In many companies you will have access to experienced people who can provide valuable insights and lessons learned from previous projects.
Identify applicable requirements – in a meaningful way
In my opinion, the IEC 60601 standards are quite long, complicated, and ill-suited to help you identify applicable requirements in a meaningful way. But there is a way to do it which adds value and builds insights along the way. The key is a document called IEC TR 62354; this technical report has three tables (table 2, 5 and 10), which in combination identify the 71 test cases defined by IEC 60601-1.
My recommendation is to use these three tables as a starting point to perform a test applicability analysis. In this analysis, you can identify which of the test cases are not applicable and justification of why that is the case. And you will end up with a reasonable number of test cases that are applicable to the device you are developing. Each of these applicable test cases should be subject to scrutiny and further analysis. Specifically, they are to be addressed in your product risk management activities.
Integrate with risk management activities
Through your risk management activities, you shall address not only the hazards and hazardous situations defined by the standards. You shall also determine if other hazards are applicable to your device.
For each applicable hazard, you shall assess if the test methods and acceptance criteria defined by the standards are sufficient and adequate – if not you must provide your own.
If you have provided your own hazards, test methods or acceptance criteria, you must also justify that the risk has been reduced to an acceptable level – equivalent to that provided by IEC 60601.
These risk management activities allow for development of safe medical devices incorporating new technologies or used in ways not foreseen by the standards. It provides some flexibility, although it can be simpler if you can justify using the requirements defined by the standards.
To avoid cluttering your risk matrix with too much technical detail, I would recommend writing down technical analysis and justifications in supporting design notes, which you can reference from the risk matrix.
Document the Safety by Design features as you go along
As for any other discipline, it is highly recommendable to document your thoughts, analysis, and justifications as you go along. If you do not, you will most likely spend significant amounts of time discussing issues that have already been resolved.
Examples of typical documents that enable efficient management of safety requirements and are relevant to provide to test laboratories include:
- Categorization and classification according to the standards
- Definition of Essential performance and basic safety
- Insulation diagram and insulation requirements
- List of safety critical components
- Labelling specification
- Normal and single fault conditions to be tested
- Enclosures – protection against the risk of spread of fire and ingress of water and particulate matter
- Other design notes explaining how the design meets requirements of the standards
Establishing and maintaining these documents is key to the execution of an effective and efficient development project. And again, it is a good idea to start documenting early and adapt as you go along.
These documents, along with a description of the design concept, the identified requirements and the risk management file, should be subject to frequent detailed technical design reviews throughout the project.
Prepare and execute tests – and follow up
Test activities are an important aspect of demonstrating conformity with the IEC 60601 standards. Test activities ranging from early pre-tests on prototypes to formal type testing of the final design should be planned in accordance with the overall design and development plan.
Prior to testing, the specific test method, test level, acceptance criteria and other details for each test case should be documented in a test protocol. These protocols help the design team communicate how to perform testing on the specific device to the test lab. Remember that the requirements of the standards can be modified and supplemented through the risk management process, the protocols should capture these important aspects and communicate them effectively.
After any testing, you should carefully review the test report for consistency with test plans and protocols. You should ensure that the report fully documents how testing was performed. And you should feed back the results to your risk management file – especially if unexpected results or observations were made.
Quite often, design and testing is an iterative process, where the design is continuously improved. It is important to continually update the supporting documentation. Once the device has passed type testing, it is time to celebrate – and quite often expect and manage changes.
Have you experienced this industry movement?
Do you work with the development of medical electrical equipment or systems? If so, you have probably experienced both the old reactive approach to type testing and at least fragments of the new approach I call Proactive Safety by Design. I would love to discuss pros and cons of various approaches and methodologies.
In my opinion, there are opportunities to improve the ways we work with safety for medical devices in most parts of the industry, including manufacturers, test laboratories and authorities alike. If you are interested, you can learn more about my approach here.
In the end, it is all about bringing novel technologies to the aid of patients and healthcare providers in a safe, effective, and efficient way.
About the author
Claus Rømer Andersen
CEO & Technical Advisor at Rømer Consulting ApS
Claus Rømer Andersen is an accomplished trainer, consultant, and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career.
He is recognized as having a pragmatic and solution-oriented approach to helping development teams focus on relevant issues throughout the entire product life cycle.
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