Feature Medical Equipment
he transition period for the Third Edition of the Medical Electrical Equipment Standard (EN 60601- 1:2006) came to an end on 1st June 2012 and it now incorporates the con- cept and application of risk management in the design and production of devices. While technology has evolved quickly, the development of tradi- tional test standards has been more sedate. So, in response to this, the new approach in the Third Edition aims to reduce this disconnect so that safety legislation keeps pace with both the rapid changes in technology and acceptance of it into our daily lives. The Second Edition was an entirely test-based standard. However, the new version requires that a detailed risk management file (RMF) be produced and many of the tests that are required to demonstrate compliance with the standard make reference to it. It also requires that the RMF be updated, so it is a ‘live’ document and must be revised to match any changes in manufacturing processes or in the materials used. The RMF allows for the required testing process to be modified depend- ing on how the device must comply with some aspects of the standard. A good example of this is that some med- ical equipment may need to be robust enough to be used in the battlefield, or withstand extreme weather conditions. While in the past there was a simple ‘pass’ or ‘fail’ against test cri- teria, now if a device does not meet some of the criteria, a manufacturer can mitigate that risk within the RMF by including a researched rationale of the associated risk and why the prod- uct is still safe to use. However, while you may be able to provide an excellent risk rationale, or prove ‘equivalent safety’, parts of the standard remain compulsory as some elements would be almost impossible
How to alleviate design risk T
Jean-Louis Evans of TÜV SÜD Product Service clears up some of the confusion surrounding the Third Edition of the Medical Electrical Equipment Standard (EN 60601-1:2006) - primarily to do with risk management
to justify, for example electrical leak- age currents.
Assessing risk
There is a whole raft of considerations that are included in the risk manage- ment process including built-in safety, usability, installation, service, the environment it will be used in, what the equipment will be connected to and any unforeseen misuses. As it is very difficult to consider all possible elements pertaining to a specific piece of equipment in a traditional standard- based approach, this actually strength- ens the process. However, how do you asses risk? Risk is a combination of the probabil- ity of occurrence of harm and the severity of that harm. Manufacturers usually work out a number for each and multiply them to reveal the risk level, but this approach is not always reliable and it is therefore important not to just accept the final risk level, but review how likely this is to occur as part of the risk management process and mitigate for it if necessary. The manufacturer’s risk manage- ment process must be used through- out the design process and it is essential that for any new product, that risk is first assessed, followed by tests to show compliance with the standard. This means thinking about the RMF first and at each subsequent stage of product development. It pays to assess if a new risk has been intro- duced at every phase, instead of look- ing at risks retrospectively, as any failure that is identified late in a development programme could result
in a costly redesign.
For existing products historical user data, such as failures, accident rates, customer complaints and warranty returns, can be used as part of the risk management process. Also, if it is a new product, it can be benchmarked against similar ones already on the market by using their data.
Above: Jean-Louis Evans, managing director at TÜV SÜD Product Service
End user misuse
For the first time, the Third Edition has introduced the term ‘essential per- formance’, expanding the scope of the standard beyond basic safety to ensure that the product does the job from the end user’s perspective. This also intro-
Above and bottom: the concept and application of risk management in the design and production of medical devices is incorporated within the Third Edition of the Medical Electrical Equipment Standard (EN 60601-1:2006)
duces the possibility of misuse within the RMF and requires that recommen- dations relating to this are included within the user manual.
While there is no definite answer on how far you should go with identify- ing possible misuse, best advice would be to ‘go as far as society’s values and common sense suggest’. The RMF is the proof that you have considered misuse as far as practicable and miti- gated risk to the best of your ability. When first considering the changes brought in by the Third Edition, manu- facturers may only see additional red tape, rather than product improve- ment opportunities. However, the RMF should actually be viewed as a useful tool that helps reduce risk at all stages of product development and can provide a genuine contribution to the development process by making a medical device more saleable.
TÜV SÜD Product Service
www.tuv-sud.co.uk T: 01489 558 100
Automation MARCH 2013
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