Medical devices, equipment and systems, comprising hardware, components and software, are an essential part of healthcare services. They monitor health and well-being and gather personal data which can be used to diagnose and treat patients.
The global medical devices market is expected to grow to USD 612,7 billion by 2025, according to a report by Fortune Business Insights, which cites a rising prevalence of chronic diseases, together with growth in surgical procedures across the world as some of the reasons for the boom.
As patients, we take it for granted that such devices and systems are safe and reliable and that the healthcare professionals operating them are able to do so safely.
IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components offers testing and certification for the safety, quality, efficiency and overall performance of 22 categories of products, including electrical equipment for medical use, to IEC International Standards.
This multilateral conformity assessment (CA) system is based on the principle that National Member Bodies ensure mutual recognition of test results, used to obtain certification or approval at national levels around the world by the National Certification Bodies (NCBs). The IECEE Certification Body (CB) Scheme offers the potential of one test and one certification, which saves manufacturers time and costs, and can help products reach markets faster.
The IECEE Testing Laboratories (CTL) Expert Task Force (ETF) 3 MEAS, MED covers two areas:
e-tech spoke with Pamela Gwynn and Ted Gartner, Joint Convenors of the Committee of the IECEE ETF3 to understand how its work contributes towards the conformity assessment system.
What does the CTL ETF do?
TG: Our work is about safety, which is key to this type of product evaluation. We ensure that medical electrical equipment used around the world is safe, through basic assessments of the devices and how they are used.
We provide the tools and requirements for laboratories to ensure an even playing field for testing this equipment, according to the IEC 60601 series of standards.
Our NCBs do the testing with their respective test laboratories. They assess the equipment and the risk management files provided to us by the manufacturers who produce the medical equipment. Each laboratory must take the same evaluation steps, so that the results from any laboratory can be mutually accepted, knowing that harmonized assessment processes have taken place, on any products. This is the principle of the CB Scheme.
Thus, it is important for each laboratory to make the right interpretations of the standard, in other words, how to evaluate the equipment and how to evaluate the product’s risk management file. We define the minimum testing equipment specifications for the laboratories, which can then be assessed using our peer assessment programme. Peer assessment of the participants ensures that NCBs, CB testing laboratories (CBTLs) and other laboratories operating in the IECEE System competently carry out the testing, by applying the standards’ requirements and the rules of the system consistently.
The ETF3 is responsible for handling questions of practice related to the test specifications and test methods detailed in the MEAS and MED standards. Additionally, we detail the way in which the tests related to the IECEE have to be carried out, so as to achieve the necessary reproducibility of test results. We also make decisions which clarify the laboratory use of those evaluations.
Our work includes updating instrument lists, in other words listing the equipment needed for the testing laboratories and assessing or modifying our operational documents (ODs) for a more unified approach to assessing risk management files.
Laboratories which are recognized by IECEE, from around the world, assign their experts to the ETF3. We discuss and prepare guidelines to make the lists and interpretations required for a uniform approach to assessing medical electrical equipment. We draw on their experience and expertise, which comes from the practice of using IEC Standards as soon as they are published.
PG: We distinguish operator safety from patient safety. This means we assume operators have more knowledge and care of operating and therefore should know what they are doing.
Along with what Ted is saying, we have usability requirements. Some verification is done to ensure the instructions for use can be followed and applied, so that the product remains safe and can be used correctly. This could be from the perspective of a hospital worker and in the case where the device is used by patients, so that those instructions are clear to them as well.
This verification is somewhat unique to medical electrical equipment, because if you cannot use the product appropriately there will be all sorts of problems.
Tell us about the work for risk management documentation.
PG: OD-2044 -The Evaluation of Risk Management in medical electrical equipment according to the IEC 60601-1 & ISO/IEC 80601-1 Series of Standards is one of the operation documents developed by the IECEE in conjunction with ETF3. It aims to provide a uniform approach to the CBTL and manufacturer on how to assess and document compliance with the relevant clauses of IEC 60601 standard series related to the standard ISO 14971, which covers the application of risk management to medical devices.
ETF3 recently created a special group of expertise specifically focused on the risk management aspects in the MED standards. I chair this group whose objective is to provide a clear understanding of the obligation and what we are looking for regarding the risk management documentation provided by the manufacturer. Our work with the operational document will continue as the MED standard recently published IEC 60601 Amendment 2 and has updated risk management requirements.
When looking at test equipment, we have to consider what changes were made to Amendment 2 and see how this impacts the current list of equipment, for example, new equipment would need to be listed for new test requirements. We must consider all these points so that from a test lab to test lab perspective, we all have the same understanding of what equipment is required.
How do you keep up with innovative technologies?
PG: Because technologies are changing rapidly, the medical electrical field has built in a risk management approach to help manufacturers produce safe, reliable products, where the standard may not have clear document requirements in the 60601 series of standards.
There are many aspects for manufacturers to consider. The CBTLs analyze the risk management information the manufacturers provide against the standard and utilize the information to evaluate and test the equipment. Some of the experts on the task force are also involved in the development of new standards/requirements and can bring additional perspective of the intention of the test.
Due to the fact that standards take years to be published, they may not address certain points of a new or updated device. If a particular task performed by the device is written in a way that is not clear, based on how the device functions today, ETF3 can offer explanations for testing materials/equipment or how to do the test based on what has changed. We want to make sure that all testing laboratories are consistent in how they carry out the tests.
Find out more about IECEE.