The Usability Engineering File should contain all the relevant documents arising from the processes as described in the Usability Engineering process. The MDR comes into force on 26 May - and with it the UDI regulation. Several amendments to the text of the international standard IEC 62366-1: Application of usability engineering to medical devices have been published in June 2020. not as intended. 2. In our data privacy statement you will find more information about cookies. Patrick Blumentritt Head of Consulting North, Quality Management & Regulatory Affairs, Tel. We develop individual solutions in partnership with our customers around the world, quickly leading to success. Implement measurements that take account of the intended purpose, users and environmental conditions. Annex D of IEC 62366 also For standalone software, this process lives in parallel to the software design process. Unsere TÜV Rheinland zertifizierten Medical Devices Usability Experts prüfen dies in formativen und summativen Studien für Sie! The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices.It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. In comparison, the concept of usability engineering is quite new to the medical device industry. Usability Testing. Although there might be different regulatory requirements for usability and medical devices, depending on the country, there is one overlap: the IEC 62366 Medical devices – application of usability engineering to medical devices. This website requires cookies for complete execution. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. Projects, Documents and Requirements in Medical Technology: Practice-proven Software. The standard describes a Usability Engineering Process with 9 stages: 1. The story begins with a plan, as usual in the quality world.The usability engineering plan shall describe the process and provisions put in place. Although, it is not to underestimate what impact usability has on healthcare. Medical devices to be safe and easy to handle is the requirement across all the regulations. Formative evaluations are a major part of the design and development process. Introduction India’s medical device market is the fourth largest in Asia-after Japan, China and South Korea. intended part of the body or type of tissue applied to, use environment and functionality including the physical principle and technical structure, Identification of characteristics related to safety: part of the risk analysis, focus on usability, User Interface characteristics related to safety and potential Use Errors, Identification of reasonably known or foreseeable hazards and hazardous situations: severity of possible harm needs to be determined, Use scenarios: should involve user interaction, need to be documented in the UEF as well, Identification of hazard-related use scenarios, User interface specification for usability verification which derives from the use specification, known or foreseeable use errors associated with the medical device and hazard-related use scenarios, User requirements specification: should provide requirements for user interface design, Evaluation plans: Description how to explore and evaluate the user interface design, User interface design and implementation: using appropriate usability engineering methods to design and implement the user interface, Risk control option analysis: defining risk control measures that are appropriate for reducing the risk, implement those in a next step, Formative Evaluation: Perform iterative design and formative evaluation until it can be assumed that all use-related risks are adequately controlled and no further refinement in user interface is required. User interface specifications can be derived from the use specifications, user interface characteristics, use errors identified within the risk management process. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. Almost all the Medical Device Regulations across the globe has recognized Usability Engineering requirements within their regulatory framework. More often, it was the term “ergonomic” that was used, and this word did make a few appearances in the Essential Requirements (Annex I) … In the past years the IEC 62366 was replaced by the IEC 62366-1:2015 + COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices. The International Electrotechnical Commission (IEC) has published the first edition of the usability engineering standard “Application of usability engineering to medical devices”. Its titled, “Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products” and is intended for manufacturers of all device classes, drug-device combination products as well as notified bodies responsible for assuring the quality of those devices. With an MDSAP-audit only! Created by > Usability Engineering. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. Usability Testing. Bionic prosthesis design concept set of four isolated compositions representing different lifetime situations with human characters vector illustration. This guidance will assist medical device developers in following appropriate human factors and usability engineering processes to maximize the likelihood that … Read the article to learn why. It is provided by several institutions and their regulations, the most frequent ones are the FDA, the MDR and the standard IEC 62366-1. Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information. That is why institutions became more and more aware of the fact, that usability engineering should be incorporated into regulations and become a substantial part of requirements to medical devices. As this article illustrates, usability engineering is a core part in the development process of medical devices and somehow it touches on every part of the process and is intertwined with many other aspects (such as risk management, quality management or requirements engineering). Abstract . A further advantage is the higher acc… A very good Usability Engineering File [UEF] will have all the documents separate and stored within the UEF. Click here in order to download the new FDA guidance. Global Human Factors and Usability Engineering for Medical Devices THAY Medical are a specialist Human Factors and Usability Engineering consultancy who partner with clients to focus on medical device users. If a medical device is lacking usability, there is a higher possibility that errors occur, or the use of the device might be slower, i.e. This standard is in some way recognised by both, the FDA and the MDR (it will be part of the harmonised standards). A quite standard procedure is the general examination. Health practices today are heavily dependent on the use of medical equipment, medical instruments and medical technology for both the observation and treatment of patients. User interface characteristics related to the safety should be identified considering the primary operating functions of the device which the user or patient is continuously using to interact with the medical device to achieve the intended use of the medical device. BS EN 62366 looks at the application of usability engineering to medical devices. This standard drives much of the usability engineering work done by Emergo by UL’s Human Factors Research & … Since January 1, 2019 the MDSAP-audit of your company has become mandatory for market access in Canada. This is evident and can be clearly identified in the documentation within the regulation, standards and guidance document. Although there might be different regulatory requirements for usability and medical devices, depending on the country, there is one overlap: the IEC 62366 Medical devices – application of usability engineering to medical devices. Usability Engineering process during and/or when the device is placed in the market, involves the following tasks:-. For approval, you as a manufacturer must prove that the operation of your medical devices is safe. The choice is left to the manufacturer, the documents could be maintained however that is feasible and practical based on the complexity of the medical device. Tools are needed to develop efficiently and with minimal errors. Medical devices must meet certain requirements to be marketed in Europe and the United States. Nevertheless, it is a central point of reference. It needs to be determined if those procedures can be carried out by an automated computer process or by a person. In this way, the manufacturer receives valuable information at an early stage, which can shorten the time to market. Usability in Medical Engineering Interactive products in medical engineering should not only be easy to use, they must also meet high safety standards. Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. In the United States (through the FDA) it has been important for many years to apply the usability aspects during the product development; you should be able to provide documentation to prove that the usability aspects have been applied. User interface specifications are the testable requirements relevant to the user interface. Usability Engineering is one of the important processes, part of the design and development of the medical devices. Poor design and usability of frequently used functions —red routes— can seriously impact safety by increasing the pr… This is the application of information about human behavior, capabilities, shortcomings, and other features to the design of medical devices like software, systems, tasks to achieve adequate usability. Thus, the UE process according to the IEC 62366 standards family is important to ensure usability of all medical devices. The usability engineering plan can be a section of the software development plan, or a separated document.The usability engineering plan describes the following to… It also indicates that a system should work the way users expect it to. Also, devices for use by lay persons need to be designed and manufactured in such a way as to ensure safety when using them properly as well as to reduce the risk of error by handling the device. The Usability Engineering PROCESS addresses USER interactions with the MEDICAL DEVICE mostly during the following processes related to use of the medical device. However, standards that address usability for medical devices do exist. You want to go to Canada? When it comes to healthcare and medical devices, usability has a great impact on it. : 07131 2774-40regulatoryaffairs(at)seleon.de, Quality Management The incoming international Quality Management System Standard “ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes,” was recently revised, and among other new requirements, emphasizes the need for usability engineering as a mandatory design input. If you want to learn about usability, then reading a standards document may not be the easiest starting point. Our “TÜV Rheinland” certified Medical Devices Usability Experts verify this for you in formative and summative studies! Summative evaluations are conducted only after the completion of the formative evaluations. Whilst the Medical Device Directive (MDD) had a few mentions of the word “usability”, it was not back in 1993 when it was written, a commonly used term. Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. If you need support or guidance through this implementation process, you are welcome to contact us, the seleon gmbh. In the past years the IEC 62366 was replaced by the IEC 62366-1:2015 + COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices. MDR (EU) 2017/745 The risk management performed, identification of the hazards and hazardous situation should be addressed with the appropriate design / risk controls to make sure the necessary action is taken to avoid the known or foreseeable hazards and hazardous situations. Other related sections refer to the output of usability requirements such as required user … Identify the device's frequently used functions. Write what you do, do what you write. If you agree, please click ok. In addition, usability is also important when it comes to post-market clinical follow-ups and PMS. AAMI HE75, Human factors engineering – Design of medical devices, Clause 9, Usability Testing, provides an excellent guide to the types of formative evaluations that are useful in early device UI development such as cognitive walkthroughs, heuristic evaluations, and walk-through-talk-through usability tests. Our experts support you in planning, conducting and documenting usability measures for your medical device and thus meet the requirements for the usability of medical devices (IEC 62366). In addition… Device manufacturers are responding by actively initiating human factors and usability engineering to many high priority devices. Part 2: Guidance on the application of usability engineering to medical devices • To be more “usable”, easier to understand than original 62366 • Contains the “what” requirements in Part 1, the “how” is in 62366-2 • Closer ties to risk management, EN ISO 14971 There could be multiple iterations in the formative evaluations until the desired safety level is achieved to conclude that the usability of the device meets the criteria of the acceptability as defined in the Risk management process or the usability Engineering process. It has issued a guidance document with the title “Applying Human Factors and Usability Engineering to Optimize Medical Device Design”. From the idea to development and approval to series production – everything from one source – made in Germany. Medical Device Usability Engineering is also known as Human Factors Engineering. In the United States (through the FDA) it has been important for many years to apply the usability aspects during the product development; you should be able to provide documentation to prove that the usability aspects have been applied. With our team of experienced physicists, engineers, computer scientists, process engineers and consultants, every one of our projects reaffirms our ambition to find innovative solutions and help our customers succeed in the market. That is why a thoroughly implemented usability process is essential to every manufacturer of medical devices. 1 * Scope. The records and documents arising from the usability Engineering process could be completely separate from the design & development documents and the risk management documents or could be a part of the entire design & development documents. We bring clarity…, Clinical affairs of medical devices requires numerous evidences and evaluations. Summative evaluations are conducted in the simulated environment or in a real use case scenario with the subjects being the users and/or the patients as defined in the use specifications. Gaining approval for medical devices is complex and quite often also confusing. The compliance to the standard, IEC 62366-1:2015 is evaluated against the documents stored in the UEF. seleon advises you on your individual questions without any obligation. Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Usability Engineering & die IEC 62366-1 für Medizinprodukte, Use Specification: the manufacturer should document the use specification of the medical device in the usability engineering file (UEF). Summative Evaluation: is performed to complete the development of the User Interface with the objective of demonstrating that the user interface can be safely used. In addition, the technical report IEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices was published to support the usability engineering process. It’s important to note that usability engineering shall be applied to all medical device, not exclusively active devices. Hazards and hazardous situations related to the use of the medical device shall be identified as part of the risk management process considering the use specifications and the user interface characteristics as identified in the early stages of the Usability Engineering process. Feedback from users and information about problems or errors need to be collected and evaluated, as well. There could be a single plan capturing the evaluations of all the user interface specifications or there could be multiple plans made at the each stage of the design and development of the medical device. At first sight, people are often confused by the term “usability engineering”, not knowing what to make out of it. IEC TR 62366-2:2016, Medical devices – Part 2: Guidance on the application of usability engineering to medical. But in fact, it is very essential to the safety and effectiveness of medical devices. In addition, usability engineering as part of mandatory risk managementshould have an overall positive effect on the quality of the product file and its evaluation. IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. The evaluation plan should have a clear objective and the method of evaluation. As well as with other aspects of medical devices, there is a regulatory framework, too, when it comes to usability. With new documents, the structures of the UDI and basic UDI-DI are also clarified. normal use. If the medical devices are not used effectively or incorrect use of the user interface may result in Use errors. All the medical devices that were manufactured prior to the publication of the standard, IEC 62366-1:2015 can also comply to this standard by assessing the medical device considering the Use specifications and User interface specifications, Post-market data, applying risk controls if necessary and by maintaining an UEF having the document evidences of Use & User interface specifications, PMS data assessment, risk management and verification of the risk controls. But in fact, the concept of usability is a very important one when it comes to the safety and effectiveness of medical devices. Usability engineering, also called as human factors engineering, is nothing but the interaction between the user and the user interface of the medical devices. Having said that, IEC 62366-1:2015 is the standard recognized by the European Union, USFDA and the other major countries where the medical device regulations are stringent and difficult to comply. Residual risk evaluation: evaluate risk using criteria defined in the risk management plan, Risk arising from risk control measures: effects of risk control measures need to be reviewed, Completeness of risk control: ensure that risks from all identified hazardous situations have been considered. We are based in the UK and Sweden and focus … The formative evaluations can be module by module, developed stage wise. Usability engineering has been applied in the automotive or aerospace industries or others for more than half a century, but only recently in the medical industry. This guidance document is of course no standard, but it gives many lists with requirements and refers to the important regulations and the IEC 62366 (in the meantime superseded by IEC 62366-1). The following paragraph depicts a short summary of each step of the process: When usability is implemented and all requirements are fulfilled, there are certain procedures that can check the usability process. What we know about it …, Product development of medical devices is subject to its own rules. Specify the application of the medical device. Next level would be verification, which examines if specific product characteristics are fulfilled, then comes validation which examines if the intended use can be reached in a specific use context by a specific user. The user interface specifications that were derived should be evaluated to make sure the design controls that will be implemented are meeting the requirements of the safety relevant to the user interface. Companies must be familiar with these requirements if they want to prove to FDA or other regulatory bodies that they have a usability program in place. But which tools are suited best? The risk of design defects in the user interface, the correction of which can be time-consuming and expensive, is lower. In the MDR, there are specific requirements for the aspect of usability, most of them are part of the General Safety and Performance Requirements, stating mainly that a manufacturer should eliminate or reduce risks that are related to error use.