As many clients and professionals are trying to understand the new requirements of European Union’s Medical Device Regulations (MDR) on Human Factor Engineering (HFE) and usability engineering. This blog tries to address some queries with proper explanation and guidance. But before we actually begin, let us offer you a brief insight of what Human Factor Engineering really is, since many professionals reading this piece will be new to the core concept.
What is Human Factor Engineering (HFE)?
Human Factor Engineering (HFE) is an area of engineering which focuses on acquiring information on human physiological and psychological characteristics and their application on designing devices and systems for human consumption.
HFE is evolved and developed through three different supporting areas which are on knowledge, process and profession. The area of “knowledge” deals with collection of data and guiding principles regarding human capabilities in terms of a machine usage and regarding the application surroundings; in case of medical devices it’s the knowledge received from the healthcare users who can be a surgeon, or any other healthcare professional. The aspect of “process” covers machines, their systems, work methods along with safety and comfort of the workers working on it, in case of the medical devices, it’s the comfort and factors related to ergonomics of the healthcare professionals as well the patients. The third area i.e. “Profession” includes scientists, Research and development persons and human-factor engineers.
EU MDR Guidelines on HFE
European Union had been using the term “ergonomics” since 1993 in the context of managing risk, which encompasses more efficient use of such medical devices which are human friendly and pose less risks for its users.
The new EU MDR regulations were previously going to be implemented from May 2020 but the implementation is delayed because of COVID-19 pandemic. They will now be imposed on May 2021. Annex I of this new MDR specifies points regarding “usability”, “ergonomics”, and “human-factor”.
Below down is statement from Section 1 of the chapter 1 of new MDR. This section deals with General requirements. The statement says:
“Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.”
EU MDR
This statement covers the confirmation of use of the medical device in such a way that both patient’s and device’s users safety is ensured. The extent of this phrase also covers “other persons” which can be interpreted as those people who come in contact with the device, such as that device’s users or machine’s technician or cleaner, which although interact with the device but do not use it.
International Standards on Usability Engineering
The usability engineering is also relevant with the same approach of HFE, and it also emphasize either on eliminating medical devices risks or by reducing to an acceptable level. There are various international standards used for the medical devices’ usability engineering. Previously, IEC 62336:2007 was jointly used by medical devices manufacturers in Europe along with the older European Medical Device Directive. Recently there are on-going efforts being made to add IEC 62366-1:2015, which is the newest usability standard, in the EU MDR framework. It is recommended to use two international standards for instance IEC 62366-1:2015 along with IEC/TR 62366-2:2016 along with the MDR guidance, to create a better usability framework.
Important Details for Usability Engineering in EU MDR
Under Chapter 1, clause 3 and subsection C of EU MDR, it emphasizes on the risk-management system of a certain medical device. It demands from the manufacturers to assess all the potential misuses of a certain device under the usability study, it states:
“In carrying out risk management, manufacturers shall: c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse.”
EU MDR
The above statement should be reinforced in compliance with the latest ISO 14971:2019, which is a usability risk management system for medical devices. In order to understand the errors that may arise, the manufacturer must keep a sound knowledge of situations from which these errors may arise. By incorporating risk-based thinking, the manufacturer will be able to determine the cause of error in its first place and hence, will be able to stop it from occurring in the first place through preventive measures. This will also keep those people safe from any hazards who interact or use the device or machine frequently. The role of risk management for human factors can be further comprehended through EU MDR Chapter 1 Clause 5 which states:
“In eliminating or reducing risks related to use error, the manufacturer shall:
a) Reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety);
b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).”
EU MDR
The device should be free from both patient oriented hazards as well those using it to provide the medical assistance concerning all the possible aspects of human usage. The process also ensures that the device is made within user’s capability; such that it can it be used with ease. Take for example, an electronic wheel chair, which is especially designed for those who have to move frequently for their chores. The manufacturer of any such wheel chair should have human factors considerations that will ensure the user friendliness of wheel chair’s electronic system, and all other physical factors can be maneuvered with great ease. The manufacturer must also be capable to determine within the risk management process about the possible limitations that could prevent the users of that chair from its intended application, and the risk management process should also identify any possible harm or injury from its usage, and in case of any potential risk, what changes should be incorporated in the design to make it user friendly. Likewise, Chapter 2 under the Section 11.4 of the EU MDR additionally endorses user’s safety regarding medical device. It states:
“Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure they are sterile when placed upon the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.”
EU MDR
It is clearly evident from the above statement, that there should be standardized method through which the user can determine and identify sterility of the device.
The Need of Subject Area Specialist
We have tried to present the elements of EU MDR by simplifying various components, however references to the international standards are itself a discussion on its own and making use of it needs a subject area specialist. We truly understand that medical device companies will be focusing on managing the production process, human resources, supply chain etc. and it will be difficult for them to manage and streamline their processes with the new requirements. Here comes the role of subject area specialist for human factor and usability engineering.
TS Q & E is a subject area specialist employing various engineers, and consultants internationally. We can offer suitable consultancy on the changes led by EU MDR, so with TS Q & E, the updated solutions can be presented for your medical devices’ risk management, human factor engineering and usability engineering studies. Please contact us through our Contact us form and let us know your requirements.
