Managing the Usability of a Medical Device
Managing the usability of a Medical Device
Amy Eikelenboom
Co-founder of NAALA
Published on 28 July 2021
Last week the Dutch Municipal Health Service (Gemeentelijke Gezondheidsdienst, hereinafter referred to as: “GGD”) halted the use of a novel COVID-19 detector, the SpiroNose, as a result of false negatives.[1] How could Usability Engineering have impacted this outcome?
The SpiroNose is an electronic nose that can detect a breath profile to be compared with other breath profiles of people with and without COVID-19 diagnosis.[2] Breathomix, the company behind the SpiroNose, says the false negatives are due to human error, fluctuations in temperature and an unstable internet connection. They furthermore state that the false negatives cannot be related to the device itself.[3] Without insinuating any lack of information provided by the manufacturer or lack of usability engineering, we inform readers in this blog on requirements stemming from the European Medical Devices Regulation (hereinafter referred to as: “EU MDR”) and the In Vitro Diagnostic Regulation (hereinafter referred to as: “EU IVDR”) aimed at minimizing the risks or human error occurring.
The Breathomix – GGD case is only used as an example. The case follows from a recent publication in a newpaper.[1] This blog does not make any assumptions about the (non-)compliance of any of the parties involved. Both the manufacturer and the user of a medical device have responsibilities related to using the medical device appropriate to the intended use as defined by the manufacturer.
Do the EU IVDR and EU MDR require to address usability?
The general requirements to ensure general safety and performance of (in vitro diagnostic) medical devices are specified in Annex I to both Regulations. An acceptable benefit-risk ratio runs as a common thread throughout both Regulations.
The general safety and performance requirements are aimed to ensure the following:
- the performance of the device intended by the manufacturer in such a way that, during normal condition of use, they are suitable for their intended purpose;
- In addition, the medical devices shall be safe and effective and shall not compromise the clinical condition of any user, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient.
- Furthermore, acceptable risks should be compatible with a high level of protection of health and safety, considering the generally acknowledged state of the art.[4]
The underlined sections of this first requirement raise the questions of (1) when a risk can be classified as “acceptable” while ensuring the health and safety of the patient and user, (2) what the normal condition of use is, and (3) how proper use can be ensured.
Both the EU MDR and EU IVDR require to perform risk analyses to identify any potential hazard during intended use and reasonably foreseeable misuse.[5] ISO 14971 for the application of risk management to medical devices can be used to meet risk management requirements.
Following a risk management plan, reasonably foreseeable misuse must be considered. This may require manufacturers to look at the internet connection required, environmental temperature and the expertise of the user (a more detailed explanation follows below).
When risks have been thoroughly detected, consulting all (internal) stakeholders, the manufacturer must classify the probability and severity of a risk. Subsequently, adequate controls must be implemented.
When the risks are mitigated, the risk classification is estimated again to identify whether risks are mitigated to an ‘acceptable level’.[6] This level is defined by the manufacturer itself, but is generally defined as a “remote probability of failure occurring” combined with a “very minor inconvenience”.
However, the probability and/or severity of some risks cannot be completely mitigated to an acceptable level. In this case, the manufacturer must argument and document whether the benefits for the patients outweigh the potential risk.
In other cases, risks cannot be completely mitigated because the risk is (partly) outside of the control of the manufacturer. Which may have been the case with Breathomix and the GGD. Nonetheless, the manufacturer must take actions to mitigate the risk as far as possible by, for example, providing trainings and instructions.[7] Furthermore, if the device is intended to be used by lay persons, they should be protected against the risks posed by this medical device.[8]
If there still is unacceptable residual risk, these must be clearly communicated to the user upon use.[9]
The “normal condition of use” is not defined in the EU MDR. This definition can, however, be derived from other information provided by the manufacturer. The EU MDR requires manufacturers to define, among other things, the intended use and to provide instruction of use.
Defining the intended use does not merely entail the intended medical indication, but also the intended user (profile) and patient population, the environment in which the device is intended to be used and the operating principle.[10]
Chapter III of Annex I details what the label and instructions for use of a medical device must contain. They specifically set requirements to inform users on the appropriate use of the device, the residual risks and information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer.
In relation to the Breathomix – GGD case, the instructions for use should include information about the fluctuations of temperature, external influences and/or environmental conditions when these could adversely affect the characteristics and performance.[11],[12] The instructions for use should additionally provide information on how to use the device properly and the intended user. [13],[14]
To give more substance to ensuring the medical device is designed and manufactured in a way that minimizes the risk of human error is to apply a process called: Usability Engineering.[15] This process is intended to identify and minimize use errors and thereby reduce use-associated risks. This process relates to the beforementioned risk management process. IEC 62366-1:2015 provides guidance in the application of usability engineering to medical devices.
The instructions for use must include a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.[16] The latter is in the Netherlands, for example, the Inspectie Gezondheidszorg en Jeugd (IGJ).
The EU MDR defines an incident as “any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.”[17] With ergonomic features, the EU MDR means the physical characteristics of the medical device. In case an error occurred may qualify as an incident, it should be reported to the manufacturer at minimum.
How to manage usability requirements?
The growing emphasis on usability and the translation of requirements into the instruction for use have become a central focus when developing a more complicated medical device intended to be used by lay persons. Satisfying these requirements asks for a multidisciplinary approach. In fact, it is not only relevant to the quality officer, but must be considered within the product development team, by the installers, and within the marketing department, among others. The important role of documentation in the ‘usability chain’ when developing a medical device must be brought to the attention of everyone involved. Careful end-to-end documentation throughout the life cycle of the medical device can support usability excellence.
Need assistance to ensure usability in the design of your medical device? Feel free to contact us, we’ll be happy to look into it.
References:
[1] Van Poll, M. (2021, 22 juli). Maker afgedankte ademtest: probleem ligt bij GGD, Financieel Dagblad, consulted via https://fd.nl/economie-politiek/1405426/maker-afgedankte-ademtest-probleem-ligt-bij-ggd.
[2] Breathomix (n.d.) Retrieved July 22, 2021, from https://www.breathomix.com/covid-ademtest/
[3] Van Poll, M. (2021, 22 juli). Maker afgedankte ademtest: probleem ligt bij GGD, Financieel Dagblad, consulted via https://fd.nl/economie-politiek/1405426/maker-afgedankte-ademtest-probleem-ligt-bij-ggd.
[4] Article 1, Chapter 1 of Annex I to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[5] Article 3(c), Chapter 1 of Annex I to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[6] Article 4, Chapter 1 of Annex I to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[7] Article 4(c), Chapter 1 of Annex I to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[8] Article 22, Chapter III of Annex I to Regulation (EU) 2017/745.
[9] Article 4, Chapter 1 of Annex I to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
[10] Article 5.1. of IEC 62366-1:2015 Medical device – Part 1: Application of usability engineering to medical devices
[11] Article 7, Chapter 1 of Annex I to EU MDR
[12] Article 23.4.(s), Chapter III of Annex I to Regulation (EU) 2017/745 and Article 20.4.1.(n), Chapter III of Annex I to Regulation (EU) 2017/746
[13] Article 23.4.(h), Chapter III of Annex I to Regulation (EU) 2017/745.
[14] Article 20.4.1.(f), Chapter III of Annex I to Regulation (EU) 2017/746.
[15] Article 5.1. of IEC 62366-1:2015 Medical device – Part 1: Application of usability engineering to medical devices
[16] Article 23.4.(z), Chapter III of Annex I to Regulation (EU) 2017/745 and Article 20.4.1.(af), Chapter III of Annex I to Regulation (EU) 2017/746.
[17] Article 2(64), Regulation (EU) 2017/745 and Article 2(67), Regulation (EU) 2017/746
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.
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