Place of High-risk Medical Devices in European Recommendations

with a Focus on End-users

G. Brunotte

, R. Beuscart

, A. Pariset

and L. Pazart

INSERM-CIC 1431, Besançon University Hospital, Besançon, France

INSERM-CIC 1403, Lille University Hospital, Lille, France

EIT Health, France

Keywords: Medical Device, High-risk, European Regulation, Recommendations, End-users, Human Factors, Usability.

Abstract As shown by recent incidents and scandals related to the use of high-risk medical devices an adapted

regulation throughout the European Union is important. The European directives and the regulation issued by

the member states include recommendations which apply to high-risk medical devices. The present study

aims at collecting the recommendations regarding high-risk medical devices and specific to each country.

Legislation, guidelines, scientific publications and grey literature have been searched. Different trends seem

to appear in the states with the most advanced legislation: an increase of controlled trials, a better traceability,

development of specialized registries, an improved vigilance system and an increased involvement of end-

users. Although poorly present in the legislation, the end-users are more and more integrated to the

development process of medical devices. Ergonomics and user experience can be seen as key factors of a

successful medical device. Several important issues are stressed regarding the training and information of

healthcare practitioners for implantation of the medical device and its initial setting if required. New avenues

have also to be envisioned such as context of use analysis and user-centred design.

1 INTRODUCTION

Medical devices cover a wide range of products

ranging from eyeglasses to active coronary stent, via

wheelchairs. Medical devices are also characterized

by a short life in the market, small patient populations

and a high potential for innovation.

Due to medical advances and to recent scandals

new European Union (EU) legislation was launched

in 2017. This new regulation has led to the

deployment of a transition period during which

manufacturers may choose to refer to Directive or

Regulation. Each country of the EU has transposed

the directive into its national texts and has treated the

fallout from recent scandals in a manner specific to its

health and vigilance system. As a consequence, the

guidelines and the recommendations for high-risk

medical devices are uncoordinated and treated in

different ways throughout the EU. For example, the

recommendations for the surgical revision of Metal-

On-Metal (MoM) hip replacements vary according to

the different regulatory authorities: some rely on a

specific protocol, other on blood metal ions. (Matharu

et al.2018).

The diversity of medical devices, their increasing

complexity, as well as the development of devices for

personal use have increased the risk associated with

misuse. There is a very wide variety of user profiles

and a lot of attention is paid to end-users.

End-users are considered to be people who

interact with or who manipulate the medical device.

There can therefore be more than one user of a

medical device. Among these, a distinction between

professional users and non-professionals (Shah et al.,

2009) can be made.

The degree of interaction between the patient and

the device may vary. For example there is no

interaction for a pacemaker, but the interaction is of

capital importance in the use of some devices such as

injectors, or pumps intended for administering drugs.

The same goes for devices requiring changes or

recharging of the battery or having a control interface.

Manufacturers are increasingly integrating

patients to the development of products before they

enter the market. This approach is considered to be

safer for the patient and result in more effective

devices (Martin et al., 2006). In addition, the

awareness of handling errors made it possible to

350

Brunotte, G., Beuscart, R., Pariset, A. and Pazart, L.

Place of High-risk Medical Devices in European Recommendations with a Focus on End-users.

DOI: 10.5220/0009375103500360

In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 1: BIODEVICES, pages 350-360

ISBN: 978-989-758-398-8; ISSN: 2184-4305

envisage the usability of medical devices as an

integral part of their development.

A major trend is to move from isolated end-user,

as in traditional clinical evaluation, to patient groups

and focus groups.

The use made by "operators", by health

professionals must also be carefully evaluated to

reduce the risk of incidents. Finally, the global

environment (care structure, etc.) must also be taken

into account. The concept of user experience indeed

takes on its full meaning by aggregating the factors

linked to the end-user, the device and their

environment.

The aim of this work was to scan the regulatory

environment and the development phases of a

medical device. The benefits as well as the potential

challenges to integrating the users' point of view into

the clinical evaluation medical devices will be

discussed. Then, examples from different countries of

the European Union will illustrate what can be done.

Finally a discussion will focus on European

disparities with regards to the place of users.

2 CONTEXT

2.1 Regulations

The legislative framework has been developed on the

principle of the new approach, the principle from the

1980s which provides for the approximation of laws

between states.

Until 2017, three directives were available:

- Directive 90/385 / EEC (EUR-lex, 1990) of 20

June 1990 on the approximation of the laws of the

Member States relating to active implantable medical

devices

- Directive 93/42 / EEC (EUR-lex, 1993) of June

14, 1993 relating to medical devices

- Directive 98/79 / EC (EUR-lex, 1998) of the

European Parliament and of the Council of October

27, 1998 relating to in vitro diagnostic medical

devices

Other more technical directives have been added

as technologies evolved. For example, at the initiative

of the French Presidency of the European Council, the

general directives were revised by Directive 2007/47

/ EC (EUR-lex, 2007). The clinical evaluation has

been made compulsory, under the conditions

specified in a new annex (in force in France in 2010).

These directives must be transposed into the

national law of each country of the European Union

(EU).

In 2017, two European regulations entered into force:

- Regulation (EU) 2017/745 (EUR-lex, 2017a) of

the European Parliament and of the Council of 5 April

2017 on medical devices

- Regulation (EU) 2017/746 (EUR-lex, 2017b) of

European Parliament and the Council of 5 April 2017

on in vitro diagnostic medical devices.

Immediately applicable, a regulation does not

require transposition into national law.

Currently, in 2019 we are in a transition period,

that is to say that a manufacturer may choose to mark

a medical device EC Directive or under the new

regulation.

Shortcomings of the current system are frequently

described, some being strongly related to end-users:

- An inadequate declarative vigilance system and

post marketing monitoring

- A lack of transparency and information sharing

2.2 High-risk and Medical Devices

Classification according to risk (class I, IIa, IIb or III)

allows to get as close as possible to the concept of

high risk. But high-risk and class III are not

necessarily totally overlapping. Our point of view is

that a medical device is considered as high-risk in

case of:

- A sensitive anatomical location

- The implantable nature of the medical device

and / or

- The use of new technologies

and / or

- The use of new materials

2.3 Usability and End-users

2.3.1 End-users, Usability, and Suitability

for Use

Users of medical devices cover a wide range of

people, professionals or non-professionals. It can be

the person responsible for fitting, adjusting the

device, but also maintenance people, their families

and caregivers in general (Shah et al., 2009).

Defining end-user is more difficult. End-users are

people who interact with or manipulate the device.

The term of end-users could restrict the previous list

to the operators and to people who uses the device

(the patient). End-users have a wide variety of

profiles. Among non-professional users, a special

place must be made for people with special needs,

especially the elderly or disabled (Shah et al., 2009).

It is noted that many of these users are likely to have

disabilities hindering their use of medical devices or

difficulties due to technological advances, in

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351

particular with interfaces. Moreover, as stated in the

UK by the Medicines and Healthcare products

Regulatory Agency (MHRA), “as healthcare evolves

and patient care is transferred to the home or public

environment, less skilled or even unskilled users,

including patients and caregivers, must be able to use

quite complex medical devices safely.” (MHRA,

2017).

The MHRA explains that Human Factor refers to

how a person will interact with the systems

surrounding them, including the technology they use.

It often encompasses other terms such as ergonomics

and usability.

The concept of usability has become increasingly

important and combines ease of use and training. It is

described as the characteristic of the user interface

that establishes effectiveness, efficiency, ease of user

learning and user satisfaction while usability

engineering is the application of knowledge about

human behavior, abilities, limitations, and other

characteristics related to the design of tools, devices,

systems, tasks, jobs, and environments to achieve

adequate usability (International Electrotechnical

Commission or IEC 62366:2015, International

Organization for Standardization or ISO, 2015)

2.3.2 The Need to Take into Account

End-users and Potential Barriers

The awareness of errors in handling medical devices

has highlighted the need to place usability at the

center of the development of medical devices.

The FDA recognizes the importance of usability

and includes requirements in this area in GMPs

(FDA, 2018a) and in other documents such as, for

example, guidelines for designing interfaces for

usability tests (Story, 2012).

Medical devices meeting users’ needs are described

as safer (Kaye, 2000) (al., 2004). On the contrary,

ignoring their needs can have disastrous

consequences (Stone and McCloy, 2004).

Meeting users’ needs is known to (Martin et al.,

2006):

• Improve the safety of devices

• Improve the usability of devices

• Reduce Device Recalls

• Limit the need for ad hoc changes

• Improve efficiency of users

• Improve patient outcomes and satisfaction

Knowledge based on user experience is a source of

valid evidence which is used to complement the

contribution of health professionals and researchers.

One could say that without this view "from

within", the panorama of Research is incomplete.

In addition, taking into account the end-users’

point of view makes it possible to manage the

expectations of this population, expectations which

are often poorly understood, as well as the gap

between these expectations and those of

manufacturers and / or professionals.

Several barriers were however identified. The

researchers, manufacturers may have difficulties to

perceive the benefits of including end-users,

especially if it is felt that they do not have the

knowledge to understand or to help the Research

process (Bridgelal Ram et al., 2008).

In 2007, Brideglelal at al. (Bridgelal Ram et al.,

2008) made the following observation: “Although

there has been academic research on user

engagement, there is a lack of commensurate work on

the practicalities of such engagement”. If the interest

in involving end-users is no longer questioned, the

way to do so remains generally insufficiently

documented and there is a lack of evidence.

The difficulty of easily accessing end-users by

manufacturers, in particular subcontractors, was

underlined (Li et al., 2011).

2.3.3 Concrete Measures

Manufacturers resort to early consultation with

professionals and non-professionals. This is even

more crucial for high-risk medical devices.

The usability of devices must be evaluated by

firstly taking into account the specific difficulties and

limitations of end-users and in various environments

(technological, social, etc.).

The user experience (UX) makes it possible to

integrate the voice of end-users at all stages of

medical devices development. Heuristic evaluations

are carried out. Pillalamarri et al. describe it as

building a highly usable, safe and efficient system

that goes beyond the requirements of end-users

(Pillalamarri et al., 2018). These same authors divide

the user-experience evaluation into 4 distinct phases:

- The Research phase: identification of unmet needs

- The conceptualization phase: a synthesis of the

identified needs is performed with a translation into

specifications for the future medical device. It is at

this stage that user groups are defined

- The design phase

- The test phase: prototypes are developed to

simulate the product that will be marketed and then

evaluated by potential users based on the identified

patients groups described above

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The authors explain that these phases are iterated

until all the success criteria are met.

It is very important that people conducting

research based on UX work with specialists in human

factors or ergonomics in order to optimize medical

devices for their use by the user and in the

environment where they will be used. For medical

devices, the human factor process is used to minimize

the risks associated with use (formative assessment),

and then used to confirm that these efforts have been

successful and that users can use the medical device

safely and effectively (summative assessment).

The FDA mentions the following benefits to

applying HF / usability engineering (FDA, 2019):

- Easier-to-use devices,

- Safer connections between device components

and accessories (eg, power cords, leads, tubing,

cartridges),

- Easier-to-read controls and displays,

- Better user understanding of the device's status

and operation,

- Better user understanding of a patient's current

medical condition,

- More effective alarm signals,

- Easier device maintenance and repair,

- Reduced user reliance on user manuals,

- Reduced need for user training and retraining,

- Reduced risk of use error,

- Reduced risk of adverse events, and

- Reduced risk of product recalls.

Patients can also fill out moodboards, storyboards

and participate in questionnaires on the creation of

user interfaces, then test prototypes.

The instructions for use and labeling are also part

of the measures that must be taken to lead to good

usability of the medical device.

2.4 Our Research

2.4.1 Aims

Our goal was to identify the recommendations /

guidelines issued in the countries of the European

Union on high-risk medical devices. In this part of our

work, we then focused our Research on the aspects

affecting end-users.

2.4.2 Identification of Sources and Reading

Documents

The sources consulted fell into two categories:

scientific literature or gray literature. The latter type

of literature refers to documents from governments,

universities, companies, and organizations in the

form of print and electronic media, and not controlled

by commercial publication.

A list of authorities and national agencies for the

28 EU countries, then websites of interest has been

drawn up, country by country. To this end training

tool kits from the French Clinical Research

Infrastructure Network (F-crin) site (European

Clinical Research Infrastructure Network (ECRIN,

2019a)) and the F-crin campus (ECRIN, 2019b) were

used, as well as documents from the World Health

Organization (WHO, 2019).

The documents were then read, with a focus on

end-users, human factors and usability.

Examples of recommendation targeting end-users

will be presented below.

3 PLACE OF THE END-USERS IN

THE EUROPEAN

RECOMMENDATIONS

The end-users have an increasing role to play at

various stages of the life of the medical device from

its conception to its appropriate use which requires

both adequate information and training. The role of

end-users is also important in care-organization,

traceability, registers and vigilance which are keys in

the optimal use and monitoring of medical devices.

3.3.1 Patient Associations

According to the European Patient Forum (EPF),

patient associations are partners providing feedback

through stakeholder advisory groups, experts, public

consultations or institutional meetings of the

European and / or national government. Patient

associations are able to help decision makers

understand the experience of living with a given

disease. They use this “end-user perspective” to

promote the interests of patients at all stages of policy

development and in a range of institutional contexts

(EPF, 2017).

In France, for example, the High Authority of

Health (HAS) has launched a number of patients

consultations for some high-risk medical devices),

like intracranial stents (HAS,

In the Netherlands, the General Inspectorate will

initiate discussions with patient associations to carry

out initiatives aimed at encouraging patients to report

incidents and complaints to healthcare professionals

and / or the healthcare facility concerned, in the case

of MoM hip prostheses.

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Patient associations are therefore consulted by

various national or European bodies. It is very

difficult to identify consultations of patient

associations by manufacturers themselves maybe

because confidentiality and intellectual property

issues might have impacted the availability of data.

3.3.2 Co-design, Co-development, and Focus

Groups

The European regulation states that: “Devices shall be

designed and manufactured in such a way as to

remove or reduce as far as possible: the risk of injury,

in connection with their physical features, including

the volume / pressure ratio, dimensional and where

appropriate ergonomic features” and also that: “Any

measurement, monitoring or display scale shall be

designed and manufactured in line with ergonomic

principles, taking account the intended purpose, users

and the environmental conditions in which the

devices are intended to be used ”

The regulations insist on taking ergonomic

characteristics into account at the design stage.

In spite of the limitations mentioned above,

manufacturers use focus groups which integrate the

science of user experience at the early stages of

development of their medical devices.

Focus groups are small groups that intervene

before the product is placed on the market. They

allow (Bridgelal Ram et al., 2008):

• The definition of unmet needs

• The translation into development concepts

• Their validation by retroactive loops

Focus groups turn out to be very interesting and

informative. They consist of small groups of selected

people with whom interviews are conducted in the

presence of a moderator. Lehoux et al describe these

focus groups as comprising 6–10 participants and

lasting between 1.5–2.5 h (Lehoux et al., 2006).

According to the same authors, if the focus groups

share characteristics of other qualitative methods,

what makes them unique are the interactions that

develop between the participants, and between the

participants and the moderator.

No reference to focus groups was identified in this

preliminary consultation of the gray literature on

recommendations related to high risk medical

devices.

3.3.3 Training / Information for Health

Professionals

Many of these recommendations concern specific

medical devices, generally those which have been the

subject of questioning or controversy.

There are few more general recommendations that

is to say that are not formulated in response to a

given problem

 In Belgium

According to report 158 of the Belgian Health Care

Knowledge Centre (KCE), particular attention must

be paid to the qualification and training of health

professionals (HulstaertHulstaert et al., 2011). This

human factor will often contribute to the safety and

then to the efficiency of the device in routine use and

therefore influences the external validity of the test.

In KCE report 249, professional end-users are

implicitly pointed out (Baeyens, 2015). It is

mentioned that clinical practice recommendations

may stipulate that specific interventions must only be

carried out in specialized centers and by trained

operators and teams experienced in performing

complex procedures. In general, however, the

immediate impact of such a measure after obtaining a

CE label is limited given the time required to develop

such clinical recommendations. In addition, these

recommendations are not binding.

Information is the crucial element to allow the

healthcare professional to consider the use of a device

and to allow the patient to make an informed choice

on this subject. The patient must therefore be properly

informed of the risks associated with the use of a new

high-risk medical device and of all the possible

alternatives. Merely mentioning that the device has

the CE label is not enough.

Health professionals may also be required to

report to the authorities the use of a high-risk medical

device in advance.

 In Austria

General recommendations have been identified:

According to Annex 1 of the Medizin produkte

betreiber verordnung (MPBV) law, the devices for

which special safety precautions must be taken

include the external active components of the active

implants (BASG, 2019). For these devices, the

operator must perform an initial inspection (or have it

carried out) before the first application.

The external active component intended for the

patient being delivered only after the implantation

operation, the operator must also carry out

verification for this component.

 In France

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There are no general recommendations on these

aspects, but only in reaction to situations or

concerning specific medical devices.

Several arrangements have been made regarding

professional end-users for the placement or the

removal of a medical device. For example, the decree

of July 3, 2012 limits the practice of implanting aortic

valve bioprostheses by transcutaneous arterial route

or by transapical route to certain healthcare

establishments in application of the provisions of

article L. 1151-1 of public health code (Legifrance,

2012).

The decree of December 14, 2018 limits the

practice of the act of explanting devices for tubal

sterilization (ESSURE) to certain health

establishments in application of the provisions of

article L. 1151-1 of the public health code

(Legifrance, 2018).

Associations, such as Euro-Pharmat, a voluntary

association, put online sheets for the proper use of

certain medical devices classes, such as for example

skin substitutes (Euro-Pharmat, 2014) or catheters

with implantable chambers (Euro-Pharmat, n.d.).

Recommendations to professionals also come

from medical societies. The National College of

French Gynecologists and Obstetricians (CNGOF)

provides professionals with a technical file on the

removal of ESSURE final sterilization implants as

well as a data collection sheet to be used before and

after removing the implant (CNGOF, n.d.). The

professional board of plastic surgeons has issued

recommendations relating to breast implants and the

risk of anaplastic large-cell lymphoma, stressing that

when there is no reasonable alternative solution, the

benefits brought to patients by breast implants, both

in reconstructive surgery and in cosmetic surgery, are

currently infinitely higher than the risk of contracting

this specific lymphoma (Directoire Professionnel des

Plasticiens, 2018 Professionnel des Plasticiens,

2018). The HAS provides documents on “good use of

health technologies” (for example on implantable

spinal neurostimulators (HAS, 2014) or for coronary

angioplasty (HAS, 2012).

The French National Agency for Medicines and

Health Products Safety (ANSM) offers

recommendations to healthcare professionals. This is

the case of the recommendations intended for

surgeons for MoM prostheses (ANSM, 2014).

 In the UK

The National Institute for Health and Care Excellence

(NICE) has made guidelines available for a number

of clinical situations (NICE, 2019), including

implants for example:

- Transcatheter aortic valve implantation for aortic

stenosis (TAVI) (NICE, 2017a).

- Leadless cardiac pacemaker implantation for

bradyarrhythmias (NICE, 2018).

- Artificial heart implantation as a bridge to

transplantation for end-stage refractory biventricular

heart failure (NICE, 2017b)

 In the Netherlands

Many recommendations follow products for which

scandals have broken out.

For example in the case of the vaginal mesh, the

NVOG “Dutch Society of Obstetrics and

Gynecology” in 2014 made recommendations for

operators / team performing interventions with the

mesh (not exhaustive) (NVOG, 2014):

- That the competent urogynecologist is the person

carrying out the intervention. Anyone who has

made at least 20 mesh placements is considered

competent. For urogynecologists starting out with

this technique, this experience must be acquired

under the supervision of a competent

urogynecologist. To maintain the quality of the

placement, and after a satisfactory learning curve,

it is recommended that the specialist performs at

least 10 placements per year.

- That in the most complex cases it is advisable to

refer to specialized centers

3.3.4 Training / Patient Information

The new regulations for medical devices stipulate

(EUR-lex, 2017a):

"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), and

(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).

 In Austria

General recommendations have been found, in

particular concerning active implantable medical

devices (BASG, 2019):

The parts of the system which are given to the

patient as a non-professional user must be handled by

him/her in accordance with the manufacturer's

instructions, a standard training of the patient being

necessary.

The patient or, where applicable, his legal

representative must receive information in

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accordance with § 81 MPG: information on the

implant, instructions for use, time when a

professional must be consulted ... Furthermore, in

accordance with § 81, paragraph 4 when patients are

informed about the use of medical devices, it is

necessary to take into account the instructions

provided in the instructions for use.

As the patient is a “lay” user, this must be taken

into account. It is the responsibility of the

manufacturer to provide instructions for use,

accompanying documents and other information

necessary for safe use for the intended users.

After the implantation and the appropriate

information of the patient by the person in charge of

the implantation of a medical device, the patient

becomes responsible for the respect of the dates of the

medical visits of control, etc.

Patients and groups of users must therefore

always be taken into account: infants, patients having

suffered a stroke, patients suffering from mental and

/ or physical impairments, etc.

It is the responsibility of the manufacturer of the

medical device / of the implant to establish

appropriate instructions for monitoring the patient

(duration, deadlines) and possible verifications. This

also includes the need to establish an active reminder

to patients about their appointments for follow-up

exams (for example, by the treating physician or the

health facility).

 In France

There are recommendations in response to events that

have occurred for specific medical devices

For the ESSURE ® final sterilization device, the

ANSM, the CNGOF and the Ministry of Solidarity

and Health have made available a patient information

sheet "You are a carrier of the ESSURE final

sterilization device" (Ministère des solidarités et de la

santé, 2018) and a "removal of ESSURE ® device"

sheet (CNGOF, 2018).

The professional directory of plastic surgeons has

posted files for breast augmentation for aesthetic

purposes and for breast reconstruction (SoFCPRE,

2019), (SOFCRPE, 2019). The HAS made it possible

to adapt the first sheet to provide answers on

reconstruction: "Additional information to be

included in the sheet intended for patients of the

French Society of Plastic, Reconstructive and

Aesthetic Surgery of April 2015 before the placement

of a breast implant for cosmetic reasons” (HAS,

2015). The French Foot Surgery Association (AFCP)

provides an “ankle prosthesis passport” for patients

(AFCP, 2012), as well as an information letter

(AFCP, 2012).

3.3.5 Care Organization

 In Austria

The implant (including external components if

applicable) is under the responsibility of the

healthcare establishment until implantation (from

appropriate storage to controls recommended by the

manufacturer). After implantation, the implant

becomes the property of the patient and, from this

moment on, the patient is considered as the "user" of

this implant (BASG, 2019).

 In Belgium

The KCE report 249 (Baeyens, 2015) mentions the

limitation of routine use of specific medical devices

to reference centers. Belgian hospital law already

provides for the possibility of using referral centers to

guarantee a high level of quality of care. The

obligation to reserve the use of high-risk medical

devices to a limited number of healthcare facilities for

a certain period could in some cases be justified.

After placing on the market, reference centers

may be asked to carry out an "appropriate study" (eg

RCT) - with an assessment of proportionality on a

case-by-case basis.

 In the Netherlands

In the context of vaginal mesh, recommendations

were made by the NVOG “Dutch Society of

Obstetrics and Gynecology” in 2014 for the structure

that offers this type of intervention (not exhaustive)

(NVOG, 2014):

- That at least two Gynecologists with a sub-

specialization in urogynecology, competent in mesh

surgery are present in the institution.

- That the structure engages in a quality assurance

approach which is specific to this use

- That the structure registers the implant and records

any complications in a database allowing the national

scale monitoring of patients based on the social

security number.

Recommendations intended for collaboration with

manufacturers (not exhaustive):

- The introduction of new materials should only take

place within the framework of studies.

- The studies will be coordinated and approved by the

Urogynecology Consortium. Observational studies

require a minimum of 118 participants, with at least

one year of follow-up

- Complications must also be reported by the

practitioner to the company that developed and

marketed the product.

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3.3.6 Traceability

Steps have been taken in Belgium where all implant

placements lead to their registration on the central

public health improvement project in Belgium, aims

to improve traceability. On June 15, 2015 the French

Care Supply Branch (DGOS) made general

recommendations as well as recommendations to the

hospital care system (DGOS, 2015).

3.3.7 Registers

The creation and the keeping of the registers is the

most represented recommendation found in the EU

countries, and there is currently a wave of creation

especially for breast prostheses.

The setting up of registers can be seen as a

measure oriented towards end-users because it

requires the active participation of the operators and

of the patients

The Scandinavian countries have a culture of

registers; some of them focusing on high-risk medical

devices. The first ever created register was collecting

information on joint replacement. The establishment

of such records is considered to have lowered the hip

prosthesis revision rate in Sweden (Herberts and

Malchau, 2000). The creation of new registers

(Lyratzopoulos et al., 2008), (or the revision of

existing records) should include a reflection on the

filling system (mandatory? Voluntary?). This should

be complemented by consideration on the patient's

consent to extend its data and on the criteria to be met

to get enough information, while respecting the

protection of patient data.

3.3.8 Medical Devices Vigilance

Countries agree that the system suffers from

significant underreporting. However, no specific

recommendation for high risk medical devices was

found. However, it is suggested to encourage health

professionals to report incidents to manufacturers.

Databases listing the incidents are available but most

of the time, their access is not public or restricted.

The MAUDE (Manufacturer and User Facility

Device Experience) database in the USA allows

patients to make their own statements (FDA, 2019b).

It is probably a very interesting opening on the role of

patients as end-users

4 DISCUSSION

This work illustrates the growing awareness of the

role of end-users in medical high-risk devices in

Europe. Very recently, and for example in France, the

HAS (HAS, 2019) and ANSM (ANSM, 2019) have

initiated patient association consultations and public

hearings to consider the patient's voice.

The place of the end-user is unequally represented

in the recommendations of various European

countries. As with other types of recommendation,

most of them were issued following incidents

affecting specific medical devices. For example, this

is the case of the vaginal mesh for which the

Netherlands have issued a number of

recommendations for professionals [32]: peer-

training, "minimal" number annual implantations,

specialized centers ... It is the same for hip prostheses

with metal-metal friction couple (Inspectie

Gezondheidszorg en Jeugd, 2015) (GOV.UK, 2017),

or the Essure ® device mentioned above. Most of the

documents found were concentrated in France,

Belgium, the UK and the Netherlands. Belgium and

Austria have issued more general guidelines about the

training / information of patients and health

professionals. The Nordic countries have further

developed the registers. This requires an active role

of professional and patient involvement.

Another point worth highlighting is the work

provided by academics and professionals. Although

little or not mentioned in the texts and

recommendations issued by the authorities, networks

of professionals have organized themselves to best

address the question of end-user. For example, in

France, the Clinical Investigation Centre for

Innovative Technology (CIC-IT) network was set up

in 2008 by the Inserm and the Ministry of Health

(CIC-IT, 2016). Recent and creative initiatives have

emerged such as living labs. Living labs are based on

user-centered methods which operate in real-life

conditions. As a result, patients are involved in the co-

developement of innovations from the very

beginning. ENoLL, the European Network of Living

Lab is the international, independent non-profit

association of bench-marked living labs with more

than 340 accredited living labs worldwide

characterized by its diversity and multidisciplinary

perspective (Europeana, 2014). The involvement of

patients in an approach gathering companies,

academics and research centers such as that promoted

by EIT Health is of importance. It is worth to note that

some initiatives are developed by patients themselves

e.g. the European Patients’ Academy on Therapeutic

Innovation (EUPATI).

Place of High-risk Medical Devices in European Recommendations with a Focus on End-users

357

A question remains to be answered: is the

harmonization at the European level desirable? For

example, would it be advisable to "delegate" the

administration and collection of data from

arthroplasty registers to countries having the best

experience (Sweden, Denmark) or would it be

desirable that each EU country takes its own register?

This preliminary work has limitations. First,

translations of documents and the language barrier

may have led to understanding defects. Then

imperfect knowledge of health systems in each

country may also have influenced the way to treat the

subject. A certain degree of subjectivity, for example

in drawing up of the list of sites of interest, is

recognized. Finally, this work should be put in

perspective with other fields such as methodology or

economy, to get a more comprehensive view of the

subject.

Maybe the main limitation of this study is to be

centered on the way guidelines, focus groups or

training are tackled by the European countries and

their regulatory authorities. A new field of progress

regarding the role of end-users is known as context of

use analysis. This type of analysis is directed toward

the intended users and associated constraints either

technical or due to the environment of use. User-

centered design is an innovative approach that

remains to be applied to medical devices in order to

promote their adaptation to all the various users’

profiles, practices variability, working environment,

and conditions of use.

5 CONCLUSION

The consideration of ergonomics is increasingly

important, and its place will further develop. It seems

important to stress that many agree on the fact that a

medical device should be inseparable from the

operator, from the recipient (patient), and from the

care structure. Patient information, training /

information of professionals and usability are the

essential components.

As a consequence, the role of end-users in high-

risk medical devices is a major public health issue.

Significant progress is to be done and the

recommendations have obviously to be adapted. New

trends of medical devices development need to be

included such as context of use analysis and user-

centered design. It therefore seems necessary to

develop new guidelines and recommendations. But

the diversity of technologies and devices available is

such, with the constant emergence of innovations that

it is legitimate to consider if global recommendations

are possible or even desirable.

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