Process description Medical devices - nvos … description for medical devices: focus on the client What is the scope of the medical devices process description? The process description

Process description

Medical devices

This is a publication of Nictiz

(National ICT Institute in

Healthcare), PO Box 19121, 2500

CC The Hague, Netherlands

www.nictiz.nl

Publication

1st edition — May 2005 (CVZ)

2nd edition — November 2008

3rd revised edition — May 2009

Ordering

information

Extra copies of this brochure and the brochure

on the Cliq classification of medical devices to

which this document refers can be ordered free of

charge from Nictiz by sending an e-mail to

[email protected]. When ordering, state your

name, your organisation, the postal address and the number of copies

you wish to receive.

For more information: www.cliq.nl

2

Process description for medical devices: focus on the client

What is the scope of the medical devices process

description?

The process description describes the entire chain of activities in

the area of medical devices: from the moment a problem is

reported to evaluation of the use of the medical device that has

been supplied. The activities have been grouped as client actions

and care expert actions. The regulatory frameworks within which

the actions are performed are indicated for each activity. What is the objective of the process

description?

Uniformity of terminology is essential to ensuring optimum

communication and information exchange between the parties.

The process description creates uniformity of terminology and

therefore is a guideline for uniform information exchange on the

subject of medical devices. In terms of the focus on needs in the

area of medical devices, the client’s perspective takes priority. For whom is the process description

intended?

The process description is intended specifically for

patient/consumer organisations, care providers, manufacturers,

vendors and insurers that draw up and publish information

about medical devices.

How can the process description be used in practice? The process description plays an important role in all situations in which information exchange about medical devices takes place. For example, when drawing up guidelines, appl i cat i on forms, protocols and regulations, when writing client information sheets, when drawing up product information or creating training materials. Obviously, this list of applications is not exhaustive. The description of the activities applies for all forms of medical device.

If there are objective reasons for doing so, the content of the

actions within these activities may be deviated from. After all,

there is a great diversity of medical devices (bespoke

products/off-the-shelf, one-off/long-term, various disabilities and

constraints, etc.). However, it is imperative that at least all the

terminology and the description of the activities be used. Further development of the process description

for medical devices

The process description supervisory group met to approve the end-

product in the spring of 2005. After all those involved had

approved the content of the process description, the discussion

turned to the future issues of its implementation and

maintenance. All the parties declared their commitment to

actually using the process description in their information

products. At the same time, there was broad consensus that the

parties should also be able to learn from each other’s

experiences. Feedback to a central point can lead to

improvements and updates to the process description. During a once-only meeting in the autumn of 2005, these parties met again in order to jointly establish what follow-up would be given to the process description. In view of the CVZ’s (Healthcare Insurance Board) task profile, it is clear that implementation is no longer a responsibility of the CVZ. Consequently, the CVZ will not play a managerial role in the further development or implementation of the process description and therefore transferred these responsibilities to the Steering Group for the Cliq project under the supervision of Nictiz. This transfer of responsibilities led to the signature of a letter of intent by seventeen healthcare organisations in December 2008. In this letter of intent, the signatories declare that they will promote the use of the process description for medical devices as a broadly supported tool. See www.cliq.nl for more details.

3

Process description for medical devices

4

exit point

if it is decided not to

use a medical device

entry point

for replacement in response

to a stable situation where

no improvement is detected

problem

reporting

identify

care need

create care plan

determine

solution

path

draw up

require-

ments

select, try

and

decide

deliver

and

instruct

use

evaluate

I have a

health

and/or

functional

problem

This is my

care need

client’s perspective

I do/do not

need a

medical

device and I

know what

that device

(those

devices) is

(are)

My medical device must satisfy these

requirements.

Link between expectations

(human-related intended use)

and the product features (product-related

intended use)

This is the

best choice

for me

The device

has been

delivered to

me and I

understand

how to use it

I use the

device

correctly

The device

does what I

want. I am

capable of

recognising

problems in

good time

Process description for medical devices

The various activities are described in detail in the following sections:

• Client actions • Care expert actions • Results of these actions for the client

• Regulatory frameworks determining the detailed descriptions of the actions

.

page 6

page 7

page 8-11

page 9-10

page 11

page 12

page 13

page 14

page 15

page 16 -22

problem reporting

identify care need

create care plan

determine solution path

draw up requirements

select, try and decide

deliver and instruct

use

evaluate

definitions and explanation of concepts

5

Client actions Care expert actions

Acknowledge the problem and

look for relevant information

Approach a care expert

Identification of the client’s

problem

Provide information about the

options for tackling the

problem

problem reporting

I have a health and/or functional problem

Result for client

I realise that I have a problem

with …..

I know what path to take

Regulatory frameworks determining the detailed description of the actions:

Classifications and standards, these include: ICF, ICPC-2-nl, ICD-9 or ICD-10, DSM IV, WGBO; reliable information

6

Identify

care need

This is my care need

Client

actions Care expert actions Result for client

Clarify the exact nature of

the problem

Complete the care application

form with the aid of care

experts

Diagnosis:

- Medical history

- Physical examination

- Additional examination Determine state of health:

make a medical diagnosis,

functional diagnosis and define

expectations

I know what my care need is

Ask questions if information

is unclear or insufficient

Give adequate information to

the client about the disability and

the functional problems

I have clear and adequate

information about the disability

and my health problems and/or

functional problems

Ask whether there are client

organisations

If asked, indicate whether

client organisations exist and

how the client can contact

them

I know which client

organisations I can turn to


Classifications and standards, these include: ICF, ICPC-2-nl, ICD-9 or ICD-10, DSM IV, WGBO; healthcare-related directives, for example: “checklist WGBO” issued by the KNMG; reliable information

7

create care plan: determine solution path

I do/do not need a medical device and I know what that device (those devices) is (are)

Client actions

Care expert actions Result for client

Describe what I want and can do

In collaboration with the client:

Describe relevant personal

factors and factors in my

environment

Discuss and agree the

treatment goal(s)

Define treatment goal(s) (in

terms of prevention, recovery,

compensation and improvement)

and explain this (these) to the

client

I have enough information and

agree to the treatment goal(s)

Describe the desired level of

function (what the client wants and

is capable of, and what is

permissible in the light of the care expert’s perspective) and inform the client of this

I know and fully agree with the

consequences of this relative to

what I want, am capable of

and am allowed to do in the

short and the long term

Discuss the options and

agree on a medical device as

(part of) the solution

Determine whether a medical

device is required as (part of)

the solution to the problem.

Otherwise, leave the care path

as documented in the process

description and inform the client

of this.

I agree with the choice of

medical device(s) as part of the

care plan


Classifications and standards, these include: ICF, ICPC-2-nl, ICD-9 or ICD-10, DSM IV, ISO 9999, Cliq, WGBO; health expense refund arrangements; healthcare-related guidelines, for example checklist WGBO, Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable information

8

create care plan: d

etermine solutio

n path

I do/do not need a medical device and I know what that device (those devices) is (are)

Client actions


Discussion of agreement to the

choice of type of medical device

or devices (go/no go)

Determine which medical

device(s)

is (are) appropriate for the

treatment goal and provide the

desired level of function and

inform the client of the pros

and cons of this (these)

medical device(s)

I know what kind of medical

devices are available and what they cost. Including sources of finance, terms and conditions and procedures

Identify contra-indications

and consequences for the

choice of medical device(s)

I have decided what kind(s) of

medical device(s) is (are) the

best solution(s) for me

Provide additional (written) in-

formation and gain client’s

consent for

the care plan

I have been adequately

informed and have rejected or

agreed to the care plan

Record details in the care plan

(this also applies to the

subsequent steps)

Relevant details from the care

plan are copied to the care file

(this also applies to the

subsequent steps)

Investigate refund

arrangements and procedures.

What are the terms and

conditions that apply to the

provision of the medical

devices.

Find out whether the client is

aware that there may be

financial consequences for

him/her personally and provide

guidance if required

I know what refund

arrangements apply to my

situation I know what the use of the

medical device means in terms

of instruction, training, use and

after-care


Classifications and standards, these include: ICF, ICPC-2-nl, ICD-9 or ICD-10, DSM IV, ISO 9999, Cliq, WGBO; health expense refund arrangements; healthcare-related guidelines, for example checklist WGBO, Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable information

9

create care plan: draw up requirements


Identify firm requirements and

nice-to-haves with regard to

the intended use (human-

related intended use)

Review of the product features

of the devices, including the

intended use (product-related

intended use) and price/quality

Inform care experts about

specific terms and conditions

in relation to refunds

Agree a list of requirements

(informed consent; see the

explanatory summary on the

following page)

In collaboration with the client,

match client requirements in

relation to the treatment goal,


expectations in respect of the

device (human-related

intended use) to the required

product features (product-


Provide information to the

client on the pros and cons of

specific product features,

price/quality and the use of the

device

If necessary, consult the

financing party

Gain the client’s agreement to

the list of requirements

Result for client

I know what the options are in

terms of devices and product

features

List of requirements has been

completed: I know the

requirements with which the

device must comply

I know what this means in

terms of financing or what

alternatives I have (e.g.

personal contribution)

I agree to this list of

requirements for the selected

medical device

Regulatory frameworks determining the detailed description of the actions: Classifications and standards, these include: ICF, ICPC-2-nl, ICD-9 or ICD-10, DSM IV, BMH, product-related CEN/NEN standards, Cliq, WGBO; refund arrangements; care-related guidelines, e.g. Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable information

10

create care plan: d

raw up requirements

Diagram summarising the list of requirements

Client Device

Desired level of function

Functions, activities and participation that the

user wants to, is able to and may perform

Human-related intended use

What the device must achieve in the opinion

of the user, based on the desired level of

function

Activities that the user wishes to carry out

using the device (e.g. shopping, sports), or

which are to be taken over by the device (e.g.

climbing stairs)

Functions that are supported by the

device (e.g. breathing) or taken over by it

(e.g. collecting urine)

match

Product-related intended use What the user may or can expect of the device

A Activities for which the device can be used (e.g. climbing stairs)

Disabilities that are alleviated by the

device (e.g. misalignment or reduced

load-bearing capability of a joint)

B Technical features of the device that

determine to what extent the desired

level of function can be achieved (e.g.

modified handle, storage capacity of

300 ml)

C Features of the device that play a role

in determining its ease of use (e.g.

ability to take the device with you,

ease with which it can be put on/taken

off)

D Features that influence the appearance

of the device but do not affect

functionality (e.g. colour)

11

select, try and decide

This is the best choice for me The 2nd and 3rd choices should also be listed here (if possible and necessary), so that an immediate switch to the second choice can be made if the initial results are disappointing

Client actions


Select an adequate device from

the available products on offer

(NB: off-the-shelf product, with

individual modifications if

required or made-to-measure)

I know what type of devices

(brand and type) comply

with the list of requirements and are suitable for what I want, can and am permitted to do

Try out devices that comply

with the list of requirements

under supervision, in some

cases a trial period

Give feedback to the care

expert(s) and financing party

about the suitability of the

device

Instruct the client in the correct

use of the device when trying it

out and ensure that the device

is fitted adequately

After testing, evaluate the

suitability of the device in the

light of the treatment goal, the


the intended use (human-


I have enough time to test the

suitable devices, which have

been fitted adequately, and also

gain expert advice

Investigate the available refund

arrangements for types, brands

and models

Test the functionality and

use of the device under

relevant circumstances

I am aware of the financial

consequences of my choice

Final selection from the

available options

I agree to a specific type,

brand and model (adequate

device)

Document and gain the client’s

consent to the choice of type,

brand and model Order (or make device and/or

arrange individual fitting and

testing)

I agree with the purchase of

this specific device

Regulatory frameworks determining the detailed description of the actions: Classifications and standards, these include: ICF, BMH, product-related CEN/NEN standard, Cliq; quality labels (GQ and List van Bernink); refund arrangements; healthcare-related guidelines, e.g. Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable information

12

delivery and

instructio

n

The device has been delivered to me and I understand how to use it

Client actions


Ask additional questions about

use of the device

Check the delivered device:

does it satisfy the set

requirements?

Finish/adjust device Warnings and preventive

measures Check whether the device

satisfies the set requirements

I take delivery of my device If problems arise, I know

who to turn to

Read and comply with

instructions

Hand over user instruction

manual and provide

explanations if required

I have been given a user

instruction manual and the

terms and conditions of

warranty and know what

servicing agreements apply

Test the client’s skills

If necessary, advise the client

to attend a training course

I know how and when I should

use my device

Explain what maintenance is

required

I know how I should maintain

my device

13

use

I use the device correctly

Client actions


Training

Use as instructed

Training I am capable of using the device

correctly

Comply with maintenance

instructions

I am capable of maintaining

the device myself

(NB service and warranty terms

and conditions)

Report problems that arise

during use in good time

Keep a record of his/her experiences

After-care Monitoring of the user’s

experiences

I am capable of reporting

problems in good time


Classifications and standards, these include: ICF, WGBO, Classification of treatment in order to clarify the type of training and after-care; healthcare-related guidelines; reliable information; terms and conditions of servicing and warranty

14

evaluate


Indicate (negative) experiences

with the device, complaints about

and side effects of the device to

expert(s) and the financing party

(awareness of how to do

this)

Report any changes in the

state of health and/or level of

function that prevent

adequate use of the device to

the care expert(s)

Evaluate the effect in relation

to the treatment goal and

desired level of function

Identify relevant changes in the

state of health and/or the level

of function and if necessary

return to one of the previous

process steps

The device does what I want. I am capable of recognising problems in good time

Result for client

I know to what extent the

device allows me to do what I

want and am capable of

I am able to recognise problems

associated with use/lack of use

in good time and report them to

the correct expert

I know when and where I

can go for checking/after-

care

I am able to recognise and

report relevant changes in the

state of my health and/or ability

to function

I know where I can share

experiences with similarly

afflicted patients if I feel the

need to do so


Classifications and standards, these include: WGBO, ICF, ISO 9000 (complaints procedure); Global medical device nomenclature; healthcare-related guidelines; reliable information; evaluation tools such as D-quest and Quote questionnaires

15

Definitions and explanation of terms Terms can be defined in various ways depending on the context in

which they are used. For example, the term “device” (hulpmiddel) is used in a different way in the Besluit Medische Hulpmiddelen (Dutch Medical Devices Decree) than in healthcare insurance legislation, the AWBZ, Wmo and WIA.

This is why it is so important to clearly define common terms in

the field of medical devices. The overview below presents the

various definitions that are recommended by the working group.

These can be used when selecting terms (again) or defining the

meaning of terms.

Definitions Sources

Activities: sub-components of a person’s actions. The term refers to function from an individual perspective. ICF

Adequate device: fitted or suitable device for the client’s circumstances. Working group

General product characteristic: see product-related intended use.

Commonly used device: device that non-handicapped people in comparable circumstances (in a financial sense also) can generally count on as part of their purchasing pattern.

Working group

Treatment goal: the goal(s) of the care plan in terms of the prevention, recovery from, improvement or compensation of problems with the client’s state of health or level of function.

Working group

Desired level of function: a description of what the client wants to do, is capable of and permitted to do. The description must take account of feasibility (e.g. in view of the seriousness of the ailment and the actual disabilities), the patient’s wishes and external and personal factors (e.g. available aid and devices, motivation, available funding, domestic situation).

Generic

Model

VRA (2002)

Intended use associated with the medical device: see product-related intended use.

Intended use associated with the user: see human-related intended use.

Constraints: the difficulty a person has when performing activities. A constraint may be a slight or serious problem in a qualitative or quantitative sense when performing the activity.

ICF

Reliable information: independent and up-to-date information, which is based on recent scientific discoveries and practical results.

Working group

BMH: Besluit Medische Hulpmiddelen (Dutch Medical Devices Decree). The European Directive that relates to medical devices is Council Directive 93/42/EEC of 14 June 1993. The Directive is intended to allow the free movement of goods within Europe. The goal is to protect the safety and health of users, patients and (where applicable) other persons (Official Journal of the European Communities; 14 July 1993).

BMH

16

Definitions Sources

In order to comply with the directive, the device must satisfy certain essential requirements. These are:

general requirements (safety of application and use, avoidance of risks, side effects), requirements

relating to the device’s design and construction (materials, infection, radiation, toxicity, compatibility). The Directive applies in all EU Member States. With the exception of made-to-measure devices and devices for clinical

research, medical devices must comply with essential requirements defined in Article 3 of the European Directive for

Medical Devices and must carry a CE conformity label if made commercially available.

Client characteristics: intended use associated with the user: see human-related intended use.

D-Quest: an instrument that can be used to measure client satisfaction in relation to the issue of a medical device. D-

QUEST (Dutch version of QUEST) is a Dutch-language version of QUEST: Quebec User Evaluation of Satisfaction with

Assistive Technology. This instrument was originally drawn up in Montreal, Canada as a French-language and English-

language instrument. It has subsequently been tested and improved by several institutes in Canada, the United States

and Europe in a joint study. It is a generic instrument in the sense that it can be used for all types of medical devices,

issued via any type of issuing system. The instrument has a strong client focus. This means that the respondent’s opinion

(i.e. the opinion of the medical device user) is the central concern.

iRv

External factors: a component of the ICF. These are all aspects of the external or extrinsic world that form the background of a person’s life and therefore influence a person’s level of function. External factors include the natural and man-made physical world and all the related phenomena, other people in different relationships and roles, social systems and services, policy, regulations and legislation.

ICF

Financing party: the party that pays for (refunds) the medical device and related care. This may be the consumer

himself, the insurer, the municipality, employer or body paying state benefit (WIA, WAO, Wajong, etc.).

CVZ

Functional diagnosis: a description of a person's disabilities and anatomic characteristics, (constraints applying to) activities and participation (problems) and the external and personal factors that have a positive or negative effect on this set.

Working group

Level of function: this is a global term referring to a person’s ability to function, anatomic characteristics, activities and participation. A person’s level of function can be described by a (combination of) function(s) and/or anatomic characteristic(s) and/or activity/activities and/or participation. If functional problems exist, there is generally a disability or combination of disabilities

and/or constraint(s) and/or participation problem(s).

ICF

Functional problem: see level of function.

17

Definitions Sources

User manual: a paper or electronic document that describes correct use (instructions relating to how one should use something correctly, which are either supplied with or affixed to the object or material).

Van Dale

Prefabricated: a prefabricated medical device (off the shelf, ready for use) is one that has been designed and

manufactured to satisfy specific functional needs and is normally only available in a number of sizes. The device does

not need to be made to measure by the supplier (prosthetic engineer or orthotist) in order to adapt it for use by an

individual user. A prefabricated medical device is manufactured in large volumes on an industrial scale based on standard

sizes and models. If required, it can be adjusted and set for use by individual users based on instructions and

information provided by the manufacturer. A prefabricated medical device may only be made commercially available if it complies with the Medical Devices Directive and carries a CE conformity mark.

Free

interpretation of

Cliq

Prefabricated with individual modifications: A prefabricated medical device that is only suitable for use by a single

specific user after it has been modified to fit (individually fitted). The prefabricated medical device is manufactured

based on standard models or patterns and does not cover all individual characteristics. An integral prefabricated

medical device that has been modified to suit a certain size is an individually fitted device that has the same status as

one that is made to measure. It does not therefore carry a CE label, although the label may apply to some or all

components and accessories.

Free

interpretation of

Cliq

Medical device: any product (device, equipment, instrument, technical system and software), regardless of whether it is specially made or generally available, which prevents, compensates, monitors, eases or eliminates disabilities, constraints and participation problems.

Derived from

ISO 9999.

Medical device care: the total coordinated care in relation to medical devices. The process starts when the problem

is reported and ends when the evaluation indicates that the medical device has achieved the desired goal. The process

may be terminated prematurely if the medical device is found not to be a suitable solution. Entry into the process at an

intermediate stage is possible when the medical device has to be replaced in response to a stable situation where no

improvement is detected.

Working group

Human-related intended use: what the device must make possible in terms of the desired level of function or must do in the opinion of the user.

The medical device must assist him/her in the performance of activities (e.g. a wheeled frame when walking) or, alternately, the medical device must take over certain activities (e.g. a stair lift for a person who can no longer climb stairs);

The medical device must support functions (e.g. an oxygen mask for breathing problems) or reduce the level of disability (e.g. incontinence materials for people who are incontinent and a prosthetic device for somebody who has lost a limb).

Cliq

ICD: International Classification of Diseases WHO 18

Definitions Sources

ICF: International Classification of Functioning, Disability and Health. The ICF describes human function from three perspectives:

man as an organism; functions (including mental functions) and anatomic characteristics (negative: disability or

disabilities); human behaviour; activities (negative: constraints); joining in in social activities; participation (negative: participation problems).

The primary term is “functioning” with the opposing negative of “functional problems” or “problems with functioning”.

In addition to a list of physiological and mental functions, a list of anatomic characteristics and a combined list of

activities and participation, the ICF also contains a list of "external factors” that can be used to analyse the positive or

negative influence of the environment at all function levels. Personal factors also influence a person’s function. “Personal

factors” have not been detailed in the Classification in the form of a list of terms.

The ICF can be used to classify various data items relating to (the prescription of)

medical devices: functional problems that the client experiences due to his/her medical situation (disease, ailment, medical intervention, medication);

the prescriber’s and client’s estimate of the client’s current function level and the possible future level of

function;

the level of function that the client desires;

the intended use of a medical device;

the level of function that is achieved after issue of the medical device (human-related intended use).

WHO-FIC

19

ICF Diagram diseases | ailments

functions/anatomic characteristics

(disabilities)

activities (constraints)

participation (participation problems)

external factors

positive and negative

personal factors positive and negative

Definitions Sources

ICPC-2-nl: the International Classification of Primary Care (ICPC) is intended to regulate the general medical practitioner

domain. This classification makes it possible to name and code the most common symptoms and complaints,

diagnoses and interventions that occur in the general medical practitioner domain. The ICPC classification system has a biaxial structure: there are 17 chapters on one axis, each of which has its own letter code; the other axis consists of seven components that each have a two-digit code.

RIVM

Instruction: instruction relating to what must be done, what actions are required (instruction in a skill). Van Dale

Medical diagnosis: diagnosis of a condition or ailment, the label that allows a doctor to describe the health of a patient in specific medical terms. The label may refer to a disease or ailment, to a syndrome or to a complaint or set of symptoms.

Pinkhof

Bespoke medical device: a medical device that is made to measure (individually made), is designed and manufactured in order to satisfy the functional needs of an individual user based on information taken from a model, imprint, set of measurements, scan, drawing or image. The medical device is intended for the sole use of a specific person. The medical device is specially manufactured in accordance with the prescription of an appropriately qualified doctor who is responsible for determining the special properties of the design. The prescription referred to above may also be issued by another person who is professionally qualified to do so. Prefabricated medical devices that have been modified to fit and are designed to satisfy specific functional requirements of individual users are considered to be bespoke medical devices.

Cliq

Participation: a person’s participation in society. The term refers to function from a social perspective. ICF

Process description for medical devices: description of the total process of medical device-related care from the initial formulation of the care need up to the ultimate evaluation. The process description for medical device-related care consists of 8 sections, which each concentrate in detail on different aspects. The goal of the process description is to create a uniform terminology for medical device-related care.

Working group

Product-related intended use: in accordance with the European Medical Device directive, this is a product feature that indicates what the user of a product can and may expect. This is therefore a feature that has legal status. This involves the following types of product characteristics:

The functionality of the medical device: Activities for which the medical device can be used (e.g. climbing stairs) and the disabilities that are compensated for by the device (e.g. misalignment or reduced load-bearing

capability of a joint);

The technical capabilities of the medical device: these characteristics determine the extent to which the functionality is achievable: e.g. how absorbent the incontinence material is, how stiff the material is, what forces can be absorbed;

BMH

20

Definitions Sources

The user convenience and comfort offered by the medical device: what are the material properties

(hypoallergenic), ease of wearing, transportability, attachment, ease of putting on/taking the device off. The

ergonomic aspects in a traditional sense; handiness, usability, generic operational aspects; The visual properties of the medical device: characteristics that determine the appearance of the medical device without affecting functionality (colour, (in)conspicuousness, etc.); Other characteristics that can influence the choice of medical device (e.g. maintenance, material, range of settings).

BMH

Product characteristics: intended use associated with the medical device: see product-related intended use.

List of Requirements: a list of the requirements that apply to a medical device. The list of requirements is generated by matching the expectations associated with the medical device (human-related intended use) to the general product characteristics (product-related intended use).

Hulpmiddelen

Kompas

Protocol: specific modification of a care-related guideline for use in a particular environment. NVN-EN 13940

Selection: selection of the medical device that complies with the list of requirements. Working group

At all times: available continuously. Working group

Gain consent: title of the practical toolkit (part 2 Implementation of the WGBO) in order to give and receive information in a responsible way in accordance with the WGBO and to gain the client’s well-considered consent. Among other things, the practical toolkit contains a manual for patients, a checklist for care providers and a model guideline for care providers on information and consent for an examination or treatment.

Combined

organisation’s

implementation

programme for

the WGBO

Training: learning how to use the medical device. Training focuses on developing sufficient proficiency in the use of the medical device in order to compensate for the functional problem.

WGBO: the goal of the WGBO (Dutch Medical Treatment Contracts Act) is to strengthen the patient’s legal position based on the care provider’s personal responsibilities for his/her actions as a qualified care provider. The WGBO is the legal framework that determines the (contractual) relationship between the care provider and the patient. The patient’s main rights in his/her relationship with a care provider are specified in the WGBO.

KNMG: Final WGBO report: van wet naar praktijk (from legislation to practical implementation)

Care expert: A person who is active in directly providing healthcare treatment. Explanation: the care expert complies with the prevailing requirements in relation to competences and skills and works in accordance with the prevailing quality guidelines.

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21

Definitions Sources

Care file: All the information that is available in relation to the state of health of the person receiving care. Additional comment made by the supervisory group: including the diagnosis and treatment that has been determined for the person receiving care and the treatment agreement.

NVN-EN 13940

Care-related guideline: set of systematically developed instructions that support care parties when making decisions about the provision of treatment in relation to the health issues in specific care situations.

NVN-EN 13940

Care recipient: person who has been scheduled to receive care, or who is currently receiving or has received care. Explanation: in the process description, we have used the term ‘client’ for this concept.

NVN-EN 13940

Care party: Organisation or person involved in the process of providing care. NVN-EN 13940

Care plan: description of planned care packages for a single person in which one or more health issues are handled and which include all the treatments that a care expert can provide to a care recipient. Explanation: the care plan may contain treatments provided by multiple care experts.

NVN-EN 13940

Care need: a need for treatment of a care recipient that is formulated by one of the care parties. Additional comment: the care expert (or experts) defines (or define) the care based on input from the client. The client is sometimes not capable of providing this input, which must then be provided by others on his/her behalf (parent(s), partner). Sometimes, the care need described by other directly involved parties is significantly different to the client’s actual requirement. The care expert must be alert to this. See also the WGBO.

NVN-EN 13940

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Responsibilities and accountability

Backgroun

d

The CVZ organised a workshop called “Care process

responsibilities and liabilities” on 20 March 2003. During the

workshop, the participants identified a lack of uniform

terminology in medical device-related care. Various models, in

some cases for specific types of medical device, provide a

process-based view of the steps in medical device-related care.

These models use different terminology for similar steps and the

same terminology for different steps. If general membership approval could be gained, the workshop participants wanted to set up a working group that would:

• agree a single model at a meta level;

• define a uniform terminology. The CVZ drew up a plan of action for improving the exchange

of information in the area of medical device-related care. This

plan called for an integral process description of medical

device–related care that would be drawn up by a working group

of experts. A supervisory group consisting of representatives from

the organisations involved in medical device-related care was

formed in order to create broad support for the product. This

action plan was approved by the members of the working group

and supervisory group in August 2003. During a kick-off meeting held on 6 November 2003, the working

group and supervisory group again discussed the primary

assumptions, working method and the project goal. It was agreed

that the working group would draw up a draft description of the

process steps in medical device-related care. The supervisory

group would then decide which subsequent steps were required

for application and implementation of the process description.

Working method and roles

The working group drew up a preliminary version of the

process description during the course of four meetings.

Different organisations that had experience with describing

care-related guidelines supplied experts in the relevant

discipline to the working group. The members of the

working group participated in the project on an individual

basis. Experts in the area of standards, classification and

legislation supported the working group by critically editing

the draft versions.

A supervisory group, which consisted of representatives from

various organisations that are involved in medical device-

related care, supervised the development of the process

description. The supervisory group’s task was to ensure the

practical usability of the process description by providing

input from and circulating the results to their members.

The working group was supported by a team of facilitators,

consisting of an independent chairperson, an expert in

knowledge support management, a medical advisor and a

project leader.

The project, which resulted in the process description of

medical device-related care, was funded by the CVZ. Cliq project

In addition to developing this Process Description for Medical

Device-related care, the required classification was also drawn up

in the Cliq project under the supervision of Nictiz. In view of the

mutual interdepency – no Cliq w i t h o u t a Process description

– and the change in priorities at CVZ, the Cliq and Nictiz steering

group have assumed responsibility for this publication and

arranged this new edition.

23

Participants

Working group

• Joop Beelen

(Nederlandse Vereniging Voor Slechthorenden)

• Ria Smeijers

(Nederlandse stomavereniging Harry Bacon)

• Theo den Haan

(Landelijke vereniging van geamputeerden)

• Jan Storck

(Landelijke vereniging van geamputeerden)

• Marie-Jose Driessen

(Nederlandse Vereniging voor Ergotherapeuten),

from October 2004 Anke Heijsman

• Franc van der Linden

(Federatie PAS: Orthopedisch schoentechnici)

• Harry Knops

(iRv)

• Rianne Quak

(TNO)

• Rob van Eersel

(KBOH)

• Ko van de Klundert

(Orde van medisch specialisten), from October 2004.

Supervisory group

• CG-Raad (Piet Vreeswijk)

• CSO (Peter Kruitbosch)

• KNMG (Michiel Wesseling)

• SOMT (Roelf van Run/mr. Ron de Graaff)

• Orthobanda/MKB (Piet de Ruijter)

• ZN (Marissa Meijer)

• LVT (Heleen Buijze)

• AVVV (Aart Eliens)

• VNG (Jeannette van Abeelen)

• NPI (Dorine van Ravensberg)

• VWS (Cees van den Berg)

• CVZ (Marja Kuijpers).

Experts in standards and classifications

• Theo Bougie

• Yvonne Heerkens

Team of facilitators

• Wim van Harten (Chairman of the supervisory group and

working group)

• Paul Iske (knowledge manager)

• Nieske Heerema (medical advisor)

• Arnold van Halteren (project leader).

24

use

Documents

Process description Medical devices - nvos … description for medical devices: focus on the client What is the scope of the medical devices process description? The process description