D6.2 Annex I Process description Medical devices description Medical... · National ICT Institute...
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Transcript of D6.2 Annex I Process description Medical devices description Medical... · National ICT Institute...
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-m
ail to
hen ordering, state your
name, your organisation,
the postal address and the number of copies
you wish to receive.
For more inform
ation: 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 m
edical 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 perform
ed are indicated for each activity.
What
is the objective of
the process
description?
Uniform
ity of
term
inology is essential to ensuring optimum
communication and inform
ation exchange between the parties.
The process description creates uniform
ity of term
inology and
therefore is a guideline for uniform
inform
ation exchange on the
subject of medical devices. In term
s 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 inform
ation
about medical devices.
How can the process description be used in practice?
The process description plays an important role in all situations in
which inform
ation exchange about medical devices takes place.
For example, when drawing up guidelines, application forms,
protocols and regulations, when writing client inform
ation sheets,
when drawing up product inform
ation or creating
training materials. Obviously, this list of applications is not
exhaustive. The description of the activities applies
for all form
s 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
term
inology and the description of the activities be used.
Further development of the process description
for medical devices
The process description supervisory group m
et 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 inform
ation
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 m
eeting 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 d
escrip
tion f
or m
edic
al devic
es
4
ex
it p
oin
t
if i
t is
de
cid
ed
no
t to
use
a m
ed
ica
l de
vic
e
en
try
po
int
for
rep
lace
me
nt
in r
esp
on
se
to a
sta
ble
sit
ua
tio
n w
he
re
no
im
pro
ve
me
nt
is d
ete
cte
d
pro
ble
m
rep
ort
ing
ide
nti
fy
care
ne
ed
cre
ate
ca
re p
lan
de
term
ine
solu
tio
n
pa
th
dra
w u
p
req
uir
e-
me
nts
sele
ct,
try
an
d
de
cid
e
de
liv
er
an
d
inst
ruct
use
ev
alu
ate
I h
av
e a
he
alt
h
an
d/o
r
fun
ctio
na
l
pro
ble
m
Th
is i
s m
y
care
ne
ed
clie
nt’
s p
ers
pe
ctiv
e
I d
o/d
o n
ot
ne
ed
a
me
dic
al
de
vic
e a
nd
I
kn
ow
wh
at
tha
t d
ev
ice
(th
ose
de
vic
es)
is
(are
)
My
me
dic
al
de
vic
e m
ust
sa
tisf
y t
he
se
req
uir
em
en
ts.
Li
nk
be
twe
en
e
xpe
cta
tio
ns
(hu
ma
n-r
ela
ted
in
ten
de
d u
se)
an
d t
he
pro
du
ct
fea
ture
s (p
rod
uct
-re
late
d
inte
nd
ed
use
)
Th
is i
s th
e
be
st c
ho
ice
for
me
Th
e d
ev
ice
ha
s b
ee
n
de
liv
ere
d t
o
me
an
d I
un
de
rsta
nd
ho
w t
o u
se i
t
I u
se t
he
de
vic
e
corr
ect
ly
Th
e d
ev
ice
do
es
wh
at
I
wa
nt.
I a
m
cap
ab
le o
f
reco
gn
isin
g
pro
ble
ms
in
go
od
tim
e
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 determ
ining 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 inform
ation
Approach a care expert
Identification of the client’s
problem
Provide inform
ation about the
options for tackling the
problem
problem reporting I h
ave a
healt
h a
nd/or f
uncti
onal proble
m
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 inform
ation
6
Identify care need This
is m
y c
are n
eed
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
Determ
ine state of health:
make a m
edical diagnosis,
functional diagnosis and define
expectations
I know what my care need is
Ask questions if inform
ation
is unclear or insufficient
Give adequate inform
ation to
the client about the disability and
the functional problems
I have clear and adequate
inform
ation about the disability
and m
y 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
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; healthcare-related directives,
for example: “checklist WGBO” issued by the KNMG; reliable inform
ation
7
create care plan: determine solution path
I d
o/do n
ot
need a
medic
al devic
e a
nd I
know
what
that
devic
e (
those d
evic
es) 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 m
y
environment
Discuss and agree the
treatm
ent goal(s)
Define treatm
ent goal(s) (in
term
s of prevention, recovery,
compensation and improvement)
and explain this (these) to the
client
I have enough inform
ation and
agree to the treatm
ent goal(s)
Describe the desired level of
function (what the client wants and
is capable of, and what is
perm
issible 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 m
edical device as
(part of) the solution
Determ
ine whether a m
edical
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
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, ISO 9999, Cliq, WGBO; health expense refund
arrangements;
healthcare-related guidelines, for example checklist WGBO, Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable inform
ation
8
create care plan: determine solution path
I d
o/do n
ot
need a
medic
al devic
e a
nd I
know
what
that
devic
e (
those d
evic
es) is (
are)
Client
actions
Care expert actions
Result for client
Discussion of agreement to the
choice of type of medical device
or devices (go/no go)
Determ
ine which m
edical
device(s)
is (are) appropriate for the
treatm
ent 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, term
s 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 (w
ritten) in-
form
ation and gain client’s
consent for
the care plan
I have been adequately
inform
ed 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 term
s and
conditions that apply to the
provision of the m
edical
devices.
Find out whether the client is
aware that there m
ay be
financial consequences for
him/her personally and provide
guidance if required
I know what refund
arrangements apply to m
y
situation
I know what the use of the
medical device m
eans in term
s
of instruction, training, use and
after-care
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, ISO 9999, Cliq, WGBO; health expense refund
arrangements;
healthcare-related guidelines, for example checklist WGBO, Hulpmiddelenkompas, Proguide and Hoorwijzer; reliable inform
ation
9
create care plan: draw up requirements
Client actions
Care expert actions
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 term
s and conditions
in relation to refunds
Agree a list of requirements
(inform
ed consent; see the
explanatory summary on the
following page)
In collaboration with the client,
match client requirements in
relation to the treatm
ent goal,
desired level of function and
expectations in respect of the
device (human-related
intended use) to the required
product features (product-
related intended use)
Provide inform
ation 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
term
s of devices and product
features
List of requirements has been
completed: I know the
requirements with which the
device m
ust comply
I know what this m
eans in
term
s 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 inform
ation
10
create care plan: draw up requirements D
iagram
sum
maris
ing t
he lis
t of
requir
em
ents
Client
Device
Desired level of function
Functions, activities and participation that the
user wants to, is able to and m
ay perform
Human-related intended use
What the device m
ust 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
. shoppin
g, sports), or
which are to be taken over by the device (e.g
.
clim
bin
g sta
irs)
Functions that are supported by the
device (e.g
. bre
ath
ing) or taken over by it
(e.g
. collecting u
rine)
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
. clim
bin
g sta
irs)
Disabilities that are alleviated by the
device (e.g
. m
isalignm
ent or re
duced
load-b
earing capability o
f a join
t)
B Technical features of the device that
determ
ine to what extent the desired
level of function can be achieved (e.g
.
modified h
andle, sto
rage capacity o
f
300 m
l)
C Features of the device that play a role
in determ
ining its ease of use (e.g
.
ability to take the d
evice w
ith y
ou,
ease w
ith w
hich it can b
e p
ut 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 t
he b
est
choic
e f
or m
e
The 2
nd a
nd 3
rd choices should
also b
e liste
d h
ere
(if p
ossible a
nd n
ecessary
), so that an im
mediate
switch
to the seco
nd choice can be m
ade
if the initial re
sults are
disappointing
Client
actions
Care expert actions
Result for client
Select an adequate device from
the available products on offer
(NB: off-the-shelf product, with
individual modifications if
required or made-to-m
easure)
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 perm
itted 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 treatm
ent goal, the
desired level of function and
the intended use (human-
related intended use)
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 m
odels
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 m
odel
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 inform
ation
12
delivery and instruction
The d
evic
e h
as b
een d
elivered t
o m
e a
nd I
understa
nd h
ow
to u
se it
Client
actions
Care expert actions
Result for client
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 m
anual and the
term
s 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 m
y device
Explain what maintenance is
required
I know how I should m
aintain
my device
13
use I u
se t
he d
evic
e c
orrectl
y
Client
actions
Care expert actions
Result for client
Training
Use as instructed
Training
I am capable of using the device
correctly
Comply with m
aintenance
instructions
I am capable of maintaining
the device m
yself
(NB service and warranty term
s
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
Regulatory frameworks determining the detailed description of the actions:
Classifications and standards, these include: ICF, WGBO, Classification of treatm
ent in order to clarify the type of training and
after-care;
healthcare-related guidelines; reliable inform
ation; term
s and conditions of servicing and warranty
14
evaluate
Client actions
Care expert actions
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 treatm
ent 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 d
evic
e d
oes w
hat
I w
ant.
I a
m c
apable
of
recognis
ing p
roble
ms in g
ood t
ime
Result for client
I know to what extent the
device allows m
e 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
Regulatory frameworks determining the detailed description of the actions:
Classifications and standards, these include: WGBO, ICF, ISO 9000 (complaints procedure); Global medical device nomenclature;
healthcare-related guidelines; reliable inform
ation; evaluation tools such as D-quest and Quote questionnaires
15
Definitions and explanation of terms
Term
s 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 B
eslu
it M
edische H
ulp
mid
delen (Dutch Medical Devices
Decree) than in healthcare insurance legislation, the AWBZ,
Wmo and W
IA.
This is w
hy it is so important to clearly define common term
s 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 term
s (again) or defining the
meaning of term
s.
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
Treatm
ent goal: the goal(s) of the care plan in term
s 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 perm
itted to do. The
description m
ust 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 perform
ing activities. A constraint may be a slight or
serious problem in a qualitative or quantitative sense when perform
ing the activity.
ICF
Reliable information: independent and up-to-date inform
ation, 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 m
edical
devices is Council Directive 93/42/EEC of 14 June 1993. The Directive is intended to allow the free m
ovement 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 m
ust 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-m
easure devices and devices for clinical
research, medical devices m
ust comply with essential requirements defined in Article 3 of the European Directive for
Medical Devices and must carry a CE conform
ity label if m
ade commercially available.
Client characteristics: intended use associated with the user: see human-related intended use.
D-Quest: an instrument that can be used to m
easure client satisfaction in relation to the issue of a m
edical 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 m
eans that the respondent’s opinion
(i.e. the opinion of the m
edical 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 m
an-m
ade 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 m
edical device and related care. This m
ay be the consumer
himself, the insurer, the m
unicipality,
employer or body paying state benefit (W
IA, 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 m
edical device (off the shelf, ready for use) is one that has been designed and
manufactured to satisfy specific functional needs and is norm
ally only available in a number of sizes. The device does
not need to be m
ade to m
easure by the supplier (prosthetic engineer or orthotist) in order to adapt it for use by an
individual user. A prefabricated m
edical device is m
anufactured in large volumes on an industrial scale based on standard
sizes and m
odels. If required, it can be adjusted and set for use by individual users based on instructions and
inform
ation provided by the m
anufacturer.
A prefabricated m
edical device m
ay only be m
ade commercially available if it complies with the Medical Devices
Directive and carries a CE conform
ity m
ark.
Free
interpretation of
Cliq
Prefabricated with individual modifications: A prefabricated m
edical device that is only suitable for use by a single
specific user after it has been m
odified to fit (individually fitted). The prefabricated m
edical device is m
anufactured
based on standard m
odels or patterns and does not cover all individual characteristics. An integral prefabricated
medical device that has been m
odified to suit a certain size is an individually fitted device that has the same status as
one that is m
ade to m
easure. 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 m
edical devices. The process starts when the problem
is reported and ends when the evaluation indicates that the m
edical device has achieved the desired goal. The process
may be term
inated prematurely if the m
edical device is found not to be a suitable solution. Entry into the process at an
interm
ediate stage is possible when the m
edical 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 m
ust make possible in term
s of the desired level of function
or must do in the opinion of the user.
The m
edical device m
ust assist him/her in the perform
ance of activities (e.g. a wheeled frame when walking)
or, alternately, the m
edical device m
ust take over certain activities (e.g. a stair lift for a person who can no
longer climb stairs);
The m
edical device m
ust support functions (e.g. an oxygen m
ask for breathing problems) or reduce the level of
disability (e.g. incontinence m
aterials 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 m
ental 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 m
ental 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 term
s.
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, m
edical
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 m
edical device;
the level of function that is achieved after issue of the m
edical device (human-related intended use).
WHO-FIC
19
ICF
Dia
gra
m
dis
ea
ses
| a
ilm
en
ts
fun
ctio
ns/
an
ato
mic
ch
ara
cte
rist
ics
(d
isa
bil
itie
s)
act
ivit
ies
(c
on
stra
ints
)
pa
rtic
ipa
tio
n
(pa
rtic
ipa
tio
n p
rob
lem
s)
ex
tern
al
fact
ors
po
siti
ve
an
d n
eg
ati
ve
pe
rso
na
l fa
cto
rs
po
siti
ve
an
d n
eg
ati
ve
Definitions
Sources
ICPC-2-nl: the International Classification of Primary Care (ICPC) is intended to regulate the general medical practitioner
domain. This classification m
akes it possible to name and code the m
ost 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 term
s. 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 m
edical device that is m
ade to m
easure (individually m
ade), is designed and manufactured
in order to satisfy the functional needs of an individual user based on inform
ation taken from a m
odel, imprint, set of
measurements, scan, drawing or image. The m
edical device is intended for the sole use of a specific person.
The m
edical device is specially m
anufactured in accordance with the prescription of an appropriately qualified doctor who
is responsible for determ
ining the special properties of the design. The prescription referred to above m
ay also be
issued by another person who is professionally qualified to do so.
Prefabricated m
edical devices that have been m
odified to fit and are designed to satisfy specific functional
requirements of individual users are considered to be bespoke m
edical 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 form
ulation 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
term
inology 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 m
ay expect. This is therefore a feature that has legal status. This
involves the following types of product characteristics:
The functionality of the m
edical device: Activities for which the m
edical 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 m
edical device: these characteristics determ
ine the extent to which the
functionality is achievable: e.g. how absorbent the incontinence m
aterial is, how stiff the m
aterial is, what forces
can be absorbed;
BMH
20
Definitions
Sources
The user convenience and comfort offered by the m
edical device: what are the m
aterial 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 m
edical device: characteristics that determ
ine the appearance of the m
edical 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 m
edical device: see product-related intended use.
List of Requirements: a list of the requirements that apply to a m
edical device. The list of requirements is generated
by m
atching the expectations associated with the m
edical device (human-related intended use) to the general product
characteristics (product-related intended use).
Hulpmiddelen
Kompas
Protocol: specific m
odification of a care-related guideline for use in a particular environment.
NVN-EN 13940
Selection: selection of the m
edical 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 inform
ation
in a responsible way in accordance with the W
GBO and to gain the client’s well-considered consent. Among other things, the
practical toolkit contains a m
anual for patients, a checklist for care providers and a model guideline for care providers on
inform
ation and consent for an examination or treatm
ent.
Combined
organisation’s
implementation
programme for
the W
GBO
Training: learning how to use the m
edical device. Training focuses on developing sufficient proficiency in the use of
the m
edical device in order to compensate for the functional problem.
WGBO: the goal of the W
GBO (Dutch Medical Treatm
ent 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 W
GBO is
the legal framework that determ
ines the (contractual) relationship between the care provider and the patient. The
patient’s m
ain rights in his/her relationship with a care provider are specified in the W
GBO.
KNMG: Final
WGBO report:
van wet naar
praktijk
(from
legislation to
practical
implementati
on)
Care expert: A person who is active in directly providing healthcare treatm
ent.
Explanation: th
e care
expert com
plies w
ith the p
revailin
g requirem
ents
in relation to com
pete
nces a
nd skills a
nd
work
s in a
ccord
ance w
ith the p
revailin
g q
uality
guidelines.
NVN-EN 13940
21
Definitions
Sources
Care file: All the inform
ation that is available in relation to the state of health of the person receiving care.
Additional com
ment m
ade b
y the superv
isory
gro
up: in
clu
din
g the d
iagnosis a
nd tre
atm
ent th
at has b
een
dete
rmin
ed for th
e p
ers
on receivin
g care
and the tre
atm
ent agre
em
ent.
NVN-EN 13940
Care-related guideline: set of systematically developed instructions that support care parties when m
aking
decisions about the provision of treatm
ent 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 p
rocess d
escription, we h
ave u
sed the term
‘client’ for th
is 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 treatm
ents that a care expert can provide to a care recipient.
Explanation: th
e care
plan m
ay conta
in tre
atm
ents
pro
vided b
y m
ultiple care
experts.
NVN-EN 13940
Care need: a need for treatm
ent of a care recipient that is form
ulated by one of the care parties.
Additional com
ment: the care
expert (or experts) defines (or define) th
e care
based o
n input from
the client. T
he client
is som
etim
es n
ot capable o
f pro
vidin
g this input, w
hich m
ust th
en b
e p
rovided b
y o
thers
on h
is/h
er behalf (pare
nt(s),
partner). Som
etim
es, th
e care
need d
escribed b
y o
ther directly involved p
arties is significantly d
iffe
rent to
the client’s
actu
al re
quirem
ent. T
he care
expert m
ust be a
lert to this. See a
lso the W
GBO.
NVN-EN 13940
22
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
term
inology 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 term
inology for similar steps and the
same term
inology 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 m
odel at a m
eta level;
• define a uniform
term
inology.
The CVZ drew up a plan of action for im
proving the exchange
of inform
ation 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
form
ed in order to create broad support for the product. This
action plan w
as approved by the m
embers of the w
orking group
and supervisory group in August 2003.
During a kick-off m
eeting held on 6 N
ovember 2003, the working
group and supervisory group again discussed the primary
assumptions, working m
ethod 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 w
ould then decide w
hich subsequent steps w
ere 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 w
as to ensure the
practical usability of the process description by providing
input from and circulating the results to their m
embers.
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 without 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 m
edisch specialisten), from October 2004.
Supervisory group
• CG-Raad (Piet Vreeswijk)
• CSO (Peter Kruitbosch)
• KNMG (Michiel Wesseling)
• SOMT (Roelf van Run/m
r. Ron de Graaff)
• Orthobanda/M
KB (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
• W
im van Harten (Chairman of the supervisory group and
working group)
• Paul Iske (knowledge m
anager)
• Nieske Heerema (medical advisor)
• Arnold van Halteren (project leader).
24
use
