IEC TR 62653:2012
(Main)Guideline for safe operation of medical equipment used for haemodialysis treatments
Guideline for safe operation of medical equipment used for haemodialysis treatments
IEC 62653:2012(E) which is a technical report, describes the technical requirements for use of equipment in haemodialysis, haemofiltration and haemodiafiltration. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the haemodialysis treatment prescription. However, the organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the scope may be applicable to the use of the equipment in paediatrics, home haemodialysis, acute and sorbent dialysis systems. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
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IEC/TR 62653 ®
Edition 1.0 2012-06
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
IEC/TR 62653:2012(E)
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IEC/TR 62653 ®
Edition 1.0 2012-06
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
U
ICS 11.040.20; 11.040.25 ISBN 978-2-83220-133-6
– 2 – TR 62653 © IEC:2012(E)
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 12
4.1 Personnel, qualification . 12
4.2 Training . 12
4.3 Infrastructure . 12
4.3.1 General . 12
4.3.2 Infrastructure requirements . 13
5 Treatment . 15
5.1 General . 15
5.2 Preparation . 15
5.2.1 DIALYSIS MACHINE . 15
5.2.2 * DIALYSIS FLUID PREPARATION . 15
5.2.3 * EXTRACORPOREAL CIRCUIT . 16
5.2.4 DIALYSIS FLUID compartment . 16
5.2.5 PATIENT . 16
5.3 Treatment . 17
5.3.1 Preparing the vascular access . 17
5.3.2 * Connection to the EXTRACORPOREAL CIRCUIT . 17
5.3.3 Initiation of treatment . 17
5.3.4 Checks to be repeated during the treatment . 18
5.3.5 * HAZARDS during the treatment . 19
5.3.6 Deviations from the treatment parameters prescribed or treatment
interruption . 19
5.3.7 Terminating the DIALYSIS treatment . 20
5.3.8 * After completion of the dialysis treatment . 20
6 Notification of INCIDENTS . 20
7 Handling medical devices . 20
7.1 Technical service, SERVICING and checks of equipment and plants . 20
7.2 * Equipment safety and device combinations . 21
7.3 Non-INTENDED USE . 21
Annex A (informative) Explanatory technical remarks . 22
Bibliography . 28
Index of defined terms used in this guideline. 30
Figure 1 – Example PATIENT ENVIRONMENT . 10
Figure A.1 – Typical central DIALYSIS FLUID delivery system, CDDS . 26
TR 62653 © IEC:2012(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
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with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 62653, which is a technical report, has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62D/976/DTR 62D/1006/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
– 4 – TR 62653 © IEC:2012(E)
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The verbal forms used in this guideline are conform to usage described in Annex H of the
ISO/IEC Directives, Part 2, 2011.
For the purpose of this informative guideline the auxiliary verb ”should“ means that this
statement of the guideline is recommended for safe operation. This term is not to be
interpreted as indicating requirements.
In this guideline the following print types are used:
– Requirements and definitions: roman type;
– Informative material, such as notes, examples and references: smaller type;
– TERMS DEFINED IN THIS GUIDELINE OR AS NOTED: SMALL CAPITALS.
An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that
there is guidance or rationale related to that item in Annex A.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
TR 62653 © IEC:2012(E) – 5 –
INTRODUCTION
HAEMODIALYSIS is a therapeutic method for treating terminal renal insufficiency, in addition to
peritoneal dialysis and renal transplantation. HAEMODIALYSIS is often used as a general term
for related extracorporeal methods of renal replacement therapy. At present, HAEMODIALYSIS is
a standard procedure in renal replacement therapy, which, when applied properly, yields high-
quality results. The treatment is a complex procedure which is under the influence of medical-
biological, physical-chemical and technical processes.
Numerous guidelines, agreements, codes, decrees and laws have been established with
regard to HAEMODIALYSIS. They contain detailed regulations about the quality of structures,
processes and results, laid down by the legislative body, executive bodies of self-government,
and funding agencies.
Since the safety of PATIENT treatment and the legal provisions are highly important, it is
reasonable to introduce a quality management system. This technical report may be an
integral part of a quality management system of the ORGANIZATION. The ORGANIZATION should
identify the residual risks, for example based on these guidelines. The ORGANIZATION should
minimise such risks by the use of appropriate standard operating procedures. This document
is intended to support the clinical management responsible for the quality management of
HAEMODIALYSIS therapies.
– 6 – TR 62653 © IEC:2012(E)
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
1 Scope
This technical report describes the technical requirements for use of equipment in
HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be
complied with to ensure safe, permissible and proper application.
The physician is responsible for the HAEMODIALYSIS treatment prescription. However, the
ORGANIZATION administering the treatment is responsible for all resources, structures and
processes used in connection with the treatment. These responsibilities will not be described
here.
If applicable, the scope may be applicable to the use of the equipment in paediatrics, home
HAEMODIALYSIS, acute and SORBENT DIALYSIS SYSTEMS.
The requirements of IEC 60601-2-16 ensure that equipment used for extracorporeal renal
replacement therapy operates with a high level of safety. Despite that high level of safety,
however, some residual risk remains, related to medical-biological, physical-chemical and
technical HAZARDS. The ORGANIZATION administering the treatment is responsible for managing
the residual risk.
This technical report is not intended to be used as the basis of regulatory inspection or
certification assessment activities.
2 Normative references
None.
NOTE Informative references including IEC and ISO standards are listed in the Bibliography on page 28.
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
NOTE An index of defined terms is found on page 30.
3.1
ACCESSORY
additional part for use with equipment in order to:
– achieve the INTENDED USE,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
Note 1 to entry: Accessories can be objects, substances, preparations of substances and software which do not
constitute any medical devices themselves.
[SOURCE: IEC 60601-1:2005, 3.3, modified – a note to entry has been added.]
TR 62653 © IEC:2012(E) – 7 –
3.2
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post-pump pressure, which is downstream of the blood pump.
[SOURCE: IEC 60601-2-16:2012, 201.3.201]
3.3
BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the
DIALYSER
Note 1 to entry: Not to be mistaken for blood loss to the environment.
[SOURCE: IEC 60601-2-16:2012, 201.3.202, modified – the original note to entry has been
replaced.]
3.4
DIALYSER
a device containing a semi-permeable membrane that is used to perform HAEMODIALYSIS,
HAEMODIAFILTRATION or HAEMOFILTRATION
[SOURCE: IEC 60601-2-16:2012, 201.3.204]
* 3.5
DIALYSIS FLUID
aqueous fluid containing electrolytes and usually buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS
Note 1 to entry: The term “DIALYSIS FLUID” is used throughout this document to mean the fluid made from DIALYSIS
WATER and concentrates which is delivered to the DIALYSER by the DIALYSIS FLUID delivery system. Such phrases as
“dialysate”, “dialysis solution” or “dialysing fluid” may be used in place of DIALYSIS FLUID.
Note 2 to entry: The DIALYSIS FLUID entering the DIALYSER is referred to as “fresh DIALYSIS FLUID”, while the fluid
leaving the DIALYSER is referred to as “spent DIALYSIS FLUID”.
Note 3 to entry: DIALYSIS FLUID does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as HAEMODIAFILTRATION and HAEMOFILTRATION.
[SOURCE: ISO 11663:2009, 3.7]
* 3.6
DIALYSIS MACHINE
HAEMODIALYSIS MACHINE
HAEMODIAFILTRATION MACHINE
HAEMOFILTRATION MACHINE
system or combination of units used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION
Note 1 to entry: The DIALYSIS MACHINE can be a batch DIALYSIS MACHINE filled with the entire DIALYSIS FLUID prior
to treatment (see Clause A.6).
Note 2 to entry: The DIALYSIS MACHINE can be supplied with DIALYSIS FLUID from a central DIALYSIS FLUID delivery
system (see Clause A.7).
3.7
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 13959 and which is suitable for
use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID, reprocessing of
DIALYSERS, preparation of concentrates and preparation of substitution fluid for online
convective therapies
– 8 – TR 62653 © IEC:2012(E)
[SOURCE: ISO 13959:2009, 2.5]
3.8
ENCLOSURE
exterior surface of electrical equipment or parts thereof
Note 1 to entry: Including all touchable parts, such as rotary knobs, handles, and the like.
[SOURCE: IEC 60601-1:2005, 3.26, modified – the original note to entry has been replaced.]
* 3.9
EXTRACORPOREAL CIRCUIT
blood lines and any integral ACCESSORY thereof
[SOURCE: IEC 60601-2-16:2012, 201.3.207]
3.10
HAEMODIAFILTRATION
HDF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by a simultaneous
combination of HD and HF
[SOURCE: IEC 60601-2-16:2012, 201.3.208]
3.11
HAEMODIALYSIS
HD
PATIENT's blood and an
process whereby concentrations of water-soluble substances in a
excess of fluid of a PATIENT with renal insufficiency are corrected by bidirectional diffusive
transport and ultrafiltration across a semi-permeable membrane separating the blood from the
DIALYSIS FLUID
Note 1 to entry: Usually, this process includes bidirectional filtration, with fluid removal normally being
predominant.
[SOURCE: IEC 60601-2-16:2012, 201.3.209, modified – the original note to entry has been
replaced.]
3.12
HAEMOFILTRATION
HF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by unidirectional convective
transport via ultrafiltration across a semi-permeable membrane separating the blood from the
ultrafiltrate and ultrafiltrate is simultaneously replaced by an approximately iso-osmolar
substitution fluid at a rate such that the difference between the ultrafiltration rate and the rate
of substitution fluid addition will lead to removal of the excess fluid over the course of the
treatment
[SOURCE: IEC 60601-2-16:2012, 201.3.211, modified – an error has been corrected]
3.13
HAZARD
potential source of harm
[SOURCE: ISO 14971:2007, 2.3]
TR 62653 © IEC:2012(E) – 9 –
3.14
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD(S)
[SOURCE: IEC 60601-1:2005, 3.40]
3.15
INCIDENT
malfunction, failure or modification of the features or the performance, or an inadequate or
incorrect labeling or instructions for use of a medical device, which directly or indirectly
resulted in, could have resulted in or might result in the death or a severe deterioration of the
state of health of a patient, an OPERATOR or another person
3.16
INTENDED USE
INTENDED PURPOSE
use for which a product, process or service is intended according to the specifications,
instructions and information provided by the MANUFACTURER
[SOURCE: ISO 14971:2007, 2.5]
3.17
MAINTENANCE
combination of all technical and administrative means, including supervising ones, to keep or
restore a unit in working condition
Note 1 to entry: Unit can be a device or a system.
[SOURCE: IEC 62353:2007, 3.19, modified – a note to entry has been added.]
3.18
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging or labelling
of medical electrical equipment, assembling a medical electrical system, or adapting medical
electrical equipment or a medical electrical system, regardless of whether these operations
are performed by that person or on that person's behalf by a third party
[SOURCE: IEC 60601-1:2005, 3.55, modified – the original notes to entry have been deleted.]
3.19
MODIFICATION
changing constructional or functional features of medical electrical equipment or a medical
electrical system in a way not described in its accompanying documents (instructions for use)
[SOURCE: IEC 62353:2007, 3.23, modified – a note to entry has been deleted and a
reference to instructions for use has been added.]
3.20
OPERATOR
person handling equipment
[SOURCE: IEC 60601-1:2005, 3.73, modified – the original note to entry has been deleted
because not relevant in the context of the present document.]
– 10 – TR 62653 © IEC:2012(E)
3.21
ORGANIZATION
entity of the persons and/or institutions responsible for the use and MAINTENANCE of systems
for extracorporeal renal replacement therapy
EXAMPLES Doctor's office, dialysis center and dialysis clinic.
3.22
PATIENT
living being (person or animal) undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005, 3.76]
3.23
PATIENT ENVIRONMENT
any volume in which intentional or unintentional contact can occur between a PATIENT and
parts of the medical electrical equipment or medical electrical system or between a PATIENT
and other persons touching parts of the medical electrical equipment or medical electrical
system
Note 1 to entry: Volume here means room area.
Note 2 to entry: An example of PATIENT ENVIRONMENT is shown in Figure 1.
1,5 m
1,5 m
1,5 m
IEC 2431/05
Figure 1 – Example PATIENT ENVIRONMENT
[SOURCE: IEC 60601-1:2005, 3.79, modified – two notes to entry have been added, including
a figure illustrating the term.]
* 3.24
PATIENT LEAKAGE CURRENT
current coming from an electric device and flowing through the PATIENT to the ground
TR 62653 © IEC:2012(E) – 11 –
Note 1 to entry: The source of such a current may, for example, be a defective electric heater of the DIALYSIS
MACHINE. The current may be transmitted through the conducting DIALYSIS FLUID and to the PATIENT.
[SOURCE: IEC 60601-1:2005, 3.80, modified – definition simplified and a note to entry has
been added.]
3.25
POTENTIAL EQUALIZATION CONDUCTOR
conductor other than a protective earth conductor or a neutral conductor, providing a direct
connection between electrical equipment and the potential equalization busbar of the
electrical installation
[SOURCE: IEC 60601-1:2005, 3.86]
3.26
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDS which can arise
[SOURCE: IEC 60601-2-16:2012, 201.3.215]
3.27
REPAIR
means for reconstitution of a defined condition
[SOURCE: IEC 62353:2007, 3.35]
3.28
SERVICING
combination of all means for maintaining the medical electrical equipment or medical
electrical system within requirements of the MANUFACTURER
[SOURCE: IEC 62353, 3.37]
3.29
SORBENT DIALYSIS SYSTEM
method of dialysis where DIALYSIS FLUID is generated from potable water and spent DIALYSIS
FLUID is regenerated into fresh DIALYSIS FLUID by recirculation through a sorbent cartridge
which removes uremic toxins from the DIALYSIS FLUID while replenishing other beneficial
chemicals
* 3.30
TOUCH CURRENT
current not necessary for proper functioning, coming from the ENCLOSURE or parts thereof
(except PATIENT connectors), which the OPERATOR or PATIENT may touch while using the
equipment as intended and flowing to the ground or another part of the ENCLOSURE after
having passed through an external connection (except the protective earth conductor)
3.31
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT
[SOURCE: IEC 60601-2-16:2012, 201.3.219]
– 12 – TR 62653 © IEC:2012(E)
4 Requirements
4.1 Personnel, qualification
OPERATORS should be qualified and have received the appropriate training for the activities
assigned to them, including the operation of all medical devices and associated disposables
and supplies.
If treatment is undertaken at home, the PATIENT and/or the person taking care of the PATIENT
should also be appropriately trained not only in the operation of the medical device, but also
in the procedures that should be followed in the event of an INCIDENT arising from the use of
the equipment.
4.2 Training
OPERATORS/PATIENTS should be trained for the activity assigned to them:
a) The ORGANIZATION should only assign persons who have been trained in the INTENDED USE
of the devices that they will operate (see 7.3). Particular attention should be paid to the
OPERATOR´s responsibility in following the instructions for use, the warnings and
precautions outlined by the MANUFACTURER.
b) The training should be based on the valid instructions for use and include any unit
protocols, including actions or interventions needed in case of alarms, cautions, or
equipment failure. The instructions for use should be available at any time.
c) Only ORGANIZATIONS who have received training from the MANUFACTURER can develop a
training program to train additional personnel within that ORGANIZATION to operate the
devices.
d) The ORGANIZATION should develop training material that ensures a comprehensive,
structured training program to include 1) training outline, 2) goals and objectives, 3)
maximum number of trainees, 4) duration of training program for the staff of the
ORGANIZATION.
e) The training program for PATIENTS should include but not be limited to: techniques
associated with the specific modality, prescription, effective administration of medications,
how to detect, report, and manage dialysis complications both medical and non-medical.
f) If MODIFICATIONS by the MANUFACTURER become necessary, the MANUFACTURER decides to
what extent an additional training guided by the MANUFACTURER is necessary.
g) The completion of any training programme should be documented by the ORGANIZATION.
The systems should be operated according to the MANUFACTURER’S instructions and based on
the knowledge and skills required for the particular medical treatment. These application
principles and/or any brief operating instructions do not replace the detailed instructions for
use or a qualified training in the handling of the systems.
4.3 Infrastructure
4.3.1 General
Safe performance of an extracorporeal renal replacement therapy requires that all
components of the system work harmoniously as intended; the systems should be used in the
appropriate rooms and drugs and medical devices should be within specified tolerances.
DIALYSIS MACHINES are provided with PROTECTIVE SYSTEMS (e.g. for monitoring the conductivity,
the temperature of the DIALYSIS FLUID and the VENOUS PRESSURE as well as for detecting BLOOD
LEAKS and air in the EXTRACORPOREAL CIRCUIT). Such PROTECTIVE SYSTEMS may be subject to
damage and should, therefore, be checked for proper functioning at regular intervals
according to the MANUFACTURER’S instructions. Failure to complete the automated checks prior
to commencement of the dialysis procedure places the PATIENT at risk, and technical advice
prior to the commencement of the treatment should be sought.
TR 62653 © IEC:2012(E) – 13 –
4.3.2 Infrastructure requirements
4.3.2.1 Technical requirements in rooms
Rooms which are intended for employment of HAEMODIALYSIS systems according to
IEC 60601-1 are medically used rooms of Group 1 as defined in IEC 60364-7-710.
The electric connection of a DIALYSIS MACHINE of class I should be established by a socket
outlet with tested grounding by protective earth and a plug which cannot be mistaken for other
socket outlets.
Possible examples are: socket outlets and plugs according to IEC 60309-2, colour code
identification of the power socket dedicated to the machine. Power cord and plugs should be
MANUFACTURER´s instructions.
according to
Each treatment location should be provided with an additional potential equalization connector
tested according to IEC 60364-7-710, (see 710.413.1.6, additional potential equalization, of
IEC 60364-7-710:2002). If central venous catheters with atrial location are used for the
vascular access, special measures might be necessary for complying with electrical safety
requirements [10, 11, 12, 13]. The MANUFACTURER´S instructions should be followed.
If an emergency occurs during the dialysis treatment, it should be possible to alert the person
taking care of the PATIENTS.
In order to prevent the DIALYSIS MACHINE from being contaminated with viruses, bacteria,
endotoxins and fungi by retroactive effect from the drain, the device MANUFACTURER’S
instructions in the instructions for use should be followed for installation of the drain tube.
In addition, it is recommended that drains intended to discharge the spent DIALYSIS FLUID be
provided with a stench trap.
If conditions are unfavourable, e.g. in case of backflow, the DIALYSIS MACHINE might become
contaminated. To prevent this, the minimum distance of the drain opening from the level of
the sewage water should not be less than 2 cm or according to the MANUFACTURER’S
specification.
4.3.2.2 Water treatment and distribution
ISO 23500 should be taken as reference.
4.3.2.3 Concentrate supply
ISO 23500 should be taken as reference.
4.3.2.4 Responsibilities for on-site preparation of fluids
ISO 23500 should be taken as reference.
4.3.2.5 Infection control
Each ORGANIZATION should have in place an infection control plan for the protection of
PATIENTS and personnel against infections [1] .
The infection control plan should include specification of how to manage both sterile supplies
and aseptic techniques. In addition the infection control plan describes management of
—————————
Numbers in square brackets refer to the Bibliography.
– 14 – TR 62653 © IEC:2012(E)
cleaning and disinfecting equipment and environmental services according to MANUFACTURER's
instructions and country specific regulations.
When the fluid pathways of DIALYSIS MACHINES are disinfected, the MANUFACTURER’s
instructions should be followed.
The infection control plan should include the disinfectant to be used for surface disinfections,
the required concentration and the minimum exposure time required by the disinfecting agent.
If the infection status of PATIENTS is unknown with regard to blood-borne virus infections, the
appropriate measures should be taken to exclude any contamination of other PATIENTS.
Special measures are required for PATIENTS with virus infection transferred by blood according
to country regulations [2].
Measures for the return of DIALYSIS MACHINEs used on PATIENTS with blood-borne virus
infections to a non-infectious area are, for example, described in “Guideline for Applied
Hygiene in Dialysis Units” [1].
4.3.2.6 Other prerequisites
The equipment combinations covered by the INTENDED USE of the system are defined by the
MANUFACTURERS in their instructions for use and are applicable.
4.3.2.7 Home HAEMODIALYSIS requirements
If the HAEMODIALYSIS equipment and associated water treatment equipment are used in the
PATIENT’S home, the requirements specified by the MANUFACTURER should be followed. To
comply with local requirements, it may additionally be necessary for the installation to be
examined by an approved expert to ensure that the quality of the alterations meets the
requirements specified by the MANUFACTURER of the DIALYSIS MACHINE and by the
MANUFACTURER of the water treatment equipment.
It is recommended that home HAEMODIALYSIS PATIENTS have a communication device to permit
contact with the supervising ORGANIZATION in the event of a medical emergency and a backup
communication device in case of malfunction of the first communication device.
It is recommended that the room used for HAEMODIALYSIS contains emergency lighting
equipment such a flashlight or torch to provide illumination in the event of a power failure.
The PATIENT or carer should also be appropriately trained as to what procedures to follow in
the event of a mains power failure.
It is recommended that initial and periodic assessment of the home environment be performed
to ensure that it meets the necessary technical and operational requirements; physical space,
plumbing requirements, water requirements, electrical requirements, storage and waste
management, and documentation.
NOTE The considerations in Annex F of ISO 23500 and in IEC 60601-1-11 should also be taken into account.
4.3.2.8 Information technology (IT) management [20]
There is widespread utilization of IT technology in hospitals or provided by third parties, and
in many dialysis units the HAEMODIALYSIS MACHINES can also be linked to such infrastructures,
HAEMODIALYSIS PATIENTS there may be a linkage to remote monitoring
whilst for home
infrastructures that may be operated by third parties rather than the hospital. The use of IT
infrastructures poses two issues: safety of the PATIENT, and data protection.
It is recommended for the ORGANIZATION to follow the standards below in dealing with above
issues:
TR 62653 © IEC:2012(E) – 15 –
• IEC 80001 series: Application of risk management for IT-networks incorporating medical
devices;
• ISO/IEC 27001: Information technology – Security techniques – Information security
management systems – Requirements.
IT risk management should be established from the beginning and subject to continuous
review. Technical and organizational security measures cannot be treated casually in either a
hospital or an office setting; there need to be defined objectives, safeguards and
responsibilities as well as defined policies well-known to all staff members. IT security should
be checked regularly including existing work routines to ensure that they are suitable and
efficient.
5 Treatment
5.1 General
The HAEMODIALYSIS treatment should be carried out by qualified OPERATORs under the
physician’s responsibility. The physician determines the prescription of the HAEMODIALYSIS
treatment, e.g. dialysis time, treatment frequency, DIALYSER, composition of the DIALYSIS FLUID,
blood flow, DIALYSIS FLUID temperature, anticoagulation if needed, and ultrafiltration rate. The
OPERATOR should only use information on DIALYSIS MACHINE displays for its INTENDED USE.
5.2 Preparation
5.2.1 DIALYSIS MACHINE
Before the dialysis treatment the DIALYSIS MACHINE should be checked for correct connections
(e.g. power supply, POTENTIAL EQUALIZATION CONDUCTOR, water, concentrate or DIALYSIS FLUID
supply as well as fluid drain).
The DIALYSIS MACHINE should be disinfected according to the MANUFACTURER´s instructions and
checked for residual disinfectant if necessary. In the case of a malfunction of the disinfection
program or if the OPERATOR is in doubt whether disinfection was completed properly, the
procedure should be repeated or the DIALYSIS MACHINE should be disabled until checked by a
technician.
NOTE 1 In case of prolonged downtimes, an additional disinfection cycle should be performed (see instructions
for use of the DIALYSIS MACHINE).
NOTE 2 Be aware that non-operational periods with closed clamps might damage the lines and impair function.
The DIALYSIS MACHINE should be subjected to a functional check according to the
MANUFACTURER’S instructions.
The DIALYSIS MACHINE should be set up in accordance with the PATIENT's treatment plan. The
allocation of the PATIENT to the DIALYSIS MACHINE should be documented.
5.2.2 * DIALYSIS FLUID PREPARATION
The concentrates used and the DIALYSIS MACHINE settings for the composition of the DIALYSIS
should be documented and verified for correspondence with the medical prescription.
FLUID
Electrolyte concentrate additives, if used, should be added and mixed according to the
additive MANUFACTURER´s instructions. The mixture should be labeled with the name of the
additive, date, dose and signature. Before the mixture is used, the labeling of the mixed
concentrate should be checked to ensure correct composition.
NOTE 1 The conductivity measurement of the DIALYSIS MACHINES does not detect any concentration of
physiologically low electrolyte concentrations (e.g. K, Ca, Mg), which poses a RISK to the PATIENT.
– 16 – TR 62653 © IEC:2012(E)
In order to prevent RISKs, such as using wrong concentrates, contamination or different
chemical composition, canisters, bags or cartridges that have already been opened should be
used up either according to the MANUFACTURER'S instructions or to the ORGANIZATION’s
standard operating procedures. Residual concentrates in canisters, bags or cartridges should
not be mixed.
NOTE 2 Preventive methods to avoid biological contaminants in central storage tanks and delivery pipes are
regular disinfection procedures.
5.2.3 * EXTRACORPOREAL CIRCUIT
The following steps should be taken according to instructions for use:
– check for use of correct EXTRACORPOREAL CIRCUIT and for its correct insertion;
– attach, prime and use the medical devices and ACCESSORIES required for the treatment;
– check all connectors and lines for tightness, absence of leaks, kinking and air entrapment.
5.2.4 DIALYSIS FLUID compartment
The following steps should be taken according to instruction for use:
– connect the DIALYSIS FLUID tubes and check for leakage and flow direction
– rinse and deaerate the DIALYSER completely;
NOTE A procedure deviating from the above description may be applicable to batch DIALYSIS MACHINEs.
5.2.5 PATIENT
5.2.5.1 Setting treatment data
The treatment parameters should be verified for compliance with the medical prescription.
5.2.5.2 Entering individual PATIENT’S treatment parameters
The PATIENT treatment parameters should be entered on the DIALYSIS MACHINE and verified for
correct input.
The following settings are common for dialysis treatment:
– treatment time;
– ultrafiltration volume / ultrafiltration rate;
– electrolyte settings;
DIALYSIS FLUID temperature;
–
– DIALYSIS FLUID flow;
– dosage and infusion rate of anticoagulants, as appropriate;
– substitution volume / substitute rate, as appropriate.
If ultrafiltration profiles are used, it should be noted that the maximum ultrafiltration rate which
is tolerable and permitted for the PATIENT might be exceeded.
If conductivity/electrolyte-sodium profiles and “parameter controlled automatic feedback loop”
procedures are used, it should be noted that the electrolyte balance and the acid-base
balance might be affected.
If parameter-controlled automatic feedback loops are used (e.g. ultrafiltration rate controlled
by haematocrit), the corresponding limits as specified by the MANUFACTURER should be set
instead of the controlled parameters (electrolyte concentration, temperature).
TR 62653 © IEC:2012(E) – 17 –
NOTE 1 Other PATIENT-related parameters may be applicable to batch DIALYSIS MACHINEs.
NOTE 2 Ultrafiltration here means amount of fluid removed to reach the prescribed weight of the PATIENT
5.3 Treatment
5.3.1 Preparing the vascular access
The access to the PATIENT’s vascular system should be prepared according to requirements
defined by the ORGANIZATION.
After completing puncture, the needles should be fixed securely.
The VENOUS PRESSURE monitor may not reliably detect leaks, blood tubing separation from the
blood access device, or needle dislodgement. Failure to detect a problem is more likely when
blood pump speeds are set above 450 ml/min or when a catheter is used at lower blood flow
rates (100 ml/min to 200 ml/min). Little or no pressure change may occur depending on the
circumstances. It is unlikely but possible for a leak to occur, the blood tubing to separate, or
access needle to dislodge without a VENOUS PRESSURE alarm.
For that reason, the PATIENT’s safety is only ensured by careful monitoring by the OPERATOR
[14, 15, 16]. The OPERATOR should only cover the puncture sites during the treatment with
sterile dressings or gauze [4]. If covered by dressings or sheets their size should allow
detection of even small blood losses. To allow detection of blood loss, the PATIENT should be
advised not to cover the puncture sites with a blanket. Additional devices can help to detect
blood losses automatically.
If central venous catheters are used, cracks and damage may be caused by application of
inappropriate disinfectants or mechanical impacts, resulting in blood loss or infusion of air.
The catheter should be visually checked for integrity prior to each use [17].
5.3.2 * Connection to the EXTRACORPOREAL CIRCUIT
When the PATIENT is connected to the EXTRACORPOREAL CIRCUIT:
– Connection sites should be tight, secure and the lines torsion stress relieved. The
connection of the EXTRACORPOREAL CIRCUIT to the appropriate needle or catheter port
should be checked (e.g. arterial line to arterial needle etc.).
– Before the blood pump is turned on, the appropriate tube clamps of the EXTRACORP
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