IEC/TR 62653 Edition 1 0 2012 06 TECHNICAL REPORT Guideline for safe operation of medical equipment used for haemodialysis treatments IE C /T R 6 26 53 2 01 2( E ) ® C opyrighted m aterial licensed to[.]
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
For effective home treatment, it is essential that the PATIENT and their caregiver receive proper training in the operation of the medical device and the necessary procedures to follow in case of an INCIDENT related to its use.
Training
Operators and patients must receive training specific to their assigned activities The organization is responsible for ensuring that only individuals trained in the intended use of the devices are assigned to operate them Special emphasis should be placed on this training to ensure safety and effectiveness.
Operators must adhere to the manufacturer's instructions for use, including all warnings and precautions Training should be based on these valid instructions and include protocols for responding to alarms, cautions, or equipment failures, with access to the instructions at all times Only organizations trained by the manufacturer are authorized to create training programs for additional personnel These organizations must develop comprehensive training materials that outline the training structure, goals, objectives, maximum trainee numbers, and the duration of the training program for their staff.
The training program for patients must encompass techniques related to the specific modality, medication prescription, effective administration, and the detection, reporting, and management of both medical and non-medical dialysis complications Should modifications by the manufacturer be required, it is the manufacturer's responsibility to determine the extent of any additional training needed Furthermore, the organization must ensure that the completion of any training program is properly documented.
Systems must be operated in accordance with the manufacturer's guidelines and the necessary knowledge and skills for specific medical treatments It is important to note that these application principles and brief operating instructions do not substitute for comprehensive usage instructions or qualified training in system handling.
Infrastructure
General
For the safe execution of extracorporeal renal replacement therapy, it is essential that all system components function together seamlessly The therapy must be conducted in designated areas, and all medications and medical devices should adhere to 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
Regularly check protective systems in the extracorporeal circuit for proper functioning, as they may be prone to damage Adhere to the manufacturer's instructions for these checks Neglecting automated checks before starting dialysis can put the patient at risk, so it is essential to seek technical advice prior to treatment.
Infrastructure requirements
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 for a Class I dialysis machine must be made through a socket outlet that has been tested for proper grounding with protective earth Additionally, the plug used should be uniquely designed to prevent confusion with other socket outlets.
Examples include socket outlets and plugs compliant with IEC 60309-2, along with the color code identification for the machine's dedicated power socket It is essential that power cords and plugs adhere to the manufacturer's instructions.
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
When using central venous catheters positioned in the atrial area for vascular access, it is essential to implement specific measures to meet electrical safety standards as outlined in IEC 60364-7-710:2002 Adhering to the manufacturer's instructions is crucial for ensuring compliance and safety.
If an emergency occurs during the dialysis treatment, it should be possible to alert the person taking care of the PATIENTS
To prevent contamination of the dialysis machine by viruses, bacteria, endotoxins, and fungi from the drain, it is essential to adhere to the manufacturer's installation instructions for the drain tube.
In addition, it is recommended that drains intended to discharge the spent DIALYSIS FLUID be provided with a stench trap
To prevent contamination of the dialysis machine due to unfavorable conditions like backflow, it is essential to maintain a minimum distance of at least 2 cm between the drain opening and the sewage water level, or adhere to the manufacturer's specifications.
ISO 23500 should be taken as reference
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
Each ORGANIZATION should have in place an infection control plan for the protection of
PATIENTS and personnel against infections [1] 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
1 Numbers in square brackets refer to the Bibliography 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
The equipment combinations covered by the INTENDED USE of the system are defined by the
MANUFACTURERS in their instructions for use and are applicable
If the HAEMODIALYSIS equipment and associated water treatment equipment are used in the
To ensure compliance with the manufacturer's specifications for the dialysis machine, it is essential to follow the outlined requirements at the patient's home Additionally, local regulations may necessitate an inspection by an approved expert to verify that the quality of any alterations meets the manufacturer's standards.
MANUFACTURER of the water treatment equipment
Home hemodialysis patients should have a primary communication device to ensure they can reach their supervising organization during a medical emergency, along with a backup device to address any potential malfunctions of the primary 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
Regular assessments of the home environment are essential to verify compliance with technical and operational standards, including physical space, plumbing, water, electrical needs, storage, waste management, and proper documentation.
NOTE The considerations in Annex F of ISO 23500 and in IEC 60601-1-11 should also be taken into account
The integration of IT technology in hospitals and third-party services is prevalent, particularly in dialysis units where HAEMODIALYSIS MACHINES can connect to these systems For home HAEMODIALYSIS PATIENTS, remote monitoring may be managed by external providers instead of the hospital However, this reliance on IT infrastructures raises critical concerns regarding PATIENT safety and data protection.
It is recommended for the ORGANIZATION to follow the standards below in dealing with above issues:
• 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
Effective IT risk management must be implemented from the outset and undergo regular reviews In both hospital and office environments, technical and organizational security measures require careful attention, with clearly defined objectives, safeguards, and responsibilities It is essential that all staff members are familiar with established policies Regular assessments of IT security, including current work routines, are necessary to ensure their suitability and efficiency.
General
HAEMODIALYSIS treatment must be conducted by qualified OPERATORs under the supervision of a physician The physician is responsible for prescribing the HAEMODIALYSIS treatment parameters, including dialysis duration, frequency, DIALYSER type, DIALYSIS FLUID composition, blood flow rate, DIALYSIS FLUID temperature, necessary anticoagulation, and ultrafiltration rate.
OPERATOR should only use information on DIALYSIS MACHINE displays for its INTENDED USE.
Preparation
D IALYSIS 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 must be disinfected following the MANUFACTURER's guidelines and checked for any residual disinfectant as needed If there is a malfunction in the disinfection program or uncertainty about the completion of disinfection, the procedure should be repeated, or the DIALYSIS MACHINE should be disabled until a technician can verify its status.
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
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
The concentrates used and the DIALYSIS MACHINE settings for the composition of the DIALYSIS
FLUID should be documented and verified for correspondence with the medical prescription
When using electrolyte concentrate additives, it is essential to follow the manufacturer's instructions for proper mixing and dosage Each mixture must be clearly labeled with the additive's name, the date of preparation, the dosage used, and the signature of the person who mixed it Prior to usage, it is crucial to verify the labeling of the mixed concentrate to confirm its 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
To mitigate risks associated with incorrect concentrates, contamination, or varying chemical compositions, it is essential to use opened canisters, bags, or cartridges in accordance with the manufacturer's instructions or the organization's standard operating procedures Additionally, residual concentrates in these containers should never be mixed.
NOTE 2 Preventive methods to avoid biological contaminants in central storage tanks and delivery pipes are regular disinfection procedures
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 andlines for tightness, absence of leaks, kinking and air entrapment.
D IALYSIS 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 MACHINE s.
P ATIENT
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:
– 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
Utilizing conductivity and electrolyte-sodium profiles alongside parameter-controlled automatic feedback loop procedures can significantly impact both electrolyte balance and acid-base balance.
When utilizing parameter-controlled automatic feedback loops, such as those where the ultrafiltration rate is regulated by haematocrit, it is essential to establish the limits specified by the MANUFACTURER rather than focusing solely on the controlled parameters like electrolyte concentration and temperature.
NOTE 1 Other PATIENT -related parameters may be applicable to batch DIALYSIS MACHINE s
NOTE 2 Ultrafiltration here means amount of fluid removed to reach the prescribed weight of the PATIENT
Treatment
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 effectively identify issues such as leaks, blood tubing separation from the blood access device, or needle dislodgement, particularly when blood pump speeds exceed 450 ml/min or when using a catheter at lower flow rates of 100 ml/min to 200 ml/min In certain situations, there may be little to no pressure change, making it unlikely, yet possible, for a leak, tubing separation, or needle dislodgement to occur without triggering a VENOUS PRESSURE alarm.
For that reason, the PATIENT’s safety is only ensured by careful monitoring by the OPERATOR
During treatment, the OPERATOR must cover puncture sites with sterile dressings or gauze to ensure proper hygiene The dressings should be adequately sized to detect even minor blood losses Patients are advised against using blankets to cover these sites, as this may hinder blood loss detection Additionally, automatic devices can assist in monitoring for any blood loss effectively.
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 must be secure and free from torsion stress, ensuring that the EXTRACORPOREAL CIRCUIT is properly attached to the correct needle or catheter port, such as linking an arterial line to an arterial needle.
– Before the blood pump is turned on, the appropriate tube clamps of the EXTRACORPOREAL
CIRCUIT and, if applicable, the HDF system’s tube clamps and ports should be opened
– The blood flow should not be too high (usually 100 ml/min)
– Air embolism should be prevented by direct observation with special considerations for catheters [8, 9]
If the venous pressure is negative and there are leaks or disconnections while the access clamp is open, air may be drawn in downstream of the air monitoring unit This undetected air can then be directly infused into the patient.
Initiation of treatment
To initiate the treatment, it is essential to adhere to the MANUFACTURER's guidelines Begin by monitoring the ARTERIAL and VENOUS PRESSURES, then gradually increase to the prescribed blood flow rate while listening for any unusual sounds from the blood pump.
– mechanical damage of the pump;
– use of an inappropriate EXTRACORPOREAL CIRCUIT;
– stenoses and kinks in the EXTRACORPOREAL CIRCUIT;
Ensure the proper installation of the extracorporeal circuit to prevent complications Regularly inspect puncture sites for signs of hematoma or vascular collapse Additionally, verify that the extracorporeal circuit is free of kinks and securely attached to the dialysis system.
To prevent kinks from forming in the lines, ensure they remain flexible even when heated to body temperature During treatment, if the patient's bed or dialysis machine is moved, recheck the extracorporeal circuit Additionally, set and verify the alarm limits for venous pressure, ensuring the lower limit is as close to the current value as possible, such as 20 mm Hg If the alarm limits are set automatically, confirm these settings and make manual adjustments if needed.
NOTE 1 The pressure alarm at the lower VENOUS PRESSURE limit is intended as a protection against blood loss to the environment Pressure monitoring will not reliably detect blood loss due to leaks and separations in the venous return or dislocation of the venous access device During dialysis, one of the most frequent complications resulting in death is caused by dislocation of the venous cannulae (slipping out of the blood vessel) Such a dislocation is not reliably detected by the PROTECTIVE SYSTEMS of the DIALYSIS MACHINES and might result in a life-threatening blood loss to the environment [14, 15, 16] Another complication that can result in serious injury or death is a leak, through separation of the venous access device (central venous catheter) from the venous bloodline [17] e) If applicable, set the alarm limits for the ARTERIAL PRESSURE f) Verify that there are no fluid leaks g) Complete any documentation in accordance with the ORGANIZATION’s requirements
NOTE 2 Batch DIALYSIS MACHINE s and central DIALYSIS FLUID delivery systems may require setting and monitoring of other parameters.
Checks to be repeated during the treatment
Carry out the following checks: a) Check the EXTRACORPOREAL CIRCUIT including puncture sites for security:
Do not cover connections in the EXTRACORPOREAL CIRCUIT Check all connections between blood tubing and catheter or cannulas for security and for leaks frequently and whenever an alarm occurs
NOTE 1 During single-needle dialysis, blood flow occurs in phases During the arterial phase, if there is a leak in the EXTRACORPOREAL CIRCUIT downstream of the venous clamp, e.g at the Y-piece, air may be sucked into the EXTRACORPOREAL CIRCUIT This air will then be transported to the PATIENT during the venous phase b) Check for kinked EXTRACORPOREAL CIRCUIT, BLOOD LEAKS and for leaks of the DIALYSIS
FLUID circuit The EXTRACORPOREAL CIRCUIT should be checked again if the position of the
During treatment, the patient's bed or dialysis machine is adjusted as needed It is important to check the arterial and venous pressure values for any deviations Additionally, verify the ultrafiltration rate, ultrafiltration volume, and substitution rate for hemodialysis and hemofiltration.
Ensure that the blood flow and dialysis fluid flow meet the prescribed values Additionally, verify the blood levels in the chambers to ensure they are at the appropriate height and check for any formation of blood clots.
NOTE 2 If the DIALYSIS MACHINE uses air detection at the venous chamber, blood clots in the chamber might affect the PROTECTIVE SYSTEM g) If applicable, check the anticoagulant infusion rate h) If applicable, check for defective filters or moisture in the hydrophobic filters in pressure relief lines i) Check the PATIENT-related parameters at regular intervals as specified in the prescription j) Prepare the documentation according to the ORGANIZATION'S internal specifications k) Document any repeated alarm situations and irregularities
NOTE 3 Repeated override of alarms may result in a HAZARD to the PATIENT because each alarm has been triggered by a deviation from a set value In some cases (e.g net fluid removal) these deviations may accumulate
If abnormalities are found during checks, identify the causes and implement necessary corrective actions to ensure the safety and efficiency of the treatment In the event of technical failures, follow the manufacturer's instructions provided in the user manual Should a failure or malfunction lead to blood entering the dialysis system, take immediate action as per the guidelines.
MACHINE, do not use the DIALYSIS MACHINE on any other PATIENT without having taken the appropriate REPAIR measures and decontamination procedures [3]
NOTE 5 Batch DIALYSIS MACHINE s and central DIALYSIS FLUID delivery systems may require monitoring of other parameters
OPERATORS of HAEMODIALYSIS MACHINEs should not rely on medical technical safety standards alone, when performing a treatment Assessment of HAZARDS requires fundamental knowledge of how to use the system [5,6,7]
For example, common HAZARDOUS SITUATIONS include:
– ingress of foreign particles, pathogens, their constituents or metabolic products into the blood pathway (e.g by improper rinsing or disinfection);
– acute or chronic toxicity (e.g caused by residual disinfectant in the EXTRACORPOREAL
– blood loss (e.g caused by disconnection in the EXTRACORPOREAL CIRCUIT including the vascular access, bleedings, coagulation in the EXTRACORPOREAL CIRCUIT, puncturing problems, or wrong positioning of puncture cannulae);
– improper fluid balance (e.g weighing, input or calculation errors);
– incompatibility reactions caused by materials used or caused by substances adhering thereto;
– improper use of cleaning agents or disinfectants;
– improper use or composition of the DIALYSIS FLUID;
– deficit between the dialysis parameters prescribed and what is actually delivered (e.g by an insufficiency of the vascular access);
– haemolysis (e.g caused by wrong setup or kinking of the EXTRACORPOREAL CIRCUIT);
– air embolism (e.g caused by defects or improper use of central venous catheters);
– electrical HAZARDS (e.g caused by defective power lines or lack of a POTENTIAL
– accidental bolus administration of drugs if the DIALYSIS MACHINE is used together with infusion pumps through a single PATIENT access
Pumps for anticoagulants are not designed according to the safety requirements for infusion pumps For that reason, they should not be used for application of other drugs.
Deviations from the treatment parameters prescribed or treatment
Any deviations from the treatment parameters prescribed require the attending physician's authorization This measure should be documented according to the ORGANIZATION’s internal policies
Treatment interruptions can occur due to medical necessities or technical issues, such as vascular access failures, coagulation in the extracorporeal circuit, water supply disruptions, power outages, or malfunctioning dialysis machines These interruptions pose significant risks to patient safety.
PATIENT Should the extracorporeal blood flow be interrupted for a prolonged time period, the blood should be returned In such a case, the ORGANIZATION’s internal policies should be followed.
Terminating the DIALYSIS treatment
Termination of treatment must follow the guidelines set by the MANUFACTURER of the DIALYSIS MACHINE It is crucial to avoid returning blood to the PATIENT by exposing the arterial side of the EXTRACORPOREAL CIRCUIT to the atmosphere and using the blood pump for this purpose.
If drugs are administered through the EXTRACORPOREAL CIRCUIT at the end of the treatment, ensure there is no loss of the substance in the EXTRACORPOREAL CIRCUIT
5.3.8 * After completion of the dialysis treatment
Thesystem and environmental surfaces should be cleaned and disinfected in accordance with the MANUFACTURER's instructions and ORGANIZATION policies The following steps are common for many DIALYSIS MACHINES:
If blood or fluid is found to have breached the pressure transducer protector and entered the dialysis machine, the machine must be taken out of service It should remain unused until it has been thoroughly cleaned, disinfected, and approved for use by the authorized Technical Service.
– The surface of the treatment system should be cleaned and disinfected The hydraulics pathway should be cleaned and/or disinfected and decalcified in accordance with the
NOTE 1 Disinfection of DIALYSIS MACHINE is a procedure which can be made by use of heat and/or chemicals The
MANUFACTURER ´s instructions should be followed in order not to damage the equipment and/or harm the PATIENT
NOTE 2 Guidance on disinfection and testing is referenced in ISO 23500 and in MANUFACTURER ' S instructions
Key parameters to be considered are choice of chemicals, length of exposure, temperature and frequency
All incidents and near misses must be documented and reported in line with local and regulatory standards The necessary form for incident notification should be readily available to the organization.
Technical service, SERVICING and checks of equipment and plants
The good working order of equipment and plants should be ensured by MAINTENANCE work according to the MANUFACTURER's instructions (e.g technical safety and measurement checks,
MAINTENANCE and REPAIR) The good working order is achieved by complying with test schedules Failures of equipment or plants should be identified and documented The
Technical Service should be notified
Medical electrical equipment must undergo the required technical safety checks within the specified time frame outlined in the instructions for use; otherwise, it should not be utilized for treatment purposes.
NOTE This also applies to any equipment connected thereto, e.g reverse osmosis systems and concentrate or
DIALYSIS FLUID central delivery systems
Medical electrical equipment failing to function properly should be marked accordingly and not be used until REPAIR following the MANUFACTURER's instructions
All modifications to the system, particularly regarding water treatment, must be documented and coordinated with the manufacturer It is essential to reference ISO 23500 when making changes to the water treatment plant.
7.2 * Equipment safety and device combinations
The MANUFACTURER's instructions with regard to the PATIENT'S protection against electric shock shouldbe taken into account
To ensure safety, it is crucial to avoid any contact with live defective power cords Regular inspections of power cords should be conducted in accordance with the manufacturer's guidelines If any damage to the insulation layer is detected, the affected equipment must be secured and removed from routine use immediately.
Equipment with a damaged enclosure must be inspected and repaired to avoid unacceptable touch currents and patient leakage currents Additionally, any spilled fluids should be promptly cleaned from the equipment to ensure safety.
To prevent excessive touch currents and patient leakage currents when multiple medical devices are used together, it is essential to adhere to the IEC 60601-1 standards, which may include the implementation of a potential equalization conductor.
When using a dialysis machine with a central venous catheter placed in the atrial location, it is crucial to adhere to the manufacturer's instructions to avoid unacceptable high touch currents and patient leakage currents.
Mains-operated, non-medical electrical equipment, such as heating pads and computers, can pose significant hazards to patients, particularly those with centrally located venous catheters This is due to the lower insulation requirements for such devices Therefore, the direct use of mains-operated non-medical electrical equipment should be limited in patient care settings.
ENVIRONMENT for PATIENTS with central venous catheters with atrial location while the treatment is in progress
Electromagnetic fields can disrupt the proper functioning of electric equipment, so it's essential to ensure that wireless communication devices do not interfere with machine operations Always adhere to the manufacturer's instructions for optimal performance.
Non- INTENDED USE
The ORGANIZATION should ensure the INTENDED USE of the medical devices according to the instructions for use by taking the appropriate training measures
Using equipment, disposables, or systems that are not approved by the MANUFACTURERS, whether intentionally or unintentionally, constitutes non-INTENDED USE by the ORGANIZATION and/or OPERATOR In these instances, the ORGANIZATION and/or OPERATOR assumes full responsibility for the safe operation of the equipment.
Any modifications made by an organization to machines, systems, or procedures without the manufacturer's approval result in the organization assuming full responsibility for the altered product This responsibility extends to the use of device combinations not specified in the manufacturer's intended use of the system.
(e.g separate devices for the operation of the EXTRACORPOREAL CIRCUIT and DIALYZER set delivery or separate infusion devices connected to the EXTRACORPOREAL CIRCUIT) for which the
The manufacturer has not confirmed whether compatibility has been tested in accordance with applicable safety standards It is the organization's responsibility to ensure compliance with the intended use and instructions for preparing and using disposables within the system.
Modern dialysis technology is designed to safeguard patients from operational risks associated with dialysis treatment, including extracorporeal blood loss and air infusion Therefore, dialysis machines must adhere to the latest standards to ensure safety Users of dialysis machines should recognize that it is impossible to eliminate all potential hazards that may affect patients during treatment solely through technical means, even when following all manufacturer regulations, including usage and servicing instructions.
Dialysis machines lack reliable systems to detect small leaks in the extracorporeal circuit and to identify improperly applied prescriptions These treatment-related risks can lead to serious accidents during dialysis therapy, which the technical systems of the machines are unable to detect or mitigate.
DIALYSIS MACHINES The ORGANIZATION should identify these risks, for example based on these guidelines The ORGANIZATION should minimize such risks by the use of appropriate standard operating procedures
Home HAEMODIALYSIS is gaining popularity thanks to advancements in technology and therapies While it is fundamentally safe and effective, resembling in-center HAEMODIALYSIS, it remains a relatively new field with ongoing innovations.
OPERATORs may benefit of guidance and recommendations to ensure best practices
Therefore we have included home HAEMODIALYSIS within these regulations
Using dialysis fluid with incorrect electrolyte levels, especially potassium, or fluid that contains residual disinfectants, toxic substances, or heavy bacterial contamination poses significant risks These issues often go undetected by water treatment systems, dialysis water supplies, concentrates, or dialysis machines due to the absence of adequate protective systems.
The standard unit for measuring conductivity often fails to identify incorrect compositions in dialysis fluid, particularly for trace ions like calcium, potassium, and magnesium While some patients may require potassium-free dialysis fluid, this can lead to severe consequences for others Therefore, the use of zero potassium dialysis fluid must be approached with caution.
FLUID is discouraged due to most serious risks Bacterial contaminations cannot be automatically detected in the fluid pathway For these reasons, the ORGANIZATION and/or
OPERATOR should take the appropriate measures to exclude risks arising from such HAZARDS
The following requirements should be met in particular:
Emergency procedures and responsibilities must be clearly established for the operation and disinfection of water treatment and distribution systems, as well as for the delivery of concentrate or dialysis fluid It is essential that these protocols are explicitly identified to ensure effective response and compliance.
– DIALYSIS WATER quality should be monitored (see 4.3.2.2);
– composition of DIALYSIS FLUID and the DIALYSIS MACHINE being used should be documented
– the DIALYSIS FLUID prescribed should be delivered to the intended PATIENT (see 5.2.2);
– when concentrates in e.g containers or cartridges are consumed, the MANUFACTURER's instructions or the ORGANIZATION’s standards should be strictly adhered to (see 5.2.1);
When incorporating electrolyte additives like potassium or calcium, it is essential to adhere to the manufacturer's instructions or establish a validated mixing procedure The concentration of these additives must be clearly labeled on concentrate containers and documented accordingly Additionally, verification testing of the resulting concentrate or the final composition of the dialysis fluid should be conducted in compliance with the organization's policies.
NOTE Particularly the last one of the above requirements, if unconsciously handled without care, has already resulted in severe and even fatal accidents
A.3 Blood loss to the environment [14, 15, 16, 17]
During dialysis treatment, a common and serious risk is unnoticed blood loss to the environment This can occur due to small leaks, a dislodged venous cannula, or separations and disconnections in the venous line.
Today’s DIALYSIS MACHINES are provided with a PROTECTIVE SYSTEM to detect such occurrences This PROTECTIVE SYSTEM is usually based on the measurement of the VENOUS
Pressure thresholds must be established to trigger alarms and potentially halt the blood pump when the measured pressure exceeds or falls below these limits These thresholds can be set either manually or automatically.
Venous pressure is composed of several components, including the pressure at the patient access point located at the tip of the venous cannula or catheter, which can be found within the fistula, plastic prosthesis, or central access Additionally, other factors influencing venous pressure are related to the extracorporeal blood flow and any restrictions present in the extracorporeal system.
The circuit involves restrictions in the bloodline at the venous Luer connector and the lumen of the blood access device, such as a needle or central venous catheter, which may have a narrow venous needle or long catheter leg The pressure drop is influenced by the haematocrit level Additionally, the venous pressure monitor may fail to accurately assess the pressure in the venous return if the transducer protector is wet or filled with blood, or if there is significant clotting in the venous drip chamber.
To ensure patient safety during dialysis, it is crucial to detect large leaks, such as those from the disconnection of the extracorporeal circuit, as they are easily identified due to the removal of restriction from the narrow cannula However, smaller leaks, like loose connectors, may not trigger a significant drop in venous pressure, potentially leading to unnoticed blood loss over time To mitigate this risk, the venous pressure monitor's lower alarm limit should be set close to the current value, and care providers must routinely check the integrity of the venous Luer connection and inspect the extracorporeal circuit for leaks at the start and throughout the dialysis treatment.
If a venous cannula slips out, the backpressure provided by the access is removed from the circuit The change in pressure may only be about 10 mmHg to 20 mmHg The VENOUS
PRESSURE is a result of the blood flowing through the lumen of the cannula If a PROTECTIVE