Medicines Healthcare Products Regulatory Agency
Details
Renal replacement therapy is treatment that are given to patients whose kidneys stop working properly, including chronic kidney disease and acute kidney injury. The therapy includes haemodialysis (HD), peritoneal dialysis (PD) and continuous renal replacement therapy (CRRT), sometimes referred to as haemofiltration.
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee, to summarise known safety issues with dialysis and CRRT and describe what to do to minimise or prevent serious injury.
This guidance is aimed mainly at healthcare professionals and patients who carry out their own dialysis.This guidance replaces the previous Dialysis Lessons Learn guidance published by the MHRA.
Information for patients
If you would like more information on any of the issues below, please contact your local renal treatment specialist, GP or other healthcare professional.
The MHRA encourages everyone who knows of a safety problem or adverse event that is or might be linked to a medical device, to report to us. You can report through the Yellow Card scheme.
The following sections will detail the potential risks, and actions that should be taken to mitigate them.
Haemodialysis (HD) and Continuous Renal Replacement Therapy (CRRT).
Pre-Use Checks and Maintenance
Potential risk: Using incorrect disinfectant for cleaning the equipment, can affect the dialysis treatment.
Action: Refer to manufacturer specific guidance to check which disinfectant is suitable. Do not rely on the colour of the disinfectant packaging to identify the disinfectants because packaging varies between brands and manufacturers.
Potential risk: Risk of haemolysis or blood loss from kinks & splits in bloodlines (blood tubing sets).
Action: Bloodlines should be checked for kinks & splits prior to connecting to the dialysis machine. Do not fully rely on machine to detect such issues.
Potential risk: Risk of air embolism from the bloodlines circuit.
Action: Priming instructions should be adhered to, and check bloodlines prior to connection, to ensure air has not entered the patient circuit. Always respond and act on air related alarms and air in the circuit while protecting the patient as per local clinical protocol.
Operating Instructions/Training
Potential risk: Repeated overriding of dialysis/CRRT alarms without first checking the cause.
Action: Device users (staff and patients) must check for the cause of these alarms and take necessary action. Only trained users (staff and patients) should attempt to problem solve alarms. Do not cancel the alarms without identifying the problem. Repeated alarms should not be ignored.
Potential risk: Incorrect user input of dialysis prescription parameters.
Action: Ensure machine users (staff and patient) understand the concept of target weight and the importance of pre dialysis weight and blood pressures; calculating ultrafiltration volume and how to programme the correct ultrafiltration volume.
Potential risk: Ultrafiltration errors may occur due to machine faults, without any suitable alarm.
Action: Patients fluid management is based on consistent assessment of weight gain between dialysis sessions, pre and post dialysis blood pressures and patient reported symptoms. A calculation of the amount of fluid removed is set as ultrafiltration volume.
Consistent measurement of pre & post dialysis weights should be undertaken to ensure the anticipated amount of fluid has been removed and ensure that machine users select the correct dialysis mode.
Potential risk: Incorrect connections and set-up of HD and CRRT treatments.
Action: Staff and patients must understand the importance of correct connections when setting up dialysis and CRRT treatments:
- Check connections when priming the machine prior to treatment
- Off-label modifications to haemofiltration systems can result in serious injury and death
- Dialysis fluid connectors should be configured as per manufacturer and local guidance
- If additional infusion is required via an automated pump, ensure it is connected on the venous side of the dialyser
Potential risk: HD machine operation without adequate training.
Action: Ensure all staff and patients have received training and are competent and up to date on the use of dialysis equipment/medical devices and accessories. This includes updates to Instructions for Use and training.
Vascular Access
Potential risk: Vascular access related infections and risk of bleeding are major causes of morbidity and mortality in chronic HD patients.
Action: Vascular access sites should undergo routine physical examination to identify known complications such as infection and any abnormal areas of dilation with skin thinning.
All staff must be educated and competent in cannulation and surveillance of vascular access sites. All staff and patients must be aware that a fistula at risk of bleeding can be life-threatening. An urgent referral for a vascular specialist opinion is essential.
Potential leaks from connection sites in the blood circuit during HD