The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for haemofiltration systems including machines and accessories.
MHRA has warned health care professionals (HCPs) that any off-label modifications to haemofiltration systems when treating COVID-19 patients could result in serious injury and death. The advice is applicable to intensive care physicians and nurses, theatre managers and renal departments.
Haemofiltration machines
Several off-label modifications such as the use of extension sets and connectors are being made to the machines to reduce cross-contamination of SARS-CoV-2. However, this may introduce new risks such as undetected blood loss, air embolism, infection and hypothermia. HCPs are advised not to connect additional extension lines between the machine and patient as the machine will lose its ability to accurately monitor pressure or blood loss. MHRA states that haemofiltration machines should be strictly set up as per the manufacturer’s instructions.
Filters used during haemofiltration
There have been reports of incorrect filters being used during haemofiltration, such as the use of plasma filter instead of a haemofilter. Although the filters may have a similar appearance, they serve different specialised functions, which are explicitly labelled. Use of a wrong filter could result in serious consequences, including death. HCPs are advised to check all the filters before use to ensure that the correct one is selected for planned treatment. Haemofilters should be stored at a separate location from plasma filters. The locations should be clearly labelled and include a warning to ensure appropriate selection of filter.
