MHRA: Mandates Filters for Parenteral Nutrition Administration

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome. Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome. Healthcare professionals are advised to use integrated or add-on filters during the administration of parenteral nutrition for patients in all care settings. All parenteral nutrition solutions should be administered via a filter with a pore size no larger than 1.2μm. Where available, it is good practice to administer aqueous/lipid-free parenteral nutrition solutions with a 0.2μm filter. The MHRA undertook a review of guidance associated with filter use during parenteral nutrition administration and identified inconsistencies in recommendations which may result in variability in clinical practice. Parenteral nutrition refers to the provision of nutrients by the intravenous route and is predominantly used when it is not possible to supply nutrition using the standard gastrointestinal tract route. Parenteral nutrition comprises a solution of nutritional products which may include a combination of amino acids, lipid emulsion, glucose, vitamins, trace elements, electrolytes and water. Concerns about physicochemical stability, microbial contamination, catheter-related sepsis coupled with high monitoring demands mean that parenteral nutrition is considered a high-risk associated therapy. Parenteral nutrition products are regulated as medicinal products but may also be made available to meet unmet patient needs as unlicenced, bespoke, variants (known as ‘specials’), or may be prepared in a pharmacy exempt from the requirement to hold a manufacturing licence. The administration set used to deliver parenteral nutrition may include an integrated in-line filter, but separate add-on filters can also be used. Following a Regulation 28 Prevention of Future Deaths report, the MHRA undertook a review of the guidance on filter use. It was identified that parenteral nutrition product providers may not issue consistent guidance or may not be consistent with the guidance outlined by the British Pharmaceutical Nutrition Group (BPNG). The BPNG’s 2025 position statement supports routine filter use for all parenteral nutrition administration, recommending a 1.2μm filter for all parenteral nutrition, 0.2μm filters for aqueous (lipid free nutrition) as good practice, and minimum filtration requirements in product literature. This has been endorsed by the British Association of Parenteral and Enteral Nutrition, Neonatal and Paediatric Pharmacy Group and National Nurses Nutrition Group. As such, all parenteral nutrition solutions should be administered via a filter with a pore size no larger than 1.2μm. Where available, it is good practice to administer aqueous/lipid-free parenteral nutrition solutions with a 0.2μm filter. The MHRA has requested all parenteral nutrition product providers to align their product information to include filter requirements. The role of filters in parenteral nutrition administration is to protect from air infusion which may result in air embolus, or particulate matter. Particulate matter may arise from the infusion systems, components of the parenteral nutrition, manual connection of the device components, manipulations or precipitates due to physio-chemical interactions between nutrient components or concomitant medications. Particles can be deposited in the mi