Filters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
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.
Summary
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.
Advice for Healthcare Professionals:
- parenteral nutrition is used to provide nutrients directly into the bloodstream bypassing the patient’s digestive system
- administration of parenteral nutrition without a filter has been associated with adverse incidents, including an embolism which resulted in a fatal outcome
- ensure all parenteral nutrition solutions are administered using a filter with a pore size no larger than 1.2µm
- where the solution is aqueous/lipid free, it is good practice to use a filter with a pore size of 0.2µm during administration
- filters and administration sets should be changed with each new parenteral nutrition container, based on the parenteral nutrition shelf-life, local infection control policies, and filter shelf-life
- use of filters integrated into administration sets are preferred but add-on filters are a suitable alternative providing infection control guidelines are followed
- report suspected adverse reactions associated with parenteral nutrition on a Yellow Card
Advice for Healthcare Professionals to Provide to Patients:
- parenteral nutrition is used to provide nutrients directly into the bloodstream while avoiding the digestive system
- it is usually administered by a healthcare professional but may also be administered by patients or carers in the home after receiving the appropriate training
- filters should be used when administering parenteral nutrition to avoid any unwanted particles entering the bloodstream which may be harmful to the patient
- an integrated filter may already be part of your administration set, if it is not, an add-on filter will be required
- if you or your family member administer parenteral nutrition at home and an add-on filter is needed, you should be given appropriate training on this
- speak to your healthcare professional if you have concerns on the use of filters with your parenteral nutrition
- report suspected side effects to parenteral nutrition on a Yellow Card
Advice for Healthcare Providers
- ensure that local protocols include reference to filter use as standard practice when administering parenteral nutrition
- intravenous administration sets and their filters are not compatible with all infusion pumps, this should be considered during the procurement process
- for home care patients , ensure that patients and carers are sufficiently trained in the use of filters if administration sets with integrated filters are not provided
- report suspected adverse reactions associated with parenteral nutrition on a Yellow Card
Explanation of identified safety issue
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 microvasculature of organs and have serious clinical consequences. Globules may be formed in unstable lipid emulsions which can be removed by filtration.
Parenteral nutrition preparation and compounding practice may vary between manufacturer and licence, which introduced variability in the recommendation for filter use on the labelling and packaging.
Filters are not a substitute for appropriate manufacturing controls or aseptic technique, but an added risk minimisation measure to reduce contamination risks, such as particulate matter or precipitation events.
This advice has also been communicated by a Drug Safety Update.
Reporting advice
Healthcare professionals should report incidents involving medical devices:
- in England and Wales to the Yellow Card website or via the Yellow Card app
- in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
- in Northern Ireland to the Yellow Card website in accordance with your organisation’s medical device policies and procedures
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Additional information
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For any enquiries, please contact info@mhra.gov.uk
Stakeholder engagement:
- NHS England National Patient Safety team and Devolved Administrations
- NHS Specialist Pharmacy Service
- Medical Device and Estates Safety (MDES) for Department of Health N. Ireland
- Incident Reporting & Investigation Centre (IRIC) for Scotland
- Welsh Government
- British Association for Parenteral and Enteral Nutrition (BAPEN) and British Pharmaceutical Nutrition Group (BPNG)