MHRA Issues DSI/2026/011 on Parenteral Nutrition Infusion Filters: Filters with a Pore Size Not Exceeding 1.2 μm Required

What the MHRA announced

On 2 September 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued Device Safety Information DSI/2026/011 on the use of filters during the administration of parenteral nutrition (PN). The conclusion is direct: all parenteral nutrition solutions should be administered through a filter with a pore size not exceeding 1.2 μm; where available, a 0.2 μm filter is preferred for lipid-free (aqueous) parenteral nutrition. The MHRA has also asked all providers of parenteral nutrition products to include the filtration requirement in their product information.

Why the notice was issued

The MHRA states that this action follows a Prevention of Future Deaths report issued under section 28 of the Coroners and Justice Act. The MHRA then reviewed guidance on filter use in parenteral nutrition administration and found that recommendations were inconsistent, which may lead to variation in clinical practice between institutions. The notice also states that administration of parenteral nutrition without a filter has been associated with several adverse events, including one fatal embolism. The role of the filter in parenteral nutrition administration is to reduce the risks arising from air ingress (which may cause air embolism) and from particulate matter.

Scope and key details

Parenteral nutrition refers to the intravenous provision of nutrition, generally used when nutrition cannot be supplied normally via the gastrointestinal tract. Solutions may contain amino acids, lipid emulsions, glucose, vitamins, trace elements, electrolytes and water. Because of this complexity, parenteral nutrition is regarded as a high-risk therapy: physicochemical stability, microbial contamination and catheter-related infection all require attention.

In terms of product status, parenteral nutrition products are regulated as medicines, but may also be supplied as unlicensed bespoke variants ("specials") or prepared by a pharmacy holding an exemption from a manufacturer's licence. On the administration side, infusion sets may incorporate an in-line filter, or an external add-on filter may be used.

Specific requirements set by the MHRA

The minimum requirement is a filter pore size of no more than 1.2 μm, applicable to all parenteral nutrition solutions; for aqueous (lipid-free) parenteral nutrition, a 0.2 μm filter should be used where available. This position references the 2025 position statement of the British Pharmaceutical Nutrition Group (BPNG), which supports routine use of filters in all parenteral nutrition administration, recommends a 1.2 μm filter for all parenteral nutrition and a 0.2 μm filter for aqueous (lipid-free) nutrition, and calls for the minimum filtration requirement to be stated in product literature. That position has been endorsed by the British Association for Parenteral and Enteral Nutrition (BAPEN), the Neonatal and Paediatric Pharmacists Group (NPPG) and the National Nurses Nutrition Group (NNG).

What has changed compared with existing practice

The change is not about whether filters should be used, but about whether the standard is consistent and whether it is written into product information. The MHRA's core assessment is that guidance issued by different product providers may be inconsistent, and may also be inconsistent with BPNG guidance, resulting in the same class of product being used differently at different institutions. The notice therefore harmonises the pore size limit at 1.2 μm, sets the 0.2 μm filter for lipid-free nutrition as good practice where available, and places responsibility on product information by requiring providers to reflect the filtration requirement in it.

Implications for procurement and clinical practice

• For users: check infusion sets and external add-on filters in stock to confirm that the filter used for parenteral nutrition has a pore size of no more than 1.2 μm, and whether a 0.2 μm filter is available for lipid-free nutrition.
• For product providers: review product information and instructions for use to confirm that the filtration requirement is stated and aligned with the pore size thresholds above.
• Note that this document is directed at the UK market and UK care settings, and its wording and conclusions are governed by the MHRA original text.

Sources and verification

Source: Medicines and Healthcare products Regulatory Agency (MHRA) — Filters should be used during the administration of Parenteral Nutrition for patients in all care settings (DSI/2026/011), published 2 September 2026.

Also checked: Medicines and Healthcare products Regulatory Agency (MHRA) — Filters should be used during the administration of Parenteral Nutrition for patients in all care settings (Drug Safety Update, Volume 20, Issue 2, September 2026), published 2 September 2026.

Scope of verification: the two MHRA pages above were accessed and compared on 11 October 2026, covering the Device Safety Information number (DSI/2026/011), the publication date, the filter pore size requirements (no more than 1.2 μm; 0.2 μm preferred for lipid-free nutrition), the BPNG position statement and its endorsing organisations, and the MHRA requirement for product providers to state the filtration requirement in product information. The latest positions of regulators outside the UK on the same issue were not reviewed.

Applicability: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. The pore size values and practices described are taken from the MHRA original text; actual implementation should follow the official text and the product instructions for use, and the information may change with subsequent official updates.

AIMEILI regulatory interpretation

DSI/2026/011 elevates filter use in parenteral nutrition from institutional guidance to a UK-wide expectation tied to product information. For manufacturers and marketing authorisation holders, the operative point is that the filtration requirement is no longer purely a clinical protocol matter: the MHRA is asking providers to incorporate it into product information. This creates a documentation-compliance obligation that sits alongside, and can be assessed together with, existing labelling and instruction-for-use content.

Because the pore size thresholds are differentiated — 1.2 μm as the mandatory minimum for all PN solutions and 0.2 μm for lipid-free (aqueous) formulations where available — product information that states only a generic filter recommendation, or that is silent on filtration, may be regarded as inconsistent with the BPNG-endorsed position now adopted by the MHRA. Unlicensed "specials" and pharmacy-compounded preparations, which are common in paediatric and home PN settings, fall within the same clinical expectation even where a formal product information document is limited.

Business impact

• Label and IFU updates: PN manufacturers and marketing authorisation holders should review the dosage and administration sections of product information and IFUs against the 1.2 μm and 0.2 μm thresholds, and plan updates where wording is absent or divergent.
• Filter portfolio and compatibility data: Suppliers of infusion sets, in-line filters and add-on filters should confirm pore size specifications and provide compatibility evidence (filter material, lipid compatibility, flow rates, priming volume, particulate retention) for PN use.
• Procurement alignment: UK NHS trusts and home-care providers are likely to consolidate purchasing on filters compliant with the 1.2 μm minimum, with 0.2 μm for lipid-free solutions; suppliers unable to document compliance may face tender exclusion.
• Compounding and specials: Hospital aseptic units and compounding pharmacies should reflect the requirement in internal protocols, batch documentation and patient or carer instructions.
• Post-market surveillance: Firms should monitor the DSI and any follow-up Drug Safety Update notices, as the MHRA has linked the absence of filtration to adverse events including a fatal embolism, which raises the risk profile of related complaints and vigilance reporting.