MHRA: DSI/2026/011 Mandates 1.2μm Parenteral Nutrition Filter

• The MHRA has issued directive DSI/2026/011, mandating the use of filters for all parenteral nutrition administration in all care settings.
• All parenteral nutrition solutions must be administered via a filter with a pore size no larger than 1.2μm, with 0.2μm recommended for aqueous solutions.
• This directive follows a review prompted by a fatal embolism and identified inconsistencies in existing guidance from product providers.
• Filters are crucial for protecting patients from air infusion, which can cause emboli, and particulate matter from various sources.
• The MHRA has requested all parenteral nutrition product providers to update their product information to include these new filter requirements.

This critical update follows a review prompted by a Regulation 28 Prevention of Future Deaths report, which highlighted adverse incidents, including a fatal embolism, linked to unfiltered parenteral nutrition administration.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a critical directive, DSI/2026/011, mandating the use of filters during the administration of parenteral nutrition (PN) for patients across all care settings. This new guidance explicitly advises healthcare professionals to incorporate either integrated or add-on filters into their administration protocols. The directive specifies that all parenteral nutrition solutions must now be administered through a filter with a pore size no larger than 1.2μm.

For aqueous, or lipid-free, parenteral nutrition solutions, the MHRA further recommends, as good practice, the use of a finer 0.2μm filter where such devices are available. This updated requirement stems from a comprehensive review that identified significant safety concerns, including a direct association between unfiltered parenteral nutrition administration and adverse incidents. Notably, one such incident tragically resulted in a fatal embolism.

Parenteral nutrition involves delivering essential nutrients directly into the bloodstream intravenously, primarily when a patient's gastrointestinal tract cannot be used for feeding. These solutions are complex, typically comprising amino acids, lipid emulsions, glucose, vitamins, trace elements, electrolytes, and water. Due to inherent risks such as physicochemical instability, potential microbial contamination, catheter-related sepsis, and the need for intensive monitoring, PN is classified as a high-risk therapeutic intervention.

The MHRA's decisive action follows a thorough review of existing guidance concerning filter use during parenteral nutrition administration. This investigation was initiated in response to a Regulation 28 Prevention of Future Deaths report, which underscored the urgent need for standardized safety measures. The review uncovered considerable inconsistencies in recommendations, leading to undesirable variability in clinical practice across different healthcare environments.

Specifically, the MHRA identified that various parenteral nutrition product providers were not issuing uniform guidance, or their recommendations diverged from established best practices, such as those outlined by the British Pharmaceutical Nutrition Group (BPNG). The BPNG's 2024 position statement strongly advocates for the routine use of filters in all parenteral nutrition administration, recommending a 1.2μm filter for all solutions and a 0.2μm filter for aqueous formulations as good practice. This position also calls for minimum filtration requirements to be clearly stated in product literature.

This comprehensive stance by the BPNG has garnered significant support and endorsement from several prominent professional bodies, including the British Association of Parenteral and Enteral Nutrition, the Neonatal and Paediatric Pharmacy Group, and the National Nurses Nutrition Group. The widespread backing highlights a consensus within the medical community regarding the critical importance of these filtration standards.

The primary role of these filters in parenteral nutrition administration is to safeguard patients from two significant hazards: air infusion, which can lead to a dangerous air embolus, and the presence of particulate matter. Particulate matter can originate from various sources, including the infusion systems themselves, components within the parenteral nutrition solution, manual connections made during device assembly, manipulations of the system, or precipitates resulting from physicochemical interactions between nutrient components or co-administered medications.

To ensure consistent and high-quality patient care, the MHRA has formally requested all parenteral nutrition product providers to align their product information. This alignment must explicitly include the updated filter requirements, ensuring that all relevant guidance is clear, consistent, and in full compliance with the new directive. This move aims to eliminate the previous inconsistencies that contributed to variable clinical practices and heightened patient risk.

This critical update follows a review prompted by a Regulation 28 Prevention of Future Deaths report, which highlighted adverse incidents, including a fatal embolism, linked to unfiltered parenteral nutrition administration.

This MHRA directive signals a heightened regulatory expectation for pharmaceutical companies and healthcare providers regarding the safe administration of parenteral nutrition. Lawyers advising manufacturers must ensure product information aligns with the updated filter requirements, while compliance officers in healthcare settings need to review and update clinical protocols to mitigate liability risks stemming from adverse incidents.

Source: Original reporting via GOV.UK MHRA directive DSI/2026/011