# Using parenteral and enteral nutrition bags manufactured by Diffuplast: guidance for patients

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/29a935e2-2ada-4708-a437-395648f3df5e
Type: Guidance
Published: April 20, 2021

> The Medicines and Healthcare products Regulatory Agency (MHRA) has released a formal notification concerning potential quality control issues identified with empty parenteral and enteral nutrition bags produced by the manufacturer Diffuplast. The primary concern identified within the regulatory framework involves a potential deviation in the sterilization protocols used during the manufacturing of these essential medical supplies. Although specific inspection dates were not detailed in the public briefing, the agency has conducted a preliminary risk assessment regarding the safety of the current inventory. Based on the available evidence, the MHRA has concluded that the actual risk of bacterial infection or related complications for patients is considered very low. As a result, the regulatory body is not mandating a withdrawal of the products at this time. The required actions for healthcare facilities and individual patients are to maintain their standard procedures and continue utilizing the Diffuplast bags as normal to avoid disruption in nutritional therapy. However, the guidance emphasizes that any individuals who harbor specific concerns regarding their health or the integrity of the equipment should proactively consult their healthcare professional for further evaluation. This communication serves as a precautionary measure to ensure transparency while maintaining the continuity of patient care across the healthcare system.

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## Content

The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified of a potential issue related to sterilisation of empty parenteral and enteral nutrition bags manufactured by Diffuplast. The information available indicates that the risk of infection is very low. Please continue to use these bags as normal. If you are concerned that you may have been affected by this issue, please contact your healthcare professional.

## Attachments

- [Using parenteral and enteral nutrition bags manufactured by Diffuplast: guidance for patients](/government/publications/using-parenteral-and-enteral-nutrition-bags-manufactured-by-diffuplast-guidance-for-patients/using-parenteral-and-enteral-nutrition-bags-manufactured-by-diffuplast-guidance-for-patients)