Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue (DSI/2021/005)

Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.

From:
Medicines and Healthcare products Regulatory Agency
Published
20 April 2021
Message type:
Device safety information
Issued:
20 April 2021

For information and action by: Chief Pharmacist, Parenteral Nutrition specialists

Instructions for Medical Device Safety Officer/Medicines Safety Officer: Please circulate/forward to relevant departments

The manufacturer (Diffuplast) has identified a potential issue with their third-party sterilisation provider, which means that while a sterilisation process has been carried out and the devices are likely to be sterile, they have not been sterilised to the usual standard. However, the risk to patients is very low and therefore patients should continue to use their products as normal.

Diffuplast has issued a Field Safety Notice (FSN).

However, note that only the following products listed on this FSN are supplied in the UK:

  • Exacta Mix parenteral nutrition bags (see FSN for specific product codes and batch numbers)
  • Di Mix parenteral nutrition bags (product codes T99000, T99021, T99022, T99023, T99025 and T99026; see FSN for batch numbers)
  • Di Eto Top Fill 2000ml enteral nutrition bags (Product code 6020V, batch number I171)

Risk involved with using affected product

The MHRA’s assessment, in conjunction with Public Health England (PHE), is that the risk to patients is very low. The MHRA consulted in-house specialists for clinical, microbiological, sterilisation as part of this review into the associated risk.

A review of data held by the MHRA shows no safety signals identified in reports of infections over the last 10 years associated with parenteral or enteral bags. The manufacturer has also not had any reports of infections related to these devices, nor have PHE’s routine systems identified any safety signals.

The available evidence shows that the benefits of continuing to use the products listed in this FSN outweigh the risk of any potential harm from infection.

Actions for healthcare professionals

  1. Reassure patients that the risk involved with use of these products is very low.

  2. Monitor patients for signs of infections.

  3. Report any suspected infections to your nutrition supplier and through your organisation’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

  4. Healthcare organisations should always act on FSNs issued by manufacturers. Do not wait for further communication from the MHRA.

Actions for patients

  1. Continue to use your TPN and enteral nutrition as normal.

  2. Tell your healthcare professional about any suspected infections. You can also report this to the MHRA through the Yellow Card scheme.

  3. If you are concerned by this issue, please contact your healthcare professional.

A patient-specific communication is available from the Department of Health and Social Care (DHSC).

Published 20 April 2021
Contents