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Updated cleaning instructions for long-term nasogastric tubes

Medical Devices Safety Update

13 March 2020

Changes to the cleaning instructions for long-term nasogastric tubes have been implemented following a TGA investigation into reports of leaking tubes and connector strap breakages.

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Health professionals are advised that a manufacturer, Medicina, has updated the Instructions for Use for its long-term nasogastric tubes to include a link to a detailed cleaning protocol (pdf,602kb)* found on the Global Enteral Device Supplier Association (GEDSA) website.

The cleaning instructions are more detailed than those found in the manufacturer's Instructions for Use and are an easy step-by-step guide for users to keep the devices' ENFit connectors clean.

Medicina's Instructions for Use have also been updated to caution users against using tools to assist in connecting or disconnecting the cap/connector. There was a recall action in May 2019 in relation to the connector strap breakages. Details of this recall action, and all others can be found on the TGA's System for Australian Recall Actions web page.

Parents are commonly responsible for cleaning and care of nasogastric tubes in children who have been discharged into the community. Health professionals should advise all parents of children with ENFit-connected nasogastric tubes in place, not just Medicina products, to follow the link to the GEDSA website and care for the tubes as directed.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS) or contact the TGA's Devices Post Market Monitoring Section on 1800 809 361.

What to report? Please report adverse events, as well as near misses

The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.

Some issues relating to medical devices that may lead to adverse events and prompt you to report include:

  • mechanical or material failure
  • design issues
  • labelling, packaging or manufacturing deficiencies
  • software deficiencies
  • device interactions
  • user/systemic errors.

Suspected adverse events or near misses can be reported directly to the TGA:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.

Disclaimer

The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.

© Commonwealth of Australia 2020

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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.