The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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) - external site 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 - external site 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:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
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
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
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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.