Peristeen anal irrigation system
Recall for product correction - Instructions for Use update
Consumers and health professionals are advised that Coloplast, in consultation with the TGA, has undertaken a recall for product correction for its Peristeen anal irrigation system. Specifically, this product’s Instructions for Use (IFU) is being updated in response to the findings of a review of best practice for transanal irrigation for adults.The Peristeen anal irrigation system is a medical device used to help empty the lower colon in patients who suffer from faecal incontinence, chronic constipation and/or the need for some time-consuming bowel management procedures.
There are no new risks associated with using the Peristeen anal irrigation system, and there are no faults or changes to the device itself. The IFU update includes highlighting prerequisites to the ‘indications’, and changes to the ‘contraindications’, ‘precautions’, ‘warnings’ and ‘how to use’ sections.
Information for consumers
Coloplast has started contacting relevant consumers and health professionals to provide further information about this issue. Please note that there are no new risks associated with using the Peristeen anal irrigation system. If you or someone you care for is being treated with the Peristeen anal irrigation system, contact your managing health professional for further advice.
Information for health professionals
Coloplast has started contacting relevant consumers and health professionals to provide further information about this issue. This includes details of the IFU update and directions to disregard any previous IFU for the Peristeen anal irrigation system.
The IFU update highlights the need for thorough patient examination before starting Peristeen anal irrigation treatment in the ‘indications’ section, and makes additions to the ‘contraindications’, ‘precautions’ and ‘warnings’ sections.
The update also provides additional information in the ‘how to use’ section. Specifically, it directs the patient to empty their bladder before using the device and makes recommendations about avoiding over inflation of the rectal balloon.
Prior to use, patients should consult a health professional who is specialised in the use of the Peristeen anal irrigation system.
If you have any questions or concerns about the above issues, contact Coloplast on 1800 653 317 (AU) or 0800 265 675 (NZ)