Device safety notice warning issued on rectal catheter use in infants

A Device Safety Information (DSI) notice warning has been issued to healthcare professionals, parents and carers on the use of rectal catheters (gas and colic relievers) on babies.

(c) Omar Lopez/Unsplash

(c) Omar Lopez/Unsplash

The MHRA said there was there was insufficient evidence the devices work as intended, adding it was concerned about the potential risks associated with their use. 

Dr Alison Cave, MHRA chief safety officer, said: ‘We understand that colic and digestive discomfort can be distressing for babies and their families. We are advising against the use of rectal catheters in babies because there is not enough clinical evidence to support their safety and effectiveness. 

‘Parents and caregivers should seek advice from a healthcare professional and follow the NHS guidance if they are concerned about their baby.'

The MHRA advised parents, caregivers and healthcare professionals to not use or recommend the use of these products in infants and that any products already purchased should be disposed of. 

While there have been no confirmed reports of serious injury, the MHRA has concerns using these products could make it harder to detect underlying conditions that may require medical attention. There is also the potential risk of injury to the bottom, including tearing or perforating the inside of an infant's bottom, which could have serious consequences. 

Anyone who experiences a problem with a medical device or suspects that their child has had a side effect related to the use of rectal catheters should report it directly to the MHRA Yellow Card scheme. 

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