MHRA advises against the use of rectal catheters in infants

The Medicines and Healthcare products Regulatory Agency has today issued a Device Safety Information (DSI) notice warning healthcare professionals, parents and carers not to use rectal catheters (gas and colic relievers) on their babies.

These products are sometimes used by parents and caregivers to help with colic, constipation or trapped wind. They are available to buy online and in shops without a prescription.

Following a review of available evidence and expert clinical advice, the MHRA has concluded that there is insufficient evidence that these devices work as intended. The MHRA is also concerned about the potential risks associated with their use.

• MHRA, bebeklerde kullanılan gaz ve kolik giderici ürünlere karşı uyardı

The MHRA is advising that parents, caregivers and healthcare professionals do 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 safety and benefits of these products remain uncertain. There are concerns that using these products could make it harder to detect underlying conditions that may require medical attention. Experts also considered the potential risk of injury to the bottom, including tearing or perforating the inside of an infant’s bottom, which could have serious consequences.

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.”

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.

Notes

• The Device Safety Information notice can be read here: Device Safety Information: All rectal catheters (gas and colic relievers)
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

SOURCE: GOV