MHRA warns parents not to use infant rectal catheters

In guidance published by the Medicines and Healthcare products Regulatory Agency, parents and carers are being told not to use rectal catheters sold for personal use on babies. These products are often marketed as gas and colic relievers, and some families may also see them suggested for constipation or trapped wind. If you have come across them online or on shop shelves, the key point is simple: the MHRA says they should not be used in infants. The regulator notes that they can be bought without a prescription, but being easy to buy is not the same thing as being proven safe or effective for routine use at home.

The reason for the warning is not panic. It is the absence of strong evidence. After reviewing the available research and taking expert clinical advice, the MHRA says there is not enough evidence to show these devices work as intended. That matters because products aimed at babies are often marketed in reassuring language, even when the science behind them is thin. **What this tells us about regulation** is worth pausing on. A product can be discussed in parenting groups, sold online and passed around by word of mouth, yet still fail the more serious test regulators apply: is there reliable evidence that it helps, and are any risks acceptable?

The agency also says the possible harms are serious enough to justify clear advice now. There have been no confirmed reports of serious injury, but the overall safety picture remains uncertain. Experts considered the risk of injury to a baby’s bottom, including tearing or perforation inside the rectum, which could have very serious consequences. There is another concern that can be harder to spot. If a baby has ongoing distress, constipation or abdominal symptoms, using a device at home could make it more difficult to recognise an underlying condition that needs medical attention. A product sold as a quick answer may end up delaying the point at which a family gets the right kind of care.

The MHRA is also careful to draw a line between consumer products and specialist medical treatment. This advice does not apply to rectal catheters used by healthcare professionals in specific clinical settings, including cases involving Hirschsprung’s, meconium ileus or gastroschisis. That distinction matters. The warning is not about every medical use of a catheter. It is about home-use products being sold to parents and carers as answers to colic, gas-related discomfort or constipation in infants.

**What this means for parents** is direct. The MHRA says these products should not be used on babies, should not be recommended to others, and should be disposed of if they have already been bought. If your baby seems unwell, or if you are worried about crying, feeding, constipation or digestive discomfort, the agency says you should seek advice from a healthcare professional and follow NHS guidance. Dr Alison Cave, the MHRA’s Chief Safety Officer, acknowledged that colic and digestive discomfort can be distressing for both babies and their families. But her message is clear: when the evidence on safety and effectiveness is not strong enough, families should not be left to experiment with devices on their own.

**What it means for media literacy** is just as important as the health advice itself. Products aimed at exhausted parents can gather momentum quickly through testimonials, short videos and the promise of instant relief. This warning is a reminder that personal stories are not the same as clinical evidence, and popularity is not proof. If a child experiences a problem with a medical device, or if a parent or carer suspects a side effect linked to one of these products, the MHRA says it should be reported through the Yellow Card scheme. Those reports help regulators build a clearer picture of safety and decide when public warnings are needed.

For families, the takeaway is not to feel embarrassed for looking for help. It is to pause before using a device that promises a fast answer for a very small baby. The safer route, according to the MHRA, is to avoid rectal catheters sold for personal use in infants and ask a health professional what should happen next. For the rest of us, there is a broader lesson here too. The best question is not whether a product sounds clever or comforting, but whether there is solid evidence that it works and that it does more good than harm. In this case, the UK’s medicines and devices regulator says that standard has not been met.