A colostrum collection device commonly offered to women by the NHS for antenatal colostrum harvesting should not be used to directly feed babies due to a serious risk of choking, the Medicines and Healthcare products Regulatory Agency (MHRA) alerted.
The regulator said there had been six reported incidents in which the push cap of the SteriFeed Colostrum Collector (Medicare Colgate) lodged in the back of a baby's mouth when it was not removed from the top end of the syringe before being used for feeding.
No fatalities have been reported, but one infant required emergency surgery as a result, the MHRA said.
Some NHS Trusts Supply Kits for Colostrum Collection
In an alert to relevant UK health authorities, the Agency said it had "become common practice in the NHS for women to be offered antenatal colostrum harvesting", and that some local trusts supplied kits for colostrum collection.
Although the device was intended only for collecting and storing colostrum, the MHRA had learnt that it had also been used for feeding colostrum to babies.
The MHRA stated: "The intended use of the device is not for directly feeding the colostrum to babies. The cap must always be removed before use. Healthcare professional advice should be sought for guidance on feeding the collected colostrum to the baby."
Safety Design Change Will Take 6 Months
A design change to minimise the choking hazard associated with the cap was underway, but the work was expected to take approximately 6 months, the regulator said. The current description on the manufacturer's website clearly states that the device is for collection only and that it should not be used for feeding.
Colostrum is often collected from 37 weeks. As well as being provided by some NHS trusts, the kits are available to buy online for use at home.
Dr Alison Cave, chief safety officer at the MHRA, said: "Patient safety is our top priority. We strongly advise anyone using the SteriFeed Colostrum Collector to contact their healthcare provider for advice on how to collect colostrum and feed an infant safely.
"This device is not intended to be used to directly feed your baby due to the risk of choking if the cap is not removed. Seek medical attention immediately if your child or a child in your care ingests an object and please report any incidences involving these devices to our Yellow Card scheme."