MHRA Issues Medical Device Alert For Neonatal And Paediatric Devices

Mould Has Been Growing On Some Products

30.09.2014

Medical device manufacturer Philips Healthcare (Children’s Medical Ventures) issued a field safety notice in May 2014 and the MHRA have now issued a Medical Device Alert urging medical professionals to dispose of some of its neonatal and paediatric products.

The firm said it had become aware of mould growth on both its Gel-E Donut – part numbers 92025-A, 92025-B, 92025-C – and Squishon 2 - part number 91033-2 – products. Analysis of the mould found it to be Cladosporium and Penicillum Fungi.

Cladosporium is a mould that can be found outside in the environment on plants and other organic matter. It can also be found indoors on surfaces such as wallpaper or carpet, particularly where moisture is present.

Penicillum Fungi can also be found indoors and outside and some species of this mould are known to be toxic. It is unknown from the Field Safety Notice what species of mould has been found on these neonatal and paediatric devices.

The products are used in neonatal care to support and cradle the head or body of infants.

An FSN was sent to customers in May 2014, but the manufacturer is yet to receive confirmation that customers have taken appropriate action and acted on the notice.

Philips Healthcare has urged medical professionals to identify the affected products, dispose of any containing mould and return the appropriate paperwork to their distributor.

Expert Opinion
All devices and products used in a medical environment should be manufactured in sterile conditions, yet this notice relates to the growth of mould, which is completely unacceptable, particularly as these products are used with vulnerable newborn infants.

“It is important for the MHRA to conduct a thorough investigation in to the manufacturing process, the manufacturing site and quality assurance processes of the manufacturer, and any failings that led to mould being able to grow on these medical devices corrected immediately.

“It is also extremely concerning that the safety notice issued in May by the manufacturer appears not to have been acted upon by medical staff. This fact continues to bring into question the adequacy of the processes for alerting healthcare professionals of device problems and the information being used to protect patient safety. The issue of a lack of response of healthcare providers is a concern and one which have been noted by the MHRA through the release of a further Medical Device Alert on 26 September 2014 which stresses the importance of cascading Field Safety Notices in an effective and timely manner to the relevant people that need to be aware of the reported problem.

“We are concerned that despite a Field Safety Notice in May 2014 that mould has been growing on devices that should be manufactured in sterile conditions, both the manufacturer and the MHRA are unsure if these products, intended to be used with newborn babies, are still being used in hospitals within the UK.

“We call for the MHRA to utilise their regulatory powers and investigate the manufacturing conditions of Philips Healthcare to determine how it was possible for mould to be present on newly manufactured products.”
Kevin Timms, Solicitor