Philips Healthcare issues alert to destroy mould-affected gel cushions for new born babies

Posted: 14/10/2014

Hospitals that use gel-filled cushions to support the heads of new born babies in their neonatal and paediatric wards have complained of visible mould growing on the cushions. The manufacturer, Philips Healthcare, has now issued an alert requesting medical institutions to identify any cushions affected, withdraw them from use, and destroy them immediately.

The manufacturer first sent a Field Safety Notice in May 2014 but it has clearly not been satisfied that its notice has been acted upon sufficiently and has been compelled to issue a further alert.

Elise Bevan, a solicitor in the product liability team at Penningtons Manches, said: “It is worrying that devices developed to aid vulnerable infants are potentially exposing them to dangerous bacteria. For the first 12 months, a child’s immune system is underdeveloped and exposure to harmful bacteria can have very serious consequences, including infection and breathing difficulties. We have acted in cases where infants have been exposed to harmful bacteria at a very early age, causing tragic consequences for the child and their family. Parents should rightly be concerned that these devices developed to aid vulnerable children could put them at risk.

“Although we welcome the manufacturer’s decision to issue an alert and raise awareness of the risks involved, it is unacceptable that this was allowed to happen at all. More robust action should have been taken when the problem came to light. The manufacturer and medical institutions now have a duty to ensure that the affected devices are withdrawn immediately.”

For more information from the MHRA website, please click here.

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