How illegal medical devices to feed newborns were sold around the world

A company and its director have been found guilty of illegally supplying specialist medical equipment for feeding newborn babies in hospital critical care settings around the world.

Medicina Ltd and Kenneth Harrison, from Bolton, were convicted of several fraud offences relating to feeding pumps and tubes for babies as well as blunt fill needle devices used to draw up and prepare fluids and medications.

The company managed to get its devices into hospitals in the UK, Spain, Australia and New Zealand.

The successful prosecution came after a complex 13-year investigation, although Medicina has said the offences took place under different management.

The fraud unravelled after the Medicines and Healthcare Products Regulatory Agency (MHRA) first identified concerns in 2013.

Its investigation found a number of devices, including enteral feeding pumps and gastrostomy "button" devices used to provide feed directly into the stomach of very sick newborn babies, were supplied with CE markings that were not valid.

They gave a false assurance to healthcare providers that the equipment used in neonatal intensive care units and special care baby units met strict safety standards, the MHRA said.

All medical devices must comply with the Medical Devices Regulations 2002 and need to be registered with the MHRA before being placed on the UK market. Failure to do so is a criminal offence.

However, the investigation discovered the pumps were placed on the market and used in hospitals without undergoing the required assessments, clinical evaluation or safety testing.

Due to the devices appearing to be compliant, NHS trusts put them into hospital use across the UK.

Doing so without meeting the necessary requirements is a criminal offence.

James Pound, of the MHRA, said: "Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies.

"This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk."

Sarah Place, of the Crown Prosecution Service, said: "The actions of Harrison and Medicina Limited were completely dishonest and from their fraudulently labelled products, they turned a substantial profit."

She confirmed confiscation proceedings under the Proceeds of Crime Act had started "to recover any available funds from this criminal activity".

The MHRA said there were no known deaths or serious adverse events reported in the UK associated with the feeding pumps, which had first been placed into the UK and EU markets in 2011.

Following a safety notice issued by Medicina Ltd and two recalls by the MHRA in 2014 and 2015, 88 pumps were recalled from 34 UK hospitals.

It is understood the Medicina Ltd feeding pumps were also removed from service in Spain, Australia and New Zealand.

Gastrostomy "buttons" and blunt fill needles placed on the market in 2012 were brought within scope of the CE certification after intervention from the MHRA in 2014.

Medicina Ltd said the charges related to historical matters which occurred between 2009 and 2014 and concerned the ownership and management of former company directors during that period.

While the company said it respected the jury's verdicts and recognised the convictions, it said they did "not reflect the standards, culture or management of Medicina Limited as it exists today".

Medicina Ltd said it had been under an entirely different ownership since 2019, with a new leadership team, governance structure and compliance framework, adding that "product quality, patient safety and regulatory integrity are central to every aspect of the business today".

Harrison is due to be sentenced on 23 September at Manchester Crown Court, with the sentencing date for Medicina Ltd yet to be confirmed.

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