Kenneth George Harrison (69) of Bolton and Medicina Limited were found guilty of a number of fraud offences after supplying medical devices with false CE markings and misleading healthcare providers about their safety and regulatory approval.  

James Pound, MHRA executive director innovation and compliance, said: ‘This has been a complex investigation led by our Devices Compliance Unit, who were dedicated to following the evidence to ensure those responsible were held to account. 

‘Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies.'

The decade long investigation revealed a number of devices, including enteral feeding pumps, gastrostomy ‘button' devices and blunt fill needles, were supplied with CE markings that were not valid.

Enteral feeding pumps were used in neonatal intensive care units and special care baby units to feed very sick newborn babies directly into their stomachs.  

The investigation discovered these 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 compliant, NHS trusts had put them into use at hospitals across the UK.  

Throughout the investigation, the MHRA took action to protect patients, including issuing safety alerts, overseeing recalls and instructing the company to stop further supply of the devices. 

The affected enteral feeding pumps were ultimately removed from the UK and EU markets. 

In acknowledging the verdicts, Medicina Limited said the prosecution arose from an investigation begun in late 2013 and related to events occurring between 2009 and 2014.

Medicina said the offences occurred under the ownership and management of former company directors during that period, adding none of the current owners or company directors were involved in, or had any knowledge of, the historical matters that formed the subject of these proceedings at the time they occurred.

The company said convictions concerned regulatory certification and associated representations, rather than findings as to the clinical performance or safety of the products themselves, adding there was no finding that any of the products were unsafe or that any patient suffered harm.