Neonatal Medical Device Firm, Director Convicted in Fraud Case

A United Kingdom-based enteral feeding device firm and its director have been convicted on fraud charges for selling products throughout the country without the proper assessments, safety testing, and regulatory approvals, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.

Kenneth George Harrison, 69, Medicina Limited, both of Bolton, U.K., were found guilty of various fraud offenses after selling medical devices with false CE markings and misleading healthcare providers about their safety and regulatory approval.  

“This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk. This has been a complex investigation led by our Devices Compliance Unit, which was dedicated to following the evidence to ensure those responsible were held to account,” stated James Pound, MHRA Executive Director, Innovation and Compliance. “Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies. The MHRA will continue to take robust enforcement action to protect patients throughout the U.K.” 

The convictions are the culmination of a decade-long investigation led by the MHRA’s Devices Compliance Unit. Investigators found that many of Medicina sold many devices—including enteral feeding pumps, gastrostomy “button” devices and blunt fill needles—with invalid regulatory approvals, thus misleading healthcare providers into believing the devices met strict safety standards. 

U.K. hospitals used the falsely-approved enteral feeding pumps in neonatal intensive care units and special care baby units to feed very sick newborn babies directly into their stomachs.  

The investigation discovered that Medicina placed these pumps on the market for use in hospitals without undergoing the required assessments, clinical evaluation, or safety testing. Because the devices appeared compliant, NHS trusts had put them into use at U.K. hospitals.  

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. 

“The MHRA will continue to take robust enforcement action to protect patients throughout the U.K.,” said Sarah Place, specialist prosecutor from the Crown Prosecution Service. “The actions of Harrison and Medicina Limited were completely dishonest, and from their fraudulently labelled products, they turned a substantial profit. CPS lawyers worked closely with the MHRA to prosecute this case, and we will continue to bring those who commit fraud to justice. We have also commenced confiscation proceedings under the Proceeds of Crime Act to recover any available funds from this criminal activity.” 

All medical devices must comply with the Medical Devices Regulations 2002 and should be registered with the MHRA before they are placed on the U.K. market. Placing devices on the market without meeting these requirements is a criminal offense, according to the MHRA.  

Harrison’s sentencing is scheduled for Sept. 23; a date has not yet been set for Medicina Ltd.’s punishment hearing.