MHRA secures convictions for medical fraud

The Medicines and Healthcare products Regulatory Agency (MHRA) has achieved significant legal victories in a decade-long investigation targeting the illegal supply of medical devices in hospitals across the UK. Kenneth George Harrison, aged 69, from Bolton, along with Medicina Limited, were found guilty of multiple fraud offences, including supplying medical devices marked with false CE certifications and misleading healthcare providers concerning their safety and regulatory approval.

This extensive investigation, driven by the MHRA's Devices Compliance Unit, began in 2013, revealing alarming facts about several medical devices that had been unlawfully marketed. Among those devices were enteral feeding pumps, gastrostomy “button” devices, and blunt fill needles, all of which were falsely presented with valid CE markings. Such misrepresentation provided healthcare providers with an incorrect sense of safety, leading them to believe that these devices adhered to stringent safety standards.

Notably, the enteral feeding pumps were critical in neonatal and special care baby units, providing essential nutrition directly to very sick newborns. Alarmingly, these pumps were utilised in hospitals without undergoing necessary assessments, clinical evaluations, or safety testing, endangering the infants they were intended to assist. NHS trusts, trusting in the redundancy of the devices, had incorporated them into their systems across various UK hospitals.

Throughout this lengthy process, the MHRA acted swiftly to safeguard patient welfare. This included issuing safety alerts, overseeing product recalls, and instructing the immediate cessation of further device supplies. Ultimately, the implicated enteral feeding pumps were removed from both UK and EU markets, helping to mitigate potential risks to patient safety.

James Pound, the Executive Director of Innovation and Compliance at the MHRA, remarked on the case, stating “This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk.” He praised the complexity and thoroughness of the investigation, emphasising that the MHRA remains committed to holding accountable anyone jeopardising patient safety. He added, “Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies.”

The Crown Prosecution Service (CPS) also played a vital role in the case. Sarah Place, a specialist prosecutor, expressed that “The actions of Harrison and Medicina Limited were completely dishonest and from their fraudulently labelled products, they turned a substantial profit.” She noted that the collaboration between CPS lawyers and the MHRA was instrumental in prosecuting this case, and they would continue to pursue those who commit fraud. Additionally, she revealed that confiscation proceedings under the Proceeds of Crime Act were underway to recover funds gained through this criminal activity.

The MHRA underscores the necessity for all medical devices to comply with the Medical Devices Regulations 2002 and stresses that they must be registered with the agency prior to being marketed in Great Britain. Violating these regulations is treated as a criminal offence. Patients who experience adverse incidents involving medical devices are urged to report those experiences directly to the MHRA through the Yellow Card scheme.

Harrison and Medicina Limited have been convicted of fraud concerning the supply of P900 enteral feeding pumps, Gastrostomy Button devices, and Blunt Fill Needle devices, along with making an article for use in fraud. Sentencing for Harrison is scheduled for 23 September 2026, while a date for Medicina Limited remains yet to be confirmed.

For more detailed information on gastrostomy care and feeding devices, as well as reporting non-compliant medical devices, additional resources can be found on the UK government's official website. The MFRA remains dedicated to upholding drug and device safety, reinforcing its crucial role within the healthcare system.