В Великобритании осудили компанию за мошенничество с медицинскими приборами

A Bolton man has been convicted after a long-running investigation into the illegal supply of medical devices used in hospitals across the UK. 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. The investigation was carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) led by its Devices Compliance Unit. This case was said to be the result of years of detailed investigative work by the MHRA, which first identified concerns in 2013 and continued to pursue the case to its end. The investigation found that a number of devices, including enteral feeding pumps, gastrostomy “button” devices and blunt fill needles, were supplied with CE markings that were not valid, giving a false assurance to healthcare providers that the devices met strict safety standards. 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 that 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. James Pound, MHRA Executive Director Innovation and Compliance, said: “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, 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 MHRA will continue to take robust enforcement action to protect patients throughout the UK.” Sarah Place, specialist prosecutor from 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. “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 need to be registered with the MHRA before they are placed on the Great Britain market. Placing devices on the market without meeting these requirements is a criminal offence. Harrison and Medicina Ltd have been convicted of fraud on all counts relating to P900 enteral feeding pumps, Gastrostomy Button device, Blunt Fill Needle devices, and making an article for use in Fraud. Sentencing for Harrison has been set for 23 September 2026. A date is yet to be fixed for Medicina Ltd sentencing. In a statement, Medicina said: “Medicina Limited acknowledges the verdicts in relation to the company on a number of charges concerning historical matters. “The prosecution arose from an investigation commenced by the Medicines and Healthcare products Regulatory Agency (MHRA) in late 2013 and related to events occurring between 2009 and 2014. “The conduct in question occurred under the ownership and management of former company directors during that period. “The convictions concern regulatory certification and associated representations, rather than findings as to the clinical performance or safety of the products themselves. “There was no finding that any of the products were unsafe or that any patient suffered harm. “While the company respects the jury’s verdicts and recognises that its conviction necessarily corresponds to those counts on which its former director was convicted, it emphasises that they concern conduct that occurred over 12 years ago and do not reflect the standards, culture or management of Medicina Limited as it exists today. “Today’s Medicina Limited is a fundamentally different business from the one considered by the Court. The company has been under entirely different ownership since 2019, with a new leadership team, governance structure and compliance framework. “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. “Since 2015 and continuing under the change of ownership, Medicina has made substantial investment in strengthening its quality management systems, regulatory compliance, engagement with its notified body, corporate governance and product oversight. “Product quality, patient safety and regulatory integrity are central to every aspect of the business today. “Medicina remains committed to continuing to supply healthcare professionals and their patients with safe, high-quality medical devices and will continue to work constructively with regulators, customers and stakeholders. “No further comment will be made while sentencing, including that of Mr Harrison, and any subsequent legal processes remain ongoing.”