LONDON, July 1 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) hassecured convictions following along runninginvestigation led by its Devices ComplianceUnitinto the illegal supply of medical devices used in hospitalsacross the UK.
Kenneth George Harrison (69) ofBolton,and Medicina Limited werefound guiltyofa number offraud offences aftersupplyingmedical devices with false CE markingsandmisleading healthcare providers about their safety and regulatory approval.
Thiscase is the result of years ofdetailedinvestigative work by the MHRA, which first identified concerns in 2013 and continued to pursue the case to itsend.
The investigation found thata number ofdevices, includingenteralfeeding pumps, gastrostomy "button"devicesand 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 feedverysicknewborn babies directly into their stomachs.
The investigation discoveredthat these pumps were placed on the market and used in hospitalswithout 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 MHRAtook action to protectpatients, includingissuing safety alerts, overseeingrecallsandinstructing the companyto stop further supply of the devices.The affectedenteral feedingpumpswereultimatelyremovedfromtheUKand EUmarkets.
James Pound, MHRA Executive Director Innovation and Compliance,said:
"This outcome sends a clear messagethat the MHRA will notholdback when patient safety is at risk.
"This has been a complex investigation led by our Devices Compliance Unit, who were dedicated to following theevidence toensure those responsible were held to account.
"Medical devices must meet strictstandards 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 mustcomply withthe Medical Devices Regulations2002 andneed 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.
Anyonewhoexperiences an adverse incident involvinga medical deviceshould report itdirectly to theMHRA Yellow Card scheme.
Notes to editors:
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Kenneth George 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 makingan article for use in Fraud.
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Sentencingfor Kenneth George Harrisonhas been set for 23 September 2026. A date is yet to be fixed for Medicina Ltd sentencing.
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For more information on Gastrostomy care and feeding devices, see here:Gastrostomy care Great Ormond Street Hospital
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More information on how to report non-compliant medical devices is available here:Report a non-compliant or suspected counterfeit medical device - GOV.UK
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
