The Medicines and Healthcare products Regulatory Agency (MHRA)
has today secured convictions following a long
running investigation led by its Devices
Compliance Unit 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.
This case is 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
theMHRAbefore they are placed on the Great Britain
market. Placing devices on the market without meeting these
requirements is a criminal offence.
Anyone who experiences an adverse incident
involving a medical device should report
it directly to the MHRA Yellow Card
scheme.
Notes to editors:
-
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 making an article for use in Fraud.
-
Sentencing for Kenneth George Harrison has been set
for 23 September 2026. A date is yet to be fixed for Medicina
Ltd sentencing.
-
For more information on Gastrostomy care and feeding devices,
see here: Gastrostomy care Great
Ormond Street Hospital
-
More information on how to report non-compliant medical
devices is available here: Report a non-compliant
or suspected counterfeit medical device - GOV.UK
-
The Medicines and Healthcare products Regulatory Agency
(MHRA)is responsible forregulating 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.
