Medical Equipment Firm Fined

A company that supplies specialist diagnostic medical instruments has been hit was a £4,500 bill after flouting safety rules designed to protect patients giving tissue samples.

Cellpath Limited, of Mochdre Enterprise Park, Newtown, Powys, Wales supplied microtome blades – used to take biopsy samples – that did not carry the CE safety mark.

They admitted three summonses at City of London Magistrates’ Court of supplying the Royal Preston Hospital, Preston, Lancashire, the Medway Maritime Hospital, Gillingham, Kent and City Hospital, Birmingham in contravention of the Medical Devices Regulations between April 1 and May 31, 2007.

“We accept no patient was put at risk by these three supplies,” prosecutor Miss Deanna Heer, representing the Medicines and Healthcare Products Regulatory Agency, told the court.

The agency’s senior device specialist Dr. Khalid Razak said the regulations were in place to ensure no blunted blades were used to obtain tissue samples from patients.

“The danger, if you have a very small piece of tissue, is that you waste a lot of it due to the blade not functioning and may have to go back for more.

“If the condition varies you may miss vital information that is lost,” added Dr. Razak. “It should be sharp from the start and if the next blade is faulty because of manufacturing problems you may have lost quite a bit of tissue.”

The prosecution agreed none of the blades supplied to the three hospitals were faulty.

“These are safety regulations and the breach arises from the fact this defendant became the manufacturer by attaching it’s own label and was responsible for the quality of the blade,” explained Miss Heer.

The company boasts it has a reputation for “innovation, novel product design and quality of both its products and service.”

Cellpath was fined £500 on each summons and ordered to pay £3,000 costs.

The prosecution dropped similar summonses regarding Beaston Institute for Cancer Research, Glasgow and all summonses against company director Philip Webber, 43, whose family founded the business were also withdrawn.