'Faulty' antibiotic test kits putting patients at risk, doctors told

Test kits are swabbed with sputum or urine to show patients' suitability for certain drugs

Patients are being put at risk by faulty antibiotic test kits manufactured by a British company, a leading medical journal has claimed.

The kits made by Oxoid, the UK arm of the $10bn-a-year US diagnostics giant Thermo Fisher were not accurate, causing doctors potentially to prescribe the wrong drugs, it is alleged.

Antibiotic test kits are used by doctors on tens of thousands of NHS patients each year to determine which drug would be most effective at tackling their infection.

The disclosure comes in the wake of scandals over medical devices involving PIP breast implants which ruptured and metal-on-metal hip replacements which wore out. A leading UK professor of microbiology has called for tighter regulation of diagnostic devices.

The investigation into Oxoid, based in Basingstoke, Hampshire, was conducted by the British Medical Journal (BMJ). Examination of internal documents and emails revealed that the company used "flawed" data and "misled" the UK regulator, the Medicines and Healthcare Regulatory Agency, when it was alerted that there was a problem, the BMJ said.

The test kits come in the form of discs pre-coated with different antibiotics. They are swabbed with sputum, urine or other samples from the patient and the reaction indicates which is the most effective drug against the infection. In some cases, Oxoid discs had too little antibiotic or none at all, creating the risk that the organism will appear to be resistant and the patient moved on to a more powerful antibiotic.

"More seriously, too much antibiotic on the discs risks giving a false impression of susceptibility. This may result in a patient being given an antibiotic that doesn't work…," the BMJ says.

It alleges that the company failed to act on a warning from one of its own employees about problems with the discs and told doctors who reported problems they were storing discs incorrectly.

Mark Wilcox, professor of microbiology at the University of Leeds and author of an editorial published beside the investigation, said it had "cast a cloud" over how the antibiotic testing kits and similar devices were approved.

Oxoid said the BMJ allegations were "unfounded". A spokesman said: "Oxoid products meet all current legal and regulatory requirements. We have every confidence that the testing method used to assure the accuracy of the antimicrobial susceptibility test discs is appropriate. We continually invest in our manufacturing processes to ensure that our products are safe and effective."

The MHRA said it had found no problems with a specific test kit made by Oxoid. A spokesman said: "We have been pressing the European Commission to strengthen regulation in Europe for the past four years. We believe that there should be tighter controls on…medical devices and more collaboration between national regulators."

Life and Style
ebookNow available in paperback
ebooks
ebookA delicious collection of 50 meaty main courses
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
SPONSORED FEATURES

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Personal Tax Senior

    £28000 - £37000 per annum: Recruitment Genius: This is an opportunity to join ...

    Recruitment Genius: Customer and Markets Development Executive

    £22000 - £29000 per annum: Recruitment Genius: This company's mission is to ma...

    Recruitment Genius: Guest Services Assistant

    £13832 per annum: Recruitment Genius: This 5 star leisure destination on the w...

    Recruitment Genius: Sales Account Manager

    £20000 - £32000 per annum: Recruitment Genius: A Sales Account Manager is requ...

    Day In a Page

    A nap a day could save your life - and here's why

    A nap a day could save your life

    A midday nap is 'associated with reduced blood pressure'
    If men are so obsessed by sex, why do they clam up when confronted with the grisly realities?

    If men are so obsessed by sex...

    ...why do they clam up when confronted with the grisly realities?
    The comedy titans of Avalon on their attempt to save BBC3

    Jon Thoday and Richard Allen-Turner

    The comedy titans of Avalon on their attempt to save BBC3
    The bathing machine is back... but with a difference

    Rolling in the deep

    The bathing machine is back but with a difference
    Part-privatised tests, new age limits, driverless cars: Tories plot motoring revolution

    Conservatives plot a motoring revolution

    Draft report reveals biggest reform to regulations since driving test introduced in 1935
    The Silk Roads that trace civilisation: Long before the West rose to power, Asian pathways were connecting peoples and places

    The Silk Roads that trace civilisation

    Long before the West rose to power, Asian pathways were connecting peoples and places
    House of Lords: Outcry as donors, fixers and MPs caught up in expenses scandal are ennobled

    The honours that shame Britain

    Outcry as donors, fixers and MPs caught up in expenses scandal are ennobled
    When it comes to street harassment, we need to talk about race

    'When it comes to street harassment, we need to talk about race'

    Why are black men living the stereotypes and why are we letting them get away with it?
    International Tap Festival: Forget Fred Astaire and Ginger Rogers - this dancing is improvised, spontaneous and rhythmic

    International Tap Festival comes to the UK

    Forget Fred Astaire and Ginger Rogers - this dancing is improvised, spontaneous and rhythmic
    War with Isis: Is Turkey's buffer zone in Syria a matter of self-defence – or just anti-Kurd?

    Turkey's buffer zone in Syria: self-defence – or just anti-Kurd?

    Ankara accused of exacerbating racial division by allowing Turkmen minority to cross the border
    Doris Lessing: Acclaimed novelist was kept under MI5 observation for 18 years, newly released papers show

    'A subversive brothel keeper and Communist'

    Acclaimed novelist Doris Lessing was kept under MI5 observation for 18 years, newly released papers show
    Big Blue Live: BBC's Springwatch offshoot swaps back gardens for California's Monterey Bay

    BBC heads to the Californian coast

    The Big Blue Live crew is preparing for the first of three episodes on Sunday night, filming from boats, planes and an aquarium studio
    Austin Bidwell: The Victorian fraudster who shook the Bank of England with the most daring forgery the world had known

    Victorian fraudster who shook the Bank of England

    Conman Austin Bidwell. was a heartless cad who carried out the most daring forgery the world had known
    Car hacking scandal: Security designed to stop thieves hot-wiring almost every modern motor has been cracked

    Car hacking scandal

    Security designed to stop thieves hot-wiring almost every modern motor has been cracked
    10 best placemats

    Take your seat: 10 best placemats

    Protect your table and dine in style with a bold new accessory