Last week a BMJ investigation reported that one of the world’s leading producers of diagnostic tests has been falsely marketing one of their products. Oxoid, owned by US diagnostics giant Thermo Fisher, has been selling antimicrobial susceptibility test (AST) discs that do not always contain the advertised amount of antibiotic.

The $10bn a year company’s website claims that it is “renowned for quality, accuracy, reliability and innovation.” However, internal documents seen by the BMJ show that this reputation may not be entirely justified. more…

Parliamentary Select Committees are only as good as the evidence they receive. Evidence is taken in the form of written submissions, then MPs of various political persuasions gather— along with their civil servant advisers —to hear a handpicked group of people give oral presentations. But, as frequently reported in the BMJ, evidence on devices is hard to come by in Europe for a variety of reasons. more…

A Department of Health review into the Poly Implant Prothèse (PiP) breast implant scandal has found that although the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), acted appropriately and followed scientific and clinical advice, there are “areas where improvement can and should be made for the future.”

Back in March 2010 the French regulator found that the manufacturer of the PIP silicone breast implants had been using a grade of silicone filler that was not of the standard previously approved for implant use. more…

Nestlé has just announced a three year partnership with the International Diabetes Federation (IDF)—an umbrella organisation representing national diabetes societies from around the world— as part of its contribution to the fight against non-communicable diseases (NCDs). Such diseases include cardiovascular disease, cancer respiratory illness and diabetes.  more…

Back in February, the BMJ reported that a whole class of implant—in this case large diameter metal-on-metal total hip replacement—was allowed to enter the global market without any clinical studies to assess their safety and effectiveness. Hundreds of thousands of patients around the world may have been exposed to toxic metal ions released from the hips and the potential risks from this that have been known and well documented for decades. more…

Over the coming weeks, the House of Commons science and technology committee will take verbal evidence about the regulation of medical implants. The BMJ—together with the Centre of Evidence Based Medicine at Oxford University—has already submitted a report based on research and investigations done over the past few years.

Specifically, the committee will look at:

• Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?
• How effectively does the Medicines and Healthcare Products Agency (MHRA) implement the directive in the UK?
• How could the legislation and regulations be improved?
• How could the European Commission ensure that potential changes to the medical devices directive do not hinder the introduction of innovations in medical implants to the market.

To read the CEBM/BMJ submission, follow the link:

Medical Implant_ Science and Techonlogy Committee_Final version_for BMJ

The reality of the lack of implant regulation in Europe is finally starting to bite.

A leaked internal FDA report “Unsafe and ineffective devices approved in the EU that were not approved in the US,” has lambasted the European system and highlighted failures in the processes.

According to the Star Tribune, the report says that the EU demands less evidence and allows private, for-profit companies to approve products for sale throughout Europe’s 27 member countries. Approvals and the evidence on which they are based are not disclosed publicly—and neither are side effects or recalls, says the newspaper. more…