The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed.
This decision has been taken jointly with the European healthcare product regulators of all EU member states.
The verdict on Silimed comes in the light of an inspection of the manufacturing plant related to the company in Brazil.
This established that surfaces of some devices contained within the plant were contaminated.
MHRA continues to investigate the situation in partnership with other major European regulators.
It is recommended for the time being that none of the devices manufactured by Silimed listed below should be implanted until further advice is provided by regulators.
Although this action has been taken by the MHRA, the regulatory body has also been at pains to point out that no threat to patient safety has been established at the time of writing.
Silimed provides a range of implants, and there is no evidence to suggest that these should be considered unsafe, or that the the impartation procedure carried out with the products previously should be a cause for concern.
Nonetheless, health regulators from the European Union continue to test samples of products from the Brazilian manufacturer in order to establish if there are any health risks.
The devices covered by the suspended CE certificate are implants for:
– silicone implants for plastic surgery: implants: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery
– bariatric surgery: gastric bands and balloons
– implants for urology: testicular implants, penile implants, vesical conformers, periurethal constrictors, tubes for hypospadias, vaginal stents
– silicone implants for general surgery: blocks and sheets
– silicone invasive devices: sizers for silicone implants
The MHRA monitors the health of all medical devices used in Europe, and it is generally impossible for a medical device to be marketed within the continent if it does not carry a CE mark of conformity.
This marking is applied by the manufacturer; an indicator that the device meets development regulatory requirements.
Speaking about the decision to suspend Silimed products, MHRA Director of Devices, John Wilkinson, struck a note of caution.
“There has been no indication at this time that these issues would pose a threat to patient safety. We are urgently investigating this issue and are working closely with our European counterparts. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic,” Wilkinson advised.
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people using steel cannula infusion sets to check them before and after use as the regulator believes there is a small risk of its needle breaking.
The needles are part of infusion sets, manufactured by Unomedical, which are used in hospitals and by people at home for the infusion of medicine through an external pump. They are primarily used by patients with diabetes, Parkinson’s disease and for the treatment of chronic pain.
The following steel cannula infusion sets are affected: (i) SURE-T; (ii) SURE-T Paradigm; (iii) Contact Detach; (iv) Contact; (v) Sub Q; (vi) Neria; (vii) Neria Detach; (viii) Neria Multi; and (ix) Thalaset.
Users are being requested by MHRA to check the specific lot numbers of infusion sets prior to and after use and to follow our advice contained within the medical device alert. A healthcare provider should be contacted if a needle has broken off in-situ as medical attention may be required.
“This is a precautionary measure and the risk of the needle breaking is low”, said Dr Neil McGuire, clinical director at MHRA. “There are millions of these needles in use and we have had only a very small number of reports of them breaking.
“The manufacturer improved the design of the device over a year ago but we advise anyone who has had this problem or who is concerned to contact their specialist nurse or GP.”
Collaborative approaches to supporting innovation and to facilitating clinical development and timely access to new treatments and vaccines for patients were unveiled in a new report this week.
The report, from the UK BioIndustry Association (BIA) and Medicines and Healthcare products Regulatory Agency (MHRA) follows their annual conference – ‘Pathway of Innovation from Research to Patients’ – in London last month.
The event was attended by over 140 delegates from patients’ groups, MHRA, the National Institute for Biological Standards and Control, the life science industry, the Wellcome Trust, the Jenner Institute, academic institutions and clinical trial units.
Key topics of discussion included: (i) the value of a patient-centred approach in informing and accelerating drug development and lessons learnt from the unprecedented response to the recent Ebola epidemic; (ii) the establishment of a patient-centred system for drug development with strong patients’ groups becoming increasingly involved in regulatory processes, health technology assessments and commissioning decisions.
Commenting on the publication of the report, Steve Bates, BIA CEO, said: “Following another successful joint conference with the MHRA, the publication of our first report from the event will provide a great lasting resource for SMEs, increasing awareness of the potential impact that patient engagement could have on regulatory pathways.”
Dr Siu Ping Lam, director of the licensing division at the MHRA, said: “This was a hugely productive conference. It is increasingly recognised that patients have a key role to play in regulatory decisions. This goes to the heart of MHRA’s mission of encouraging, supporting and enabling innovation”.
“We will continue to use our scientific and regulatory expertise to advise industry and make drug development programmes as efficient as possible, facilitating safe and timely patient access.”
Dr Peter Nightingale has been appointed as chairman of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Devices Expert Advisory Committee (DEAC).
The DEAC has been formed following an independent review on MHRA access to clinical advice and engagement with the clinical community. It will be responsible for providing independent, expert strategic advice to the agency in support of its role to ensure that medical devices are acceptably safe and are used both safely and effectively.
Dr Nightingale is a consultant in anaesthesia and intensive care medicine and was president of the Royal College of Anaesthetists until September 2012. He was formerly president of the Intensive Care Society and vice chair of the Academy of Medical Royal Colleges.
MHRA Devices Director John Wilkinson said: “I am delighted that Dr Nightingale has accepted this appointment at a time when the agency is busy implementing the recommendations of the review chaired by Professor Terence Stephenson into access to clinical advice.
“His expertise and experience will be invaluable in helping the agency as it responds to the demands of the future.”
Dr Nightingale said: “I am delighted to be taking on this role. The new committee will play a vital role in providing expert advice for MHRA on a huge range of medical issues and will help to ensure safe use and management of medical devices.”
The Medicine and Healthcare products Regulatory Agency (MHRA) have issued a warning to people who may have purchased an unlicensed medicine called GcMAF – labelled as ‘First Immune’ – from an online website or other unregulated sources.
GcMAF (Globulin component Macrophage Activating Factor) is a blood product which claims to treat a range of conditions including cancer, HIV and autism.
During an unannounced inspection by MHRA investigators of a production site in Milton, Cambridgeshire, 10,000 vials were seized and production of GcMAF has now ceased as the site was considered not to meet Good Manufacturing Practice (GMP) standards.
The product had been sold through various European websites and it is believed that UK patients may have bought it from one of these sites.
“These products may pose a significant risk to people’s health”, said Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards. “Not only were the manufacturing conditions unacceptable but the originating material was not suitable for human use. GcMAF products labelled as ‘First Immune’ are not licensed medicines and have not been tested for quality, safety or effectiveness.
“People should not start treatment with these specific products. It is important that patients currently taking these products seek their doctor’s advice as soon as possible. People should continue taking prescribed medicines and follow the advice of their doctor.”