Category: Medical
MHRA issues a medical device failure alert as all HeartStart MRx defibrillators might not deliver lifesaving shocks
According to our Medicines and Healthcare products Regulatory Agency (MHRA), certain defibrillators may fail to deliver controlled shocks, cardioversion, pacing or monitoring.
The HeartStart MRx defibrillators are manufactured by Philips Healthcare and it’s believed the fault lies with the batteries. The lifesaving medical devices could fail to turn on or reboot themselves repetitively, therefore hindering administrators from being able to deliver shocks. The device could also “fail to deliver a shock or undertake pacing” after it has been unplugged from AC mains.
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MoM hip replacements potentially causing long-lasting injuries
All Metal-on-Metal (MoM) hip replacement patients are being recalled for advice and investigation in the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued an updated medical device alert on 29th June 2017.
It’s estimated that 49,000 patients in the U.K. were given the MoM implants (with width of 36mm or above). The NHS notes that around 3,387 surgeries in 2010 used the 36mm (or above) MoM implants.
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Rogue surgeon who performed unnecessary mastectomies on patients jailed
“Monster” surgeon jailed for 15 years.
Former breast surgeon Ian Paterson has been jailed for 15 years after he was found guilty of unnecessary mastectomies to several patients, and was convicted of multiple counts of wounding with intent.
This is a unique case – we hope victims will find some comfort in this decision, although we know the lifelong effects of his criminal activity may never be repairable.
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DePuy Synthes elbow implants recalled by the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for radial head elbow artificial replacements amidst concerns over post-operative loosening of the device.
Manufactured by DePuy company Synthes, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved Radial Stem implants are both affected by the recall. The recall follows on from a Field Safety Notice (FSN) issued back in December 2016 by the company’s Senior Quality Assurance Manager, Anne Brisson.
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Philips Respironics V60 ventilator medical devices recalled
The Medicines and Healthcare products Regulatory Agency (MHRA) recently initiated a medical device alert as a result of Philips Respironics’ faulty software that could lead to a sporadic shutdown of the medical device.
The Respironics V60 ventilator’s are used in hospitals to assist in patient ventilation. Recently the medical manufacturer issued a Field Safety Notice (FSN) to notify users of the risk.
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MHRA publishes a class 2 Medicines recall for Sodium Cromoglicate eye drops
The Medicines and Health products Regulation Agency (MHRA) published a medical drug alert on the 18th May 2017 issuing a precautionary recall for bottles of eye drops amidst concerns that the solution can solidify in its container.
Sodium Cromoglicate solution eye drops are typically used to treat red, watery and itchy eyes. Common users are allergy suffers who react adversely to animal hairs, dust or pollen. Marketed as anti-inflammatory, it’s a remedy to alleviate itching and prevent damage to the eyes and delicate surrounding skin by rubbing. The eye drops are also used by contact lens wearers too.
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Issues with battery life of the Accu-Chek Insight insulin pumps
All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns.
The first warning for the medical device was issued on the 4th August 2015 where Roche Diabetes Care, the medical manufacturers of the insulin pump, issued advice about the correct battery specifications and appropriate pump settings.
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BD Plastipak 100ml catheter tip syringes with Luer slip adapters have been recalled after fears of leakage
The government’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert and announced the recall for reportedly defective plastic syringes.
Manufactured by Becton Dickinson, the catheter tip syringe with Luer slip adapters have reportedly failed routine stability tests. Under testing, the syringes can leak through the syringe stopper, rendering administration of medicine inaccurate and unsafe.
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Teleflex nasal drug atomiser device recalled
Following a medical device alert back on the 21st April this year, LMA MAD Nasal has recalled their intranasal mucosal atomisation devices after complaints that the device failed to deliver medication properly.
The device provides an alternative administration of medication that otherwise may require a needle. Marketed as “safe, painless and rapidly effective treatment”, many may prefer the nasal atomiser over a sharp needle in the arm.
However, problems have arisen where the medication may not actually be delivered properly or at all, which can of course be incredibly dangerous for users relying on vital medication for their health.
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Dangerous anti-malaria drug – Lariam – may be giving British troops severe depression
British soldiers deployed abroad in certain tropical countries may be prescribed drugs to prevent contracting malaria. For many years, troops were prescribed Lariam, but for over a decade there have been a whole string of complaints that it causes significant psychological problems.
Various countries all over the world stopped prescribing or selling the drug amidst fears that Lariam causes depression and violent behavioural changes, and our lawyers are investigating the issues surrounding use of the drug.
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GlaxoSmithKline to recall almost 600,000 asthma inhalers
Pharmaceutical company GlaxoSmithKline (GSK) are recalling hundreds of thousands of reportedly defective asthma inhalers.
The life-saving medical devices help asthma sufferers breathe, especially when suffering from asthma attacks, but a reported defect in the Ventolin inhalers has been found to provide insufficient doses.
The drug company, based in the U.K., supplies asthma inhalers to hospitals, pharmacies, retailers and wholesalers around the world, with defective units being found in the U.S.
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As medical companies join forces to advance medical technology, the rise in recalls and risks of hacking remain in our minds
Over the past few years, we have seen the digital world explode and incorporate in to everything we do. We have apps and gadgets for all sorts of things!
The medical industry has grasped this fairly new development to improve medical equipment and devices too. With ever advancing technology in treating patients, different medical companies are joining forces to introduce upgraded robotics, better visualisation, and improved bioelectronics.
However, the advancement of creations and collaborations have also seen a similar rise in medical device failures and the ever-present risk of hacking…
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