Category: Medical
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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Washington Supreme Court ruled that medical device makers have a duty to warn hospitals as well as doctors and physicians of product risks.
The Washington Supreme Court in the U.S recently gave a 6 – 1 judgement on whether or not medical device manufacturers have a responsibility to warn hospitals as well as doctors and operators of the risks their products come with.
In this recent Supreme Court decision, it was held that manufacturers must also warn hospitals as the purchaser of the medical devices (and thus the consumer), as well as doctors. The lawsuit was made against Intuitive Surgical Inc. after a man died from a fatal operation involving the manufacturer’s robotic medical device. The Da Vinci system is used for minimally invasive operations whereby a doctor operates on the patient through a robotic arm controlled by an electric remote.
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Court case over De Puy metal hip prosthesis may alter product liability laws in the U.K
Following on from the recall issued by De Puy Orthapaedics on their hip implants in 2012, a recent decision has been made at the Court of Appeal over the defective hip replacement devices, where the Court has decided that a safety expectation test must be passed too.
Whilst the claimant Wilkes had suffered from an implant fracture 3-years after the hip replacement implant, the Court looked towards surrounding circumstances like ‘risk benefits’ and how it could have been avoided.
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Medical device maker Medtronic has recalled their adjustable pressure valves across the world
Medtronic has issued a worldwide recall over their unused StrataMR valve devices after numerous complaints have been raised.
In one of the complaints, one patient death is suspected to be related to the device. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent Field Safety Notice to distribute news of the recall in the U.K.
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Lawyers seeking product liability claims against Zimmer for problems associated with their knee replacement implants
Zimmer NexGen knee implants are supposed to provide patients with new artificial knees to last at least 15-20 years. However, there have been numerous reports that the implants have been loosening; causing pain, discomfort and other complications.
With the level of complaints, the implants are believed to be defective and a recall has been issued by the U.S. regulators. However, this isn’t a broken toy that you can just bring to a supermarket for a refund; individuals who have had the knee replacement surgery may be at risk of the implant moving or loosening, and if this occurs, the individual may need knee revision surgery.
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Health and safety regulators are warning consumers of fake cancer treatments being sold online
Regulators have found 65 fake health products circulating the web that are falsely advertised as cancer treatments.
“Miraculously kills cancer cell in tumours,” “more effective than chemotherapy” – These kinds of potentially fraudulent and unsubstantiated claims are being used to advertise alternative cancer remedies, and the concern is that the vulnerable are being preyed upon.
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Studies shows that companies wait too long to recall medical devices
How long is too long?
It seems that medical device companies do not prioritise the safety of their products above profits and reputation, as a study conducted by the University of Minnesota revealed that these companies tend to delay in recalling defective products.
When problems are not reported to relevant authorities – like the MHRA here in the UK – healthcare professionals and the public may be unaware of the complaints, and thus may continue to use defective products that may carry a significant risk of harm.
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Lithium-ion batteries in a medical device can cause smoke and sparks if dropped
Damaged lithium-ion batteries in a medical device have been a cause for concern for the Medicines and Healthcare products Regulatory Agency (MHRA).
The CARDIOSAVE hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE rescue IABP have been reported to have damaged lithium-ion batteries that may give off smoke, a bad smell, or produce sparks.
Macquet, the manufacturer of the medical device, has warned users to avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.
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The Government has issued a medical drug alert alongside a voluntary recall of Viridal Duo Powder amidst concerns over defective cap seals compromising the sterility of the contents.
UCB Pharma Limited is voluntarily recalling their Viridial Duo Powder and Solvent for Injections after concerns that the cap seals are not strong enough. The cap seals are vulnerable to breaking and thus compromising the sterility of the contents.
Viridal Duo Powder and Solvents contain the active ingredient ‘Alprostadil’ and is used for adult males for diagnostic evaluation and treatment of erectile dysfunction. The prescription only injections for diagnostic evaluation purposes are carried out by a trained physician, who will monitor the dose need to produce an erectile response.
For the treatment of erectile dysfunction, this can be administered by a physician or by self-injection.
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CareFusion syringe pumps are incompatible with any syringe type
Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA/2016/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine.
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Mylan EpiPen recall information
Anaphylaxis is a life-threatening reaction to certain allergens which can be found in foods, drugs, and even venom like in a wasp sting. Depending on the sufferer’s sensitivity to the allergens, anaphylactic shock can be caused by ingestion or even mere contact on skin.
Otherwise more commonly known as an allergic reaction, without the simple treatment, the consequences can be serious and even fatal. Anaphylactic shock can come on immediately, and in severe cases, symptoms can develop just as quickly. Some symptoms include swelling of the throat and face; wheezing; dizziness and fainting spells. If left untreated, individuals may have difficulty breathing to a point where they may stop doing so.
For these reasons, any life saving EpiPen recall is always a major concern.
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Class 3 recall: does the small crack in the blistering of tablet packaging impact their effectiveness?
The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended recalling instant pain relief tablets due to an issue with some batches.
Bayer plc is a pharmaceutical company who manufactured the pain relief tablets in question; Alka-Seltzer Original & Alka-Seltzer XS. Bayer noticed an issue with the blister foil and as a result, are voluntarily recalling them as a precautionary measure.
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