Category: Medical
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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Manufacturers of vital ventilation machines issued a Medical Device Alert after reports that the emergency devices stop working due to oxide build up.
Drager has issued a ‘risk of failure’ alert to all users after multiple reports were made complaining that ventilation devices had stopped working.
This is reportedly not the first time the company has received these complaints. Dräger has now issued a second Field Safety Notice for the Oxylog 3000 and Oxylog 3000 plus ventilators.
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Vaginal meshes used to treat bladder problems still causing catastrophic problems
Thousands of women worldwide have experienced catastrophic injuries as a result of having a synthetic transvaginal mesh, transvaginal tape, or a bladder sling implanted.
The net-like implant is commonly used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Common side effects reported from the use of the vaginal mesh implants include continuing urinary incontinence; recurrent bladder infections; erosion; haematomas; nerve damage; inability to have sexual intercourse; pain during sexual intercourse; auto immune reactions; and life-long disabilities and even death.
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MS Tecfidera medication caused liver injury to 14 people
Pharmaceutical company Biogen Inc has recently received a scare from its big-selling oral multiple sclerosis drug, Tecfidera.
Tecfidera has been well-known to treat relapsing multiple sclerosis, and although, Tecfidera’s historic side effects have been linked with serious viral infections to the brain, which could lead to disability or death, more recently, the medicine has been linked to liver injuries.
Of the 230,000 patients treated with Biogen’s Tecfidera, there have been 14 reported cases of liver injury, according to a Biogen spokeswoman.
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Heart pump device production has been halted due to patient death
A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.
Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.
The device was initially thought to be commercially promising, but the problems identified are serious.
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Class 4 MHRA alert: Mirena inserters incorrectly mounted
Bayer plc, a global pharmaceutical company, has received two complaints with regards to its Mirena inserters. The complaints detail that the insertion tube was mounted inversely to the handle, and this has led to an inversion of the insertion depth scale, which may lead to incorrect insertion depth; consequently reducing the efficacy and/or causing injuries.
An investigation has shown that both complaints involve one batch of inserters and a Mirena batch number TU01BPE. The affected batch was first distributed on 29th August 2016, with an expiry in June 2019.
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Arthritis tablets may adversely affect users who rely solely on Braille
The Medicines and Healthcare products Regulatory Agency (MHRA) recently issued a caution relating to a drug that treats adult patients with active rheumatoid arthritis or active psoriatic arthritis.
Global pharmaceutical company Sanofi informed the medical agency of the error on the Braille on the packaging of some batches of the Arava 10mg film-coated tablets. The affected batches were distributed in May 2016, August 2016, September 2016 and October 2016 with batch numbers 5JK2A, 5JK3A, 5JK6G and 6EV2A accordingly.
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