Category: Medical
The reported danger of Intersurgical’s BVM resuscitation device
A reported manufacturing fault of a medical device has caused a great deal of concern within the healthcare industry. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a field safety notice to notify healthcare providers and users alike.
Due to a reported manufacturing fault, the Bag-Valve-Mask (BVM) manual resuscitation system could cause injury or even death as the valve may become stuck during storage, possibly resulting in the intended airflow not being delivered. Consequently, there may be a delay in the treatment.
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Medical device alert issued for Prismaflex Haemofiltration machines
A medical device alert has been issued warning hospitals and healthcare institutions that Prismaflex Haemofiltration machines are susceptible to software failure.
Machines manufactured by Baxter, and installed with the 6.10 version of software, may not compute information about syringe size and the brand of syringe used. As a result, the machine may revert back to default settings, which means it will work at the lowest possible plunger speed which may therefore lead to under-dosage.
When under-dosing occurs, a lack of anti-coagulants may be added to the blood. Without carefully measured anti-coagulants, the patient’s blood may then be at a high risk of clotting, which can of course lead to potentially serious consequences.
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Medtronic: “Infuse lawsuits coming to a close”
Medical device company, Medtronic, has recently suffered a lengthy legal headache when the company faced allegations of defrauding shareholders by reportedly covering up negative side-effects of its Infuse bone growth product for 10 years.
Infuse is a genetically engineered protein that causes bones to fuse for use during lower spinal surgery; intended as an alternative to bone grafts. Thousands of patients complained that the product was used inappropriately and that it had caused permanent and devastating injuries.
These were allegedly covered up.
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Call for U.K. public inquiry into vaginal mesh implants
Senior doctors in the U.K. have called for a public inquiry into the use of vaginal mesh surgery. This comes after growing concerns that patients who have undertaken the surgery have been scarred for life.
Vaginal mesh implants are a net-like implant usually made out of polypropylene plastic and are used to treat pelvic organ prolapse, and stress urinary incontinence in women who may have these conditions as a result of hysterectomy, menopause or childbirth.
The problems that can occur if the devices fail can be catastrophic.
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Class 2 recall for Diclo-SR 75 pain-relief tablets
A Watford-based pharmaceutical company has issued a voluntary recall for batches of Diclo-SR 75 pain relief tablets – AKA diclofenac sodium.
The tablets are commonly used for pain relief and swelling for arthritis, musculoskeletal disorders, gout and pain caused by injury or minor surgery. The tablets are classified in a group of medicines called non-steroidal anti-inflammatory drugs.
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Regulators issue urgent recall over “toxic” spinal fusion stimulators
Regulators have issued a top-level recall over Zimmer Biomet SpF spinal fusion stimulators amidst concerns that the medical devices contain chemicals that can seriously harm patients, and even be fatal.
This is a serious recall given there is a reasonable probability that using a certain defective product can serious injure or kill the patient. It’s reported that 33 affected units were manufactured and distributed.
The affected stimulators are the SpF-XL IIB (22 units) and the SpF- Plus (11 units)
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Alvogen recalls 24 lots of hypertension drug off the market due to chemical contamination
A medical drug manufacturer has initiated a voluntary recall on 3rd July 2017 after concerns their Nifedipine tablets have become contaminated with other medication ingredients.
The company, based in Iceland, makes the hypertension drug under the brand name Adalat, which is supplied to Bayer HeathCare. It’s used for channel blocking and as treatment for hypertension (high blood pressure).
The recall was initiated after a potential cross-contamination between the Nifedipine and another drug in the same facility.
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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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