Tag: mhra
UK government investigating the scale of harm caused by vaginal mesh implants
Our legal team have been assisting people in various situations involving harm caused by vaginal mesh implants.
The UK government review update is welcome news.
Years after the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) investigated issues and decided against recalls and bans, the National Institute for Health and Clinical Excellence (NICE) has suggested the surgery should be banned, and New Zealand have become the first country in the world to put an outright ban in place.
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MHRA issue “Class 4” drug alert warning for Focus Pharmaceuticals after barcode errors found on 8 medicinal products
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Class 4 (caution in use) warning over eight Focus Pharmaceutical medicinal products after a problem was found with the barcodes.
The packaging fault may interfere with prescriptions as the wrong product may be identified when they’re scanned.
The medicines themselves have no reported faults and the rest of the packaging including the name, strength and pharmaceutical form of the medicine is correct as far as the manufacturer and the MHRA are aware.
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Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Bleo-Kyowa powder over a ‘minor’ defect being reported.
The agency cites glass particles being detected in a batch of the medicine back in April 2017.
Hospitals, pharmacies and other healthcare providers are requested to take caution in using the Bleomycin Sulphate powder that acts as an anticancer chemotherapy medicine.
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Ceftazidime antibiotic concentration may deteriorate if stored at the wrong temperature
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a medical device alert over the test disc for the antibiotic ‘Ceftazidime’, warning that storing the test discs at the wrong temperature can increase the chances of false resistance results.
The antibiotic is used to treat all sorts of bacterial infections including joint infections, sepsis, pneumonia, urinary tract infections and more. In cases where the Ceftazidime test disc was not frozen between the temperatures of +2o and -20o, notably at +8o, the antibiotic’s shelf-life may have been degraded.
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MHRA issues warning for Gentamicin Sulphate Active Pharmaceutical Ingredient over increased levels of histamine
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) for trace contamination of histamine.
The situation is reportedly not serious enough to warrant a recall.
Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA was made aware that testing of the finished products has uncovered higher levels of histamine than expected. The unwanted histamine is thought to be a residual from the manufacturing process, with the potentially affected range between July 2014 and June 2017.
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Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation
Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths may have occurred as a result.
The heart controls the blood flow in our bodies and relies on aortic valves to ensure the blood is pushed in the right direction to reach our organs and limbs. However, over time, these valves can become weak or damaged and don’t close properly which can lead to blood leaking back into the heart, making it much harder for the heart to pump it outwards to the rest of our bodies, resulting in heart failure. Artificial mechanical valves can be fitted to replace the weakened or thickened valve.
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Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet/Getinge. The alert closely follows the one issued over the Datascope Corp’s similar devices that were found to have an electrical fault.
This new alert identifies a “false blood detection alarm and/or fluid ingress” that can also risk failure of therapy to patients. The medical device is used to help the patient’s blood flow, pumping at the same rate as a heartbeat, and is usually used for patients whose hearts may not be strong enough to function alone.
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Medical device alert for Datascope Corp intra-aortic balloon pumps
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp.
Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.”
The medical device cites at least one report of a death involving an allegedly failed CS300 intra-aortic balloon pump. It’s not known how many non-fatal injuries have been caused by the faulty pumps as well.
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MHRA issues medical alert over Comprehensive Nano Humeral Components
The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components over risks of needing revision surgery when used in reverse configuration.
The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices.
The comprehensive ‘nano humeral component’ is usually used in the anatomic or reverse configuration, but after an annual review was conducted, the study data indicated the device was not fit for use in the reverse configuration.
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Medical device alert issued over damaged VITEK 2 test cards exposing risk to antibiotic degradation
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert over VITEK ® 2 AST Test Cards after the discovery that when the cards are exposed to moisture, it can stop antibiotics from working.
Manufacturer BioMérieux published a Field Safety Notice to inform consumers of the issue at hand, and confirm the potential problems. The Notice explains that a defective test card may:
- Yield false resistance for antibiotics on the AST panel
- Cause a false negative ESBL test
- Result in a false positive urea reaction on ID cards
Depression and chronic pain relief drug, Duloxetine, recalled after failing tests
The drug Duloxetine, more commonly known as its brand name Cymbalta, is generally used to treat depression, anxiety, and chronic pain. It’s an active ‘serotonin-norepinephrine reuptake inhibitor’, providing pain relief for patients with diabetes or sufferers from chronic or widespread pain.
The drug is commonly prescribed to people with arthritis and fibromyalgia. However, select batches of the Torrent Dutor Gastro-resistant Capsules have been recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) because “out of specification results for dissolution were obtained during routine stability testing”.
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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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