Category: Medical
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.
Continue Reading…
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.
Continue Reading…
NovoPen insulin pens recalled over risk of hyperglycaemia
Certain batches of insulin pens manufactured by Novo Nordisk have been recalled as the cartridge holders may not be strong enough to withstand some household cleaners.
The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a medical device alert to notify hospitals and users to return affected batches to Novo Nordisk for replacement.
NovoPen Echo and NovoPen 5 are both affected by the recall. A total of 87 batches in the U.K. have been recalled by way of a field safety notice, citing broken or cracked cartridges as the problem.
Continue Reading…
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.
Continue Reading…
DePuy Synthes Impactor for PFNA blade recalled over risk of infection
Manufactured by Synthes, the DePuy impactors used for Proximal Femoral Nail Antirotation (PFNA) have been recalled over potentially dangerous risks of infection. PFNA’s are metal devices inserted into the femur bone to strengthen it.
The U.K.’s Medicines and Healthcare Products Regulation Agency (MHRA) has noted a defect with the medical device as a crack in the weld of the handle. The recalled blade is used to insert and position the PFNA in the centre of the bone, and the operating physician uses the handle to grip and position the attached PFNA. It is the handle for the PFNA Blade impactor that can crack, and continued use may mean bodily fluids like blood or bony debris can get inside the device, risking cross-contamination when it’s used for other patients.
Continue Reading…
Are we facing an “opioid epidemic”?
We’ve already acknowledged a reported over-reliance on prescription medication here in the U.K., with fears of an “opioid epidemic” in America creeping across the pond to our shores as well. Unless, it’s already here…
In what’s being described as an “epidemic” and a “crisis” in the U.S., opioids are apparently being used way too much, leading to serious and needless addictions whilst reportedly lining the pockets of the super-rich pharmaceutical corporations.
We look at this growing problem and comment on why we ought to be concerned.
Continue Reading…
Pregnant mothers given antidepressants linked to children born with psychiatric illness
A new study reportedly shows that children whose mothers took antidepressants whilst pregnant with them may have an inflated risk of psychiatric illness.
The study, published by the British Medical Journal (BMJ), found that 32,400 of the 905,000 children participants in a 16-year-long study were diagnosed with a psychiatric disorder. Although statistically only 3% of the total study group, 32,400 is still a significant number that may have in theory been reduced if expectant mothers received more warning about the potential risks to their unborn child.
Continue Reading…
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
Endo International Plc to put aside more than £580 million to pay off mesh lawsuits
Global pharmaceutical company Endo International Plc are reportedly putting aside another £583 million to settle the remaining vaginal mesh lawsuits made against them. The staggering but deserved sum is to go towards settling some 22,000 lawsuits internationally, and Endo are to begin paying the amount in instalments at the end of this year and into 2019.
They have not admitted any liability.
The £583 million is in addition to the over £2 billion already agreed for 48,000 cases. Last year, Endo reportedly paid out over £800 million in mesh legal settlements.
Continue Reading…
Lawsuit filed against EpiPen manufacturers for alleged “price gouging”
A lawsuit has been filed against a medical manufacturer who are alleged to have charged higher prices for its asthma medication.
High charges for asthma medication is a hot topic here in the U.K., with many believing it’s not something people should have to pay for.
The EpiPen – the medication at the centre of the allegations – is an injector pen that contains epinephrine; a chemical that narrows blood vessels and opens airways in the lungs. It’s frequently used to treat severe allergic reactions (anaphylaxis) against insect stings or bites, foods, drugs etc. It’s a device that can save lives.
Continue Reading…
Major drug manufacturers and distributors suspected of colluding to inflate profits at consumers’ expense
Several drug manufacturers, suppliers and pharmacy benefit managers have reportedly been caught colluding to fix prices for insulin.
In what’s believed to be efforts to allegedly inflate profits, companies reportedly worked together to set consistently high prices for the drugs. This way, no matter where consumers purchased their insulin from, they’d be paying high prices. By price-fixing, no company undercuts the other by offering a cheaper price, which is anti-competitive behaviour that can be extremely harmful for competition and for the consumer.
These are the accusations being brought by those bringing a legal action.
Continue Reading…
Novo Nordisk agrees to settlement for questionable sales tactics
Danish multinational pharmaceutical giant Novo Nordisk is one of the leading global manufacturers of medical drugs.
They stand accused of using questionable tactics to drive up sales.
Novo Nordisk reportedly took their marketing a step further by disguising salespeople as medical professionals and educators. The Novo Nordisk employees would apparently pretend to be experts in medicine and recommend the company’s own drugs like professors advertising their own textbooks to students. The drug maker is also accused of paying kickbacks to doctors and medical staff to encourage them to prescribe the company’s own medicines.
Continue Reading…