MDA
The MDA has issued an alert on GE Healthcare Anaesthetic CareStations because an intermittent electrical connection with the on/standby switch can cause the machine to shutdown unexpectedly. The machine alarms and then a message appears on screen stating “system shutdown in 8 seconds”.
Any stocks of Mikrozid sensitive wipes (alcohol free surface disinfection wipes for medical devices) manufactured by Schulke & Mayr should not be used because their disinfectant properties cannot be guaranteed.
The Better Regulation Executive (BRE) has today published its report of the Hampton Implementation Review (HIR) into the Medicines and Healthcare products Regulatory Agency (MHRA). It found the agency was a proportionate, transparent and risk-aware regulator.
SIGN
SIGN has published the first of its ROCKET summaries of its guidelines - Recommendations Online: Clinical Knowledge Evidence Translation. The five ROCKETs now available are - management of oesophageal and gastric cancer, diagnosis and management of head and neck cancer, management of cervical cancer, control of pain in adults with cancer and management of genital Chlamydia trachomatis infection.
A draft guideline on diagnosis and pharmacological management of Parkinson’s disease has been published and is out for consultation.
Cochrane Library
Cognitive Behaviour Therapy (CBT) and Behaviour Therapy (BT) show some effect in helping the disability associated with chronic pain, according to a Cochrane Systematic Review. The researchers assessed the use of Cognitive Behaviour Therapy and Behaviour Therapy (BT) on chronic pain, mood, and disability.
Oral etoricoxib is at least as effective as other drugs commonly used for pain relief after surgery. A Cochrane Systematic Review has confirmed the effectiveness of the drug, which is sold under the brand name of Arcoxia.
NICE
Professor Sir Ian Kennedy has been commissioned by NICE to carry out a short study on valuing innovation in health technology appraisals. Thirty-eight submissions of written evidence were received by 3 April, which was the deadline. Two workshops on 18 and 19 May will explore the most important themes arising from these submissions.
ABPI
The ABPI has made a submission to Professor Sir Ian Kennedy’s call for evidence on how NICE should value innovation.
EMEA
The European Medicines Agency, European Commission and Health Canada (the Canadian regulatory authority for medicines) have agreed an implementation plan for a confidentiality arrangement on information sharing.
FDA
The US Food and Drug Administration has announced that Coast IRB, LLC of Colorado Springs, Colo, has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.
An updated alert on ceftriaxone (marketed as Rocephin and generics) has been issued warning of the drug’s interaction with calcium-containing products following two in vitro trials. The alert contradicts concomitant use of ceftriaxone and intravenous calcium-containing products in neonates (<28 days of age) and outlines precautions for use in older age groups.
The US Food and Drug Administration has amended its ban on the production and distribution of certain unapproved prescription opioids to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis. This follows concerns from patients and health care professionals in the palliative care community that the ban would cause a shortage of 20 mg/ml morphine sulfate oral solution, widely used to alleviate pain in terminally-ill patients.
Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), has announced that it has begun a voluntary withdrawal of this product from the U.S. market because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.
