Anaesthesia

The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.

A recent Europe-wide survey of Anaesthetists, delivered by UK medical device research firm Creative Medical Research, claims to have revealed the views of the profession in relation to existing and future technologies.

J&J division, Sedasys says its sedation system is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation in defined patient groups undergoing colonoscopy and esophagogastroduodenoscopy procedures.

Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE(TM) Absolute Tissue Oximeter, which it claims is more accurate than its predecessor.

Critical care device company Teleflex Inc, has announced that its Anesthesia and Respiratory business unit has received FDA 510(k) clearance for its ISO-Gard® Mask with ClearAir™ Technology. The company says this novel product helps to reduce clinician exposure to hazardous waste anesthetic gases exhaled in “recovery”.

Vital 5, LLC, a VentureMD portfolio company, has received clearance from the U. S. FDA for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.

Creative Medical Research (CMR), a fast growing UK-based business focusing on innovative research into the medical device market, has recently begun a comprehensive survey of 100 anaesthetists across Europe into their awareness and prediction of technological advances.

The FDA has seen fit to publicise GE Healthcare’s Class I recall of its T-piece circuit used with its Giraffe and Panda resuscitation units. Customers have been advised not to use the identified parts, although no patient has yet suffered injury as a consequence of device performance.

Teleflex Incorporated has announced the U.S. launch of its new Arrow® FlexBlock™ Continuous Peripheral Nerve Block Catheter at the annual meeting of the American Society of Anesthesiologists, and product will begin shipping to customers in November.

Device company Teleflex Inc. has announced the FDA 510(k) clearance of its Arrow® FlexBlock continuous peripheral nerve block catheter designed for clinicians who use ultrasound guidance when placing peripheral nerve block catheters.

UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of the EMS ET Tube Clamp/Holder because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.

Carefusion is clearly busy with recall issues, three ventilator products having suffered problems in the past year (two in the past month). the company is now updating its guidance on the Enve® recall issued in June.

Maquet is recalling certain of its Flow-i Anesthesia Systems due to a software problem which requires a fix. FDA considers the recall Class I which implies use of the product may cause serious adverse health consequences or death.

Covidien’s acquisition of Oridion Systems Ltd. is complete, expanding the medtech giant’s portfolio of key monitoring technology to include the Israeli company’s capability in airway management.

Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.

Covidien is announcing the global launch of its Nellcor SpO2 module designed for use on Philips patient monitoring platforms.