A Medical Device Daily

Aspect Medical Systems (Newton, Massachusetts) said that the Australian and New Zealand College of Anesthetists (ANZCA) and the Madrid Centro Society for Anesthesia (MCSA) have each published recommendations for monitoring level of consciousness during anesthesia.

The recommendations were written to guide ANZCA and MCSA members in recognizing the problem of unintended awareness and adopt a consensus on how to reduce the incidence of inadvertent surgical wake-ups. Aspect noted that unintended awareness occurs when patients do not receive enough anesthesia, leaving them at risk for becoming aware of what is happening and remembering this experience after the surgery is over.

“The ANZCA and MCSA recommendations are consistent with the clinical guidance provided by other medical societies in the U.S. and Europe and reflect an increasing global recognition of the need to address awareness as a patient safety concern,” said Nassib Chamoun, president/CEO of Aspect. “We believe this is an important step toward improving patient safety and reducing the risk of awareness.”

He said that Aspect's Bispectral Index (BIS) “is the only brain monitoring technology or clinical intervention that has been shown in large scale, prospective clinical research to reduce the incidence of awareness.”

Using a sensor placed on the patient's forehead, BIS monitoring translates information from the electroencephalogram into a single number that represents each patient's level of consciousness. This number – the BIS value – ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value allows clinicians to make better-informed decisions to achieve optimal anesthesia, the company said.

The ANZCA has said that consciousness monitors should be used in all high-risk anesthetics and that equipment to monitor the anesthetic effect on the brain should be available for use on patients at high risk of awareness during general anesthesia.

For its part, the MCSA said that it promotes the use of depth-of-consciousness monitors and supports education on how to best use the monitors to reduce the incidence of intraoperative awareness. The society defines preventative measures that apply to the clinician, the equipment, the medical staff, and the patient, identifying a list of high-risk patient characteristics.

The recommendations of the two groups follow similar statements made by the American Society of Anesthesiologists, Joint Commission on Accreditation of Healthcare Organizations, American Association of Nurse Anesthetists and the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland About BIS Monitoring

To date, Aspect's BIS technology has been used to assess more than 16.3 million patients and has been the subject of some 2,370 published articles and abstracts.

Medistem in partnership with ICM

Medistem Laboratories (Scottsdale, Arizona), a developer of what it calls “non-controversial” adult stem cell sources, said that its affiliate, the Institute for Cellular Medicine (ICM), has received approval from the Costa Rican Health Ministry to begin operations of its adult stem cell bank and clinic.

ICM said it will begin working with doctors to treat patients with stem cell therapies based on Medistem's technologies, applying its adult stem cell technologies sourced from umbilical cords, placentas, fat, bone marrow and muscle.

The opening of the ICM bank and clinic represents a milestone in Medistem's plan to deliver stem cell treatments on a fee-for-service basis through its international affiliates.

The ICM laboratory will be one of the first stem cell banks in Latin America to produce the adult stem cells necessary for the development of stem cell based medical treatments, it said.

The stem cell bank and clinic will focus on the treatment of stroke, cerebral palsy and other neurological disorders. ICM said it also would develop treatments for other healthcare needs, such as cardiovascular disease.

Medistem granted a license to ICM – which is controlled by Medistem's CEO – to use certain of its intellectual property and agreed to fund all expenses in exchange for certain revenues and profits involving both adult stem cells and non-stem cell-based activities.

VScan test kits okayed in Russia

Medical Services International (MSI; Edmonton, Alberta) said it has received regulatory approval for its VScan HIV, tuberculosis and hepatitis C test kits in the Russian Federation.

The company said its distributor in Russia, Intertest , will immediately implement the marketing program for the approved test kits. MSI projected that sales will exceed 1 million kits in the first year in Russia.

The VScan HIV test detects the IgM antigen that shows up in the blood within two to 11 days of HIV infection. The VScan TB test kit is the only test kit that measures only active TB and therefore does not give false positives.

BioMag approved for Mexican trials

BioMag (Orangevale, California) said it has been approved by the Mexican Health Ministry to conduct clinical trials for the company's High Throughput Screening-Magnetic Testing Platform (HTS-MTP).

The company has partnered with the largest social institute in Latin America, Instituto Mexican del Seguro Social (IMSS), to conduct clinical trials in Mexico.

The company said it believes that clinical trials will confirm that its system will provide confirmatory and viral load diagnostics at the same cost of screening assays. It added that the HTS-MTP will detect any virus or bacteria and count the viral load in a matter of minutes, and has the capabilities of screening several hundred percent more assays per hour at a fraction of the cost of current technologies.

NanoMask achieves Australian registration

Emergency Filtration Products (Henderson, Nevada) said its NanoMask has been registered with Australia's Therapeutics Goods Administration as a Class 1 medical device.

As a result of this registration, the company's exclusive Australian distributor, the Friedmann Group , will launch an extensive marketing campaign in that country.