CE Mark Opens Market to More Than 30 European Countries
HONOLULU, Aug. 29 /PRNewswire/ -- Hoana Medical, Inc. announced today that it has successfully completed the intensive regulatory audits for ISO 13485 and the Medical Device Directive (for most European Union countries), which allows the use of the coveted CE Mark -- or Conformite Europeene Mark -- for the LifeBed(TM) Patient Vigilance System. This expands Hoana's patient safety reach to include more than 30 countries in the European Union (EU). The CE Mark is similar to the U.S. Food and Drug Administration (FDA) clearance, which Hoana previously acquired for U.S. markets. It is a mandatory regulatory approval system for all medical devices to be sold in the EU, which indicates that a product conforms to the relevant European health, safety and environmental quality standards. The mark itself is often found on the packaging or actual product offering and is required by most healthcare organizations in Europe.
Traditionally, obtaining CE Mark certification and approval is a rigorous 12- to 18-month process. Hoana is proud to have completed this certification process in under 6 months due to its prior expertise in navigating the FDA clearance process and highly effective regulatory team.
"We are thrilled to have obtained the CE Mark for the LifeBed(TM) Patient Vigilance System," said Dr. Patrick Sullivan, chief executive officer of Hawaii-based Hoana Medical, Inc. "We have received tremendous interest in the LifeBed from hospitals all over Europe and will now be able to partner with them to bring cutting-edge, 24-hour vigilance to their various hospital units. In the U.S., our experience shows that something as simple as finding patients in trouble early makes an enormous difference in their outcome. Using something as simple as the LifeBed to find patients in trouble is clearly enhancing the effectiveness of rapid response teams nationwide -- it's the missing link to solving an enormous problem that touches 25 percent of Americans and untold numbers of Europeans each year."
In a recent study, four out of five European citizens viewed medical errors as an "important problem in their country (Eurobarometer 241)," with Italy, Poland and Lithuania leading the way. Nearly one in four Europeans has been directly affected by a medical error -- either having the experience themselves or through a family member, with errors in Latvia, Poland and Denmark affecting nearly one in three people. Almost HALF of all preventable adverse events in Europe are caused by medical errors.
Hoana's technology transforms any hospital bed into a LifeBed, which invisibly tracks a patient's basic vital signs without any connection to the patient whatsoever. However, if the patient begins to deteriorate, the LifeBed immediately notifies the hospital nursing staff -- all invisible to the patient. It essentially provides "another set of eyes" to look after the patient. Changes in a patient's condition due to medications, changes in physiologic conditions, or other treatments are identified early by the LifeBed, which results in early interventions and positively impacts patient outcome. The LifeBed has also helped reduce falls in partner hospitals by as much as 90 percent, a costly and dangerous problem facing many hospitals today.
The LifeBed has experience on more than 15,000 acute-care medical-surgical patients around the U.S., or more than 1.5 million patient hours, and has shown that errors and accidents don't discriminate between social or economic classes; it can happen to anybody, anywhere.
Research has shown that rapid response teams (RRT) are not effective if the patient is found too late -- many times patients are found in critical condition, or even deceased, also referred to as a 'dead in bed.' The U.S.'s Joint Commission (hospital accreditation authority) released new patient safety goals for 2009 that highlight the fact that merely responding to a patient in need is not enough -- early recognition of these patients in distress is the key to saving lives and Queen's has always been a leader in this area.
Recent studies also show respiratory function is the leading indicator of pending patient distress. The Joint Commission wrote that "4 to 17 percent of inpatient admissions have critical events such as cardiopulmonary and respiratory arrests and vital sign changes, with warning signs preceding events by an average of 6 to 8 hours."
With nearly 40 percent of all unexpected U.S. hospital deaths occurring on the medical-surgical floor, continuous patient vigilance is a rapidly growing trend. Hospitals across the country are working to implement solutions that meet the Joint Commission's patient safety goals for 2009, while enhancing nurse and patient satisfaction. With most medical facilities around the country looking for ways to improve patient safety and satisfaction, the LifeBed represents new technology that will enhance the standard of care on the general care floor.
About Hoana Medical, Inc.
Launched in 2002, Hoana Medical, Inc. is the world's leading healthcare company focused on "Intelligent Medical Vigilance" in acute care hospitals where approximately 200,000 people die from errors and mistakes. It's first U.S. Food and Drug Administration (FDA)-cleared offering, the LifeBed(TM) Patient Vigilance System ("LifeBed"), transforms any hospital bed into a LifeBed(TM) System by tracking a patient's vital signs without any wires or connections to the patient. At the intersection between information technology and medical devices, the LifeBed(TM) System acts like another set of eyes for the nurse and alerts if a patient is in trouble. It delivers "vigilance" in an un-tethered and invisible manner, however, if the patient is in trouble, the LifeBed(TM) System calls for help. Experience on more than 15,000 individual hospital patients around the U.S. has yielded dramatic stories of nurses intervening to save a patient's life. Hoana is headquartered in Honolulu, Hawaii. For more information, please visit http://www.hoana.com
|SOURCE Hoana Medical, Inc.|
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