HONOLULU, Sept. 17 /PRNewswire/ -- Hoana Medical, Inc. announced today that it has successfully completed the intensive regulatory audits for CAN ISO 13485 and the J-GMP, which allows the use of the coveted CAN ISO and GMP Marks -- for the LifeBed(TM) Patient Vigilance System. This expands Hoana’s patient safety reach to include Canada and Japan, two first-world nations that are implementing new patient safety goals each year. The ISO and J-GMP Marks are similar to the U.S. Food and Drug Administration (FDA) clearance and the CE Mark, which Hoana previously acquired for U.S. and European markets, respectively. These are mandatory regulatory approval systems for all medical devices to be sold in Canada and Japan, which indicates that a product conforms to the relevant Canadian and Japanese 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 these two countries.
Traditionally, obtaining CAN ISO and J-GMP 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 and CE Mark clearance process, led by its highly effective regulatory team.
“Obtaining the CAN ISO and J-GMP Marks for the LifeBed(TM) Patient Vigilance System is another giant step towards bringing cutting-edge patient safety technology to countries with which we have close economic ties,” said Dr. Patrick Sullivan, chief executive officer of Hawaii-based Hoana Medical, Inc. “We have received tremendous interest in the LifeBed from hospitals in both Canada and Japan and will now be able to work with them to not only meet Joint Commission International’s patient safety goals, but also improve healthcare. Patient safety is an international issue facing citizens of every country.”
In Canada, a study showed that one in nine Canadians were victims of preventable medical errors and more than 24,000 people die each year from medical mistakes. In Japan, medical error figures are harder to come by because of the administrative reporting requirements and cultural barriers. Japan leads the world in medical resonance imaging and other medical technology and has some of the healthiest people in the world. Medical errors in Japan are prosecutable in the criminal courts versus the civil courts in the U.S., leading to fewer reported cases. The government has acknowledged the need for dramatic improvements in patient safety and the need to find technological solutions on this front.
In 2007, the World Health Organization (WHO) Collaborating Centre launched a special WHO Action on Patient Safety Initiative known as the High 5s Project. It seeks to improve the safety of patients around the world with Canada, Germany, the Netherlands, New Zealand, the United Kingdom and the United States participating in the project.
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.,’ 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.’
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. Patients with LifeBed intervention stories can share their “intervention” by registering with Hoana’s LifePAC team at http://www.hoana.com/LifePAC and clicking on the Patient Stories button; for every story, Hoana will donate valuable dollars to the patient’s favorite health-related charity. Hoana is headquartered in Honolulu, Hawaii. For more information, please visit http://www.hoana.com
Source: Hoana Medical, Inc.
