Published:
Hoana Medical Acquires CAN ISO and J-GMP Marks to Expand Patient Safety Technology to Canadian and Asian Market
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 includeCanada andJapan, 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 inCanada andJapan, 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 ofHawaii-based Hoana Medical,
Inc. "We have received tremendous interest in the LifeBed from hospitals in
bothCanada andJapan 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."
InCanada, 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. InJapan, 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
inJapan 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, theUnited Kingdom andthe
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.
Copyright © 2008, PRNewswire
Copyright © 2008, NewsBlaze,
Daily NewsTags: ,HEA,MTC,CPR,PDT,ASI,HI-Hoana-Medical-ISO
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