HONOLULU, Aug. 29 Hoana Medical, Inc. announced today thatit has successfully completed the intensive regulatory audits for ISO 13485and the Medical Device Directive (for most European Union countries), whichallows the use of the coveted CE Mark -- or Conformite Europeene Mark -- forthe LifeBed(TM) Patient Vigilance System. This expands Hoana's patient safetyreach to include more than 30 countries in the European Union (EU). The CEMark is similar to the U.S. Food and Drug Administration (FDA) clearance,which Hoana previously acquired for U.S. markets. It is a mandatory regulatoryapproval system for all medical devices to be sold in the EU, which indicatesthat a product conforms to the relevant European health, safety andenvironmental quality standards. The mark itself is often found on thepackaging or actual product offering and is required by most healthcareorganizations in Europe.
Traditionally, obtaining CE Mark certification and approval is a rigorous12- to 18-month process. Hoana is proud to have completed this certificationprocess in under 6 months due to its prior expertise in navigating the FDAclearance process and highly effective regulatory team.
"We are thrilled to have obtained the CE Mark for the LifeBed(TM) PatientVigilance System," said Dr. Patrick Sullivan, chief executive officer ofHawaii-based Hoana Medical, Inc. "We have received tremendous interest in theLifeBed from hospitals all over Europe and will now be able to partner withthem 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 patientsin trouble early makes an enormous difference in their outcome. Usingsomething as simple as the LifeBed to find patients in trouble is clearlyenhancing the effectiveness of rapid response teams nationwide -- it's themissing link to solving an enormous problem that touches 25 percent ofAmericans and untold numbers of Europeans each year."
In a recent study, four out of five European citizens viewed medicalerrors as an "important problem in their country (Eurobarometer 241)," withItaly, Poland and Lithuania leading the way. Nearly one in four Europeans hasbeen directly affected by a medical error -- either having the experiencethemselves or through a family member, with errors in Latvia, Poland andDenmark affecting nearly one in three people. Almost HALF of all preventableadverse events in Europe are caused by medical errors.
Hoana's technology transforms any hospital bed into a LifeBed, whichinvisibly tracks a patient's basic vital signs without any connection to thepatient whatsoever. However, if the patient begins to deteriorate, theLifeBed immediately notifies the hospital nursing staff -- all invisible tothe patient. It essentially provides "another set of eyes" to look after thepatient. Changes in a patient's condition due to medications, changes inphysiologic conditions, or other treatments are identified early by theLifeBed, which results in early interventions and positively impacts patientoutcome. The LifeBed has also helped reduce falls in partner hospitals by asmuch as 90 percent, a costly and dangerous problem facing many hospitalstoday.
The LifeBed has experience on more than 15,000 acute-care medical-surgicalpatients around the U.S., or more than 1.5 million patient hours, and hasshown that errors and accidents don't discriminate between social or economicclasses; it can happen to anybody, anywhere.
Research has shown that rapid response teams (RRT) are not effective ifthe patient is found too late -- many times patients are found in criticalcondition, or even deceased, also referred to as a 'dead in bed.' The U.S.'sJoint Commission (hospital accreditation authority) released new patientsafety goals for 2009 that highlight the fact that merely responding to apatient in need is not enough -- early re