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A high priority has been placed on improving incident reporting as the first step in reducing unintended patient injuries. The incident reporting system in many health care organizations is evolving into one that focuses on near misses, provides incentives for voluntary reporting, ensures confidentiality (not necessarily anonymity), and emphasizes data collection, analysis, and improvement.
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The quality professionals role continues to evolve, with many professionals stepping into leadership and business roles, according to the latest Hospital Peer Review salary survey.
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The Abbott Vascular Devices (Redwood City, California) division of Abbott Laboratories (Abbott Park, Illinois) reported in mid-September that it had enrolled the first patient in its ZOMAXX I drug-eluting coronary stent clinical trial. ZOMAXX I is a 400-patient, randomized clinical trial that will be conducted in more than 30 centers in Europe, Australia and New Zealand.
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CoreValve (Paris) will begin a European Phase I clinical trial of its ReValving System at The Heart Center (Seigburg, Germany), having received institutional review board (IRB) approval at that institution. The trial calls for use of the ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. The principal investigator will be Eberhard Grube, MD, chief of cardiology at The Heart Center.
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Automated blood processing systems developer Haemonetics (Braintree, Massachusetts) reported that it has acquired all of the blood conservation technologies assets of Harvest Technologies (Plymouth, Massachusetts), a company that designs products intended to accelerate healing naturally, for roughly $4 million.
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Abiomed (Danvers, Massachusetts) last month submitted to the FDA an application for market approval of its AbioCor implantable replacement heart under a Humanitarian Device Exemption (HDE). Approval under an HDE would make the AbioCor commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients.
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Catalyst Pharma Group (Pasadena, California) has entered into a strategic partnership with Spacelabs Medical Data (Issaquah, Washington).
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Implantable cardioverter defibrillator (ICD) implantation may contribute to a lower incidence of ventricular fibrillation (VF)-related out-of-hospital cardiac arrest treated by emergency medical services (EMS), according to a study published in the September issue of Heart Rhythm, a journal of the Heart Rhythm Society (formerly NASPE; Natick, Massachusetts).
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Abiomed (Danvers, Massachusetts) named Frank Menzler general manager for Abiomed BV, the company's European division. Menzler most recently was marketing manager for cardiac surgery for Guidant Europe and was a co-founder of Impella Cardiotechnik AG, a developer of minimally invasive blood pumps.
