New National Electronic Health Record Safety System Launched

/PRNewswire/ -- A new electronic health record (EHR) safety reporting system was announced today by the iHealth Alliance, a not-for-profit organization composed of medical society and professional liability carrier executives in collaboration with federal agencies and PDR Network. EHRevent.org establishes a national system where physicians and other health care providers can report issues related to the implementation and use of EHRs.

Using a standardized online format, EHRevent will collect reports from physicians and other health care providers who use EHRs and create reports that medical societies, professional liability carriers and government agencies, such as the U.S. Food and Drug Administration (FDA), will use to help educate providers on the potential challenges that EHR systems may bring. The system will be available directly via the Internet at www.EHRevent.org and also integrated into the web sites of participating liability carriers, medical societies, PDR Network and other partners, including EHR system vendors.

EHRevent was modeled after other national reporting systems, including the system used in the aviation industry, and its reports include issues related to software problems, inadequate user training, security breaches and near-misses. Reports will be confidential but used to better understand challenges associated with the adoption and implementation of EHRs and to improve patient safety.

"Electronic health records are being adopted at record rates and present an opportunity to advance patient care," said Nancy Dickey, M.D., iHealth Alliance chair and former president of the American Medical Association. "As with any new system, there is a learning curve for the software providers and for the doctors who use these systems. EHRevent will help us all get smarter about EHRs and assure that patient care advances are also patient-safe advances."

Professional liability carriers who insure doctors against malpractice claims are among the strongest supporters of EHRevent.

"EHRs can impact both the care that is delivered and the record of that care," explained David Troxel, M.D., medical director for The Doctors Company, which is the country's largest professional liability carrier. "EHRs can play a major role in advancing the practice of good medicine, but there are often unanticipated consequences when new technologies are deployed and it is important to collect and disseminate EHR user experience as these powerful systems are adopted."

Alan Lembitz, M.D., vice president of Patient Safety and Risk Management for COPIC Insurance Company, added, "Our experience indicates that EHRs have the capacity either to induce or to reduce medical errors in very unique ways, and we have seen data that indicates that EHR adoption may reduce physician liability. It will be increasingly important to understand best practices to improve patient safety for EHRs and for their users, and EHRevent will help both."

EHRevent is also working directly with EHR vendors as well as Regional Extension Centers (RECs), which are federally designated groups that assist physicians with EHR selection and adoption. Participating EHR vendors and RECs will help educate physicians regarding the importance of EHR event reporting and will receive reports as EHRevent partners.

"Patient safety is at the core of our mission to assist in the adoption of EHRs," explained Kathy Mechler, co-director and chief operating officer for the Texas A&M Health Science Center Rural and Community Health Institute, which includes the CentrEast REC. "We look forward to working with the many EHRevent partners to help educate providers and drive safe EHR adoption."

Michael Stearns, M.D., president and CEO of e-MDs, Inc., a leading EHR vendor, and board president of the Texas e-Health Alliance said, "EHRs have tremendous potential to improve the quality and efficiency of healthcare, but like any tool they must be designed and implemented in a way that uses best practices that strive to eliminate medical errors. We are anxious to collaborate with the EHRevent effort and we encourage all EHR vendors to participate because we believe that EHRevent can be an important communication platform to improve patient safety related not only to EHRs but to medical devices and drugs."

Data collected by EHRevent will also be used by the FDA to help evaluate any safety issues that may arise during the widespread implementation of this technology.

"We applaud the efforts of the iHealth Alliance to help assure the safety of EHRs," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We look forward to working with the iHealth Alliance to encourage physicians and EHR vendors to report information on their experiences with electronic health records to EHRevent and other appropriate reporting systems."

EHRevent and a similar service for reporting adverse drug events via EHRs will be governed by the iHealth Alliance, with network operations provided by PDR Network. PDR Network CEO, Edward Fotsch, M.D. explained, "EHRevent, and RxEvent for adverse drug events, will collect information using online forms that include the Common Format developed by the Agency for Healthcare Research and Quality (AHRQ) and will keep the information confidential through PDR Secure, a Patient Safety Organization, allowing only participating organizations to access the reports.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care," said William Munier, M.D. Director for the Center for Quality Improvement and Patient Safety, AHRQ. "Patient Safety Organizations (PSOs) facilitate a shared-learning approach that supports effective interventions to reduce risk of harm to patients and improve quality. We are collaborating in efforts to facilitate reporting to PSOs those adverse events that are related to EHRs and other health information technology, in order to facilitate the development of safer health information technology solutions."

Starting today, U.S. physicians and other healthcare professionals will learn about and be encouraged to use EHRevent by their medical societies, liability carriers, the FDA, PDR Network and other participating groups.

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Haemonetics Files a New Legal Action to Stop Fenwal Inc.'s Continued Patent Infringement

/PRNewswire/ -- Haemonetics Corporation (NYSE:HAE) announced today that it has filed a new legal action to stop Fenwal Inc.'s continued patent infringement resulting from Fenwal's just released red cell collection kits, using a modified separation chamber. Fenwal allegedly modified its separation chamber to circumvent Haemonetics' patent and the injunction entered by the Court prohibiting Fenwal's continued sale of infringing products after December 1, 2010. According to statements made by Fenwal's counsel today in the United States District Court, Fenwal is determined to proceed with commercialization without 510(k) clearance from the U.S. Food & Drug Administration.

On December 7, 2009 Fenwal announced that it began shipping a red cell collection kit with a modified separation chamber, and that it is discontinuing sales of its original kit. Ten months ago, on January 31, 2009, a federal jury had determined that Fenwal's original collection kit infringes a Haemonetics patent, and found Fenwal liable to Haemonetics for over $15 million in damages. The United States District Court for the District of Massachusetts later added millions of dollars in pre-judgment interest and ordered the product removed from the market by December 1, 2010. The District Court also ordered that between January 31, 2009 and December 1, 2010, Fenwal must pay Haemonetics a 10% royalty on the offending product's sales. The damages have not been paid, and the royalties are being escrowed pending decision on Fenwal's appeal to the United States Court of Appeals for the Federal Circuit. A decision by the appellate court is not expected before late 2010 at the earliest.

Haemonetics filed a new lawsuit against Fenwal on account of the modified collection kit, requesting another jury trial that seeks multiple damages for willful infringement, and a permanent injunction. The new matter has been assigned to the same federal judge who issued the permanent injunction on Fenwal's original red cell kit.

Brian Concannon, Haemonetics' President and CEO said, "We commit to supporting blood collectors who wish to assure an orderly transition away from infringing product well in advance of the December 2010 injunction. It is our genuine desire to protect customers from involvement in this commercial dispute between competitors. As we continue to make multi million dollar investments to bring new technologies and blood management offerings to the blood community, we are likewise committed to protect our intellectual property, which is the foundation of the business we've built."

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