St. Jude Medical, Inc. STJ -0.80% , a global medical device company, today announced the worldwide launch of its EnSite™ Velocity™ System Version 3.0 software. The new benefits of this software release are designed to help shorten procedure times for patients undergoing electrophysiology (EP) procedures guided by a cardiac mapping system and improve workflow efficiencies in the EP lab.

A new feature in the EnSite Velocity System is the OneModel™ tool, which can increase the physician’s confidence in anatomic and electrical mapping data by creating a highly detailed and precise model of a patient’s cardiac anatomy. Initial clinical experience with the OneModel tool has demonstrated a 54 percent reduction in cardiac model creation time while significantly improving dimensional accuracy, resulting in an image comparable to a CT scan.

“The EnSite Velocity System has always been able to create detailed chamber models; however, the OneModel tool provides even more detail in significantly less time,” said Dr. Larry Chinitz, director of clinical cardiac electrophysiology at New York University Langone Medical Center. “The greater level of anatomic detail and resulting reduction of discrepancies in the anatomic model will help drive better procedural success rates with fewer complications. It is possible that for some patients, a pre-procedure CT or MRI scan may not be needed to guide cardiac mapping system procedures.”

Another enhancement designed to increase procedural efficiency is the Adaptive Respiration Compensation feature, which automatically compensates for changes in patient respiration patterns throughout an entire procedure.

The EnSite Velocity System is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into a cardiac chamber; these electrodes are then located or visualized by the system, which records electrical information from the heart and displays it in a three-dimensional anatomical model. The highly detailed anatomical models, or maps, enable physicians to diagnose and guide therapy for abnormal heart rhythms. The EnSite Velocity System is an open platform and is the only cardiac mapping system that supports the translation of the user interface into eight non-English languages.

“The enhancements delivered in the EnSite Velocity System v.3.0 software further establish the EnSite Velocity System as the premier cardiac mapping system,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “St. Jude Medical is committed to offering physicians efficient and effective tools that help deliver curative solutions to improve patients’ lives.”

Source:http://www.marketwatch.com/story/st-jude-medical-announces-next-generation-software-for-ensite-velocity-cardiac-mapping-system-2012-03-22

Malfunctions in medical devices don’t usually make the headlines the way airplane or train accidents do. For patients, however, medical device failures can have equally tragic consequences.
Some of the best-known safety-related standards address functional safety—safety that relies on the continued operation of a (software) system to ensure that persons, property and the environment are kept free from unacceptable risk or harm. IEC 61508 (electrical, electronic, programmable), ISO 26262 (automotive), and the CENLEC 5012x series (rail transportation) all deal with functional safety.
In contrast, IEC 62304, which is becoming the de facto global standard for medical device software life cycle processes, does not address functional safety. Instead, it addresses the “framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software” and, through ISO 14971, the risk management associated with those processes.2
Because IEC 62304 doesn’t address functional safety, it doesn’t define numerical values for acceptable failure rates. Conformity to IEC 62304 doesn’t imply a safety integrity level (SIL) as does, for example, conformity to IEC 61508, which is meaningless without one
Although IEC 62304 sets out the processes required to produce a compliant device, it is not clear how the quality of those processes relates to the quality of the device produced. This article looks at:
•Nondeterministic systems and the limits of testing
•Building safety
•Validation, including testing, design validation, implementation validation, remaining fault estimation
•COTS and SOUP: commercial off-the-shelf software and software of uncertain provenance

Source:http://www.eetimes.com/design/medical-design/4235024/Build-and-validate-safety-in-medical–and-other–device-software

Students enrolled in the healthcare programs at Alexandria Technical and Community College (ATCC) now have one more tool to enhance their education.

In September, Healthland of Glenwood donated and installed Centriq at the college.

Centriq is a comprehensive electronic health records solution designed specifically for rural hospitals. It integrates a hospital’s financial, clinical, and patient information by linking essential information in the healthcare delivery chain and complies with the latest regulatory requirements in the healthcare field.

The computer software has a retail value of approximately $500,000.

In addition to donating the software, Healthland completed the installation and is providing training to ATCC instructors.

“This donation allows our students to be trained in state-of-the-art medical information technology, giving them the knowledge and confidence to contribute their expertise in all healthcare settings,” stated Greg Latterell, ATCC instructor.

The donation was a result of Glenwood Community Day in March. Healthland hosted leaders from education, business, and government to share its commitment to job growth in the area.

Latterell and Judy Bertram, also an instructor at ATCC, attended the open house. After reviewing the software program, they voiced their excitement about Centriq and how it would enhance the learning opportunities for students in the medical administration programs at the college.

As part of the Healthland Giving Program, the company’s effort to give back to rural communities where clients are located, Healthland donated the software to the college.

“The marriage of industry and education has provided this excellent opportunity for our students to excel in the healthcare field,” Latterell said.

Source:http://www.echopress.com/event/article/id/90118/group/News/