FDA Clears SCC Soft Computer’s SoftBank®II, with New Microsoft® .NET Connection Software User Interface

June 18, 2004

PALM HARBOR, FL- SCC Soft Computer’s new SoftBank II, version 23 with a new SoftScape™ user interface, received 510(k) FDA Clearance from the Food and Drug Administration last month. The software product has undergone the FDA’s stringent review process, and has demonstrated it is safe and effective compared to predicate (similar) devices. The new user interface, built on Microsoft® .NET connection software technology, now provides a graphical screen and field presentation of the robust SoftBank II, version 23.

SCC received FDA clearance only three weeks after submission of SoftBank II, a centralized blood service management system. “This is another great success for our Blood Services Department,” says Susan Hudson, Blood Services Product Manager of SCC Soft Computer. “What’s important about this new interface, is that it allows the user to navigate even more smoothly in a clear and concise fashion, including the flexibility of using a mouse or a keypad. This is consistent with why SoftBank II prevails leading in the marketplace.” The FDA requires that most devices, including software intended for direct human use, go through the 510(k) application process.

“Our products utilize only the newest generation technology like Microsoft’s .NET,” states Gilbert Hakim, CEO of SCC Soft Computer. “This user interface adds a new dimension to SoftBank II.” With .NET’s many features and advantages, hospital and laboratory administrators are finding it is one of the easiest technologies to deploy in a variety of environments. With the first version just released in 2002, thousands of leading high tech companies including Honeywell and Xerox, are realizing the time and cost opportunities of the .NET Framework, and the technology’s overall long-term viability.

The module’s new navigation allows the user to customize and access option specific links on their toolbar, including Microsoft Excel® spreadsheets and Antibody ID products. “This should integrate well for people already using GUI, and allows the use of a mouse for continuity of programs if desired,” says Becky Mackel, SCC Blood Bank Team Lead and Medical Technologist. “Also, with the new screens, the user has extensive sorting capabilities and can look for things faster than ever. It’s a more updated, friendly look.”

Along with the new, user interface, SoftBank II is recognized for its overall high level of flexible features and functionality. The centralized transfusion testing feature allows centralized performance of compatibility testing, with the distribution of units from separate satellite facilities. The instrument interface technologies feature provides the automatic electronic transfer of information to SoftBank II for verifications and posting to patient’s records, thus reducing any data entry errors. SoftBank II’s management reports can be produced immediately across all facilities, and allows for a large variety of reports to be queried. SCC’s blood bank management software has superior multi-site capabilities, offers trauma-emergency issue, a daily trace and audit trail, and bar code technology.
When teamed with an automated blood banking instrument, SCC’s software also helps address the critical trend in the Medical Technologist employment shortage. “It’s basically a resource issue,” points out Becky Mackel. “Decision-makers are looking to free up technologists so they can perform more management-oriented tasks, or work up a difficult sample. SoftBank II and the automated instruments can easily take over the routine tasks.”

SCC’s SoftBank II is one of most proven, stable systems available on the market. Uniquely positioned as a stand-alone system, or as a part of SCC’s integrated LIS Suite, the module provides critical safety functions throughout the system through exceptional quality control. The module was first developed and released in response to market demand in 1992 when most blood bank systems were still operating manually. Developed under the company’s regimented Software Development Life Cycle guidelines, SoftBank II has thorough specific phases of design development and testing, which includes a system of checks and balances that insures a paper trail for internal or external agency audit. Beta testing for the product was done at Meritcare Health System, Fargo, North Dakota; Protestant Memorial Medical Center, Belleview, Illinois; and Aultman Health Foundation in Canton, Ohio.

SCC Soft Computer is celebrating its 25th Anniversary this year. From its humble beginnings in 1979, SCC Soft Computer has been meeting the needs of the Healthcare Industry by providing powerful, best-of-breed clinical information solutions to hospitals and laboratories. SCC's fully integrated suite of clinical information management products includes SoftLab (laboratory), SoftRad® (radiology), SoftRx® (inpatient and outpatient pharmacy), SoftPath® (anatomic pathology), SoftMic® (microbiology), SoftA/R® (accounts receivable), SoftWeb™ Outreach Suite (Web-based module suite for outreach program application), SoftBank®II (blood transfusion management), SoftDonor® (blood donor software), and SoftWorkflow™ (Workflow). For more information, contact Ellie Vahman at (727) 789-0100 x4052.


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