Aramark CTS moves to expanded facility; ECRI’s healthcare standards directory available; FDA seeks comments on device user fee program

Aramark CTS Moves to Expanded Facility
Approximately five months after closing on its acquisition of Premier’s Clinical Technology Services (CTS of Charlotte, N.C.) business, managed services provider Aramark (Philadelphia) was planning to move all CTS employees and operations into a new facility, still in Charlotte.

 A birds-eye view of the Twin Lakes Business Park plant that is the new home of Aramark CTS.

Located in the Twin Lakes Business Park, the new 90,000-square-foot plant triples the 30,000-square-foot space in two separate locations that Premier had allocated to CTS.

The new location will house executive management resources, business development, contract management resources and a technical resource center for Aramark CTS.

“One hundred percent of the employees who worked for Premier in CTS in Charlotte are still working for Aramark CTS,” said Bob Doster, president, Aramark CTS, formerly senior vice president, Premier CTS. “We’re not laying people off; we’re actually adding people. There will be more people working in Charlotte than when Premier was sold to Aramark.”


ECRI’s Healthcare Standards Directory Available
The “Healthcare Standards: Official Directory,” 2003 edition, is available from ECRI (Plymouth Meeting, Pa.).

Meanwhile, for the first time, subscribers to the 2003 print publication also are able to access ECRI’s Web-accessible Healthcare Standards (HCS) Online at www.ecri.org.

The annual directory, now in its 15th edition, carries approximately 36,000 new and updated titles of healthcare standards, clinical guidelines, and U.S. federal and state laws and regulations from more than 1,200 organizations in the United States, Canada, the United Kingdom, Europe, Australia and Southeast Asia.

For copies of the 2003 Healthcare Standards publication contact ECRI by mail at 5200 Butler Pike, Plymouth Meeting, Pa., 19462-1298; by phone at (610) 825-6000, ext. 5891; by fax at (610) 834-1275; or by e-mail at [email protected].   Price is $545, plus shipping and handling.


FDA SEEKS COMMENTS ON DEVICE USER FEE PROGRAM
The FDA has established a public docket to collect comments on the implementation of the Medical Device and User Fee and Modernization Act of 2002.

To see the Federal Register notice announcing the public docket, go to http://a157.g.akamaitech.net/7/257/2422/14mar20010800/
edocket.access.gpo.gov/2003/pdf/03-2604.pdf
.

To submit electronic comments, go to http://www.fda.gov/dockets/ecomments.


FDA CLARIFIES 510(k) FEES
The FDA is clarifying its policy regarding rates and interim procedures for medical device user fees for fiscal year 2003.

The agency said its previous announcement was “inadvertently published with confusing language regarding the fee that must be paid by a small business that submits a 510(k) premarket notification” for FDA review this fiscal year. The correct policy is that all 510(k) applications submitted in FY03 are subject to the standard fee of $2,187.

Additional information is available at http://www.fda.gov/cdrh/mdufma.


AFSMI to Present EZe-Learning to Members
The Association for Services Management International (AFSMI of Ft. Myers, Fla.) recently entered into a partnership with management and technology consulting firm Vivoconcepts (Ft. Lauderdale, Fla.).

Under the terms of the agreement, AFSMI will use and market Vivoconcepts’ EZe-Learning product, a Web-enabled, client-server-based learning suite.

AFSMI will use EZe-Learning to create accredited continuing education courses for its members. AFSMI also will market EZe-Learning, to its international members for their own organizational training needs at a special member price. Currently, EZe-Learning is available in eight languages.


Fluke Offers Calibration Procedures, Training
Fluke Corp. (Everett, Wash.) introduces new Met/Cal Plus V 7 calibration procedures for three of its precision Tektronix oscilloscope series.

At the same time, the company is announcing its 2003 calibration and metrology course schedule for U.S. locations.

The automated Met/Cal Plus V 7 procedures allow technicians to conduct their own verification procedures on the TDS 5000 Series, the TDS 6000 Series and the TDS 7000 Series oscilloscopes.

Fluke says the procedures reduce performance-verification time to approximately 60 minutes — a “substantial reduction” in downtime, according to the company.


Clinical Dynamics Unveils SmartSat Upgrade
Clinical Dynamics Corp. (Wallingford. Conn.) recently upgraded its SmartSat Pulse Oximetry analyzer with software and accessories for testing a new Nellcor (Pleasanton, Calif.) product.

The software upgrade, version 3.08A, and the new Nellcor OxiMax Simulator Cable, provides Nellcor and other customers with the capability to test Nellcor OxiMax pulse oximeters and OxiMax pulse oximeter probes. As with all Clinical Dynamics’ test equipment, this newest release includes the company’s three-year parts and labor warranty.

Customers interested in upgrading their SmartSat analyzers should have the serial number of their analyzer handy when contacting the company. Call, toll-free, (800) 247-6427, ext. 210, or (203) 269-0090, ext. 210, for international customers; fax Clinical Dynamics at (203) 269-3402; or e-mail [email protected]


Axeda Adds Usage Application to DRM Product
Axeda Systems Inc. (Mansfield, Mass.) in January announced the latest component of its device relationship management (DRM) software and services — the Axeda Usage application Axeda Usage enables original equipment manufacturers (OEMs) and their service providers to use the Internet to remotely monitor, manage and service their devices without involving the customer.

The application remotely collects data from devices through the Axeda DRM system on a predefined schedule. The Axeda Usage rules engine then processes the data and compares it to specified conditions such as previous values, averages, expected minimum and maximum targets, and more. Based on results, the system triggers notifications to personnel or to business applications.


 Service in Space
Sound may not travel in the near-vacuum of open space, but on board the International Space Station (ISS), sound not only makes itself heard, it is considered comforting and familiar for the crew. Some sounds come from the omnipresent plumbing, wiring and mechanical hardware; the whir of air-circulation fans, the hum of electric motors and the switching sounds of pumps going on-off-on-off imbue the ISS with its own bit of personality. Other sounds, however, are the sounds of service — as in maintenance on health and fitness equipment.

In this October 2002 photo released by NASA in January, ISS Expedition Five mission commander and cosmonaut Valery G. Korzun (left), and Expedition Five flight engineers cosmonaut Sergei Y. Treschev and astronaut Peggy A. Whitson perform maintenance on the Treadmill Vibration Isolation System (TVIS) in the Zvezda Service Module. Korzun and Treschev represent Rosaviakosmos.


CDRH Aims to Shorten PMA, 510(k) Reviews
Speeding device reviews will be a top goal for the Center for Devices and Radiological Health (CDRH) in coming years, according to a recent FDA report. The center has set a goal of issuing decisions in 320 days for 80 percent of premarket approval (PMA) applications received in fiscal year 2006. In fiscal year 2007, that goal will rise to 90 percent of PMAs.

CDRH also pledged to revise its PMA filing guidance to more clearly define criteria for filing PMAs so that fewer incomplete applications will be submitted. In addition, the center plans to develop more special control guidances to communicate clearly the regulatory requirements and scientific information expected in premarket submissions.


20,000 Predicted to Attend HIMSS 2003
More than 20,000 healthcare professionals were expected to attend the 2003 Health Information and Management Systems Society (HIMSS of Chicago) conference at the San Diego Convention Center, Feb. 9-13.

In the exhibit area, more than 600 vendors were scheduled to display their latest IT products and services.

HIMSS 2003 also marks the fourth year of the Integrating the Healthcare Enterprise (IHE) initiative with the Radiological Society of North America (RSNA of Oak Brook, Ill.). At this point, the collaboration to develop cohesive interfaces between different information technology systems within the healthcare industry is expanding beyond radiology, demonstrating the progress being made by IHE towards integration.

Agfa HealthCare (Ridgefield Park, N.J.) will demonstrate its integrated RIS/PACS software, which Agfa currently is tailoring for Agfa Impax PACS in North America. The software is designed to include privacy and security enhancements, billing features and language.


New Program Assesses Field-Service Performance
ServicePower (Annapolis, Md.) and Blumberg Associates Inc. (BAI of Fort Washington, Pa.) announce a consulting program that assesses field-service performance.

Called the Optimization Impact Study Program, the program enables service executives to evaluate their organization’s field-service performance against industry benchmarks. By creating a simulation of a company’s service business based on real-world data, the program also measures gains in productivity and customer service via optimization software.


USCS Renews MedAssets, NCHN Contracts
Capital asset management firm USCS Equipment Technology Solutions (Brookfield, Wis.) recently extended its working relationships with two long-term customers.

USCS and GPO (group purchasing organization) MedAssets HSCA Inc. (St. Louis) in December 2002 renewed their preferred-provider relationship for an additional three years. According to their agreement, USCS provides its Lifecycle Managed Maintenance Program and Equipment Acquisition Resource to MedAssets HSCA members.


CORRECTION
The Biomedical Association of Southeastern Wisconsin (Milwaukee) addressed the topic of PACS training at a recent meeting but does not offer monthly PACS seminars.

To purchase the full text of Browser articles, click here…