Cdex, Inc. (fka CDEX)

[Viking65]

CDEX-INC. A nice compilation of info regarding our company and what professionals think of it. Found this on another board: Thanks, Viking65

April 2005 USP797 Sterile Compounding New NIOSH Guidelines plus PhaSeal
http://www.pharmacy.utah.edu/continuinged/USP%20brochure.pdf

New NIOSH Guidelines
Jim Jorgenson, RPh., MS, FASHP,
Director of Pharmacy Services,
University of Utah, College of Pharmacy,
Salt Lake City, UT

The University of Utah College of
Pharmacy is accredited by the
Accreditation Council for Pharmacy
Education as providers of continuing
pharmacy education.

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State why PhaSeal® is considered a closed
system when preparing cytotoxic drugs.

PhaSeal
Jim Jorgenson, RPh., MS, FASHP,
Director of Pharmacy Services,
University of Utah, College of Pharmacy,
Salt Lake City, UT

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VERY IMPORTANT READING-Huntsman, Jorgenson, MD Anderson, PhaSeal etc
http://ww1.prweb.com/prfiles/2003/11/25/91277/HuntsmanStudy.pdf

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A tidbit more regarding PhaSeal
http://www.prweb.com/releases/2003/7/prweb74462.php
MD Anderson and PhaSeal®: A Leader in Science Leads Adoption of New Closed System Technology For Safe Handling of Hazardous Drugs

http://www.prweb.com/releases/2004/5/prweb128807.php

http://www.in-pharmatechnologist.com/news/news-ng.asp?id=26607-phaseal-protects-cancer
PhaSeal protects cancer drug handlers

http://www.pshp.org/about_pshp.html
Established in 1970, the Pennsylvania Society of Health System Pharmacists (PSHP) is the fifth largest state affiliate of the American Society of Health-System Pharmacists.

http://www.pshp.org/midyear_programs.html
Pharmacists and Technicians Working Together for our Oncology Patients
Demonstrate and give an overview of the PhaSeal* closed system for chemotherapy preparation.
Discuss our experience training and educating technical staff for competency in IV chemotherapy preparation.

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A tidbit more regarding USP797…
http://www.valimed.com/usp797_compliance/usp797compliance.htm

“New Technology Addresses USP 797 Worries”

The Solution
The ValiMed Regulatory Compliance Solution provides validation of your sterile preparations and documentation of your quality process to meet the USP 797 requirements.
The ValiMed solution gives the assurance that sterile admixtures have been manufactured accurately. This reduces undetected errors in medication selection, the manufacturing of admixtures, inadvertent substitution, or the mislabeling of the medication. If to err is human, then to prevent is ValiMed’s.
ValiMed combines a revolutionary new technology to validate medications, equally innovative software to define and automate the quality process, and a library of the unique spectral fingerprints for a range of relevant medications. As your needs expand, so too can this library.
With a flash of the VailMed light source, your personnel can compare the fingerprint of a given medication under review to a selected fingerprint from a library of spectral fingerprints. The ValiMed system registers a match—or a failure to match—between the fingerprint of a test sample and that of a chosen medication from the library. No interpretation of results is required. It’s that simple.
This allows for near real time medication validation and documentation of your quality process. Daily activity reports can be easily generated to comply with USP guidelines and to facilitate JCAHO surveys.

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A tidbit more about Jim Jorgenson, RPh., MS, FASHP,Dir Phar Services Univ of Utah College of Pharmacy, and CDEX/Valimed …

http://www.valimed.com/media_center/pr/012605.htm

Press Release


University of Utah Health Sciences Center Addresses Narcotics Diversion

ValiMed system meets JCAHO and ASHP Standards by validating return of controlled substances from the operating room.

ROCKVILLE, Md. and SALT LAKE CITY, Ut.—January 26, 2005—Narcotic drug diversion is a long-standing problem for healthcare organizations. Many studies find that between five and 10 percent of anesthesiologists, nurses, and pharmacists have used this class of medications illegally. By substituting saline or water, narcotics-abusing clinicians had an undetectable source of drugs that compromised patient safety.

At the University of Utah Health Sciences Center, the University of Utah Hospital is one of the first hospitals in the country to tackle the problem at the source. Using ValiMed, a new device from CDEX, the hospital now validates the contents of all returned narcotics from the operating room.

“ValiMed pretty much eliminates a major source of narcotic drug diversion,” said Jim Jorgenson, Director of Pharmacy Services, and Associate Dean for Clinical Affairs, University of Utah College of Pharmacy. “Its spectral analysis ensures every returned syringe contains narcotics and not just water. The machine is the size of a shoebox and fits in our satellite pharmacy; any pharmacy technician can perform the validation in seconds.”

“University of Utah is a perfect partner for us,” noted Malcolm Philips, CEO of CDEX. “Besides the obvious value of proving capabilities, the staff’s input was invaluable. They helped us take a good product to great, ensuring we delivered a device that worked just as well in the real world as it does in the lab. This reflects the second client to successfully complete the two month acceptance test which is included in our sales contracts.”

The system comprises three components: the instrument, a proprietary library of chemical “fingerprints,” and process automation software. The reporting capabilities of the system can help healthcare organizations document compliance with JCAHO standards for controlled substances.

“The success of the implementation proved the value of the device,” said Jorgenson. “It also got us thinking about other ways it could help us. We are launching another CDEX pilot in the pharmacy at the University of Utah’s Huntsman Cancer Institute to provide additional assurance that our compounded chemotherapy injections are correct. Putting medication validation at the front end will help us eliminate medication error.”

“Looking forward, we expect to expand the use of ValiMed to all of our OR and oncology pharmacies,” added Jorgenson. ‘We are also interested in working with CDEX as they develop additional uses for their ValiMed products.”

Jorgenson noted that using ValiMed for pre-administration drug validation may require additional testing to comply with applicable FDA and other legal requirements.

About University of Utah Health Science Center

The University of Utah Health Sciences Center includes a medical school; colleges of Pharmacy, Nursing, and Health and comprehensive clinical services that include the University of Utah Hospital, University of Utah Neuropsychiatric Institute, Huntsman Cancer Hospital and Huntsman Cancer Institute; Moran Eye Center, University of Utah Orthopaedic Center, a network of community clinics, and various other institutes and centers. The health sciences center excels in education, research, patient care and community outreach throughout Utah and the Intermountain West.

For more information, please visit www.uuhsc.utah.edu

About CDEX

ValiMed is a line of CDEX products for the healthcare market. CDEX is a technology development company with headquarters in Rockville, Maryland and laboratories in Tucson, Arizona. CDEX is also developing products in other markets, including homeland security and brand protection.

For more information on ValiMed, please see www.ValiMed.com.


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