College of American Pathologists
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  Safety at the center of glucose meter developments


CAP Today




April 2008
Feature Story

Anne Ford

Cleanliness may be next to godliness, but at some hospitals, it’s also next to reimbursement. “If an infection-free patient arrives at a hospital and then acquires an infection while in the hospital, the hospital risks losing its reimbursement for treating that infection,” says Mary Catherine Coyle, MS, MT(ASCP), director of product marketing in the professional diagnostics division of Roche Diagnostics. “Partly because of this issue as well as because of an interest in improving patient care, some hospitals have decided that a medical device”—such as a bedside glucose testing system—“that travels from bed to bed must be completely or thoroughly disinfected after each use.”

So what skin is this off a manufacturer’s nose? Well, “the products weren’t necessarily built to withstand that level of disinfecting,” Coyle says. “So vendors are working on new products that are more water-resistant and more durable.” Roche plans to incorporate these concerns into future additions to its Accu-Chek line of blood glucose meters. One of those forthcoming products: a meter designed for ICU use that, Coyle says, “could also be used throughout hospitals that are focused on tight glycemic control programs throughout their patient care areas.”

Other developments from vendors whose products are featured in this month’s instrumentation survey—which covers bedside glucose testing systems for professional use—include Abbott’s Precision Xceed Pro glucose monitoring system, launched last November and meant for use with the company’s PCx Plus test strips. “It is the only system that has individually foil-protected, bar-coded strips, which help prevent contamination and help ensure that approved reagents are used for testing,” says company representative Catherine Bryan. Ergonomically designed for ease of use and durability, she adds, the system features “state-of-the-art bar-code scanning,” an alphanumeric keypad that enables manual entry and confirmation of patient data on the meter, and settings to warn operators when certification is close to expiring.

In addition, the Xceed Pro meter offers a technology called TrueID that Bryan says is designed to support one of the Joint Commission’s patient safety goals, namely, the need for positive patient identification with patient name and date of birth, as well as an active operator confirmation step. “The Xceed Pro meter has features that, when enabled, help simplify this important safety step by automatically uploading admissions and discharges and transferring information to the glucose meter from your HIS/LIS,” she says.

Remaining available from International Technidyne Corp. is the IRMA TruPoint portable blood analyzer, which also has blood gas, hematocrit, electrolytes, creatinine, lactate, and other testing capabilities, and which allows operators to measure glucose in whole blood enzymatically.

And new at LifeScan: The OneTouch TGC Advisor Software, which generates reports in conjunction with the OneTouch DataLink data-management system and helps users assess compliance with tight glycemic control protocols and measure patient outcomes. Another new LifeScan product, the OneTouch DataLink wireless V2 connectivity solution, provides data transfer from the company’s OneTouch Flexx meter.

Finally, news from Nova Biomedical includes the newly CLIA-waived status of the company’s StatStrip glucose monitor. “As a result of StatStrip’s waived status, simplicity of use, and accuracy, it can now be operated in point-of-care settings, screening clinics, and non-hospital locations that perform testing under a CLIA certificate of waiver,” marketing communications manager Harlan Polishook says.

But in what Polishook calls the most significant development regarding StatStrip, in the past year studies have appeared “that provide strong, independent validation of the laboratory quality performance of the StatStrip analyzer.” Such studies have been published by the Mayo Clinic in Diabetes Technology and Therapeutics (Karon BS, Griesmann L, Scott R, et al. Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters. 2008 Apr; 10[2]: 111–120) and by Holmes Regional Medical Center in Point of Care (Holtzinger C, Szelag E, DuBois J, et al. Evaluation of a new POCT bedside glucose meter and strip with hematocrit and interference corrections. 2008 Mar;7[1]:1–6). “As corroborated by these analytical evaluations,” Polishook says, “StatStrip avoids hematocrit and other interferences common with competitive glucose analyzers, resulting in a new level of analytical performance at the point of care that is comparable to the quality of central laboratory testing.”

CAP TODAY’s survey of bedside glucose testing systems includes products from the aforementioned manufacturers and from Arkray USA, HemoCue, and Medtronic MiniMed. Vendors supplied the information listed. Readers interested in a particular product should confirm it has the stated features and capabilities.

Anne Ford is a writer in Chicago.