As many as 250,000 people in the U.S. die from catheter-related bloodstream infections each year. Cook Medical (Bloomington, Indiana) has developed a device that has the potential to greatly reduce those infections.
The company said that its device, the Spectrum Turbo-Ject PICC, is the industry's first antibiotic-impregnated PICC capable of accepting the contrast media injection rates required for CT scans. The ability to power-inject contrast media, combined with the Spectrum technology's proven ability to prevent CRBSIs, means that patients receiving PICC lines will gain the highest possible protection from deadly CRBSIs, while clinicians will have access to the industry's best flow rates.
Demand for the new PICC is so high that the first units were shipped to customers even before Cook's official introduction of the device to key customers at the Society of Interventional Radiology (Fairfax, Virginia) meeting earlier this year in San Diego.
In fact the FDA approved the device in record time according to the company.
"We received FDA approval in less than 30 days," Tyson Rugenstein senior global product manager of Cook's Interventional Radiology business unit, told Medical Device Daily. "It was a very quick approval. We are currently pursuing the CE mark."
Here's how the device works
The combination of the antibiotics minocycline and rifampin that are impregnated within the material of the Cook Spectrum catheters work synergistically to provide broad-spectrum protection against gram positive, gram negative and fungal organisms in both short- and long-term use. Unlike most systemic antibiotics, this combination has the ability to penetrate the biofilm that forms on all indwelling catheters.
Additionally, research has conclusively shown that use of these catheters does not promote the growth of antibiotic-resistant strains of bacteria in patients receiving Spectrum catheters. In fact, the use of Spectrum technology has demonstrated reduced antibiotic-resistant strains in on single-center study.
The Cook Spectrum Turbo-Ject PICC will be complimented by the PICC Procedural Tray, designed to efficiently supply the essential components for a clinician placing a PICC, whether bedside or in an interventional radiology lab. The tray provides the vital components for maximal sterile barrier precautions, a significant part of patient safety and infection control.
With the Spectrum Turbo-Ject PICC, clinicians can choose from multiple catheter configurations that offer a range of flow rates in order to meet patient needs, including:
• Maximum pressure limit settings of 325 psi
• 5 Fr single and double lumen with a maximum flow rate of 7 5 mL/seco and 5 mL/second, respectively
• 4 Fr single lumen with a maximum flow rate of 4 mL/second
• 50 cm and 60 cm length available
"Cook's new Spectrum Turbo-Ject PICC lines provide industry-leading technology to interventional radiologists, nurses and other health care professionals in the fight against costly, life-threatening hospital-acquired infections, and also provide industry-best flow rates for contrast media," said Dan Sirota, global business leader of Cook Medical's Interventional Radiology division. "This innovation further demonstrates [our] commitment to reducing infections by providing a unique Cook technology that is proven to improve patient outcomes."
The demand for the device has become overwhelming since on Oct. 1, 2008, Medicare eliminated reimbursement to hospitals for treating CRBSIs and other hospital-acquired infections. Catheters impregnated with Spectrum technology are a scientifically proven tool hospitals and clinicians can use to eliminate preventable CRBSIs and avoid the risk of Medicare nonpayment.
The domestic market in the U.S. is nearly $3 million, the company said.
In the U.S. alone, more than 3 million central venous catheters (CVC) are inserted annually, with more than 250,000 patients developing a CRBSI associated with their CVC. Additionally, about 30,000 U.S. patients die each year from these systemic infections.
Costs associated with treating these preventable infections average $34,508 to $56,000 each, making CRBSI prevention a major health care cost reduction issue. Numerous peer-reviewed publications, including a landmark study published in the New England Journal of Medicine, have demonstrated both the safety and superior efficacy of Spectrum technology in preventing CRBSIs.
The Spectrum technology has been shown to establish zones of inhibition greater than 15 mm for up to 63 days against the leading cause of CRBSIs.