|Elcam continuously strives to provide our customers with updated information. Enhancing safety with the ISO 80369 standard and closed blood sampling are two examples we wanted to share with you.|
Injuries and fatalities have been caused by misconnecting different tubes that deliver patients’ medication, nutrients, fluids, and gases.
Around 2007, an international group of manufacturers, clinicians, and regulators including FDA began collaborating with ISO and AAMI to develop a suite of new connector design standards, the ISO 80369 series of small-bore connector standards. The group’s goal was to establish global standards that would reduce the risk of connectors for two unrelated patient delivery systems being physically misconnected.
Currently, eight different connector standards have been published by ISO or are under different stages of reviewing (see Figure 1).
Figure 1. The ISO 80369 standards publication stages
Expected Publication Date
- General requirements for small bore connectors, which convey liquids or gases in healthcare applications.
- Misconnection test methods
- Published 2010
Breathing systems and driving gases
Enteral and gastric
Urethral and urinary
TBD— currently not active
Limb cuff inflation
Intravascular (IV) or hypodermic (traditional luer with additional dimensional specifications)
Test methods for each application
Elcam has been taking a proactive approach to the implementation of the new standard regulations allowing our customers to prepare themselves for the upcoming change.
Elcam's new Enteral feeding stopcock includes the new Enfit connector design that is fully compatible with the new ISO 80369-3 standard, serves as a great example for this approach. This stopcock is already available for sale.
A specific concern for patient safety in the ICU is related to blood loss and infections associated with the very common blood sampling procedure.
One of the methods for overcoming the issue of blood loss following frequent blood sampling (sometimes referred to as "ICU Anemia") is the usage of the so called Closed-system which incorporates to the set an internal reservoir that is used for pulling the waste and pushing it back to the patient circulatory system.
A study conducted by Silver et al, compared the blood loss in patients with or without the usage of a closed system. In a seven-day period, 340ml of blood was saved per patient averaging to 49ml per day when a conservative device was used.  Another study conducted by Peruzzi showed a reduction of almost 80 to 90 ml of blood loss per day when a conservative device was used for a four-day trial period. 
Infection to the already critically ill patients of the ICU can prove fatal. Studies have shown that hospital-acquired infections in intensive care patients are commonly due to an indwelling catheter . Blood draws involve catheter manipulation which can cause catheter-associated infections .
Blood Sampling with Elcam's Marvelous™ Tandem option can increase patient safety with no additional costs.
Closed systems help reduce the incidences of iatrogenic anemia and catheter-related infections, but closed blood sampling systems are usually expensive.
Using Elcam’s Marvelous™ Tandem option facilitates closed blood sampling using two Marvelous Luer activated valves, is easy to use and requires minimal training, without additional costs.
Patient Safety is enhanced by minimizing the blood waste, as the clearing volume is reinfused back to the patient after sampling is completed, thus decreasing the risk of anemia. Continuous line flushing, closed in-line operation and residue clearing all help in reducing microbial contamination.
1. Silver M, Li Y, Gragg L, Jubran F, Stoller J. Reduction of Blood Loss From Diagnostic Sampling in Critically III Patients Using a Blood-Conserving Arterial Line System. Chest. 1993;104(6):1711-1715. doi:10.1378/chest.104.6.1711.
2. PERUZZI W, PARKER M, LICHTENTHAL P, COCHRAN-ZULL C, TOTH B, BLAKE M. A clinical evaluation of a blood conservation device in medical intensive care unit patients. Critical Care Medicine. 1993;21(4):501-506. doi:10.1097/00003246-199304000-00007.
3. Valles JLeon C. Nosocomial Bacteremia in Critically Ill Patients: A Multicenter Study Evaluating Epidemiology and Prognosis. Clinical Infectious Diseases. 1997;24(3):387-395. doi:10.1093/clinids/24.3.387.
4. Tinmouth A, McIntyre L, Fowler R. Blood conservation strategies to reduce the need for red blood cell transfusion in critically ill patients. Canadian Medical Association Journal. 2008;178(1):49-57. doi:10.1503/cmaj.071298.
Developed in response to market requirements, the holder is intuitive, easy to use and includes safety features.
Simple and safer manifold assembly and use:
Intuitive manifold assembly
Safe fix, with no lateral sliding
No risk of disassambly by pulling down or lateral pressure
No risk of accidental disassembly
Easy disassembly by pushing up
Pole assembly made easier:
Clear positioning with "UP" indication
Two options for screw fixing
Igal (Guli)Kohen, CEO and General Manager
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