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.
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.
ISO 80369
Luer connectors have been the connectors of choice for many years, because of their universal design, low cost, and simplicity. The universal design of the estimated 1 billion luers manufactured each year increases the chance of healthcare staff unknowingly connecting tubes from different applications.

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

ISO Standard

Description

Expected Publication Date

ISO 80369-1

  • General requirements for small bore connectors, which convey liquids or gases in healthcare applications.
  • Misconnection test methods
  • Published 2010

ISO 80369-2

Breathing systems and driving gases

Currently removed

ISO 80369-3

Enteral and gastric

Published, 07.2016

ISO 80369-4

Urethral and urinary

TBD— currently not active

ISO 80369-5

Limb cuff inflation

Published, 08.2016

ISO 80369-6

Neuraxial devices

Published, 03.2016

ISO 80369-7

Intravascular (IV) or hypodermic (traditional luer with additional dimensional specifications)

Published, 10.2016

ISO 80369-20

Test methods for each application

Published, 05.2015

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.



Marvelous™ Tandem for increased blood sampling safety
Patient safety has become a major concern in the healthcare industry. Patient safety is even more crucial in patients admitted to high pressure departments, such as ICU.

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. [1] 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. [2]

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 [3]. Blood draws involve catheter manipulation which can cause catheter-associated infections [4].

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.

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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.

References
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.
Manifold Holder
Elcam's Manifold holder provides the support your treatment needs.
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

Best Regards,
Igal (Guli)Kohen, CEO and General Manager

Upcoming Exhibitions

MD&M East

June 13–15, 2017
New York, NY
Booth 1645

E3D- Bio International congress

June 19-22 , 2017
San Diego, California
Booth 3124

Medtec

September 20-22, 2017
Shanghai , China
Booth A208

Service & Contact

Head Office / Manufacturer
Elcam Medical

BarAm 1386000, Israel
Tel: 972 4 698 8120/1
Fax: 972 4 698 0777
sales@elcam.co.il

USA
Elcam Medical Inc.

2 University Plaza, Suite 620
Hackensack, NJ 07601
Tel: +1 201 4571120
Fax: +1 201 4571125
info@elcam-medical.com

Europe
Elcam Medical Europe

Via Emilia Romagna 15,
41012 Carpi
(Modena) Italy
Tel: +39 059 697710
Fax: +39 059 697705
sales.eu@elcam-medical.com

China
Elcam China Office

Room 3309, Jinhai Mansion
No. 89 of Anshun Road,
Shanghai, PRC. Zip: 200051
Tel: +86 21 62829967
Fax: +86 21 62829967
johnliu02@126.com