Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
is a world class producer of disposable medical devices for the OEM market, and a provider of innovative solutions for specialized flow control needs. Elcam offers an extensive range of products in order to add efficiencies to our customers’ sourcing processes while providing superior customer service. Elcam Medical works with the medical industry’s leading companies, with particular expertise in the areas of Fluid Management, IV Therapy, Vital Sign Monitoring, Interventional Cardiology & Radiology, Dialysis and Drug Delivery.
IV Therapy and Anesthesia
Elcam Medical is your source for the widest variety of IV Therapy & Anesthesia devices including our renowned Elcam Stopcocks brand. Providing differentiating, innovative solutions along with the everyday devices needed for any IV or Anesthesia sets, Elcam leads the effort to maximize patient and caregiver safety.
– Safety in the Details
Elcam Medical strives to provide the building blocks for safer and more effective medical fluid management in acute settings.
- Improving safety with contamination prevention
The Marvelous™ (MRVLS) is a closed-swabbable stopcock with a proprietary flow channel feature specifically designed for IV administration and pressure monitoring applications, assuring minimal residual volume. The Marvelous™ allows to automatically flush drugs and blood residuals, without the need to expose the system to the open air, with minimal manual steps, and with maximal compliance to best practices.
- Additional protection against disconnections
Elcam's Safe2 Rotator™ spinning lock feature, available in both stand-alone connector for tube bonding and stopcock configurations can provide a small yet significant contribution to the efforts of keeping medical teams and patients safe. It was designed to ensure secured connection along the entire treatment so critical to safe and effective IV therapy, The Safe2 Rotator™ and its 360° rotational flexibility can help prevent accidental disconnections, reduce tube kinks and twists in the tubing set, and facilitate convenient approach to injection and sampling ports.
The Safe2 Rotator™ Stopcock configuration is CE approved for non-sterile products and 510(k) cleared.
Elcam Medical has developed a new SafeT™ Stopcocks and Connectors series of Lipid Resistant devices made of Eastmam TritanTM copolyester providing increased safety in drug therapy through protection for patients and care givers from connectors’ erosion by lipids and other aggressive drugs.
The potential for Environmental Stress Cracking (ESC) is a well-known concern when plastics are used in medical device components. The use of lipids and other aggressive solutions may initiate microcracks in the polymer and compromise the material’s mechanical integrity. This event may lead to serious patient injury and also jeopardize medical personnel.
Tritan™ is a new-generation copolyester that has been shown in bench-top testing to be resistant to a large spectrum of medical fluids such as oncology drugs, lipids, drug carrier solvents, and nutrition which minimizes the risk of cracking and increases patient safety.
Tritan™ is also BPA-free, and it is additionally known for its toughness, low residual stresses, and color stability post sterilization.
This new line provides our OEM customers with tools to mitigate lipid and drug related hazards during fluid administration. It will also enable Elcam to offer a BPA-free line of components for customers who are concerned with emerging legislation.
Promoting patient safety by preventing misconnections
Luer connector misconnections are an under-recognized but common dangerous events. The objective of the new ISO 80369 Standards that are gradually being implemented is to prevent these adverse events so crucial to patient safety.
Elcam Medical has taken a proactive approach to the implementation of the new ISO 80369 standard regulations and is in the process of implementing those standard drafts well in advance allowing our customers to prepare themselves for the upcoming change.
The ISO 80369-3 Standard, Enteral Feeding applications
Elcam Medical has launched a new Enteral Feeding Stopcock that includes the Enfit connector design that fully complies with the new standard.
ISO 80369-6 Standard, Neuraxial applications
Among relevant devices that will be affected by this new standard are epidural devices, pain pumps, and their administration sets, regional anesthesia catheters, and needles.
Elcam’s new Neuraxial (NRFit) stopcock is fully compliant with the new ISO 80369-6 standard. The NRFit Stopckocs completed the development stage but have not yet been cleared for marketing by regulatory authorities. They are available for sale as non-sterile bulk devices and It is the responsibility of the customer to obtain regulatory authorization prior to their commercial distribution as a final device.
Elcam's also offers ISO 80369-6 connectors that include both male and female versions. The connectors...
For more information contact Elcam Medical, Inc.