Volume 16, Number 3
Elcam Accessories is Elcam Medical’s brand for sourcing your everyday needs of accessories for medical fluid control applications, such as Infusion Therapy and blood lines for Dialysis.
Elcam Accessories end to end customer experience includes clinical, engineering, manufacturing, QA, regulatory and logistics support. This support allows seamless integration of our components into your products, providing peace of mind when sourcing medical products.
The comprehensive Elcam Accessories product portfolio, provides our customers one source for all their needs in the area of disposable medical flow control.
Whether an injection site, a male luer lock connector, an IV filter or tube assembly, our Infusion Therapy Accessories are a perfect fit for your customer’s sets.
The Elcam Dialysis Accessories offer a wide variety of options, providing our customers with solutions for their bloodline products, whether customized or standard.
Elcam believes that Accessories are not merely components, we believe that they are a crucial part of the set and as such their development and production are managed with Elcam’s meticulous high quality standards.
The New NeedleFree connector (NIP ®), the recently added tube assembly capabilities, EU regulation updates and raw material changes are all part of this activity and serve as excellent examples.
As a medical device company, Elcam is well aware of the risks involved in IV Therapy and understands the importance of minimizing them. The newly developed NIP® – a needle-free alternative that reduces the chances of device-associated infections and accidental needle stick injuries, is part of Elcam’s efforts to improve the safety of care.
Elcam’s needle-free stand-alone connector can help reduce line contamination and enhances patient and caregiver safety. With a swabbable Luer-activated valve that maintains a fully closed connection throughout use, the NIP® is a safer, more reliable option for patients and caregivers. Plus, with confirmed bacterial barrier protection for 11 days – including seven days with lipid solutions – the NIP® is an ideal solution for ICU needs.
As part of Elcam’s continuous efforts to expand product range to best answer stopcocks needs, Elcam is offering its stopcocks with a variety of extension tube lines as cost effective sub-assemblies.
Elcam’s Stopcock with extension Tube line delivers the ultimate convenience and efficiency while maintaining the top-quality standards customers have come to expect. And with Elcam’s wide range of stopcocks and tubes, you can customize your setup to fit your specific needs
Elcam offers the widest variety of tube fitments for bonding, or oversizing, off the shelf or tailor made and also offers its professional support in building and tweaking your bonding process.
Many of Elcam components that are manufactured in Italy are made from PVC plastic and may include substances that act as plasticizers and stabilizers. The new European Regulation 2017/745 for Medical Devices includes new requirements for limiting the usage of Hazardous substances such as DEHP and DOTE and to inform users when their content is more than 0.1% in weight of the device.
The limitation and restriction of using hazardous substances in medical device has been an increasing trend and main focus for regulatory authorities over the last few years in alignment with the MDR implementation. It is a critical aspect of the regulation that medical manufacturers should consider in the coming years including during the transitional period that recently has been extended per Amendment Regulation 2023/607 until December 2028, at the latest.
What is Elcam doing about it? – Getting ready!
Any part number (P/N) ordered from Elcam that ends in “NDL” means that the product is DEHP-free PVC and part numbers that end in “DOL” represent both DEHP-free and DOTE-free PVC. Elcam currently offers these options for drip chambers, connectors, pillows, luers and other components, and is currently molding and validating more components.
Please inquire with your customer service representative for additional information.
As shared in one of Elcam’s previous newsletters, during 2022 LyondellBasell announced the discontinuation within 2023 of its polypropylene material Purell HP 371-P.
As Over 400 codes from Elcam Italy’s product portfolio include this raw material,Elcam Medical Italy has devoted many resources to the great project of replacing Polypropylene grade which is going to be discontinued.
Elcam confirms that the project is ongoing and the company is keeping its commitment to its customers : a large number of components made with the new Polypropylene Bormed RF830MO are already available and distributed, Elcam plans to complete the switch over by the end of 2023, and has already granted coverage of material for the excess demand from our customers.
Please contact your local customer service representative for further information
Igal (Guli) Kohn, CEO and General Manager
Booth B1- H003
September 9 – 12