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Bain Medical  & Hexamoll® DINCH -

World Kidney Day

March 12, 2020 – in honor of World Kidney Day, let’s celebrate how Bain Medical Equipment (Guangzhou) Co., Ltd. and Hexamoll® DINCH from BASF contribute to the best possible treatment for chronic kidney disease patients.

Bain Medical was established in China in 2003 and has become a leading manufacturer of medical equipment for blood purification.  The company is committed to research and development, manufacturing and sales of devices and disposables for blood purification, which mainly help kidney disease patients worldwide.

One potential therapy is hemodialysis. It is one of the replacement therapies for acute and chronic renal failure. During the treatment, blood is drawn out through an extracorporeal blood circuit and it flows through the dialyzer. Within the dialyzer, extracorporeal removal of waste products takes place and the blood is then pumped back into the human body.

Bain Medical manufactures various parts for this therapy, e.g. the extracorporeal blood circuits. They need to be flexible, which makes PVC the material of choice. And as they are in touch with the blood that is re-directed into the body, it is of greatest importance that the material is suitable for this application. That’s why Bain Medical uses Hexamoll® DINCH from BASF in the extracorporeal blood circuits.

Hexamoll® DINCH is BASF’s trusted non-phthalate plasticizer especially developed for applications with close human contact: medical devices are one application area, but Hexamoll® DINCH is also ideal for children’s toys or food contact materials as it has an excellent toxicological profile and is approved and certified by many authorities and institutions worldwide.

Dr. Yu Liu, R&D Director of Bain Medical, explains why they chose Hexamoll® DINCH from BASF: “Customer safety is of utmost importance to us. Therefore, one key reason we chose Hexamoll® DINCH from BASF was that scientific studies prove its suitability even for blood storage1. It more so shows advantages compared to other products: Hexamoll® DINCH demonstrates lower migration rates than DEHP (DOP) (a phthalate plasticizer still dominant in the market).”

That means less plasticizer is taken up by the blood and ultimately by the human body. In addition to this scientific argument, BASF’s regulatory compliance is another major reason why Bain Medical uses Hexamoll® DINCH. “It is included in the European Pharmacopoeia, which provides common quality standards for medical devices and pharmaceutical products”, explains Dr. Liu. “By selecting a product, that is listed in there, we can ensure patients’ safety.”

For a medical device to be approved for patients, it must undergo a complex process, which differs by country and aims at ensuring safe applications for patients.  In China, manufacturers of medical devices need a company-specific approval of the medical device by the National Medical Products Administration (NMPA). This requires intensive documentation in various languages, covering e.g. toxicological data, ingredient properties, application details and details on formulation.

Bain Medical highly appreciates BASF’s regulatory expertise. “The dedicated regulatory team at BASF helped us to prepare all the documents needed for the National Medical Products Administration. With their support, we could introduce several new products with Hexamoll® DINCH into the market over the past years. Therefore, we would like to thank them very much!”

 

We at BASF highly value the partnership with Bain Medical to ensure high quality medical devices. It allows us jointly contribute to future-oriented products.

Here, you can find more information on Bain Medical and on Hexamoll® DINCH.

 

Images: Bain Medical and BASF SE.

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