Medical Devices

The low migration property of Hexamoll^® DINCH makes it an extremely suitable plasticizer for all kinds of medical devices: it is a required property in artificial nutrition products and blood bags to prevent the plasticizer from migrating into the product but also into the human body. The latter is equally important for infusion/ IV treatment products as well as catheters, which are inserted into the human body. Masks, gloves and medical training dolls have high skin exposure and may also get in touch with saliva and require a plasticizer like Hexamoll^® DINCH, which is suitable for close human contact. Furthermore, inhalative uptake is of interest when using breathing masks. Schossler et al. (2011)¹ showed that the maximum achievable air concentration of Hexamoll^® DINCH is < 0,5 µg/m³, which is reached after ca. 600 h at 23°C in an emission chamber. Hence, inhalative uptake of Hexamoll^® DINCH is negligible. The reduced migration (compared to DEHP) makes Hexamoll^® DINCH perfectly suitable for artificial nutrition applications. In regulation (EU) No 10/2011 on substances in contact with food, Hexamoll^® DINCH is listed (FCM 775) and the overall migration limit applies (i.e. 60 mg/ kg food).  Welle et al. (2005)² found that only Hexamoll^® DINCH-plasticized nutritional sets comply with the TDI threshold (tolerable daily intake) in contrast to DEHP, TEHTM and ATBC (for nutrition solutions with 4.4% fat content). The reduced leaching of Hexamoll^® DINCH from PVC perfusion lines into different lipid emulsions for premature infants under clinical conditions (about 10 times lower than that of DEHP) was confirmed by Faessler et al. (2017)³.

There is particular experience with Hexamoll^®DINCH in blood bags as there are several products in use, which are approved by the notified bodies, e.g. the Dutch national blood bank Sanquin has been using pediatric platelet bags based on Hexamoll^® DINCH since 2012. Compared to DEHP (DOP), migration of Hexamoll^®DINCH into the blood product is ca. 10 times lower and it stabilizes red blood cells just as good as DEHP (DOP) and is also capable of storing platelets and fresh frozen plasma. Furthermore, the extensive toxicological research on Hexamoll^®DINCH showed no adverse effects, also not on the intravenous route. Hexamoll^® DINCH was even awarded with the SolVin Award special prize in 2013 as substitute for DEHP (DOP) in blood product containers.

In the Danish evaluation on “Alternatives to classified phthalates in medical devices” (Danish Ministry of the Environment, DK EPA, Environmental Project No. 1557, 2014), Hexamoll^® DINCH was evaluated as one of the most promising alternatives to DEHP. In 2015, the Swedish Chemicals Agency KEMI concurred with the Danish conclusion on medical devices in their Report 4/15 (“Phthalates which are toxic for reproduction and endocrine-disrupting – proposals for a phase out in Sweden”, Report from a government assignment). In January 2018, Hexamoll^® DINCH was included in the European Pharmacopeia. CE-marked Medical Devices based on Hexamoll^® DINCH are available in Europe, Asia and North America.