Colour concentrates made by US-based PolyOne Corporation have been chosen for use in a suture fixer, also known as a suture guide for cardiac surgery. The cardiovascular medical product is being produced by an unnamed medical device manufacturer in Beijing, China.
The manufacturer chose PolyOne’s OnColor HC Plus colour concentrates as it is using medical grade resins as an alternative to stainless steel. To meet regulatory standards the designers required a material with pre-certified biocompatibility and chose OnColor HC Plus because the range is pre-certified to meet ISO 10993 and USP Class VI requirements.
The suture guide is used with a sternal retractor to stabilise silk sutures during cardiac surgery. It is an approved Class II product under the auspices of the State Food and Drug Administration of China (SFDA). In under four weeks PolyOne developed five customised colours, with ethylene oxide (EtO) sterilisation compatibility, for the customer.