Reprocessing is regulated by the FDA and the CDRH. NES must maintain a quality system that adequately addresses all of the procedures, tracking, labeling, preventative actions and reporting required by all medical device manufacturers. We encourage all healthcare providers to review the FDA's site as well CDRH's site and gain an understanding of reprocessing. They can be found here:
NES carries liability insurance of more than 6 million per occurrence. We do this because we assume all liability for reprocessing of the devices. We are confident that our products are as safe if not safer than the OEM product. We inspect 100% of our products for integrity and functionality while the OEM inspects approximately 1% of the millions of products they manufacture every year.