Medical device reprocessing is regulated by the FDA's Center for Devices and Radiological Health (CDRH) division. Northeast Scientific (NES) is required to meet FDA regulations by maintaining a quality system that adequately addresses the same procedures, tracking and labeling systems, preventive actions, and reporting required by the original equipment manufacturers (OEMs) of medical devices. NES carries liability insurance of greater than $10 million per occurrence. We assume all liability for the reprocessing of our reprocessing product devices. Northeast Scientific is confident that are our products are as safe, if not safer than, the new OEM representation of the product. We fully inspect 100% of our products for integrity and functionality — while, on average, an OEM may fully inspect fewer than 2% of the millions of units they manufacture every year. We encourage all healthcare providers to review the FDA's website, as well as the CDRH's website, to gain a clear understanding of reprocessing. Their websites are listed below, along with other resources for healthcare and workplace safety and regulations.

› www.fda.gov

› www.cdrh.gov

› www.reuse.gov

› www.aami.org

› www.osha.gov

› www.iso.org

› www.aha.org