Ascent Healthcare Solutions Receives FDA Clearance to Increase Cycle Count for Reprocessed EP Catheters.PHOENIX, Ariz. -- Ascent Healthcare Solutions (Ascent), the industry's leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance to increase the reprocessing Reprocessing may refer to:
"The FDA's decision to grant Ascent with increased cycle count clearances illustrates the agency's confidence that the reprocessed devices are at least as safe as the originals," said Don Selvey, vice president, Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: With the reprocessing cycle count increased to six for the Diagnostic EP catheters, Ascent's customers will be able to reduce the number of times they are replenishing their supply of original and full cost devices, to further capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. their saving potential. Through extensive testing and validations at the high cycle count, these devices meet the highest standard of quality that are as safe as the original devices. Diagnostic EP catheters, specially designed electrode electrode, terminal through which electric current passes between metallic and nonmetallic parts of an electric circuit. In most familiar circuits current is carried by metallic conductors, but in some circuits the current passes for some distance through a catheters that transmit electrical impulses, are intended to be used for temporary intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Ascent has safely reprocessed more than 40 million SUDs for over 1,700 healthcare facilities nationwide. Ascent expects to help its customers save in excess of $92 million in supply expenses in the coming year, which may be redirected to patient services. Ascent is a major contributor to the healthcare industry's environmental responsibility efforts as an award winning member of Hospitals for a Healthy Environment (H2E). Ascent provides its customers with unparalleled opportunities to promote environmental stewardship The integration and application of environmental values into the military mission in order to sustain readiness, improve quality of life, strengthen civil relations, and preserve valuable natural resources. and expects to eliminate over 7,000 tons of medical waste from the nation's landfills annually. About Ascent Healthcare Solutions Ascent Healthcare Solutions is the leading independent third-party reprocessor of specific single-use medical devices (SUDs) and has reprocessed more than 40 million SUDs for over 1,700 healthcare facilities nationwide. The company's home office is in Phoenix, Ariz. with reprocessing centers in both Phoenix and Lakeland, Fla. Ascent holds agreements with all leading national group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors. as well as numerous nationally recognized hospital integrated delivery networks that collectively represent more than 5,000 healthcare facilities. For more information about Ascent Healthcare Solutions, visit www.ascenthealthcaresolutions.com. |
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