ReNu™ Medical, the leading reprocessor of non and semi critical (single use) medical devices announced results from their 2005 FDA inspection-No 483 report!
Everett, WA (PRWEB) January 20, 2005 -- "NO 483 REPORT” came over the public address system at ReNu™ Medical today; followed by applause and loud cheers.
Chief Operations Officer, Bruce Pierson and Randy Long, Chief Executive Officer were ecstatic as they received word that the FDA found no deficiencies at the ReNu™ medical device reprocessing laboratory in Everett, Washington, and would not be issuing a 483 report.
"ReNu™ received what would be the equivalent of a Gold Medal to an Olympic athlete,” said Bruce Pierson, COO.
Issuing a 483 report is standard operating procedure for the FDA and is usually issued after they complete an inspection. This report outlines any and all deficiencies and provides the (inspected) facility management a clear direction and understanding of what must be corrected or changed. It is almost unheard of for this report not to be issued.
Prior to a hospital contracting with a medical device reprocessing company, the 483 report should be reviewed and discussed with management. These reports are also available through the FDA via the Freedom of Information Act.
"ReNu™ Medical, since it's inception in 2000 has been uncompromising in our attention to product quality and safety. Our commitment to providing the safest, highest quality product, in a working environment that places our employee safety first is exemplified and authenticated by this FDA inspection,” said Mr. Pierson.
"High-Level Disinfection reprocessing is here to stay. HLD is non-toxic, environmentally friendly, provides hospitals twice the savings compared to sterilization reprocessing and substantially reduces hospital medical waste.” said Randy Long, CEO.
ReNu™ continues to build clientele especially among hospitals who understand the savings advantages and reduction of hospital waste associated with (HLD) versus sterilization.
"Our experience has shown that once hospitals and GPO's understand the advantages of high-level disinfection over sterilization, they usually add our service to their existing reprocessing contract. This can be done without having to make any substantial changes or modifications in their contract or hospital procedures and protocol,” said Loren Timmons, VP, Marketing and Business Development.
Bruce Pierson, ReNu™ COO said, "Sterilization is not the appropriate method for these non and semi critical medical devices. We have demonstrated conclusively that high-level disinfection saves more money than sterilization, is safe, effective and ReNu™ should be a hospital's number one choice in medical device reprocessors.”
ABOUT RENU™ MEDICAL:
ReNu™ Medical is the leading reprocessor of non-invasive single use medical devices (SUD's). ReNú's unique services focus on providing the safest product for the patient, reducing medical waste and significantly reducing supply costs by maximizing available savings.
ReNú's™ unique focus on non and semi critical devices provides a significant source of cost savings with very little associate risk. These devices go ON the body not IN the body. High Level Disinfection (HLD) offers significant cost saving advantages over sterilization methods. For example, ReNú's™ non-toxic method of HLD has the proven ability to turn an individual medical device 2-3 times more than a sterilizing reprocessor which equates to 2-3 times the cost savings. Additionally, with our quick turn around time, two weeks compared to 8-12 weeks, less inventory is required thus saving you even more money. Finally, ReNú™ has the proven lowest discard rate in the industry (less than 10% on average) allowing you to get more devices back. These advantages offer significant savings far above other reprocessors.
High-Level Disinfection technology is 100% non toxic, environmentally friendly and a safe gentle alternative for the non and semi critical devices. HLD offers twice the life span and double the saving of toxic Ethylene Oxide Gas (EtO) utilized by sterilization reprocessor's. No harmful air emissions are released into the environment and no chemical residue is left on the device. HLD is supported by the CDC, APIC, and other healthcare organizations.
ReNu™ Medical is a supporter and Champion of Hospitals for a Healthy Environment. We recommend you visit their website (www.h2e-online.org) to learn more about how to reduce hospital medical waste.
VP, Marketing & Business Development