ReNu Medical Announces Results of Their January 2005 FDA Inspection
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 18, 2005 -- “NO 483 REPORT” came loud and clear
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.
Contact Information:
Loren Timmons
VP, Marketing
& Business Development
PH: 425-353-1110
FAX: 425-353-9116
www.renumedical.com
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Source : http://www.prweb.com/releases/2005/1/prweb199109.htm