ReNu Medical Alerts Hospitals to Misuse of FDA 5-10ks
ReNu Medical has the legal 5-10k’s to high-level disinfect (HLD) reprocess non and semi critical (single use) medical devices for US hospitals.
Everett, WA (PRWEB) May 31, 2005 -- “It’s misleading; the FDA website lists
only the company or individual who originally filed and was issued a 5-10k. Much
like the listing of a Patent and/or Trademark, the websites do not publish the
selling, purchase or assignment of the original document. Unless a medical
device reprocessing company is honest enough to mention this fact, a healthcare
facility would never know they could be held liable for illegally marketed HLD
reprocessed medical devices they receive from a vendor,” said Loren Timmons, VP
Marketing and Business Development at ReNu Medical.
In 2002, ReNu Medical
purchased and was assigned several FDA 5-10k’s from Hygia Health Services
located in Birmingham, Alabama. On that date according to the FDA, Hygia Health
Services lost all rights to market reprocessed single use medical devices
specific to those 5-10k numbers.
“A 5-10k is a company’s “license” to
legally market reprocessed medical devices. It is important to understand that
5-10k’s can be bought and sold on the open market. According to the FDA, they
can only be used (marketed) by the company it is assigned to. This means, once a
company sells or assigns their 5-10k to another company, they lose all rights to
legally market reprocessed medical devices specific to that 5-10k,” said Randy
Long, CEO at ReNu Medical. “ReNu’s 5-10k documentation was re-verified in
January 2005 during our last FDA inspection.”
“Patient safety and FDA
compliance is the cornerstone of ReNu Medical. Not having the FDA 5-10k for
high-level disinfection reprocessing of single use medical devices is like
driving a car on the wrong side of the road; it is simply a matter of time
before you get caught: or worse kill someone,” said Bruce Pierson, Chief
Operations Officer at ReNu Medical. “Information published on the FDA website
may not be current or correct. Hospitals need to understand they have the final
liability and risk of using such information.”
ABOUT RENU
MEDICAL:
ReNu Medical is the leading reprocessor of non-invasive single
use medical devices (SUD’s). ReNu's unique services focus on providing the
safest product for the patient, reducing medical waste and significantly
reducing supply costs by maximizing available savings.
ReNu's unique
focus on single use (non and semi critical) devices provides a significant
source of cost savings with very little associated 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, ReNu'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 (HLD) 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.
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Source : http://www.prweb.com/releases/2005/5/prweb245268.htm