Patient Safety Concerns?
Things to Consider
What is HLD?
High-level disinfection (HLD) is not sterilization. Our process uses nothing more dangerous than high temperature water. No chemicals or carcinogens are used as in sterilization methods. We utilize a pasteurization method that reaches temperatures high enough to kill all viruses, bacteria, and a majority of spores. No harmful air emissions are released into the environment and no chemical residue is left on the device. The CDC, APIC, and other healthcare organizations support this method of HLD.
What is ReNu Medical's pass/fail rate of reprocessed devices?
Maximizing the return rate of medical devices to the hospital is strength at ReNu Medical. Our process utilizes specific pre-cleaning protocols and an industry leading automated washing; prior to HLD assuring the highest return rates. ReNu Medical averages a 90% return of medical devices.
Will reprocessed devices pose residual germicide exposure or carcinogenic threats to staff and patients?
No. ReNu Medical is the ONLY reprocessor that utilizes pasteurization technology exclusively. Devices are not subjected to harsh chemical sterilants of any kind. Our process is 100% non-toxic and the only bi-product is hot water.
When was ReNu's latest FDA inspection?
ReNu's latest FDA inspection was completed in June 2008 with no 483 report issued. ReNu Medical meets or exceeds all FDA regulations and is 100% compliant with the FDA.
How does your product quality and value compare to other reprocessors?
ReNu Medical is classified as a test quality laboratory as certified by the Washington State Department of Labor. Our highest priority is patient safety and product quality. We strive to provide the highest quality product while maintaining the strictest quality standards at a competitive price. We invite your infection control personnel, risk management or other clinical experts to tour our laboratory and see our quality first hand.
Does ReNu Medical provide a warranty for their reprocessed devices?
ReNu Medical functionally tests 100% of all devices prior to returning them to the facility. This extraordinary level of quality assurance is your guarantee all devices returned to the hospital are visually, functionally, and substantially equivalent to a new device.
Do you outsource any of your service to other companies?
No. Patient safety and product quality are the number one priorities at ReNú. Unlike other reprocessors, we control all phases of device reprocessing within our laboratory in Everett Washington.
Should I utilize two separate vendors (reprocessors) for a reprocessing program to be successful?
According to the CDC, APIC, AORN, High-Level Disinfection is the appropriate and recommended method for reprocessing non-critical and semi-critical (non-invasive) devices. Further, utilizing the appropriate method for these devices provides a safe non-toxic method to save twice as much as sterilizers.
Are there companies that sterilize single use medical devices and do pasteurization (High-Level Disinfection)?
No. Unless the company has FDA 5-10K authorizations to provide both High Level Disinfection and sterilization. Sterilization is not pasteurization or HLD. ReNu Medical is an FDA approved and compliant High-Level Disinfection medical device reprocessor.
