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.
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.
What is the Food and Drug Administration (FDA) opinion or view of reprocessed single use medical devices?
The Food and Drug Administration (FDA) has issued enforcement priorities governing reprocessing, and the safe reuse of devices labeled "single-use only". The FDA considers reprocessed devices "substantially equivalent" to (original) manufactured devices and subjects third party reprocessors to the same applicable regulatory guidelines as the original device manufacturer (OEM). The FDA has stated that certain specific single-use medical devices may be reprocessed and are "substantially equivalent" to the OEM device. The General Accounting Office (GAO) and Centers for Disease Control (CDC) have stated there is no evidence reprocessed devices have harmed ANY patients. Further, there has never been an adverse claim on a non-critical or semi critical reprocessed device.
Does ReNu Medical provide reprocessing services nationally?
Yes. ReNu Medical currently services hospitals nationwide.
Is ReNu Medical registered with the FDA? What classification?
Yes. ReNu Medical is classified as a third party medical device reprocessor, FDA registration number 3034520.
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.
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.
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.
How much staff time and effort is necessary to add your service?
NONE! ReNu Medical handles every aspect to insure a successful reprocessing program from staff education to pick up and delivery of the devices.
Is adding your service expensive?
There is NO capital investment to start our service in your facility.
Do you offer free trials?
Yes. We offer a two-week trial within defined parameters. ReNu provides all the collection containers for devices to be shipped to our laboratory. Call customer service for details.
What is the implementation process?
ReNu Medical representatives meet with your facility to in-service and set up device collection locations within the hospital. The facility can begin collecting devices immediately. ReNu Medical handles all the details; from pick up to delivery.
How much money could our institution expect to save by reprocessing single us medical devices?
You can expect at least a 30-75% savings over the cost of purchasing a new OEM device. If you are currently utilizing a sterilizing company to reprocess non-critical and semi critical devices, ReNu Medical can save your hospital twice as much (100%). ReNu Medical reprocesses single use medical devices for considerably less than the original acquisition cost. Savings per facility can range from thousands of dollars to even millions per year. Additional savings are realized through decreased waste disposal costs, inventory reduction, and reduced freight premiums.
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.
Should my facility charge full price for a reprocessed single use medical device?
Yes. The Centers for Medicare and Medicaid Services (CMS) agrees with the FDA that since a reprocessed device is "substantially equivalent" to a new device, Medicare will pay for devices used in outpatient procedure. For inpatient services, Medicare and most insurance companies use a patient diagnosis payment system; a fixed reimbursement according to the patient diagnosis. Hospitals then utilize "best practices" within that reimbursement- including approved reprocessed medical devices.
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.
What about hospital liability?
There has never been a confirmed patient or staff adverse incident from the use of a reprocessed non-critical or semi-critical device. ReNu Medical maintains a $5,000,000.00 transferable liability insurance policy.
How are my devices collected, cleaned and disinfected?
ReNu Medical will place collection containers in the hospital unit and in-service the staff. ReNu Medical maintains the responsibility of collecting, reprocessing, and returning medical devices to the hospital. All recovered devices undergo a thorough initial hand cleaning designed to eliminate bio-burden and enhance appearance. Cleaned devices are sorted for disinfection. Our process is redundantly verified and High Level Disinfection is assured.
How is a reprocessed device functionally tested?
ReNu Medical utilizes end point testing to functionally test 100% of the devices before they are returned to the hospital for patient use. All reprocessed devices meet OEM specifications.
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.
Does my hospital always receive our original devices after reprocessing?
ReNu Medical does not take ownership of medical devices to be reprocessed. ReNu performs reprocessing services in compliance with FDA guidelines and returns only the devices that have passed all of our stringent quality system criteria prior to returning to the originating hospital. Device segregation and return of the original device to the original hospital is assured using a unique identifier attached to individual devices.
To what extent must devices be pre-cleaned onsite, prior to collection?
None, ReNu Medical does it all for you.
Is there any staff time required for collecting devices?
There is no counting, sorting, cleaning or packaging. It is as simple as throwing devices into a ReNu Medical collection container conveniently located where the devices are normally discarded.
How long does ReNu Medical take to reprocess my devices and return them to my hospital?
ReNu Medical offers the quickest turn-around time in the industry. Your hospital receives the same devices we ship from your hospital today: in two weeks. This quick turn-around time allows for accurate inventory management.
Others may make similar claims, however, these are devices collected 4-6 weeks earlier. Although you receive a shipment from them every week, your actual turn time (for the same devices removed from your hospital) is frequently in excess of 8 weeks.
How does ReNu Medical determine and document the number of times an item has been reprocessed?
ReNu Medical’s Re-Trac™ custom device tracking and reporting system and software is designed to make available valuable information detailing unit compliance, device discard rate, and facility cost-benefit. Advanced barcode technology is used to provide immediate and ongoing data for ensuring documentation.
