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Frequently Asked Questions


Quality & Savings

How does ReNu Medical's quality and value compare to other reprocessor's?
I'm already reprocessing, why should I consider ReNu Medical?
What is ReNu Medical's pass/fail rate of reprocessed devices?
Does ReNu Medical provide a warranty for their reprocessed devices?
How much money could our institution expect to save by reprocessing single-use medical devices?


HLD Technology

What is HLD?
Why should I use an HLD reprocessor in addition to a sterilizing reprocessor?
Are there companies that sterilize single use medical devices and also offer HLD via pasteurization?
Will HLD reprocessed devices pose residual germicide exposure or carcinogenic threats to staff and patients?
How does ReNu Medical determine and document the number of times an item has been reprocessed?


FDA

Is ReNu Medical registered with the FDA? What classification?
When was ReNu's latest FDA inspection?
What is the Food and Drug Administration (FDA) opinion or view of reprocessed single use medical devices?
Should my facility charge full price for a reprocessed single use medical device?


Service

What is the implementation process?
How are devices collected, cleaned and disinfected?
Do you outsource any services to other companies?
How much staff time and effort is necessary to add your service?
How long does ReNu Medical take to reprocess my devices and return them to my hospital?
What about hospital liability?

How does ReNu Medical's quality and value compare to other reprocessor's?

ReNu Medical's highest priority is patient safety and product quality. ReNu's customers have recognized as the highest quality reprocessor and we have been named the gold standard for large, national, industry leading healthcare organizations. We strive to provide the highest quality product while maintaining the strictest quality standards at a competitive price.


I'm already reprocessing, why should I consider ReNu Medical?

ReNu Medical provides the highest quality reprocessed devices, the most competitive pricing and is authorized by the FDA to process the devices the most times- maximizing savings and waste elimination benefits.


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 prior to HLD assuring the highest return rates. ReNu averages a 90% success rate for reprocessed medical devices.


Does ReNu Medical provide a warranty for their reprocessed devices?

Yes. 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. ReNu Medical warrants that all successfully reprocessed devices perform to manufacturers specifications.


How much money could our institution expect to save by reprocessing single-use medical devices?

Hospitals 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 and savings per facility can range from thousands of dollars to millions annually. Additional savings are realized through decreased waste disposal costs, inventory reduction, and elimination of freight premiums.


What is HLD?

High Level Disinfection (HLD) is not sterilization. ReNu's technology uses nothing more dangerous than high temperature water. No chemicals or carcinogens are used as in sterilization methods. We utilize a pasteurization process that reaches temperatures high enough to kill viruses, bacteria's and all microorganisms, except for small numbers of bacterial spores. No harmful air emissions are released into the environment and no chemical residue is left on the device.


Why should I use an HLD reprocessor in addition to a sterilizing reprocessor?

Utilizing two reprocessors for my reprocessing program ensures the most success. According to the CDC, APIC, AORN, Spaulding and many others, High-Level Disinfection is the appropriate and recommended technology for reprocessing semi and non-critical (non-invasive) devices. Further, utilizing the appropriate technology for these devices provides a safe non-toxic method to save twice as much as other reprocessor's employing sterilization. Maintaining sterile reprocessing in the OR and adding ReNu Medical maximizes your reprocessing programs savings and waste benefits. When there is a quality issue in the OR and that segment of reprocessing is stopped for resolution, ReNu's program is not impacted and the savings continue. There is no overlap in collections as the sterile reprocessor collects in the OR and ReNu collects everywhere else.


Are there companies that sterilize single use medical devices and also offer HLD via pasteurization?

No. Unless the company has FDA 510K clearances to provide both High Level Disinfection and sterilization they must outsource services to other companies. ReNu Medical is an FDA compliant High Level Disinfection medical device reprocessor.


Will HLD reprocessed devices pose residual germicide exposure or carcinogenic threats to staff and patients?

No. ReNu Medical is the ONLY reprocessor that utilizes HLD (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.


How does ReNu Medical determine and document the number of times an item has been reprocessed?

ReNu Medical's device tracking and reporting system and software is designed to make available valuable information detailing overall savings and waste elimination. Advanced barcode technology is used to provide 'real time' immediate and ongoing data ensuring appropriate device history documentation.

*Be sure during evaluations of reporting capabilities your reprocessor delineates how many devices are actually collected from 'your' facility. Only delivering reprocessed devices to your facility provides half the service and does not eliminate waste. Contact your ReNu Sales Team for more detailed information.

[email protected] 877-252-1110


Is ReNu Medical registered with the FDA? What classification?

Yes. ReNu Medical is classified as medical device reprocessor and manufacturer.
FDA registration number 3034520.


When was ReNu's latest FDA inspection?

ReNu's latest FDA inspection was completed in December 2014. ReNu Medical is 100% FDA compliant and meets or exceeds all FDA regulations.


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 reprocessor's 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.


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 diagnostic related group payment schedule reimbursement system. Hospitals then utilize "best practices" within that reimbursement- including approved reprocessed medical devices.


What is the implementation process?

ReNu Medical's implementation team works with a key representative from each facility to define an operation and Implementation schedule and manage the logistics. ReNu 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 are devices collected, cleaned and disinfected?

ReNu Medical places collection containers in appropriate hospital units and in-service the staff. ReNu Medical maintains the responsibility of collecting, reprocessing, and returning devices to the facility. All recovered devices undergo a thorough initial hand cleaning to eliminate bio-burden and enhance appearance. Cleaned devices are sorted and receive High Level Disinfection.


Do you outsource any services to other companies?

No. Patient safety and product quality are the number one priorities at ReNu. Unlike other reprocessor's, we control all phases of device reprocessing at our reprocessing center in Everett Washington.


How much staff time and effort is necessary to add your service?

ReNu Medical handles every aspect to insure a successful reprocessing program from implementation, staff education to pick up and delivery of the devices. There is no counting, sorting, cleaning or packaging. It is as simple as throwing all target devices into (the same) ReNu Medical collection container conveniently located where 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 (less than 7 days in our reprocessing center). 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 make similar claims, however, these are devices collected 5-6 weeks earlier. Although you may receive a weekly shipment from others, your actual turn time (for the same devices removed from your hospital) is frequently in excess of 8 weeks. Additionally, ReNu returns the devices collected from your facility ' back to your facility (other reprocessor's do not).


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 $10,000,000.00 liability insurance policy.