arjo-pure-faqs-header.jpg

Frequently asked questions (FAQs)

Quality and savings

How do Arjo Pure’s quality and value compare to other reprocessors?

I'm already reprocessing; why should I consider Arjo Pure?

What is Arjo Pure pass/fail rate of reprocessed devices?

Does Arjo Pure 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 reprocessing?

Why should I use two reprocessing vendors?

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 Arjo Pure determine and document the number of times an item has been reprocessed?

FDA

Is Arjo Pure inspected and registered with the FDA?

What is the FDA's 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 Arjo Pure take to reprocess my devices and return them to my hospital?


How does Arjo Pure’s quality and value compare to other reprocessor's?

Arjo Pure’s highest priorities are patient safety and product quality. Our customers recognize that quality, and we have been named the gold standard for large, national, industry-leading health care organizations. We strive to provide the highest-quality product while maintaining the strictest quality standards at a fair and competitive price. Back to top


I'm already reprocessing, why should I consider Arjo Pure?

Arjo Pure provides the highest-quality reprocessed devices, offers the most competitive pricing and is FDA cleared as a result of the 510K process. Back to top


What is Arjo Pure's pass/fail rate of reprocessed devices?

Maximizing the return rate of medical devices to the hospital is a priority for Arjo. Our process utilizes specific precleaning protocols prior to HLD, assuring the highest return rates. We average a 90% success rate for certain reprocessed medical devices. Back to top


Does Arjo Pure provide a warranty for their reprocessed devices?

Yes. Arjo functionally tests 100% of all devices prior to returning them to the facility. This extraordinary level of quality assurance is your guarantee that all devices returned to the hospital are visually, functionally and substantially equivalent to a new device. Arjo warrants that all successfully reprocessed devices perform to manufacturers' specifications. Back to top


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 Original Equipment Manufacturer (OEM) device. If you are currently utilizing a sterilizing company to reprocess semi- and noncritical medical devices, Arjo Pure can save your hospital up to twice as much. Arjo Pure reprocesses single-use medical devices for considerably less than the original acquisition cost. 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. Back to top


What is HLD reprocessing?

High-level disinfection (HLD) is not sterilization. Arjo Pure’s technology disinfects previously used single-use medical devices and uses nothing more dangerous than high-temperature water. No chemicals or carcinogens are used as in sterilization methods. We utilize a pasteurization technology that reaches temperatures high enough to kill viruses, bacteria 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 after reprocessing. Back to top


Why should I use two reprocessing vendors?

Utilizing two reprocessors for your reprocessing program ensures the most success and benefits to your facility in each device category (HLD for noninvasive devices and sterilization for invasive devices). According to the CDC, APIC, AORN, Spaulding and many others, high-level disinfection (HLD) is the appropriate and recommended technology for reprocessing semi- and noncritical (noninvasive) devices. Furthermore, utilizing the appropriate technology for devices, HLD provides a safe, nontoxic technology delivering twice as much savings as other reprocessors employing sterilization. Maintaining sterile reprocessing in the OR and adding Arjo Pure in all patient care areas maximizes your reprocessing program savings and waste benefits. When there is a quality issue in the OR and that segment of reprocessing is stopped due to safety concerns, Arjo Pure’s program is not impacted, and the savings continue. There is no overlap in collections as the sterile reprocessor collects in the OR and Arjo collects everywhere else. Back to top


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

No. Unless the company has FDA 510(k) clearances to provide both high-level disinfection (HLD) and sterilization, they must outsource services to other companies. Arjo Pure is the only FDA-compliant high-level disinfection (HLD) medical device reprocessor. Back to top


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

No. Arjo Pure is the only reprocessor that utilizes HLD (pasteurization) technology exclusively. Devices are not subjected to harsh chemical sterilants. Our technology is 100% nontoxic and the only byproduct is hot water. Back to top


How does Arjo Pure determine and document the number of times an item has been reprocessed?

Advanced bar code technology is used to track every device reprocessed and provide real-time immediate and ongoing data ensuring appropriate device history documentation. Arjo Pure's device tracking and reporting system software is designed to make available valuable information detailing overall savings and waste elimination on a per-device basis. *Reporting data is critical to the success of your reprocessing program. Verify that your reprocessor actually delineates how many devices are collected from your facility (not just how many are processed). Without accountability of all collections, your facility may be receiving partial or incomplete data, with savings and waste calculations that are compromised and/or inaccurate. Back to top


Is Arjo Pure inspected and registered with the FDA?

Our FDA registration number is 3034520. Our latest FDA inspection was completed in October 2017. Arjo Pure via ReNu Medical is 100% FDA compliant and meets or exceeds all FDA regulations. Back to top


What is the FDA's 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 and Prevention (CDC) have stated that there is no evidence that reprocessed devices have harmed any patients. Furthermore, there has never been an adverse event on a semi- or noncritical reprocessed device. Back to top


Should my facility charge full price for a reprocessed single-use medical device?

Yes. The Centers for Medicare & Medicaid Services (CMS) agrees with the FDA that a reprocessed device is "substantially equivalent" to a new device, and Medicare will pay for devices used in outpatient procedures. 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. Back to top


What is the implementation process?

Arjo Pure’s implementation team works with a key representative from each facility to define an Operation and Implementation schedule and manage all the logistics. Arjo representatives meet with your facility to educate, in-service, brand and set up device collection locations within the hospital. The facility can begin collecting devices immediately. Arjo handles all the details, from pickup to delivery. Back to top


How are devices collected, cleaned and disinfected?

Collection containers are placed in appropriate hospital units, and staff is then in-serviced. Arjo maintains the responsibility of collecting, reprocessing and returning devices to the facility. All recovered devices undergo a thorough initial inspection and cleaning to eliminate bioburden and enhance appearance. Cleaned devices are sorted and receive high-level disinfection (HLD). Back to top


Do you outsource any services to other companies?

No. Patient safety and product quality are the highest priorities at Arjo. Unlike other reprocessors, we control all phases of device reprocessing at our reprocessing center in Everett, Washington. Back to top


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

Arjo Pure handles every aspect to ensure a successful reprocessing program from implementation staff education to pickup and delivery of devices. There is no counting, sorting, cleaning or packaging. It is as simple as throwing all target devices into the same Arjo Pure collection container, conveniently located where devices are normally discarded. Back to top


How long does Arjo Pure take to reprocess my devices and return them to my hospital?

Arjo Pure offers the quickest turnaround time in the industry (less than seven days in our reprocessing center). Back to top