1. Can my hospital legally reuse a device designated as "single use only" by the original equipment manufacturer?
Absolutely! The Food and Drug Administration (FDA) has issued enforcement priorities governing reprocessing and the safe reuse of devices labeled "single use only." In fact, the FDA considers reprocessing of devices equivalent to manufacturing of those devices and subjects third party reprocessors to the same applicable regulatory guidelines as the original device manufacturer.
2. How much money can my hospital save through reprocessing?
Hygia reprocesses target devices for a fraction of a hospital's original acquisition cost. Cost-avoidance potential is hospital dependent. However, savings can range from tens/hundreds of thousands of dollars to even millions per year. Additional savings may occur through decreased waste disposal costs, decreased freight premiums, and an elimination of sales taxes on reprocessed devices (where applicable). A Hygia representative will gladly assist you in predicting exact cost-avoidance benefits for your facility.
3. 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. However, Hygia maintains a $5,000,000 transferable liability policy to satisfy Risk Management concerns.
4. How are recovered devices cleaned and disinfected?
All recovered devices undergo a thorough initial cleaning designed to eliminate bioburden and enhance appearance. Cleaned devices are then batched for disinfection. CDC, APIC, and AORN recommend Hygia's High-Level Disinfection (HLD) technology for target device disinfection. Disinfection conditions are redundantly validated and HLD is assured.
5. How is reprocessed device functionality assured?
Hygia functionally tests 100% of devices after reprocessing and before delivery to source hospital. All reprocessed devices are guaranteed to perform within defined tolerances.
6. Will reprocessed devices pose residual germicide exposure or carcinogenic threats to staff and patients?
No. Hygia utilizes a clean disinfection technology that does not subject devices to harsh chemical sterilants.
7. How does my hospital collect devices and send them to be reprocessed?
Hygia's program is designed to promote maximum staff compliance with minimal staff effort. Hygia will locate device collection containers in each participating hospital unit and will train affected staff to participate in the reprocessing protocol through a brief unit in-servicing. Hygia maintains the responsibility of collecting, reprocessing, and returning these devices to their source hospital.
8. Does my hospital always receive our own devices after reprocessing?
Absolutely! Hygia performs reprocessing services in compliance with FDA guidelines and returns reprocessed devices to their source hospital. Device segregation and return to the source hospital is assured through the use of a unique identifier attached to individual devices for the life of that device. If there are some devices that cannot be returned due to our stringent device protocols regarding efficacy, cleanliness and reuse life, some hospitals request us to replace them with devices from our device store.
9. What non-critical and semi-critical devices are eligible for inclusion in the protocol?
There are dozens of devices eligible for reprocessing, providing dramatic cost-avoidance benefits at any hospital. A Hygia representative will be pleased to assist you in determining which devices are eligible at your facility.
10. Why reprocess non-critical and semi-critical devices?
Reprocessing of non-critical and semi-critical devices provides a diminished Infection Control and Risk Management concern. Remember, there are no reports of adverse patient or staff incidents resulting from the reuse of a non-critical or semi-critical device. Also Hygia target devices are typically high in volume and therefore can produce substantial cost-avoidance benefits.
11. Can a hospital use more than one reprocessing company at the same time?
It isn't uncommon for hospitals to reprocess those devices that we do not reprocess with another company.
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