FDA

Compliant and Verified

As part of our essential clinical commodity patient room reprocessing management service, HYGIA uses FDA cleared reprocessing in accordance with guidelines and regulations.

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.

We do not reprocess those devices that can cause your physicians concerns. Our expertise and methods are targeted to the highest volume of devices used today that are sometimes referred to as non-invasive, non-critical and occasionally semi-critical.


HYGIA's Sporicidal Decontamination Process

Validation of HYGIA’s Ethylene Oxide (EO) Decontamination Process for Appropriateness of the Biological Challenge

HYGIA’s sporicidal decontamination EO process has been validated against industry methods and standards to establish a minimum six log reduction of Bacillus atrophaeus, a known spore former and the FDA recognized indicator test organism for EO sterilization processes. This established six spore log reduction (SLR) demonstrates that products exposed to the decontamination process would achieve a minimum six log reduction of the naturally occurring bioburden load.

The HYGIA sporicidal decontamination process utilized a standard Steris Spordex® Biological Indicator (BI), containing a minimum of 1 x 106 organisms of B. atrophaeus, placed inside a Process Challenge Device (PCD). Relative resistance studies performed on HYGIA’s product, at Nelson Laboratories Inc., identified the appropriate PCD for the product mix, which in turn was used to validate the decontamination process. Because HYGIA’s process demonstrates the appropriate deactivation, or lethality, of B. atrophaeus, and B. atrophaeus is known to be more resistant than other microorganisms such as Methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. diff.), the sporicidal decontamination EO process validated by HYGIA is considered effective and appropriate for nosocomial infection control.

Ethylene Oxide possesses excellent microbicidal activity as demonstrated in several studies and summarized in numerous published reports. Many literature sources categorize bacterial spores as the most resistant organisms to chemical sterilants and disinfectants such as EO. More specifically, E.H. Spaulding’s classification of the resistance of various microorganisms to sterilization and disinfection, lists spore-forming organism as the most resistant organisms. EO inactivates all microorganisms; however, studies show Bacillus atrophaeus is more resistant than other microorganisms to EO sterilization. It is for this reason that B. atrophaeus is the FDA and ISO required biological indicator for validating and monitoring EO processes.

As mentioned previously, because B. atrophaeus is used as the challenge indicator to EO processes, objectionable organisms such as MRSA and C. difficile, although challenging to some antibiotics, do not pose the same challenge to HYGIA’s sporicidal decontamination EO process as the deactivation or lethality of the B. atrophaeus biological indicator would demonstrate the deactivation or lethality of organisms of lesser resistance.

205.314.3920

434 Industrial Ln. |
Birmingham, AL 35211

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HYGIA is a proud member of Association of Medical Device Reprocessors (AMDR).