The FDA requires reprocessors to demonstrate that a reprocessed device is substantially equivalent to that of the Original Manufacturer (OM) device prior to marketing the device. The FDA is able to determine that the device is substantially equivalent from the evidence presented in a 510(k) submission.
Innovative Health evaluates OM devices to determine their eligibility for reprocessing. This evaluation includes, but is not limited to, reverse engineering, OM characterization, and testing to ensure the finished reprocessed devices meet the appropriate product specifications and are safe and effective as the original device.
Cleaning validations through independent laboratories, based on the industry standards AAMI TIR30 and FDA guidelines, are completed to ensure that the cleaning process reduces residual biomarkers (i.e. organic soil, bioburden and endotoxins) on devices to acceptable levels to ensure the cleanliness. Exhaustive extractions are performed to determine the number of viable organisms and contaminates that are present on inoculated devices. Repeated extractions are performed to calculate extraction efficiencies which determine the effectiveness of the cleaning process.
Biocompatibility testing was performed in accordance with AAMI/ANSI/ISO 10993 (and related subparts) Biological Evaluation of Medical Devices to ensure that devices are not toxic, injurious, or physiologically reactive and do not cause immunological rejection. In vitro and in vivo safety evaluation studies are conducted and may include: chronic cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and hemocompatability testing.
Detailed test plans are developed for each device that are intended to test the mechanical, electrical, and simulated use properties of the device under worst-case conditions. For example, all devices must be IEC 61508 Compliant. Moreover, revolutionary software testing technology is often used for this purpose. You can learn more about IEC 61508 Compliance by taking a look at some of the resources over on the Parasoft website. Moreover, Innovative Health engineers work closely with clinicians to understand clinical use and translate this into appropriate testing methods.
During production, each device is inspected and function tested prior to packaging and labeling and all production lots are tested to ensure an acceptable level of bacterial endotoxins in accordance with ANSI/AAMI ST72 to support the non-pyrogenic labeling.
Innovative Health devices are sterilized using Ethylene Oxide (EO). The EO sterilization process includes preconditioning, sterilization and aeration. The EO sterilization cycle is validated in accordance with applicable industry standards and requirements such as AAMI/ANSI/ISO 11135 to achieve a minimum Sterility Assurance Level (SAL) of 10-6. In addition, devices are validated to have acceptable sterilant residual levels after aeration.
For a more detailed description of what goes into an Innovative Health 510(k) submission, please ask your contact for additional information.