The FDA has finalized the long awaited guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” on March 17, 2015 following the draft of the document which was issued on May 2, 2011. While the majority of changes made include minor rewording, additional reference to resources, and expansion upon topics to provide clarity, there is a notable emphasis placed on device design and reprocessing of complex devices. The document outlines new recommendations intended to encourage manufacturers to develop safer reusable devices and to provide appropriate validation of reprocessing. The following highlights some of the ways the new document differs from the May 2, 2011 draft document.
Section III Scope – The scope was expanded to include reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.
Section IV General Considerations for Reusable Medical Devices – A new sub-category for design consideration of reusable devices has been added. The FDA has identified that there are challenges associated with reprocessing of complex devices and encourages manufacturers to consider alternative designs in the earliest stages of development. It will be important for manufacturers to describe how they have addressed the risks associated with their device design. They must be able to demonstrate with a great degree of assurance that the cleaning and disinfection or sterilization instructions will produce consistent reduction of organic and microbial contamination.
Section VI FDA’s Six Criteria for Reprocessing Instructions – The document has combined the previously listed “FDA’s Seven Criteria for Reprocessing Instructions” into six criteria. Coinciding with its recommendation to develop safer designs and improve successful reprocessing of devices, several additions were made to this section. Criterion 2 added specific guidance for flushable devices (e.g., endoscopes, laparoscopic instruments and other devices with flush ports). The FDA encourages inclusion of flushing instructions and diagrams for users to provide effective cleaning of the device. Addition of photographs and/or diagrams for each cleaning, rinsing and drying step is also suggested to further enhance accurate execution by the user. An additional section added to this criterion emphasizes the need to validate reprocessing method(s) as a means to demonstrate compatibility of the device with the method as well as the ability of the method to reprocess specific device features. The document states specifically, “The validation should demonstrate that soil and contaminants have been effectively removed and that the device is free of viable microorganisms” implying the need for a cleaning validation to demonstrate soil removal and a sterilization validation to demonstrate the device can be effectively sterilized.
In Criterion 4 the FDA has restated their position on the use of “Extended Cycles” for sterilization of reusable devices. An extended cycle is defined as a cycle that includes specifications that deviate from those found on FDA cleared sterilizers and for which there are limited or no FDA-cleared sterilization accessories. The FDA previously advised against the use of extended cycles, however in this new document the FDA recognizes the need for extended cycles to achieve sterilization of complex devices and larger loads and acknowledges they may be appropriate provided the accessory devices (ex: sterilization wraps, pouches, etc.) have been cleared for use in the extended cycle.
Section VII Validation of Reprocessing Methods in Accordance with the Quality System Regulation – Guidance has been added to this section for defining and allowing the use of product families to minimize reprocessing validations. The document states that the use of a well-defined “master device” may be possible to validate all products in a family of products.
Section VIII Validation of Cleaning Process – Section 1a. Artificial Soil, Inoculation Sites and Simulated Use has been expanded to state that the artificial soil chosen for validation should allow for at least two quantifiable soil components to be quantified. In order to assess the potential for soil accumulation over time, the cleaning validation should include devices that have undergone simulated full use and cleaning cycles.
Section 1c. specifies the use of sample positive and negative controls in validation studies, the use of these controls has historically been part of LexaMed’s protocol.
Section 3a. states specifically that in addition to analysis of residual cleaning markers, visual inspection of external and internal surfaces be performed as part of the validation.
FDA expands upon expectations of a 510(k) submission with more detail regarding inclusion of reprocessing instructions and validation documentation. Appendix E may be the most prominent addition to the guidance document. The Appendix identifies a subset of medical devices that generally pose a higher probability of microbial transmission and represent a greater risk of infection if they are not adequately reprocessed. As such, the 510(k)s for the identified device types should include protocols as well as complete test reports of the validation of the reprocessing instructions for review.