The U.S. FDA issued guidelines for instructions and labeling of reusable medical devices in 2015, and the European Commission issued guidelines for instructions for reusable and resterilized medical devices in 2020. In 2019, China issued a draft of the guidelines for the technical review of the registration of reprocessing instructions and confirmation methods for reusable medical devices. On 2023-11-07, the two previously released drafts for comments were revised and improved. At present, countries are paying more and more attention to the reprocessing of reusable medical devices. Reprocessing is the validated process of treating used or contaminated medical devices to meet the requirements for subsequent use. Reprocessing typically involves cleaning, disinfection, or sterilization, with the cleaning process used to remove contamination and disinfected or sterilized to kill microorganisms. Cleaning is the use of liquid solvents to remove contaminants on the product according to a certain procedure, reducing the initial contamination of the product before sterilization, so as to ensure the final sterilization or disinfection effect of the product.
The purpose of confirming the cleaning process in the reprocessing instructions is that the method (manual or automated) will allow the instrument to meet the requirements for further processing and ultimately be safe for reuse. Requirements: Cleaning Validation ProtocolFor each step of cleaning, the shortest time, lowest temperature, weakest diluent, etc. should be used.
1. Selection and inoculation of artificial pollutantsa.Man-made contaminants should be representative of the contaminants they may be exposed to during clinical use and be the most challenging to clean the process.
b.The suggestion is a mixture, not a single ingredient; Protein is the primary pollutant, others are carbohydrates, small amounts of hemoglobin and endotoxins;
c.For endovascular devices and devices used for sterile body cavity surgery, whole blood or diluted blood or serum is appropriate. d.The contaminant selected for testing should be quantified for at least one representative clinically relevant contaminant component (e.g., TOC or protein).
e.Contaminant inoculation should mimic worst-case clinical use conditions: all surfaces in contact with tissue, hard-to-clean locations, etcValidation studies need to mimic clinical use environments: e.g., multiple life cycles to simulate the accumulation of contaminants; Heating or energizing all aspects of operation are simulated.
2. Commonly used pollution markersProteins, carbohydrates, hemoglobin (blood), endotoxins, lipids, sodium ions, bioburdens, total organic carbon, etc. 3. Confirmation of cleaning methodWhen testing the method, the following comparative controls are required:
a.For the control of positive devices --- artificially polluted devices, the ** rate needs to be calculated, and the residual amount is equal to or slightly less than the added amount; b.Negative device control --- uncontaminated device, and the residual amount is equal to or slightly greater than that of the blank sample;
c.Negative sample control --- uninstrumented extract (equivalent to blank); d.Positive sample control --- extracts with no instruments but contaminants added (added at or slightly greater than the limit of quantification LOQ) to account for the interference of extracts and contaminated extraction methods on detection.
4. Extraction method1) The device should use a validated extraction method to calculate the ** rate of residual pollutants. The extraction method should be fully described, with ** rate determination as part of the validation;
2) Limit extraction and addition of known amounts of pollutants are common methods for determining the rate;
3) Extraction needs to be carried out in the harshest conditions: aExtraction should be for all contact surfaces;
b.When determining the rate, it should be done with the components that are most difficult to remove contaminants;
c.The volume of the extracted liquid is moderate so that the analyte does not dilute below the limit of detection. CIRS Hicco Test