嘉峪检测网 2022-12-02 18:03


The complexity of medical devices has increased over the past 10 years, and outbreaks of infections due to contaminated devices have focused attention on the need to adequately clean medical devices in order to ensure the adequacy of disinfection and sterilization. There has been a paradigm shift in reprocessing of medical devices, with increased emphasis on a quality management systems approach that requires validated cleaning instructions from manufacturers and ongoing monitoring by reprocessing personnel to ensure adequacy of cleaning.
Reusable medical devices are designed to be used repeatedly on patients,and the manufacturer’s instructions for use (MIFU) must include specific, validated instructions for cleaning as well as for disinfection and/or sterilization. If medical devices are not properly reprocessed, there is a risk that they will be contaminated with microorganisms that could be transmitted to multiple patients, causing colonization or infections.
As awareness of infection transmission through contaminated medical devices increases, it is becoming increasingly apparent that a quality management systems (QMS) approach is needed, regardless of the type of medical device being processed. A QMS approach has been defined as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization;s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.” The quality monitoring processes for sterilization technologies are well established; however, for highlevel disinfectant (HLD) processes, only recently have quality monitoring processes been introduced that go beyond just checking reusable HLDs to ensure a minimal effective concentration. Despite this progress, there has been little in the way of establishing quality monitoring of manual or automated cleaning efficacy for any type of reusable medical device, despite the recognition that disinfection and sterilization processes will fail if the cleaning has not been performed adequately.
The microbial load on patient-used surgical instruments is relatively low. The microbial levels varied depending on the type of surgery, with cesarean section surgery showing the highest CFU/cm2.Significantly fewer organisms were detected from clean-contaminated vs contaminated surgeries (average of 41±84 CFU/device vs 201±126 CFU/device), and infected surgical procedures were found to have the highest level of contamination. The most common microbes detected from surgical instruments used for clean orthopedic surgery were coagulase-negative staphylococci, Staphylococcus aureus, and Bacillus spp. Detection of Gram-negative bacteria increased in clean-contaminated and infected orthopedic surgery, but the predominant isolates were still Staphylococcus and Bacillus spp., a finding similar to data from other published studies. Although surgical instruments typically have low microbial levels, the level of organic residuals is high, and inadequate removal of patient secretions, tissue, and bone, for example, may result in failure of the sterilization process. These findings emphasize the importance of the cleaning process to ensuring adequate sterilization.
Medical devices are cleaned manually as well as by automated washers. The current ANSI/AAMI ST79 guideline supports the efficacy of automated washer-disinfectors (WDs) for reprocessing the majority of surgical instruments (often with sonication before cleaning in the WD). The automation of cleaning ensures that the process will be reproducibly performed and done more efficiently than manual cleaning, and the WD provides thermal decontamination of instruments which reduces the infection risk to reprocessing personnel who then handle the instruments for packaging and sterilization.
    医疗器械通常用手洗或者机洗处理。ANSI/AAMI ST79肯定了自动清洗消毒机对大多数手术器械再处理的有效性(通常在机洗前进行超声处理)。洗消机的运用提高了器械处理效率,同时,对器械进行热消毒,减少了操作人员的感染风险。
The adequacy of cleaning of medical devices can be evaluated by monitoring the WD when automated methods are used or by monitoring the cleaned device itself. Current guidelines recommend that monitoring the cleaning efficacy in WDs should be performed at least weekly, preferably daily. A wide range of commercial cleaning monitoring tests are available for WDs, but it is difficult to compare the efficacy of one WD cleaning monitor to another as there are no current standardized criteria for such tests; for example, what level of defect in detergent concentration, temperature, water quality, or spray-arm water impingement pressure will cause the cleaning monitor to fail? More research is needed to establish standardized criteria for WD cleaning monitors so guidelines can be developed. Despite this limitation, the use of such cleaning monitors does ensure that there is regular monitoring of WD cleaning efficacy within the constraints of the cleaning monitor used.
Rapid cleaning monitoring tests can detect organic residuals such as TOC, protein, hemoglobin, and carbohydrate on the surface of surgical instruments. The ninhydrin test for protein has been evaluated for monitoring surgical instruments; however, this test does not detect all proteins and there are many false negative results, so it has not been widely implemented. Recently, ATP testing has been used to demonstrate that the cleaning of ultrasound probes requires improvement. Although rapid ATP tests have been used to assess cleaning adequacy for surgical instruments and ultrasound probes, more clinical studies are needed to establish the cut-off level of ATP (often measured as relative light units [RLUs]) for each test kit that reliably indicates that adequate cleaning has been achieved. 
文章翻译自 Alfa M . Medical instrument reprocessing: current issues with cleaning and cleaning monitoring.[J]. American journal of infection control, 2019, 47S:A10-A16.



关键词: 医疗器械 医疗器械清洗


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