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Concerns about Implementing the Spaulding Scheme
对实施斯波尔丁计划的担忧
One problem with implementing the aforementioned scheme is oversimplification. For example, the scheme does not consider problems with reprocessing of complicated medical equipment that often is heat-sensitive or problems of inactivating certain types of infectious agents (e.g., prions, such as Creutzfeldt-Jakob disease [CJD] agent). Thus, in some situations, choosing a method of disinfection remains difficult, even after consideration of the categories of risk to patients. This is true particularly for a few medical devices (e.g., arthroscopes, laparoscopes) in the critical category because of controversy about whether they should be sterilized or high-level disinfected. 28, 86 Heat-stable scopes (e.g., many rigid scopes) should be steam sterilized. Some of these items cannot be steam sterilized because they are heat-sensitive; additionally, sterilization using ethylene oxide (EtO) can be too time-consuming for routine use between patients (new technologies, such as hydrogen peroxide gas plasma and peracetic acid reprocessor, provide faster cycle times). However, evidence that sterilization of these items improves patient care by reducing the infection risk is lacking.29, 87-91 Many newer models of these instruments can withstand steam sterilization, which for critical items is the preferred method.
实现上述方案的一个问题是过于简单化。例如，该计划不考虑通常对热敏感的复杂医疗设备的再处理问题或灭活某些类型的传染源（例如朊病毒，如克雅氏病 [CJD] 病原体）的问题。因此，在某些情况下，即使考虑了对患者的风险类别，选择消毒方法仍然很困难。对于一些属于关键类别的医疗器械（例如关节镜、腹腔镜）来说尤其如此，因为对于它们是否应该进行灭菌或高级别消毒存在争议。28、86 元热稳定内窥镜（例如，许多硬质内窥镜）应进行蒸汽灭菌。其中一些物品无法进行蒸汽灭菌，因为它们对热敏感;此外，使用环氧乙烷 （EtO） 进行灭菌对于患者之间的常规使用来说可能过于耗时（过氧化氢气体等离子体和过氧乙酸再处理器等新技术可提供更快的循环时间）。然而，缺乏证据表明这些物品的消毒通过降低感染风险来改善患者护理。29， 87-91这些器械的许多较新型号可以承受蒸汽灭菌，对于关键物品，蒸汽灭菌是首选方法。
Another problem with implementing the Spaulding scheme is processing of an instrument in the semicritical category (e.g., endoscope) that would be used in conjunction with a critical instrument that contacts sterile body tissues. For example, is an endoscope used for upper gastrointestinal tract investigation still a semicritical item when used with sterile biopsy forceps or in a patient who is bleeding heavily from esophageal varices? Provided that high-level disinfection is achieved, and all microorganisms except bacterial spores have been removed from the endoscope, the device should not represent an infection risk and should remain in the semicritical category. 92-94 Infection with spore-forming bacteria has not been reported from appropriately high-level disinfected endoscopes.
实施斯波尔丁方案的另一个问题是处理半临界类别的仪器（例如，内窥镜），该仪器将与接触无菌身体组织的关键仪器结合使用。例如，当与无菌活检钳一起使用或用于食管静脉曲张大量出血的患者时，用于上消化道检查的内窥镜是否仍然是半临界项目？如果实现了高水平消毒，并且已从内窥镜中去除除细菌孢子外的所有微生物，则该装置不应构成感染风险，应保持在半临界类别。92-94 尚未从适当的高水平消毒内窥镜中报道孢子形成细菌的感染。
An additional problem with implementation of the Spaulding system is that the optimal contact time for high-level disinfection has not been defined or varies among professional organizations, resulting in different strategies for disinfecting different types of semicritical items (e.g., endoscopes, applanation tonometers, endocavitary transducers, cryosurgical instruments, and diaphragm fitting rings). Until simpler and effective alternatives are identified for device disinfection in clinical settings, following this guideline, other CDC guidelines 1, 22, 95, 96 and FDA-cleared instructions for the liquid chemical sterilants/high-level disinfectants would be prudent.
实施斯波尔丁系统的另一个问题是，高水平消毒的最佳接触时间尚未定义，也因专业组织而异，导致对不同类型的半关键物品（例如，内窥镜、压平眼压计、腔内传感器、冷冻手术器械和隔膜配件环）进行消毒的策略不同。在确定更简单有效的临床设备消毒替代方案之前，遵循本指南，其他 CDC 指南 1、22、95、96 和 FDA 批准的液体化学灭菌剂/高浓度消毒剂说明将是谨慎的。 |
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发表于 2024-9-9 09:46
发表于 2024-9-9 10:02
