•ANSI/AAMI ST90:2017, Processing of health care products-Quality management systems for processing in health care facilities. 医疗产品的处理-用于医疗机构内处理的质量管理体系；

•ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.医疗机构压力蒸汽灭菌和无菌保障综合指南；

•AAMI TIR67:2018, Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities. 促进医疗机构安全使用灭菌剂和消毒剂化学品；

•AAMI TIR68:2018, Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces. 在医疗环境中对医疗器械、患者护理设备和无菌处理环境表面进行中低水平消毒。

In addition to these newly published standards, several other sterilization standards and technical information reports (TIRs) are being developed or revised. The following projects are currently underway among the sterilization standards working groups:

•A revision of ANSI/AAMI ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities. ANSI/AAMI ST91：2015的修订，在医疗机构中软式和半硬式内窥镜的处理。

•A new document, AAMI TIR99, Dilators, transesophageal and ultrasound probes processing in health care facilities. 新文件AAMI TIR99, 医疗机构中扩张器、经食管和超声探头处理。

•A new standard, AAMI ST98, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices, which will replace AAMI TIR30. 新标准AAMI ST98将替代TIR30, 医疗产品的清洗验证-医疗器械清洗过程的开发和验证要求。

•A new standard, AAMI ST100, End-to-end sterility assurance. 新标准AAMI ST100, 端到端的无菌保障。 

•A revision of ANSI/AAMI ST58:2013/ (R)2018, Chemical sterilization and high level disinfection in health care facilities.  ANSI/AAMI ST58:2013/ (R)2018的修订，医疗机构中的化学灭菌和高水平消毒。

• A revision of ANSI/AAMI ST77:2013/ (R)2018, Containment devices for reusable medical device sterilization.  ANSI/AAMI ST77:2013/ (R)2018的修订，用于复用器械灭菌的防护/包装装置。

The following section highlights a few of these projects in more detail. 详细描述如下：

ANSI/AAMI ST91

Since its debut release in 2015, ANSI/AAMI ST91 has brought much needed attention to the problems associated with endoscope processing. The document holds all processing areas to the same standard of care and calls for standardization of practice across different settings within a facility. As a result, ST91 has been instrumental in elevating practices among the many facilities that have adopted it.

However, errors in endoscope processing and reports of infections continue to be reported and are widely publicized. As more research becomes available, the value of adopting a quality systems approach toward endoscope processing has gained momentum. Due of these factors—and because ST91 serves as a comprehensive, best practice guide for endoscope processing—the AAMI Endoscope Reprocessing Working Group (AAMI ST/WG 84) felt that there was an urgent need to revise ST91.

The revision was initiated in 2016, and currently, the WG84 is compiling a fourth working draft of the document. The next round of comments by committee members will be reviewed during the spring sterilization standards meetings. From there, the group will decide whether to move the document into a committee draft.

AAMI TIR99

Within the framework of WG84, a new document, AAMI TIR99, has been accepted as a work item. This new TIR will focus specifically on the proper processing of items that are commonly used in healthcare facilities, such as dilators and transesophageal and ultrasound probes (e.g., vaginal and rectal probes). Despite being excluded from the scope of the current version of ST91, these ancillary endoscopic equipment items often are cleaned and undergo high-level disinfection in the same functional areas of healthcare facilities as flexible endoscopes.

Currently, no real guidance exists on the proper processing of these types of devices, and after a call to action for more information from healthcare personnel, WG84 took on the task of writing this new TIR. Unfortunately, because clear recommendations do not exist beyond what is found in the device instructions for use and because facilities are being cited by surveyors for not performing processing steps adequately, the forthcoming guidance in TIR99 should be of great value to facilities that are processing these types of devices.

It is expected that TIR99 will provide much needed detail on the required individual steps for proper processing of these devices, such as precleaning, transport, electrical leak testing (if necessary), manual cleaning, high-level disinfection (both manual and automated), sterilization, storage, and clean transport.    

AAMI ST98

The new standard AAMI ST98 will replace AAMI TIR30—a longstanding and widely accepted cleaning validation TIR for device manufacturers. Currently in its early draft stages, ST98 is an ambitious effort to better define and extend the requirements for validating the cleaning procedures developed by manufacturers for their devices. As part of this increased focus on cleaning, the AAMI Sterilization Standards Committee essentially made the decision to “upgrade” TIR30 to a full-blown standard. ST98 represents a major step forward in presenting requirements for validation of cleaning instructions.

AAMI ST100

Another new standard, AAMI ST100, currently is being drafted. ST100 will provide a comprehensive framework for ensuring the end-to-end sterility of medical products. This document will serve to connect the sterility assurance activities that might be addressed during each phase of the supply chain, starting with the definition of the product during research and development and moving toward the manufacture and distribution of the product to customers and patients.

The purpose of ST100 is to provide a comprehensive overview of the microbiological quality aspects that need to be considered during the development, validation, and routine control of microbiologically controlled, terminally sterilized, reusable, and aseptically processed healthcare products. The end-to-end sterility assurance framework also will link to other sterilization and supporting standards.