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QUALITY IMPROVEMENT


aren’t we doing the same in the device processing area?’ arose. As a result, a proposal was presented to the AAMI Standard Board to approve a working document that could bring similar qual- ity management systems to device pro- cessing areas of health care facilities. Over a three-year period, this standard was developed by the AAMI Quality Systems for Device Processing Work- ing Group. In June 2017, ANSI/AAMI ST90 was completed with ISO 13485 as the foundational document of reference. QMSs all follow the same eight requirements: scope, normative refer- ences (foundational documents con- taining provisions that, through refer- ence in the text, constitute provisions of ST90, such as AAMI standards and Association of periOperative Registered Nurses [AORN] guidelines), definitions and abbreviations, QMS, management


Quality management can bridge the silos within an organization and become the catalyst for communication between staff.”


— Richard W. Schule Steris Corporation


responsibility, resource management, product realization, and measurement, analysis and improvement. There are several sterile processing departments that have implemented various degrees of QMSs. One accred- itation organization, DNV-GL (https:// www.dnvgl.us/assurance/healthcare), works with more than 600 healthcare organizations to meet CMS require-


ments while also embracing quality management systems; of those, there are many sterile processing depart- ments that participate in their organiza- tion’s implementation of QMS efforts. I advise health care professionals


involved with device processing to take small steps during QMS implementation and to remember we are already focusing on quality performance in most sterile processing departments; we may just not be aware how those dots connect to an official QMS. For those thinking this is going to be a lot of work to implement— it will be, but anything worth doing cor- rectly is not always easy. Success can only be achieved with team effort, clear vision and supportive leadership.


Richard W. Schule is the director of clinical education at Steris Corporation in Mentor, Ohio. Write him at richard_schule@steris.com.


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26 ASC FOCUS JUNE/JULY 2019 | ascfocus.org


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