AAMI News November 2017

Standards Spotlight: New Standard Brings Quality Systems into Sterile Processing


Processing of health care products—Quality management systems for processing in health care facilities

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Although most medium-to-large healthcare delivery organizations have a department that focuses specifically on quality, very few of those departments have much to do with sterile processing, according to Damien Berg, sterile processing manager for St. Anthony Hospital & OrthoColorado Hospital. He hopes this is about to change with the release of a new standard, ANSI/AAMI ST90, Processing of health care products—Quality management systems for processing in healthcare facilities.

“ST90 is the blueprint for a process that will ensure that sterile processing departments can maintain and deliver quality outcomes to our customers and patients,” said Berg, who is co-chair of the AAMI Quality Systems for Device Processing Working Group.

ST90 specifies the minimum quality management system (QMS) requirements needed for a healthcare organization to effectively, efficiently, and consistently process medical devices to prevent adverse patient events and non–manufacturer-related device failures.

“It is my hope that ST90 provides the framework and structure for device processing areas within a healthcare facility to be more effective, efficient, and consistent in their device processing processes,” said Richard Schule, director of clinical education services at Steris Corporation and AAMI Quality Systems for Device Processing Working Group co-chair. “I also hope ST90 provides technicians, supervisors, and department leadership with a systematic approach to take their department to the next level.”

Staff at all levels of the organization would benefit, Schule added.

For the processing technician, such an approach would result in:

  • A better understanding of what to do and how to do it
  • The ability to check work against requirements
  • The ability to adjust processes when results are not meeting requirements
  • A means of getting help to solve problems
  • Opportunities to communicate problems in a nonthreatening manner by focusing on process issues
  • An environment where the technician is not blamed for issues that can only be resolved by managers

For the middle manager or shift supervisor, using ST90 would lead to:

  • Better control of processes
  • A higher level of consistency
  • The ability to manage using data rather than opinions
  • Enhanced communication throughout the organization
  • Clarity of responsibility and accountability
  • Standardization of processes, reducing variability and making it easier to solve problems
  • The establishment of continual improvement as a core value of the department

For senior leadership, the approach would provide:

  • Greater clarity on departmental goals and objectives
  • Improved ability to understand and meet customer requirements in a consistent manner
  • Alignment of employees and processes to meet organizational objectives

“For those thinking it is going to be a lot of work to implement a QMS in their department—it will be, but anything worth doing correctly is not always easy,” Schule said. “Success can only be achieved with team effort and clear vision.”