QMS system for Sterile Processing

We can all agree on the fact that hospitals & clinics thrive on efficiency! The proper care, cleaning and decontamination of medical equipment is a crucial part of driving efficiency as well as patient care. In recognition of that, ERD has built a company of experts dedicated to implementing quality management systems (QMS) and efficient sterile processing standards into hospitals and clinics. 

ERD is at the forefront of the biomedical community encouraging all healthcare facilities to implement QMS according to the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) ST90. The standard states, “ST90 specifies the minimum 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.”

ST90 for processing technician:

  • 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

ST90 for middle manager or shift supervisor:

  • 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

ST90 for senior leadership:

  • 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

Click here to download the ANSI/AAMI ST90:2017

Leave a Reply