Ensuring Your Instrument Processing Maintains the Highest Standards





A growing number of healthcare organizations and practices are seeking accreditation for their facilities as a means of ensuring a safer healthcare experience and environment for patients, clinicians and staff.

Our Midmark experts speak with healthcare professionals across the US who are considering or going through the voluntary accreditation process. One thing is consistently clear, the process to attain and maintain accreditation can become pretty overwhelming and confusing. 

There are a number of key players, guidelines and regulations when it comes to compliance for your instrument processing area. There are regulations from organizations such as the Food and Drug Administration (FDA) and Occupational Health and Safety Administration (OSHA), evidence-based guides that include standards and best practices from the Association for the Advancement of Medical Instrumentation (AAMI) and the Centers for Disease Control and Prevention (CDC), and  key players like The Joint Commission that provide accreditation based on these standards and regulations.

One thing we stress with customers looking to gain or renew accreditation for their facility is the importance of assessing the current state of their entire infection prevention program, including how they approach the process.

A fragmented or inconsistent approach to infection prevention is inadequate when applied to today’s evolving point of care ecosystem that includes new technology, equipment and best practices. Taking a broader, holistic approach to infection prevention helps ensure all your bases are covered and better positions your instrument processing space for a successful accreditation survey visit.

Our clinical education program, led by professional clinical educators, offers an on-demand training module that focuses on the basics of the instrument processing workflow, instrument processing area design principles and sterilizer technology.

The Joint Commission, the largest standards-setting and accrediting body in healthcare, has developed a hierarchy guide to help organizations comply with the vast amount of regulations and standards:


  1. Rules and Regulations (from FDA, EPA, OSHA, local and state health authorities)
  2. The Centers for Medicare & Medicaid Services (CMS) Requirements (e.g., conditions of participation, conditions for coverage)
  3. Manufacturer’s Instructions for Use (IFU) (e.g., intended use of Spaulding Classifications and validating cleaning, disinfection and sterilization)
  4. Evidence-Based Guidelines and National Standards (e.g., AAMI ST79 and from CDC, World Health Organization)
  5. Consensus Documents (e.g., professional organizations, expert panels)
  6. Organization’s SOP (e.g., explain how your organization came to this conclusion within the context of the hierarchical approach)
Training image


You should have an adequate understanding of this hierarchical approach and be able to present a strong rationale for the processes and procedures you have in place for your facility.

The Joint Commission also offers a Survey Activity Guide that includes a variety of information to help prepare you for the survey visit, including a description of the onsite survey events and a list of documents, information and participants you will need for the visit.

So, while the accreditation process can be complex and confusing, there are resources available to help you prepare. You should also put together a plan and timeline for all preparation activities and fully brief necessary staff and participants on the process. Ensure everyone is familiar with the standards and understands where your instrument processing is compliant and where work still needs to be done before a survey.

Taking advantage of available resources and putting a plan together will better position your facility for accreditation and reaffirm your commitment to help safeguard the well-being of patients and staff.

Contact us to learn how Midmark can help you strengthen your infection prevention program. You can also click here to learn how we can help you standardize your instrument processing workflow.