Maintaining Quality Control With “Table-Top” Sterilizers Part I

Over the past 30 years, there has been a tremendous increase in the number of outpatient surgical procedures done in the United States. The number of outpatient procedures surpassed 54 million in 2018 and now nearly equals the number of procedures done in hospitals.1 All of this growth in outpatient procedures has attracted the attention of numerous healthcare accreditation bodies and regulatory agencies. Among other things, these organizations are now paying much closer attention to the reprocessing of reusable medical devices and instruments in office based practices and outpatient clinics. This is true for both independent clinical practices and also practices affiliated with larger healthcare or hospital systems. When it comes to reprocessing issues, one area of increasing concern is the operation and maintenance of “table-top“ sterilizers. AAMI ST79 defines a table-top sterilizer as a “Compact steam sterilizer that has a chamber volume of less than or equal to 2 cubic feet and that generates its own steam when distilled or deionized water is added by the user.”(2) These small sterilizers are the primary piece of sterilization equipment in many office-based medical practices along with the majority of ambulatory-care/outpatient surgery offices and clinics. They are also used on occasion within smaller departments in hospitals. As was discussed in a previous blog, The Joint Commission (TJC) has been taking a much more aggressive stance when it comes to instrument pre-cleaning, cleaning and sterilization.  A primary reason for a facility or for a health care system to standardize their reprocessing program is The Joint Commission’s Standard IC 02.02.01 which states, “The hospital reduces the risk of infections associated with medical equipment, devices, and supplies.”3 An instrument contaminated with organic debris is an infection risk to patients, even after sterilization. This is why TJC is so interested in the reprocessing activities/processes in a healthcare facility, regardless of size or specialty. TJC standard recommends implementation of standard processes which address:

• “Orientation, training, and competency of health care workers who are processing medical equipment, devices and supplies
• Level of staffing and supervision of the health care workers who are processing medical equipment, devices, and supplies
• Standardization of process regardless of whether it is centralized or decentralized
• Reinforcing the process (for example, the use of placards which list the steps to be followed, according to the manufacturer’s guidelines)
• Ongoing quality monitoring”4

Given the on-going migration of surgical procedures from hospitals to outpatient clinics and surgi-centers, in 2016 the CDC published Version 2.3 of their summary guide entitled, “Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care.”(5) A companion Infection Prevention Checklist for Outpatient Settings (included as Appendix A in the document) contains several important points:

• “Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use.”
• “Cleaning must always be performed prior to sterilization and/or disinfection.”
• “Single-use devices (SUDs) are labeled by the manufacturer for a single use and do not have reprocessing instructions. They may not be reprocessed for reuse except by entities which have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs.”6

Every office-based practice, outpatient clinic or surgi-center can use the checklist to conduct a self-audit on their reusable device reprocessing, especially prior to a visit from TJC. The checklist includes items specific to sterilizer quality control along with broader questions about reusable medical device reprocessing. Some of the more important items include:

• “Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s)
• HCP {Healthcare Personnel] responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: i. Upon hire, prior to being allowed to reprocess devices ii. Annually iii. When new devices are introduced or policies/procedures change.
• After cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, items are placed correctly into the basket, shelf or cart of the sterilizer so as not to impede the penetration of the sterilant, hinged instruments are open, and instruments are disassembled if indicated by the manufacturer) .
• Sterile packs are labeled with a load number that indicates the sterilizer used, cycle or load number, date of sterilization, and, if applicable, the expiration date.
• After sterilization, medical devices and instruments are stored so that sterility is not compromised.”7

In Part II of this blog we’ll look at the steps that need to be taken to ensure the proper operation and maintenance of table-top sterilizers.   1 https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/outpatient-surgery 2 Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2017. Arlington (VA): AAMI, 2017. 3 The Joint Commission. 2018 Hospital Accreditation Standards. https://www.jointcommission.org/accreditation/hap_standards_information.aspx 4 Op. Cite. 5 Centers for Disease Control and Prevention. Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care, 2016. Accessed 6.12.2018. https://www.cdc.gov/infectioncontrol/pdf/outpatient/guide.pdf 6 Op. Cite. 7 Op. Cite.