HEALTHCARE SELF-STUDY SERIES N


PURCHASING EWS


August 2018 The self-study lesson on this central service topic was developed by 3M Health Care. The lessons are administered by Endeavor Healthcare Media


Earn CEUs After careful study of the lesson, complete the examination at the end of this section. Mail the completed test and scoring fee to Healthcare Purchasing News for grading. We will notify you if you have a passing score of 70 percent or higher, and you will receive a certificate of completion within 30 days. Previous lessons are available at www.hpnonline.com.


Certification The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of five (5) years from the date of original publica- tion. Successful completion of the lesson and post test must be


documented by facility management and those records maintained by the individual until re- certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding certification contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.sterileprocessing.org. IAHCSMM (International Association of Health-


care Central Service Materiel Management) has pre-approved this in-service for 1.0 Continu- ing Education Credits for a period of three


years, until July 5, 2021. The approval number for this lesson is 3M-HPN 180507. For more information, direct any questions to


Healthcare Purchasing News (941) 927-9345, ext. 202.


LEARNING OBJECTIVES


1. Review the importance of device reprocessing in the clinic setting.


2. Discuss the recommended quality control practices for table-top sterilizers provided in AAMI ST79.


3. Review sterilization


documentation considerations in the clinic setting.


Sponsored by: Susan Flynn, 3M Health Care T


Sterilization quality control in the clinic setting


o provide the best possible patient outcomes and because accreditation bodies are paying closer attention to the processing of reusable medical devices, it is important that clinics reprocessing medical devices, whether in an indepen- dent practice or an office affiliated with a larger healthcare system, are familiar with current recommended practices. ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, is the ‘go to’ document for steam sterilization, including table-top sterilizers often used in clinics. A table-top sterilizer is defined in AAMI


ST79 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.”1


It is an essential


piece of equipment in many office-based medical and dental practices and small ambulatory-care clinics. Across the country, many health care systems have initiatives to standardize reprocessing of medical devic- es throughout their system. As part of this standardization effort, Sterile Processing Managers and/or Infection Preventionists typically identify all the various locations that perform device reprocessing in their system and work to ensure that common policies and procedures are adopted system-wide. The 3M Sterilization Tech Line often hears from systems which have recently identified or acquired clinics using table-top steam sterilizers. We also have fre- quent discussions with clinics determined to implement best practices. Both groups have questions about appropriate steriliza- tion quality control procedures. This article will review the quality control practices specific to table-top sterilizers provided in the recently published AAMI ST79:2017.


The rationale for this standard is based on the infection risk posed to patients


The Joint Commission One of the drivers for health care systems to standardize device reprocessing system- wide 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 sup- plies.”2


36 August 2018 • HEALTHCARE PURCHASING NEWS • hpnonline.com


if medical devices are improperly cleaned and sterilized. The 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”2


A companion Infection Prevention Checklist for Outpatient Settings (included in the document as Appendix A) reminds the reader that: • “Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use.”


Centers for Disease Control Recognizing the opportunity for improved infection prevention practices in the non- hospital setting, 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.”3


• “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.”3 The checklist can be used by office-based


practices to conduct a self-audit on their reusable device reprocessing. In addition to the checklist items specific to sterilizer qual- ity control, broader questions about device reprocessing include: • “Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s)


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