Guidelines for Table Top Sterilizers

Medical advances have led to an increased use of unconventional health care sites, such as offices, ambulatory-care centers, dental and other specialty clinical settings. Clinical or office-based practices may differ greatly from hospitals in their education and training of reprocessing employees and the physical design. ANSI/AAMI ST79:2017b Comprehensive guide to steam sterilization and sterility assurance in health care facilites clarifies that the concepts in the ST79 for steam sterilization applies to office-based, ambulatory-care medical, surgical, and dental settings. In some sections, processes or equipment used often in the office-based and ambulatory setting are addressed specifically.1

The Joint Commission (TJC) accreditation standards for ambulatory care facilities and office-based surgery practices have essentially the same requirements as hospital-based standards, sometimes with a slight modification to take into account the different settings.  TJC’s standard IC 02.02.01 states, “The facility reduces the risk of infection associated with medical equipment, devices, and supplies.”2,3 This standard addresses staff competencies, standardization of processes, centralized or not, and ongoing quality monitoring. 2,3

Reprocessing of reusable medical devices in these alternative sites often means the use of table-top steam sterilizers. For a point of clarification, table-top sterilizers are compact steam sterilizers with a chamber volume two cubic feet, or less, and generates its own steam with distilled or deionized water added by the user.1,4,5

 

Water for table-top sterilizers

Table-top steam sterilizers characteristically have a water tank that injects a set volume of water to generate steam during the cycle. These are not dependent on a utility system to generate steam, therefore steam quality monitoring by a facility engineer is not necessary, although water quality is important.4

Drying time

For gravity-displacement table-top sterilizers and sterilizers without an active drying cycle, the stated drying time refers to the time that the sterilizer door is left open to complete the drying of sterilized items.4

Chemical indicators

All sterilized packages must be monitored with internal and external chemical indicators.  AAMI recommends a Type 5 or Type 6 chemical indicator be used inside each package because these types of CIs provide the user with more information on the critical steam sterilization parameters.

Biological monitors

As with all sterilizers, table-top sterilizers should be routinely tested with a biological indicator (BI) inside a process challenge device (PCD) weekly and preferably each day the sterilizer is used. The user must construct a PCD representative of the load as there is no standardized pre-assembled PCD for table-top sterilizers.

 Recording devices

AAMI ST79 section 13.5.1 recommends “Sterilizers that do not have recording devices should not be used, with the exception of sterilizers used together with accessory recording devices or printouts.”  It is imperative to recording devices because they provide real-time measurements of cycle parameters. This information is necessary in order for the user to verify that all the parameters were met.

Traceability

Every package should be traceable to the load and sterilizer. Label each package with a lot control number including the sterilization date, sterilizer identification, and the load number.1,3,4 This information in vital in case investigation is necessary due to a process failure of patient infection.

 

The principles of steam sterilization are the same no matter the size of the sterilizer.  Staff competency in all settings plays a vital role in patient safety.

For more comprehensive information of on table-top sterilizers, the author encourages the readers to review ST79:2017 and the 2018 AORN Guidelines for Sterilization.  In addition, there is a very well written article published in the August 2018 Healthcare Purchasing news, titled “Sterilization quality control in the clinic” setting, by Susan Flynn, available at https://www.hpnonline.com/1808-sterilization-quality-control-in-the-clinic-setting/. 

 

References:

 

  1. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
  2. Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys.
  3. Flynn, S. Sterilization quality control in the clinic setting. Self Study Series in Healthcare Purchasing News. August 2018. P36-39.
  4. Guidelines for Sterilization. In: Guidelines for the Perioperative Practice. Denver, CO: AORN, Inc; 2018
  5. Central Service Technical Manual. International Association for Healthcare Central Service Materiel Management (IAHCSMM), Chicago IL. eighth ed.

 

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