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medical office spore test audits

Medical Office Spore Test Audits — Is Your Practice Inspection-ready?

We’ve all been paying closer attention to the processing of reusable medical devices, with the rise of COVID-19 and the Flu Season upon us. Whether you’re an independent practice or an office affiliated with a larger healthcare system, sterilization and sterility assurance in healthcare facilities should be monitored using biological, mechanical, and chemical indicators.


Keeping track of your sterilization procedures protects your practice — and your patients. It’s mandatory for your inspections and has to be conducted at least weekly here in the US for your sterility assurance and risk management program.


A table-top sterilizer is defined in AAMI ST79’s “Comprehensive Guide To Sterility Assurance” 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.


It’s an essential piece of equipment in your medical or dental practice. So, what do you need for your weekly spore test when proof of testing is required?

What Needs To Be Included In The Logging Of Mechanical Quality Assurance?


Biological indicators, or spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms. However, because spore tests are only done weekly and the results are usually not obtained immediately.


There are three required methods of sterilization monitoring:


1. Mechanical. The gages read on the dashboard of the sterilizer

2. Chemical. Testing the parameters of steam penetration leading to sterilization but not confirming sterilization

3. Biological. Testing sterilization, the only means of confirming sterilization.


For record-keeping compliance, each test must be logged!


Items Specific To Sterilizer Quality Control

Via “Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care.”

— CDC, Version 2.3, Summary Guide


  • 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 that have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs.
  • 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.
  • 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.


The entire CDC checklist is available here.

Why not schedule sometime this week to perform a self-audit? Better yet, check out 1:1 risk management consulting with a Done Desk expert! Also, check out a live monthly webinar on infection controls, processes, and disciplines to get your whole team on board here.

Want to learn more about taking the stress of compliance off of your shoulders?

Schedule a quick demo to see how Done Desk helps you spend effective time managing your business so you can get back to medicine.

Let’s Talk!

Although every effort has been made to ensure the accuracy of this information, Done Desk is not responsible for any errors and omissions, or anyone’s interpretations, applications, and changes of regulations described. This ain’t a substitute for review of the applicable regulations and standards, and should not be construed as legal advice, okay? Check with your state board for details on this and all compliance programs for your practice. We’re happy to help you implement the appropriate programs using our platform Done Desk.

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