Every device that you acquire for use on your patients comes with a manufacturer’s handbook. Before acquiring any device, however, I strongly suggest that you go to the following websites to determine what you need to do, and whether or not the device you are considering is suitable for use on multiple patients; and also if it is on the list of CLIA Waived devices.
Even if appears on either of these lists, check with the manufacturer to see that it has been approved for use on multiple patients.
Within the handbook, or at least in a product insert if there is no handbook, there should be recommendations for cleaning the devices, especially in between patient uses. As part of AAAHC surveys, we look at your CLIA waived testing procedures, logs and cleaning processes for the devices in between patients’ uses.
As we review your policies, we check to see that you are, at a minimum, following manufacturers’ recommendations on use and cleaning. Most manufacturers’ handbooks recommend 70 percent isopropyl alcohol as a suitable surface disinfectant, and many organizations use this because it is convenient to open an alcohol wipe. It does not have any significant impact on the finish of most devices, nor does it interfere with the ability to read the test results.
Most surveyors have accepted this recommendation myself included but some organizations have been cited by CMS inspectors for this practice. Although the FDA has sent a letter to all registered device manufacturers on this subject, the manufacturers do not appear to be required to revise their handbook recommendations, so many accredited organizations are still using alcohol. In their letter, the FDA recommendation to the manufacturers is as follows:
Selection of cleaning and disinfection solvents and procedures that do not result in physical deterioration of the device overall, or deterioration of any device component such as the housing or touch pad or buttons. Please make note of these physical indicators during your study and provide this information for our review. The disinfection solvent you choose should be effective against HIV, Hepatitis C, and Hepatitis B virus. Outbreak episodes have been largely due to transmission of Hepatitis B and C viruses. However, of the two, Hepatitis B virus is the most difficult to kill. Please note that 70 percent ethanol solutions are not effective against viral bloodborne pathogens and the use of 10 percent bleach solutions may lead to physical degradation of your device. A list of Environmental Protection Agency (EPA) registered disinfectants effective against Hepatitis B can be found at www.epa.gov/ oppad001/list_d_hepatitisbhiv.pdf.
The complete FDA letter can be found at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ ucm227935.htm.
As you may note, the letter refers to 70 percent ethanol, rarely found or used in most facilities. Seventy percent isopropyl alcohol is most commonly used.
As you look at your policies and procedures, check also at the following CDC website, which in some ways does not fully agree with the FDA letter, particularly as to the action of the alcohols and bloodborne pathogens.
After you read all of these guidelines and recommendations, you will have to determine what is best for your organization and – at the time of your AAAHC survey – explain how you are doing the surface disinfection of your CLIA waived devices. I suggest you also include in your written policy a reference to whatever disinfection method you have adopted:
Even though manufacturers are not required to notify users of changes in their handbooks and/or product inserts, they are required to update these as new guidelines and requirements come forward. You should check regularly with the device manufacturers to see if there have been any changes since your devices were manufactured. You may need your device serial number to determine date of manufacture, since many devices sit on shelves for quite some time before they reach you, the end user.
So in conclusion, manufacturers’ recommendations are generally good enough, but it is your responsibility to be sure that you have the latest recommendations and they are not superseded by other recommendations from regulatory agencies.
About the author
Dr. Egnatinsky is an anesthesiologist with extensive experience in the ambulatory surgery arena, both hOPD and ASC. Since starting medical school in 1961, he has been involved with many local and national professional societies and organizations and is a past President of the Board of FASA, a predecessor to the ASC Association, and Past President of AAAHC. He remains extremely active as a Medical Director for AAAHC, in addition to being a well-travelled AAAHC accreditation surveyor, both in the USA and internationally.