On May 2, 2011, the U.S. Food and Drug Administration (FDA) submitted a draft superseding “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance,” submitted in April 1996 and officially issued on March 17, 2015.
The FDA (www.fda.gov) and the Association for the Advancement of Medical Instrumentation (AAMI;
www.aami.org) held a summit on Oct. 11, 2011, to work together for the betterment of the health-care industry and the reusable reprocessing of medical devices.
What Is ‘Reprocessing’ Anyway?
The FDA describes reprocessing as “intended to remove blood, tissue and other biological debris and to inactivate infectious microbes so that devices are safe for the next patient. Reprocessing is labor-intensive and time-consuming. Each reusable medical device requires a specific reprocessing regimen.”
Within the past several years, the Central Sterile Processing Department (CSPD) has started following these reprocessing standards to reduce hospital-acquired infections.
The AAMI has published the Technical Information Report (TIR) 34 standard since 2014 and recently revised it in 2021. TIRs address a particular aspect of medical technology. The TIR 34 standard goes into depth regarding the importance of sterile processing of medical devices and the effects of poor water quality.
Many of you already know the difference between a standard, guideline or recommendation. Still, for the benefit of our younger readers, everyone needs to understand the differences between a standard and a recommendation. These two are subject to a formal process by a committee, similar to many code committee processes.
Below is an excerpt from the AAMI TIR34 standard, which will help in understanding the process and differences between a standard and a recommendation:
“A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology.
“Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it.
“A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents.
“Standards and recommended practices are subject to a formal process of committee approval, public review and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute.
“A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.
“Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted on — reaffirmed, revised or withdrawn — and the action formally approved usually every five years but at least every 10 years.
“For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still useful — that is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation.
“A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues.”
As designers, you must ask if your project will follow the AAMI TIR34 Standards early on to prepare for the space required to house the required equipment, i.e., reverse osmosis deionization (RO/DI).
If you work in Texas and on a Central Texas Veterans Health-Care System, you must follow certain testing requirements (https://bit.ly/3WGswsr).
In my own AAMI TIR34 research to understand what this was all about, I came across an Evoqua site that had two nicely laid-out tables: one indicating the categories of medical devices and another for recommended levels of water quality for medical device reprocessing (see Tables 1 and 2).
To save time, let’s jump ahead to the equipment used to reprocess instruments and other reusable medical devices.
Examples of Reprocessing Equipment
Pass-through scope washer;
Each piece of equipment includes its own water quality requirement; you will need to review the manufacturers’ water requirements.
The equipment has varying flow rates to consider when determining how much RO/DI water to make and store. With this comes the backwash or regeneration cycle, which will dump plenty of water as well.
Remember to size your drainage accordingly and use the correct piping materials. The high-level discussion here should be enough to point you in the right direction to make sound decisions.