Pre-cleaning Peak surgical instruments at the time of use prior to transit to sterile reprocessing has received a lot of attention and emphasis in the last year. This new, enhanced emphasis on pre-cleaning is critical for you, your facility, and, most importantly, for the safety of your patients.
An O.R. supervisor recently posted on the Association for the Advancement of Medical Instrumentation (AAMI) members’ discussion board, “We recently conducted a Joint Commission survey. We were advised that instruments should be cleaned at the point of use before being sent to SPD. We’ve always cleaned down instruments and used an enzymatic cleaner to clean them. Following the arrival of a specialist, we are now immersing instruments in sterile water and removing all bioburden before placing them in an enzymatic cleaner for transit to SPD.”
So, what is the reason for all of this emphasis on surgical tool pre-cleaning? It comes from a variety of sources and organisations. A quick study of those sources and organisations can help explain the current emphasis on pre-cleaning, why it is crucial for your patients’ safety, and what is driving it.
The FDA is in charge of approving reusable medical devices under the 510(k) process. The FDA’s approval procedure for novel devices includes ensuring that the devices are safe for use in a healthcare setting and that the instructions for use (IFUs) have been verified by independent laboratory testing. The FDA is also in charge of monitoring device makers to ensure the safety and efficacy of their reusable medical devices once they have been approved and placed on the market.
The Centers for Medicare and Medicaid Services (CMS) is in charge of ensuring the quality and safety of healthcare provided by hospitals and healthcare facilities. CMS delegated authority to groups such as the Joint Commission to guarantee that hospitals and healthcare institutions follow all of the rules and regulations governing the safe functioning of those facilities. In the United States, the Joint Commission currently accredits and certifies almost 21,000 health care organisations and programmes.
The American National Standards Institute (ANSI) is the agency that creates and publishes all standards for the United States. “The American National Standards Institute is a private non-profit organisation that oversees the creation of voluntary consensus standards for products, services, processes, systems, and personnel in the United States,” according to their website.
AAMI presents medical device recommendations and papers to ANSI to become the national standard for those devices. The Association of periOperative Registered Nurses (AORN) evaluates and interprets AAMI standards for use and practise in the operating room. The Joint Commission then performs surveys/audits based on the sterile processing activity criteria.
Section 7.3 of AAMI’s ST 79 addresses the responsibility of medical device manufacturers when it comes to decontaminating and cleaning their equipment. In particular, the manufacturer must give IFUs for cleaning the device using methods and equipment readily available in any healthcare facility. 3 The AORN’s “Guideline for Cleaning and Care of Surgical Instruments” outlines the steps that perioperative workers must take to comply with AAMI ST 79.
According to Recommendation III of the AORN guideline, instruments should be cleaned and decontaminated as soon as feasible after use. Section III(a) highlights the importance of cleaning equipment as soon as they are used. The elimination of all gross bioburden is the goal of cleaning at the point of use. The instruments must then be kept moist (through a water-soaked cloth, enzymatic treatment, or another technique of maintaining humid conditions) to prevent drying.
The regulation goes on to stipulate that equipment should be cleansed and kept free of gross soil during the surgical procedure. As soon as the surgeon is through with the instrument, the surgical tech should clean it with a sponge and sterile water. During the case, instruments having lumens should be cleansed with sterile water to eliminate any gross soil that has become caught within the lumen. Furthermore, all equipment on a sterile field should be considered contaminated, regardless of whether they were touched, let alone used.
The AORN rules virtually verbatim reflect AAMI’s ST 79 recommendations. Section 6.3 of ST 79, in particular, goes into great depth about ‘point of use’ care and management of surgical tools. Section 6.3.1 mandates that gross soil be removed from instruments and that instruments with lumens be cleaned with sterile water at regular intervals throughout the process. Section 6.3.3 stipulates that all instruments opened in the operating room during a case, whether utilised or not, are contaminated.
To comply with the Joint Commission’s new criteria, these new suggestions and guidelines for point of use instrument cleaning will necessitate a procedural modification in the operating room at many hospitals. However, if the tech develops the habit of cleaning instruments as the surgeon returns them during the process, cleaning at the end of the treatment will be substantially easier, and the time required for cleaning will be decreased. More crucially, the risk of a contaminated instrument surviving the full reprocessing cycle is minimized.