Chemicals, Compliance, and Keeping Your Hospital Out of the News

Author: Hank Balch

In the world of surgical services, ensuring patient safety is paramount. One critical aspect of this mission that often goes unnoticed is the role of compliant chemical usage in reprocessing reusable medical devices. The proper selection and use of chemicals throughout the life cycle of these devices play a crucial role in supporting instrument integrity and preventing contamination – thus keeping patients safe AND hospitals off the front page of newspapers for exposes about dirty instrumentation.

In this article, we will explore the various stages of the device life cycle and highlight the importance of compliant chemical usage at each step. Additionally, we will provide three keystone concepts for chemical usage that will enable you to hardwire this vision for chemical use and patient safety in your facility today. By understanding and implementing these best practices, healthcare facilities can fulfill their commitment to patient safety and equip their teams with the knowledge necessary to advocate for compliance at each step. 

The Chemistries of Clean: Chemical Usage throughout the Life Cycle of a Reusable Medical Device
To truly appreciate the significance of compliant chemical usage, and the challenges involved with it, it's essential to understand the role chemicals play at every stage of a reusable medical device's life cycle. The following is an overview beginning immediately post-procedure, and tracing the instruments through Sterile Processing and eventually back to be used in the next procedure:

  1. Pre-Cleaning: Proper preparation at the point of use is crucial to the success (or failure) of the entire reprocessing workflow. The right pre-cleaning chemicals at this stage, such as the ProEZ Gel™ enzymatic gel or spray, help begin the process of breaking down and removing visible debris and organic matter, ensuring an effective cleaning process upon arrival in the decontamination area. Dried protein and blood bond tightly to instruments by fibrin strands, and can contribute to biofilm development, especially in lumens and channels, which can be nearly impossible to remove in a difficult-to-reach spot such as a scope lumen. Industry organizations like AORN, AST, and AAMI have clear guidance around the requirements and importance of pre-cleaning instrumentation. 
  2. Transport: During the transport and holding of medical devices, proper chemical treatment maintains adequate moisture around the instrumentation and prevents the drying of blood and debris, which can compromise the functionality of the instrumentation itself. Blood is high in salts and is very corrosive, which presents a serious risk to the integrity of the instrument if it is in contact for long periods of time, capable of causing irreparable damage to the device. Once instrument surfaces and channels begin to rust and form pitting, there is not a safe way to restore the metal surface to a smooth, cleanable surface again.
  3. Decontamination: Upon receipt to the decontamination area, instruments begin both manual and automated cleaning processes using additional chemicals to remove any remaining organic and inorganic residues. This includes chemicals such as single-, dual-, and multi-enzyme detergents, ultrasonic cleaning solutions, rinsing agents, and lubricants. In addition to the previous stages, decontamination is one of the most critical steps in the reprocessing workflow as it is the last time true “cleaning” will occur. Special attention must be given to chemical instructions for use, such as dilution rates and contact times, as well as safety data sheets (SDS) to highlight required personal protective equipment (PPE) which may be necessary for use. 
  4. Prep & Pack / Assembly: While most chemical usage at this point in the workflow has already occurred, there may be the need to wipe down assembly workstations with surface disinfectant wipes prior to inspecting and re-assembling surgical instrument trays. Additionally, certain instrument manufacturer instructions for use (IFUs) may call for manual lubrication at this stage, which should be made available. Prep & Pack is the primary stage at which visual confirmation of the effective chemical and cleaning protocols is made, and any process breakdowns identified for reprocessing. 
  5. Sterilization & Storage: Once devices are reassembled and packaged, the final stage of the reprocessing workflow before the devices are ready for reuse is sterilization, which eliminates any remaining pathogenic microorganisms. While chemicals such as ethylene oxide and hydrogen peroxide play a vital role in achieving effective low-temperature sterilization, the primary means of hospital sterilization today is done via high-temperature steam sterilization. Importantly, a key aspect of successful sterilization and protecting the integrity of instrumentation is ensuring there are no residual chemicals remaining on the instruments from the previous decontamination process. 

Compliant Chemical Usage that Keeps Hospitals Out of the News

While the fundamental goal of healthcare providers is to serve the patient, there is also a very reasonable desire on the part of clinicians to guard the credibility and trustworthy nature of the healthcare system itself. Eroded public trust in a particular hospital not only has dramatic revenue implications for that facility, but it can also contribute to patients opting to delay care with any healthcare provider that they otherwise would have pursued. If serious quality breakdowns occur in our health systems, the public does deserve to know about it. But the goal is obviously to keep those breakdowns from occurring in the first place. 

In addition to understanding the life cycle of chemical cleaning, disinfection, and sterilization that medical devices undergo, mentioned above, there are a few keystone concepts that your facility can focus on to ensure you are motivating healing, not making headlines in your hospital:

Keystone Concept #1 - TIME
Every chemical used in the medical device reprocessing workflow is dependent on the function of timing. Often it is a combination of different timing scenarios that the frontline clinician must 1) be aware of and competent around, and 2) be able to control during the execution of their roles. For example, effective pre-cleaning chemical application must be done immediately (time #1) upon completion of the surgical procedure. In addition to the timing of the application of pre-cleaning chemicals, these chemicals also have specific contact times (time #2) required by the chemical manufacturer to ensure they are effectively able to breakdown soils – and this can vary depending upon the amount of soil present on the instruments. Pre-cleaning chemicals will also have a validated wetting action time (time #3) which defines how long the chemical will sustain moisture, dissolve soils, and protect instrumentation without reapplication of the chemical. Finally, all chemicals will come from the manufacturer with a stated shelf life and/or use life (time #4) which must be followed to ensure the chemical is still effective when used. If any of these four timing functions mentioned here are unknown by the clinician or simply not followed, the chances of a serious quality breakdown rise precipitously. 

Keystone Concept #2 – TYPE
While chemicals are powerful tools in the mission of device reprocessing, each particular chemical is designed with specific functions in mind, and if used for functions they were not designed for – even within the same workflow – they will either lead to ineffective cleaning, damage to the medical device, or even potential harm to the patient or provider. Clinicians must know what type of chemical they need for each step of the reprocessing workflow, and ensure it is used appropriately at this step. For example, one of the most common mistakes in this category is trying to use disinfectant chemicals in the place of detergents. Much of the confusion around chemical usage can be solved by a thorough review of the instructions for use (IFUs) of any chemical prior to purchase, and regular vendor in-services at the department level to ensure all members of the surgical services team can speak to which chemicals should be used at which steps of the reprocessing workflow.

Keystone Concept #3 – Dilution
The final keystone concept we will cover in this article is the critical role of dilution in various chemical uses during the reprocessing life cycle. Some chemicals, such as the pre-cleaning examples shared above, do not require dilution prior to use. However, other chemicals such as manual cleaning and automated cleaning detergents, for example, do have very important dilution ratios needed for effective use (i.e., 1 oz for every one gallon, etc.). The function of these dilution rates ensures that the chemical is able to have enough water present to effectively clean and remove soil, while also not having so much chemical that the cleaning cycle is unable to remove the chemical, leaving chemical residuals that can be harmful to the instrument and/or patient later in the workflow. Non-compliance around chemical dilution is one of the more common audit failures caught in reprocessing departments by both internal and accreditation audits.

Do You Have the Chemical Confidence You Want? Contact for Consultation
As you can see, the challenges involved in keeping up with the ever-evolving landscape of healthcare regulations and best practices are daunting ones, especially in the world of chemical usage in medical device reprocessing. Our team at MicroCare™ is well-versed in the industry standards and equipped to supply strategic advice tailored to the unique needs of your facility. We offer comprehensive consultation services, covering areas such as chemical selection, safety protocols, staff training, and constant compliance monitoring.

In addition to our advisory services, we also offer educational programs designed to equip your staff with the knowledge and skills necessary to maintain adherence to healthcare compliance guidelines. Our training programs are designed to ensure that your facility has not only the theoretical understanding of compliant chemical usage but also the practical ability to implement these protocols effectively.

Our team’s expertise, coupled with our commitment to excellence, ensures that our healthcare customers receive the utmost in quality service. We don't just provide a one-time consultation; we strive to establish a long-term partnership with healthcare providers, offering ongoing support and advice as needed. We believe that maintaining a safe and compliant healthcare environment is a continuous journey, and we are here to guide you every step of the way. Contact us today to learn more about how we can assist you in enhancing the safety and compliance of your healthcare facility.