Mastering Disinfecting in Healthcare: Critical Insights about Onsite Hypochlorous Acid (HOCl) Generators

Have you ever wondered why many onsite hypochlorous acid (HOCl) generators, also known as Electrolyzed Water (EW) generators, are not EPA-registered? It's a surprising fact, especially considering that EPA registration is a requirement by the Centers for Medicare and Medicaid Services (CMS) for healthcare settings.¹ So, why is there a growing interest in these devices in healthcare despite this requirement?

The answer lies in the details, which can often be challenging to uncover. In this blog, I will delve deeper into the world of onsite HOCl generators, shedding light on crucial considerations for you and your Environmental Services (EVS) team before making a purchasing decision.

Why many Onsite HOCl Generators are NOT EPA-registered

Generally, onsite hypochlorous acid (HOCl) generators that produce a substance are classified as "devices" by the U.S. EPA and do not require pre-market EPA registration.² However, there are some exceptions where the device must be registered:

• • If the device is sold with or contains a substance (e.g., a salt additive).
• • If a company provides a service using a device that generates a substance (e.g., a hypochlorous acid generator used as part of a sanitization service). This scenario may be considered the sale or distribution of a pesticide, which could apply if you use a contracted cleaning company in your facility.

This contrasts with ready-to-use (RTU) disinfectants, which must undergo a rigorous, evidence-based review process for pre-market EPA registration before they can be sold in the United States. This process ensures that the disinfectant is safe to use and that its claims, particularly regarding micro efficacy, are valid.³.

Regardless of whether EPA registration is required, due to previously mentioned CMS regulations and to also avoid any audit findings, it is essential to ensure that a device is EPA-registered when used in a healthcare facility. Let's explore how to verify this.

How to determine if and onsite HOCl generator is EPA-registered

The first step is to ask the manufacturer or sales representative for the EPA registration number of the device. Once you have this number, you can look up the master label on the EPA Pesticide Product and Label System website (see references below for the link).⁴ If they do not provide the number or you cannot find the master label, it is a red flag that the device is not EPA-registered.

Once you locate the master label, read it thoroughly. This will help you understand which pathogens the product is approved against, how to use the device and the resulting disinfectant effectively and safely, and what the required contact time is. During my research for this blog, I encountered devices that claimed to be EPA-registered but were not, those that were EPA-registered but had very few relevant healthcare kill claims, and those that were EPA-registered but had impractical 10-minute contact times.

Important!

An EPA registration number and an EPA establishment number are not the same thing and just because a pesticidal device has an EPA establishment number does not mean the device is EPA-registered to produce disinfectant. EPA registration is required by the CMS for use in healthcare facilities, so having only an EPA establishment number is not sufficient. Here's the difference:

• • An EPA establishment number tells you where the device or disinfectant was made. Any easy way to remember this is that EPA establishment numbers contain a state abbreviation (e.g., KY, MN, WI). An EPA establishment number is not enough in healthcare.
  • • Example: EPA establishment number (sometimes referred to as "EPA Est #"): 5813-CA-3
• • An EPA registration number, on the other hand, indicates that the disinfectant has undergone a rigorous process at the EPA and has been approved for sale in the United States. An easy way to remember this is that EPA registration numbers only contain numbers. CMS requires the use of an EPA-registered product in healthcare.
  • • Example: EPA registration number (sometimes referred to as "EPA Reg #"): 67619-30-5813

Additional important factors to consider when purchasing an onsite HOCl generator for healthcare use

Onsite HOCl generators offer promising benefits but, even those that are EPA-registered, come with limitations. After confirming the device is EPA-registered and reviewing the master label, consider the following questions with your EVS team before making a purchasing decision.

Micro efficacy:

• • Is the disinfectant approved for use in healthcare? Ensure the product is approved for use against pathogens like Pseudomonas aeruginosa, which is necessary for healthcare settings.⁵
• • Is the device registered against the relevant pathogens in your facility? Verify that the disinfectant is effective against the specific pathogens present in your facility.
• • How much effort is required to ensure the disinfectant is at the approved concentration? Onsite HOCl devices can produce various concentrations, so it's crucial to test and confirm the concentration matches the master label. This may require additional staff training and resources.

Shelf life:

• • What is the shelf life of the disinfectant? Many disinfectants produced by onsite HOCl generators degrade quickly, often within 24 hours.
• • Who is responsible for cleaning reusable bottles and containers? Dirty containers can accelerate degradation and may not be properly labeled, leading to compliance issues.⁶
• • Are there specific water requirements, and does your facility meet them? Water quality can impact the disinfectant’s efficacy too, so ensure it meets the necessary standards.

Costs:

• • What is the initial cost of the purchase and set up? Upfront costs for onsite HOCl devices can be significant, but the expectation is that the lower cost disinfectant will offset these expensive over time.
• • What parts need to be purchased regularly? Consider ongoing costs for filter and other maintenance parts.
• • What other costs need to be considered? Factor in increased water and electricity usage, repair costs, and potential personnel expenses.

Efficiency:

• • What is the process for making the disinfectant? Assess the time required to product the disinfectant, confirm it’s concentration, and any downtime needed between batches.
• • Can the disinfectant also clean? Some devices produce a solution that can clean and disinfect in one step. If not, a separate cleaning product may be necessary.
• • Is the contact time acceptable for your facility? Many disinfectants require a 10-minute contact time. Ensure this is feasible for your facility and consider the impact of transitioning from a product with a different contact time.

Maintenance:

• • What does regular and preventative maintenance involve? Maintenance is crucial and can be time consuming and costly. For example, some manufacturers recommend replacement of the pH sensor and electrolytic cell every 24 months and rinsing the decanter weekly. Not performing regular maintenance could also put the device warranty at risk.
• • What type of training is needed? Determine the training requirements for staff, including who will make the disinfectant, confirm the concentration, and clean the containers.
• • Where will the device be located? Onsite HOCl generators that product enough disinfectant for daily use are typically large units requiring a dedicated storage area with shelves, water and electricity hookups (see example image below).

Conclusion

Many onsite HOCl generators are not EPA-registered, which is a CMS requirement in healthcare today. To ensure a device is EPA-registered, it is critical to thoroughly review the master label. If a vendor cannot provide an EPA-registration number for the disinfectant, it is likely not EPA-registered and should be avoided. Remember, an EPA-registration number and an EPA-establishment number are NOT the same thing. A product must have an EPA-registration number (not just an EPA-establishment number) to be considered EPA-registered.

Once EPA-registration is confirmed, a detailed review of the master label is essential. This review can answer important questions about micro efficacy, shelf life, costs, ease of use, and maintenance. Collaborate with your facility's EVS team to determine if the device is the right fit for your needs.

If you need further assistance, don’t hesitate to reach out to your local Clorox Professional sales representative or send an email to AskThePros@clorox.com. We would be happy to discuss onsite HOCl generators or help you explore our RTU HOCl products, such as Clorox Healthcare Fuzion Cleaner Disinfectant for patient rooms and Clorox Anywhere Daily Disinfectant and Sanitizer for food service areas.