Complete Guide to Dental Unit Waterline Compliance

If talking about the various regulatory bodies in dentistry makes you feel like you’re on the receiving end of a behavioral management acronym, you’re not alone. As dental professionals, you are in the world of health and, understandably, there are guidelines for dental unit waterline compliance that you must follow to keep yourself and your patients safe.  

So, we wanted to make it as straightforward as possible and walk you through the various groups that have a voice in the microscopic world of dental unit waterline maintenance and what they say on the matter.  

We’ve broken up these bodies into three different segments based on the role they play in compliance for dental unit waterline maintenance.

Here are the primary agencies and their roles in dictating dental unit waterline compliance.

Agencies that have set the standards for safe water and dental waterline maintenance: 

• EPA 
• CDC 

Agencies that support these standards:  

• FDA 
• ADA 

Regulatory bodies that enforce these standards: 

• State Dental Boards 
• OSHA 
• DOH 

Agencies that Have Set the Standard for Compliant Dental Waterlines 

The Environmental Protection Agency (EPA) Drinking Water Standards 

While the EPA does not specifically address standards for water in dental lines, in 1986, (with the passing of the Amendments to the Safe Drinking Water Act) it defined the standard for potable (drinking) water as being less than or equal to 500 colony forming units (CFUs)/mL. This has become the industry standard not just for drinking water, but also for what is considered safe for use in routine dental procedures. This foundational measurement has been what all other regulatory bodies have built their compliance requirements. 

Center for Disease Control (CDC) Dental Unit Waterline Infection Control Guidelines 

The CDC was really the first agency to apply the EPA’s standards specifically to dental waterlines. In its 2003 publication Guidelines for Infection Control in Dental Health-Care Setting, the CDC provided detailed specifications that dental offices should follow to be considered compliant. While this publication goes into great detail about all things dental infection prevention, when it comes to dental unit waterlines, both supporting and enforcing agencies evaluate dental offices with the CDC’s simple checklist:

1. Dental unit waterline treatment products/devices are used to ensure water meets EPA regulatory standards for drinking water (i.e., ≤ 500 CFU/mL of heterotrophic water bacteria) for routine dental treatment output water.
   ❑ Yes ❑ No
2. Product manufacturer instructions (i.e., waterline treatment product, dental unit manufacturer) are followed for monitoring the water quality.
   ❑ Yes ❑ No
3. Sterile saline or sterile water is used as a coolant/irrigant when performing surgical procedures (Note: Use devices specifically designed for delivering sterile irrigating fluids (e.g., sterile bulb syringe, single-use disposable products, and sterilizable tubing). Examples of surgical procedures include biopsy, periodontal surgery, apical surgery, implant surgery, and surgical extractions of teeth.)
   ❑ Yes ❑ No

If you can confidently answer yes to all three of the above items (and have documentation to show evidence of this) you can feel confident that your practice is keeping itself and its patients safe. Notice the CDC is taking one step further from the EPA by outlining water use in surgical settings. 

Agencies that Support the Standards Set for Safe Water and Dental Unit Waterlines 

US Food and Drug Administration (FDA) Dental Unit Waterline Maintenance Recommendations 

The FDA is not considered a regulatory agency for dental health, however, the FDA does regulate the manufacturers of chemical treatment, source water treatment systems, point-of-use filters, and dental operative units, which means they are helping to ensure you have access to tools and solutions that can achieve a standard of safety.  

Additionally, their recommendations for waterline maintenance are based on the foundation established by the EPA and CDC. Here is a summary of the do’s and don’t’s the FDA has provided for dental unit waterline maintenance: 

DO: 

• For surgical procedures, use sterile irrigating solutions (e.g. sterile water or saline), appropriate delivery devices for delivering solutions (e.g. bulb syringe, single-use disposable products), or dedicated surgical irrigation systems (including handpieces) 
• Know and follow manufacturer-specified service life and maintenance of the dental operative unit and its components and accessories. 
• Follow the manufacturer’s instructions to clean and disinfect the dental unit at recommended intervals.  
• Test dental unit waterlines regularly (we recommend quarterly) to ensure bacterial counts are lower than 500 CFU/mL of water as recommended by ADA. 
• Always properly dispose of single-use disposable items after they have been used. 

DO NOT: 

• Use the dental unit without following the cleaning and disinfection procedures in the manufacturer’s instructions. 
• Attach dental handpieces or dental instruments to dental unit waterlines that have not been cleaned or disinfected per the manufacturer’s instructions. 
• Use cleaning and disinfection agents that are not recommended by the device manufacturer, as material incompatibility could result in damage or increase the risk of biofilm formation or toxicity to patients. 

 For the official list of recommendations, you visit the FDA’s site directly.  

American Dental Association (ADA) Dental Unit Waterline Maintenance Recommendations 

Similar to the FDA, the ADA standard behind and reiterates the standards for safe water and dental waterline maintenance that were put forth by the EPA and CDC. They also provide a near word-for-word DO’s and DON’Ts list that the FDA produced. 

You can check out the ADA Do’s and Don’ts for Maintaining Dental Unit Water Lines here. 

Each of these agencies have built a foundation for legislation that is enforced through the regulatory bodies mentioned below. 

Regulatory Bodies that Enforce the Standards Set for Safe Water and Dental Unit Waterlines 

Dental board dental unit waterline regulations 

State dental boards are one of three agencies that can enforce standards. Currently, 33 states specifically require compliance with CDC and EPA guidelines as it pertains to dental unit waterline maintenance. Washington state, in January 2022, put into effect additional regulations to the 2003 CDC guidelines. There are other state dental boards considering similar additions.

Occupational Safety and Health Administration (OSHA) 

While OSHA falls under the department of labor and does not have specific recommendations regarding dental unit waterlines, they are often the first to identify lapses in infection control coming from internal staff complaints.

If OSHA is called to investigate any breach in the standard of care, they will utilize the CDC guidelines to evaluate the dental practice. With the dental boards’ involvement, these complaints can have serious consequences ranging anywhere from a dental office being shut down, to dental licenses being suspended, to 5-figure fines per infection control breach. 

Department of Health (DOH) 

Similarly to OSHA, the DOH does not directly regulate or manage dental waterline maintenance. However, if a patient files a complaint, the DOH will use the CDC’s checklist to evaluate the dental practice. Even if the patient filed a complaint that had nothing to do with dental unit water, regulatory bodies will still inspect a practice using the whole CDC checklist. 

That is why it’s essential to remember that even in states that have not openly adopted the waterline maintenance standards set by the CDC, dental practices are often still held responsible to the CDC guidelines by the DOH and OSHA. 

Consequences of non-compliant dental unit waterline maintenance 

As you may already know, depending on the severity of non-compliance, this oversight can lead to temporary dental office closure, suspension of license, or hefty fines (e.g. $10,000/day) but, in more severe cases, dental offices can be shut down or licenses can be removed. An unfortunate example of this is the Anaheim and Atlanta cases.  

As we mentioned earlier, even if your state dental board has not implemented official regulations, any complaint can still be evaluated based on the CDC guidelines. 

So, how can you ensure your waterlines are compliant? 

Great question! We know you want your dental office to be safe for both you and your patients. So we’ve developed some guides to get you started in developing a simple yet effective waterline maintenance protocol. 

To start, check out our Simple Guide to Dental Unit Waterline Compliance for a recap of everything we’ve talked about so far. 

Next, let’s get you started on the 3 Steps to Safe Water. You’ll start by shocking your dental unit waterlines.