You're not the boss of me! Dental hygienists have no choice but to follow medical device directions

Feb. 17, 2016
By Noel Kelsch: Sometimes comes down to laws, rules, and regulations, such as those pertaining to a medical device. There are agencies that are the boss of dental hygienists!


I recently watched my dear friend's child while she finished an errand. I have known this child since birth, so I did not anticipate any confrontation on the rules of my house. I was surprised when the door closed and the first words out of her mouth were, "You are not the boss of me." In a sense, she was right. But I quickly reminded her that she was in my house, and I am the boss of my house. I invited her to my "tea party," and I let her know the consequences for not following my rules.

There are times in dentistry that you have to go by other people's rules. You can throw a fit and recite the reasons why other people are "not the boss of you." But it sometimes comes down to laws, rules, and regulations. There are agencies that are boss of you!

Food and Drug Administration: For example, the FDA is regulates the sterilization of reprocessed medical devices that we use in the dental setting. They remind us that we have to go to the source. We have to read the instructions that they approved for the specific device. In 2015, the FDA manual "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" stated, "Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use." The FDA then recognized the critical role and responsibility of the device user community to follow the validated reprocessing instructions.

Every device that the FDA approves comes with an Instructions For Use (IFU). Your role is to know those directions that keep the patient safe, teaching and following those directions each time with each and every encounter with that device. It is not a choice. I will be discussing IFUs more next month.

Environmental Protection Agency: The EPA oversees and approves the pesticides known as hospital grade disinfectants. Those are the disinfectants that you are using to clean and disinfect clinical contact surfaces that can be contaminated with bloodborne pathogens and other potentially infectious materials. The disinfection agent you use has to have that EPA approval on it.

Please go look at the label of the EPA registered hospital grade disinfectant you are using. One of the first things it should say on the label is, "It is a violation of federal law to use this product in a manner inconsistent with its labeling."

To ensure patient safety, it is vital that you adhere exactly to the label directions. The label direction is the science behind the product. They are what they did in the laboratory to prove this product works.

Training: To make sure the entire office is on the same page, everyone that works with a product or performs a procedure must be trained to follow the IFU directions and the competency of the product is verified. If you do not have those directions, call the manufacturer of the device and ask them to give you a copy. Most companies will email them directly to you.

I frequently see people trying to take the easy way out. They ask on Facebook or other social media what other people are doing with a device. Please do not ask other people's opinion on how to use a device. There is no assurance they are doing the right thing.

On one recent thread about how to load a sterilization pouch into the sterilizer, there were 13 answers; 11 of them were the wrong instructions for the sterilizer they were discussing. You must follow the specific IFU for the specific product. The only place you will find those for your specific device is in the directions from the manufacturer.

A periodic review of steps of compliance should be conducted so that accuracy can be verified. Simple things can assure you that you are doing the right thing. Examples include making sure items are not being removed from the sterilizers until the cycle is complete (drying is part of the cycle) or that clinical contact surfaces that may have debris are both cleaned and disinfected. The consequences of not following directions are putting both your patients and staff at risk.

My friend's daughter and I had a great time together over a cup of spotted dog tea. After being reminded where she was, she followed the rules of my house. Everyone has a responsibility to look at the rules, laws, and regulations of the dental setting. Realize that there are reasons why those rules exist. Those rules keep patients and clinicians safe. We do not have a choice; we have to follow them. RDH

NOEL BRANDON KELSCH, RDHAP, is a syndicated columnist, writer, speaker, and cartoonist. She serves on the editorial review committee for the Organization for Safety, Asepsis and Prevention newsletter and has received many national awards. Kelsch owns her dental hygiene practice that focuses on access to care for all and helps facilitate the Simi Valley Free Dental Clinic. She has devoted much of her 35 years in dentistry to educating people about the devastating effects of methamphetamines and drug use. She is a past president of the California Dental Hygienists' Association.