The directions for your devices need your immediate attention
NOEL BRANDON KELSCH
For the past three days, after much debate with my daughter Moe, I gave in and drove her car. An orange Dodge Challenger with a 6.4-liter HEMI V8/392 that looks like it drove off the setting for a car racing movie is hard to miss.
I have put the pedal to the metal in the past while driving my husband's race car. I knew I could drive my daughter's car; I simply did not want to. I soon found myself on a busy freeway coordinating acceleration with shifting and was distracted by too many new buttons to push. While some things have stayed the same in driving a sports car, some things have truly changed. I needed to know what those buttons were for, and quickly, so I pulled off the freeway.
In dentistry, many of the tasks we perform involve devices that have to be approved by the Food and Drug Administration (FDA). I referred to this in my February column. These devices are termed medical devices. Each of those devices include instructions for use (IFU). IFU help to keep you and the patient safe. All employees that are using or will be exposed to the device must be trained in IFU. They must follow these directions each and every time the device is used.
A few months ago in this column, we discussed loading pouches into sterilizers and following the IFU. I received many emails stating that I did not give the answer to the "paper up or plastic up" question in the headline about loading self-sealing pouches. I cannot do that. This is an area where opinions do not count. No one on Facebook can or should answer that for you. You have to find out for your specific sterilizer and your specific method for loading the device.
No one knows what specific sterilizer you have or what method you are using (with a vertical rack, without a vertical rack, etc.). The answer to that question for the specific unit you are using comes directly from the IFU.
Some of the IFU that have been out there have been hard to decipher. In March 2015, the FDA announced some reminders about IFU and medical devices, and the need to have these directions easy to comprehend. They have focused on the need for easy-to-use formats for IFU, and for all manufacturers to conduct validation testing to demonstrate that by following their cleaning/disinfection or sterilization instructions, microbial contamination will be reduced and the item will be safe for use.
The FDA states, "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 has to approve these directions and has requested the following from manufacturers:1,2
- Labeling should reflect the device's intended use.
- Reprocessing instructions should advise users to thoroughly clean the device.
- Instructions should indicate the appropriate microbiocidal process for the device. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
- Reprocessing instructions should be comprehensive.
- Reprocessing instructions should be understandable.
The IFU are included with each medical device, ranging from the curing light to the sterilizer. Each office has the responsibility to know the IFU, to comply with them, and to make sure that compliance is valid. It goes further though. Offices must train all the staff who will be using the device in directions for use and risks involved. That includes educating patients about their role in use of these devices. For example, patients must be trained to wear the safety glasses that specifically accompany lasers during treatment. They need to be educated about the risks involved in removing the glasses during use of the laser.
We lost the directions!
The manufacturer of the FDA-grade medical device is required to supply you with IFU. If you do not have a copy of them in your office, get them now. Many companies post them online, and you can find them by simply doing a search. You may have to contact other companies directly. To get the contact information, go to the unit and find the manufacturer label that is required for all medical devices.
I found the contact information for one of my ever-reliable ultrasonic scalers on the bottom of it. It included everything from the manufacturer contact information to the serial number of the device. Take a picture of this information so you have everything you need when you contact the manufacturer.
If online directions are not available, call the manufacturer and ask for a written copy of the directions. Do not just get your answer over the phone. Get them in writing. It is important to have this document so you can verify the IFU, train staff properly, and have it for future reference if there is a change in staff.
All staff that use the product must be trained, and correct use of the directions must be verified at each use. These directions include steps for use and reprocessing of the devices, including cleaning and disinfection.
My daughter's car and I did survive. I pulled off the freeway, opened the glovebox, and read the directions for using one of the many buttons that confused me. It took me a few minutes, but it was well worth the effort. I found some simple solutions to my confusion. As you incorporate your medical devices' IFU into your practice, you may be surprised at the built-in buttons to make your job easier. RDH
References
1. http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=1944
2. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf
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.
