Product safety
A coordinated evaluation helps a dental office on whether to use new system or stick with the current one.
By Noel Kelsch, RDHAP
Dear Noel:
I know that OSHA and the CDC say we should screen safety devices, but I like what I am using now. Why do I need to screen new devices when I like what I already have?
Kelly
Thank you for asking Kelly! I recently discussed this concept with a hygienist who I was volunteering with at an event. She was using the same anesthesia syringe she was given in her kit 25 years ago in hygiene school.
I showed her equipment that I purchased last year and suggested that she try my self-aspirating petite syringe that was developed for small hands. Not only does this syringe work well for me and help prevent me from harming myself, but the self-aspirating feature is safer for the patient. She was taken back at how much easier it was to use and how much safer she felt with it.
Staying updated about industry innovations can help all of us lower the risks involved in dentistry.
History
In 2001, this concept of screening for more effective safety devices was put into place. It was not a should; it was a mandated as a must. It is part of the Needlestick and Prevention Act (NPA) from Occupational Safety & Health Administration’s (OSHA) bloodborne pathogen standard. Employers must select and make available safer needle devices as they evolve. They also must include employees in the process of both identifying and choosing the devices.
Dentistry was behind on the evolution of safety devices. Before NPA was in place, there were very few dental devices that incorporated safety features in their product. The other issue was that most dental health care providers did not know the elements to look for, or how to evaluate safer devices.
An amazing collaboration happened at San Francisco General Hospital during the development of this program: American Dental Association and the Training for Development of Innovative Control Technologies Project worked together to develop this program. Out of that program, the Centers for Disease Control and Prevention (CDC) pilot tested and developed two sample forms and instructions. These forms take all the guesswork out and help you simplify the evaluation process. They look not only at safety and compatibility in the dental setting, they also have instructions for use. The basic form is for an anesthetic syringe (see sidebar) but, it can be adapted for any product.
To find the form:
https://www.cdc.gov/oralhealth/infectioncontrol/screening.htm
Sample Screening Form Dental Safety Syringes and Needles
The CDC States:This form collects the opinions and observations of dental health care personnel (DHCP) who screen a safer dental device to determine its acceptability for use in a clinical setting. This form can be adapted for use with multiple types of devices. Do not use the new device being tested on a patient during this initial screening phase.
To find the form:
https://www.cdc.gov/oralhealth/infectioncontrol/device.htm
Sample Device Evaluation Form Dental Safety Syringes and Needles
The CDC States: This form collects opinions and observations from dental health care personnel (DHCP) who have pilot tested a safer dental device. This form can be adapted for use with multiple types of safer devices. Do not use this form to collect injury data because it cannot ensure confidentiality.
Evaluate the device
Everyone from the clinician to the person ordering needs to be part of the process screening. Screening is not just physically examining the product, it includes comparing what you have been using with the new system. It is important to remember that the CDC states that no new device should utilized for patient care before it has been screened to ensure that it meets clinical and patient safety needs.
A step-by-step process includes:
- Finding new products: Keep your eyes open for new devices. Look online, in journals, trade magazines, scientific literature, at conventions, ask peers and reps, etc. Find out what is working for them. Ask the manufacturer for a sample and do not limit your experience to a single vendor. The same product can be very different from manufacturer to manufacturer.
- Set evaluation criteria: What are you looking for in this item? There are several things to take into consideration. The first being the criteria phase. This phase helps you determine if the device is safe enough to use on a patient and whether it also protects the dental health care professional from harm. Other issues to consider is ease of purchase, practicality, compatibility, single use, and effective sterilization.
If the item passes the criteria phase, you can then move on to the evaluation phase. This is where you are going to look closely at the impact on the patient, the acceptance of staff, and finally the cost. Once an item has passed these steps, you can move on to screen the device. If it does not pass these steps, you will not use the item.
- Screening devices: This part of the process is where you will pilot test the product. It allows a hands-on experience in the clinical setting to determine if it is practical and safe to use in the clinical setting.
I pilot tested a self-sheathing needle device last year for the delivery of anesthesia. I could not get the device to fit in the vestibule to deliver a PSA. It was not an acceptable or practical device. My process included the CDC’s basic steps for pilot testing:
- Identifying a safer dental device to test (example: self-sheathing needle)
- Selecting the area of the facility to be used as the test site and the staff who will be the end users of the device (dental chair for anesthesia, dentist and hygienist delivering anesthesia)
- Selecting evaluation criteria, and determining how long the test will last (forms from CDC, ½ day with four staff members who were having dental work done).
Because we had immediate failures with the product, we immediately brought back the product we had been using. All testing should include plans for immediately returning to regular protocols if the item does not work in the dental setting or has been found unsafe. The safety coordinator in the office should be provided with enough information from this process to make an informed decision on whether the new device should replace the old device. CDC forms that each staff member involved in the process will use allows unbiased evaluations.
Kelly, staying updated and caring enough to ask about the reasoning behind this law is half the battle. Choose an area to focus on in your office. Do you need to look at needle recapping? The type of syringe you are using? The container you are transporting instruments? Choose one area at a time and research and evaluate the innovations that are available to keep you and patients safer.
NOEL BRANDON KELSCH, RDH, RDHAP, MS, 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.
