2023 has been filled with challenges for us and for our clients, but here we are in 2024 anticipating what this new year will bring and ready to meet the expectations of our clients. Here is a look at some of the highlights from 2023 and what to plan for 2024.
As the SafeLink Consulting team looks back over 2023, we realize the importance of assessing our mission statement to ensure that everything we have done, and will continue to do, meets that expectation. Our WHY is to serve others so that they are empowered to succeed. Our ultimate purpose is to empower our clients to thrive and achieve success through serving them.
Health & Safety / OSHA Dental Compliance:
>> The maximum penalties and number of OSHA inspections increased in 2023. The primary cause for employers being inspected by OSHA in 2023 was unprogrammed inspections, primarily initiated by employee complaints.
>> The Pregnant Workers Fairness Act went into effect June 27, 2023. All employers with at least 15 employees are required to extend to pregnant workers “reasonable accommodations.”
>> Due to investigations of suspected nontuberculous Mycobacteria (NTM) in water quality, the CDC has brought more awareness in dentistry and to the public of the need for better maintenance and monitoring of dental waterlines for water quality. CDC reminds dental providers to become familiar with the CDC’s recommendations “on how to properly maintain and monitor their dental equipment to ensure that dental treatment water is safe for patient care.” In 2024 dental providers should adhere to the CDC guidance on dental unit water quality. State Boards of Dentistry seem to be taking a closer look at this issue so licensed dental providers need to stay abreast of their state licensing requirements.
>> As you prepare your strategic plans for 2024, it is crucial to prioritize the strength of your health and safety program in order to safeguard your employees and patients.
Learn more about Safety / OSHA Review 2023 and Outlook in 2024.
Quality Assurance / FDA Compliance:
Quality should be considered a necessity for not only patient protection but also for the liability of the dental laboratory and the dentist.
>> FDA had more inspections in 2023 than in prior years from our viewpoint. Manufacturing classified devices requires FDA registration which puts the manufacturer on FDA’s inventory for an inspection.
>> From SafeLink Consulting’s experience in 2023 and reports from the NADL (National Association of Dental Laboratories) during last year, FDA inspections of dental laboratories have significantly increased. Inspections are typically based on the type of registration so ensuring that an establishment is registered correctly is critical. The next critical factor is the development and implementation of an appropriate Quality Management System.
>> The inspections that SafeLink Consulting has participated in have indicated a real need for a good document control system as well as methods in place that document the standards that are in place and that they are being followed.
>> The plan by FDA to adopt ISO 13485 as the format for a quality management system, caused SafeLink to search out and strategically align with Grand Avenue Software. This eQMS software will help companies achieve compliance quickly, standardize processes, increase productivity, control overhead expenses, and ultimately increase profit. When facing an FDA inspection, a dental laboratory needs to be able to quickly produce the evidence that the FDA inspector asks for and be able to show that standards are being followed.
Learn more about Quality Assurance / FDA Dental Review 2023 and Outlook 2024.
In Summary
Your first step should be to ensure that your management team has access to a knowledgeable resource on the regulations that apply to your business. Contracting with an expert such as SafeLink Consulting is a step in the right direction. Contact us to learn how we can assist you and your business in achieving a more successful and prosperous 2024!
Learn more about:
Dental Practice OSHA Compliance
