OSHA Compliance
Did You Know:
- OSHA regulates dental laboratories (some exemptions apply).
- An effective safety program helps you reduce worker’s comp claims.
- OSHA has the right to conduct a random inspection - just show up!
- There were 49 dental labs inspected by OSHA in 2010 - mostly in WA, MN, NC.
- The most frequently cited standards for dentistry are Hazard Communication Standard, Bloodborne Pathogen Standard, Emergency Preparedness, Respiratory Protection, Lockout/Tagout.
- OSHA requires written documentation of your safety program.
- Your safety program must be evaluated for its effectiveness.
- In certain states, dental labs must still complete OSHA’s Injury Logs.
A Health & Safety Program Must Cover:
- Chemical Hygiene - Hazard Communication Plan
- Infection Control - Exposure Control Plan
- Hazard Assessment and Safety Procedures
- Personal Protective Equipment Assessment
- Annual Safety Training
- Annual Evaluation of Safety Program
- Emergency Action Plan
- Investigation of Work-related Injuries and Illnesses
- Method of Enforcement of Safety Rules
- Compliance with State-specific OSHA plan as applicable
FDA Compliance
Did You Know:
- FDA regulates dental laboratories
- Dental labs that outsource to foreign labs must register with FDA
- FDA has a right to inspect all dental labs
- All dental labs must have a documented quality system
- Approximately 35 dental labs were visited by FDA in 2010
- CAPA (Corrective Action) is required and helps you reduce remakes
- If you manufacture sleep apnea devices or snore guards, then you must register
- with FDA as a contract manufacturer
- A contract manufacturer must pay an annual fee to FDA
- You must formally evaluate your vendors and subcontractors
- You must trace your patient contact materials in the event of recall
- You must conduct an internal audit of your quality system at least annually
- You must document all complaints from dental clients
- You must implement an effective corrective action process for complaints
- You must comply with FDA to become DAMAS certified
A Quality System Must Cover:
- Review of Non-conforming product
- Assignment of Management Responsibility
- Corrective and Prevention Action procedures
- Defining of Purchasing Controls
- Control of Labeling and Packaging
- Identification and Traceability of Patient Contact Materials
- Handling, Storage, Distribution & Installation of materials and finished items
- Production and Process Controls
- Records retention and control
- Acceptance of Final Product
How To Reduce Waste In Your Lab and Extend the Life of Your Equipment
- Develop preventive maintenance schedules for all equipment critical to the manufacturing process as required by FDA and DAMAS by using SafeLink's Quality Connection materials.
- Document repair records and review the records regularly to determine if equipment should be retired and replaced - another requirement by FDA and DAMAS as shown in SafeLink's Quality Connection materials.
- If equipment requires calibration ensure that it is properly calibrated as required by FDA and DAMAS as shown in SafeLink's Quality Connection materials.
- Keep areas where equipment is located clean and free of debris as required by FDA, DAMAS, and OSHA. Use SafeLink's Quality Connection and Health and Safety materials.
- Train workers on proper use of the equipment and provide operating instructions at point of use as required by FDA and DAMAS as shown in SafeLink's Quality Connection materials.
- Make sure there are no tears or distortions in the impression.
- Use burs, stones, discs, and diamonds for their full life. Don’t partially use them and discard them.
- Use the water to stone ratios that are with the stone. They will usually tell you how much water and stone is needed for each model.
- Weigh out wax patterns to determine how much metal to use in each casting.
- Cast to the most accurate thickness possible. There will be less grinding and therefore less waste.
Using Cold-Sterilants, i.e. Glutaraldehyde (excerpted from the 2003 CDC MMWR for Infection Control in Dental Settings)
Heat-sensitive critical and semicritical instruments can be sterilized by immersing them in liquid chemical germicides registered by FDA as sterilants. When using a liquid chemical germicide for sterilization, certain poststerilization procedures are essential. To use this method, items need to be:
- 1) rinsed with sterile water after removal to remove toxic or irritating residues;
- 2) handled using sterile gloves and dried with sterile towels; and
- 3) delivered to the point of use in an aseptic manner.
If stored before use, the instrument should not be considered sterile and should be sterilized again just before use. In addition, the sterilization process with liquid chemical sterilants cannot be verified with biological indicators.
Because of these limitations and because liquid chemical sterilants can require approximately 12 hours of complete immersion, they are almost never used to sterilize instruments. These chemicals are more often used for high-level disinfection. Shorter immersion times (12--90 minutes) are used to achieve high-level disinfection of semicritical instruments or items. These powerful, sporicidal chemicals (e.g., glutaraldehyde, peracetic acid, and hydrogen peroxide) are highly toxic.
Manufacturer instructions (e.g., regarding dilution, immersion time, and temperature) and safety precautions for using chemical sterilants/high-level disinfectants must be followed precisely. These chemicals should not be used for applications other than those indicated in their label instructions. Misapplications include use as an environmental surface disinfectant or instrument-holding solution.
Because of their lack of chemical resistance to glutaraldehydes, medical gloves are not an effective barrier. Other factors that might apply when using these chemicals are the addition of room exhaust ventilation or ensuring 10 air exchanges/hour, keeping the container closedwith a lid at all times, testing for proper dilution, and disposal practices to ensure worker and environmental safety. For all of these reasons, using heat-sensitive semicritical items that must be processed with liquid chemical germicides is discouraged; heat-tolerant or disposable alternatives are available for the majority of such items.
Call 1.800.330.6003 for more information.
