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What is the FDA responsible for?
setting and enforcing public health regulations
evaluation and approval of pharmaceuticals (drugs) and medical devices (ex joint replacement piece)
classifying medical devices based on how dangerous they are
Class one medical devices
according to FDA
minimum risk to user and patients
gloves and glasses
Class two medical devices
according to FDA
devices for which general regulatory controls can’t assure safety and effectiveness
X-ray machines and surgical gowns/ masks
Class 3 medical devices
Devices that pose the greatest risk and their safety/effectiveness can’t be assured solely through special regulatory controls
Endosseous dental implants (implants that go through bone)
environmental protection agreement EPA
regulates disinfectants, sterilants, and certain aspects of waste disposal
Centers for disease control CDC
set guidelines and recommendations for infection control
Occupational safety and health administration OSHA
care about the safety and health of workers not patients
could file a complaint when guidelines and recommendations aren’t being followed in workplace
Label hazardous products of material
Blue- health hazard
Yellow- chemical stability
White- PPE needed
Red- fuel and explosive
OSHA SDS
Safety data sheets
tells you about the product and how to treat an accident
OSHA hazard communication standard
requires employee training with every new employee
all employees need to know where manual is and understand it
employees need to be informed of new hazardous material and any procedure modifications
OSHA blood borne pathogen standard
Sanitary conditions
Standard precautions
Hand and eyewash stations
Sharps and Infectious waste disposal according to EPA regulations
Employee training
Employee immunization and medical file
Exposure incident protocol and follow-up
PPE
Exposure control
barriers for patients and clinician
Exposure control plan
Provides optimal protection from exposure to infectious agents
Professional obligation of DHCP (dental health care personnel) to ensure this is being done correctly
Personal protection of the dental team
Immunizations and periodic testing
PPE
Personal hygiene (handwashing)
Record keeping
Immunizations testing
DHCP immunization status
Basic scheduled vaccination
booster and re-immunization
Periodic testing
Annual recommended tests
Medical consultation
Protective clothing
Prevent contamination of skin from:
Aerosols
Spatter
Droplets
Large amounts of microbes on soiled material
protect community
Protective clothing
Disposable
Reusable
Selection
Fabric
Coverage
Protocol for protective clothing
Hair and head covering
Clear field of operation (out of face, eyes, neck/shoulders)
Barrier to aerosol and spatter
Facial hair consideration