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The Basics of Sterile Processing Ch.1 Roles and Responsibities P2

Teacher: Mr. Wm Moran
Across
______ diamond= instability (color)
Failure to comply with policies and __________ can result if different standards of care for patients, which is not acceptable.
The ___ mission is "to promote and protect the public's health by helping safe and effective products reach the market in a timely way, to monitor products for continued safety after they are in use, and to help the public get the accurate, science-based information needed to improve health"
________ devices are those that are exposed to normally sterile areas of the body.
It is the responsibility of SPD ________ to obtain and continually update the manufacturer's IFU.
The facility should require vendor compliance with the AAMI recommendation that the _______ weight of each set, including the container, should not exceed 25 pounds.
Devices only touch skin or come into contact with persons indirectly.
______ diamond= Special hazard information (color)
OSHA's _______ communication (Right to Know) Standard requires facilities to obtain and make available to employees a safety data sheet (SDS) (formerly called a Material safety Data Sheet) for each chemical used in the workplace
______ diamond= flammability (color)
User _______: Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met.
In 2000, FDA began regulating the _______ of single-use devices by healthcare facilities (hospitals) and third-party reprocessors.
The FDA also requires that medical device manufacturers provide end-users in healthcare facilities with specific ___on how to clean and sterilize their products. Noncompliance is not an option.
___ requires medical device manufacturers and distributors to report patient deaths, serious injuries, and serious device malfunctions to FDA. (Acronym)
____ must be readily available for employee review at all times you are in the work place. (Acronym)
Permissible Exposure Limits (Acronym)
Society of Gastroenterology Nurses and Associates (Acronym)
__________ practices are statements of sound principles of practice that are based upon scientific data and the opinions of experts.
All _____ products must be located, retrieved, and documented.
If the state regulation is ______ it takes precedence.
______ diamond=health hazard (color)
Many loaner instruments and sets require extended soaking and/or cleaning. Therefore hospital policy might require the loaners to be delivered 48to72 hours in advance of the ________ surgery date and time.
The CDC has classified medical _______ according to their uses.
Down
Class "D" fire extinguishers are for use on combustible _______ such as magnesium, titanium and sodium.
The fire triangle: Fuel source, Ignition source and __________ source.
Devices com in contact with intact mucous membranes during use.
______ greatly affects SPD through its regulation of occupational exposure to airborne contaminants, occupational exposure to bloodborne pathogens, and communication of workplace hazards.(Acronym)
_________ is performed by the manufacturers, not by the end users.
Emergency _________ Stations should permit hands free operations, have a stay-open feature, and have the ability to flush both eyes at the same time.
Occupational Exposure to Bloodborne pathogens: This standard was the first action that OSHA had taken concerning a _________ hazard to workers.
Healthcare facilities also have regulations, called ________.
Second, the EPA controls _______ into the air (under the Clean Air Act) and into the water (under the Clean Water Act) of such substances as ethylene oxide
Although the device manufacture is responsible for qualifying the sterilization process for the device, healthcare ________ are responsible for demonstrating that they can replicate that process exactly and consistently.
The eyewash unit should be connected to _____ -not hot - water (60 to 100 degree F) to prevent burns to eyes
If an applicable federal regulation is stricter than the corresponding state regulation, then is takes __________.
_____ specifies a labeling code for types and severity of hazards. Hazards are color coded (0) no hazard; (4) most severe hazard.
The job of creating and maintaining a safe and healthy environment is a team effort shared by both the facility and its _________.
Class "C" fire extinguishers are for use on energized ___________ equipment.
Class "B" fire extinguishers are for use on flammable _______ such as gasoline, alcohol, diesel oil, oil-based paints, lacquers, and flammable gases.
When a facility passes a Join Commission inspection, it is accredited for a period of _____ years.
_____ training should: be on-site, be hands-on, provide for return demonstration, and provide for competency verification. (Acronym)
The Association for Professionals in Infection Control and Epidemiology. (Acronym)
The ____ is not a regulatory agency, but if dose publish widely respected recommendations and guidelines on such topics as hand hygiene, Isolation precautions environmental infection control and disinfection and sterilization,