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What do FDA regulations have to do with treatment devices used in the radiation therapy field?

They inform you on the correct use of a device

It is a federal requirement that all devices used on humans, and their manufacturer are registered with the FDA

The FDA does not control treatment devices

Federal Regulations Title 21, Part 807, 21 CFR Part 820 states that,

It is a requirement to follow quality system regulations relating to methods used in manufacturing, designing, storing and installing and servicing medical devices

The FDA may not require a manufacturer to follow quality system regulations relating to methods used in manufacturing, designing, storing and installing and servicing medical devices

OSHA may require a manufacturer to follow quality system regulations relating to methods used in manufacturing, designing, storing and installing and servicing medical devices

The FDA:

does control the labeling of medical devices

does not control the labeling of medical devices

As you progress from Class I to Class III classification of medical devices, the regulatory control:

increases

decreases

Smithers Medical Products, Inc. is registered with the FDA, as are all products, and the company received an exemplary review from an on-site inspection

False, the FDA does not perform inspections on-site

True

MSDS stands for

Material Sheets Defective Standards

Method of Safety and Directive Standards

Material Safety Data Sheet

The purpose of the Right to Know Law is

to inform OSHA what chemicals are in use at your facility

to inform a user of all the uses of a chemical

to ensure potential hazards are evaluated and passed on to employers and employees

The Community Right to Know Law falls under the domain of the

hospital safety officer

OSHA

EPA

MSDS contains valuable information

for firefighters if there is a fire, on the manufacturer of a chemical, and on proper storage

on proper storage

on the manufacturer of a chemical

for firefighters if there is a fire

only to the department safety officer

on the manufacturer of a chemical and on proper storage

Section III, Physical/Chemical Characteristics

explains detailed technical data for the physicist

provides chemical reactivity data

provides fundamental information important to your safety

MSDS for foaming agents used in radiation therapy

may not be used interchangeably from one brand of product to another

may be used from one brand to another as long as the products are similar

Obtaining MSDS from one company to use for another company's similar type product is

probably not ethical but certainly legal

a violation of federal and state laws

up to the discretion of the hospital safety officer

Toxicology of chemicals (PEL) is regulated by

MSDS

OSHA

EPA

FDA

Toxicology of chemicals is

provided by SMP for its foaming agents

provided by OSHA and the EPA

provided by every manufacturer of foam

When an outside, independent lab tested SMP Alpha Cradle brand foam

they determined that MDI PEL limits were satisfactory

found TDI vapors present in the foam

the levels of detected MDI vapors were less than the limit of detection

What vapors are given off by Alpha Cradle brand foam?

TDI

formaldehyde

TDI, formaldehyde, and CFCs

not TDI, formaldehyde, and CFCs

What vapors may be found in other polyurethane foams?

TDI

formaldehyde

CFCs

TDI, formaldehyde, and CFCs

not TDI, formaldehyde, or CFCs

If you use a foam outside of a medical company at your hospital on a patient

it is not covered by the FDA, so toxicology is no concern

you will save time and money and get the same effect

you will be in violation of federal law and may subject your patients and staff to toxic gas

Attenuation describes

what happens to a radiation beam as it passes through a material or object

information that can be found on the MSDS

how skin sparring affects the patient

When tested with microwave radiation for one hour at temperatures up to 50ÂºC

forms began to break apart due to the intense heat

the foam softened and started to lose its shape

the form got too hot for the patient to remain inside for the 60 minute treatment

no changes were noticed in the mechanical properties of the foam

minor changes were noticed in the mechanical properties of the foam

Placement of the probes on the bottom surface of the slab detected

a significant absorption of microwave radiation

no significant absorption of microwave radiation

a significant rise in temperature at the base of the foam that did not cause damage to the foam

a significant absorption of microwave radiation and a significant rise in temperature at the base of the foam that did not cause damage to the foam

no significant absorption of microwave radiation and a significant rise in temperature at the base of the foam that did not cause damage to the foam

When tested for hyperthermia, there was a temperature gradient at the top of the slab. The bottom of the slab temperature was raised

due to the heat transfer

due to the microwave power absorption

due to both heat transfer and microwave power absorption

The Alpha Cradle Advantage gives you a critical edge with

IGRT and IMRT

CT on Rails

TOMO Therapy, SBRT, and Particle Therapy

Interstitial Radiation Therapy

IGRT, IMRT, TOMO Therapy, SBRT, and Particle Therapy

IGRT, IMRT, CT on Rails, TOMO Therapy, SBRT, and Particle Therapy

IGRT, IMRT, TOMO Therapy, SBRT, Particle Therapy, and Interstitial Radiation Therapy

Alpha Cradle forms increase comfort and accuracy and can be used for what type of patients?

curative

palliative

curative and palliative

Alpha Cradle brand foam can be used by pouring the amount of foam needed from each bottle

True

False

Accordion-style bottles are used to

increase the shaking time of the foam

provide a safety measure if you shake the bottle too long

contain the foam until you are ready to use it

Alpha Cradle brand foam is the same as other foams on the market

False. Alpha Cradle foam is proprietary and has never been duplicated

True. Polyurethane foams have the same general chemical ingredients and properties

ACMMII and ACPRS are

types of Alpha Cradle brand foam

regulated by federal, state and local laws

physical and chemical characteristics found on MSDS sheets

products of SMP

types of Alpha Cradle brand foam, regulated by federal, state and local laws, and physical and chemical characteristics found on MSDS sheets

types of Alpha Cradle brand foam and products of SMP

Differences between ACPRS and vac bags are

ACPRS have flat bases, vac bags do not

a small cut will ruin a vac bag, but will not harm an ACPRS

vac bags pull away from patients, ACPRS push foam tight against a patient

ACPRS can have ports cut into them, vac bags cannot

ACPRS have flat bases, vac bags do not; a small cut will ruin a vac bag, but will not harm an ACPRS; vac bags pull away from patients, ACPRS push foam tight against a patient; and ACPRS can have ports cut into them, vac bags cannot

If there's more foam than I need for my purpose, and I just use part of the mixed foam, I should recap the remaining foam in the bottle

True

False

If the foam is shaken too long, and the bottle becomes firm or starts to expand, the bottle must be opened carefully, but immediately

True

False

If I get foam on my skin, I should

wait until the form is made, then simply wash off

get some KY Jelly and wipe the foam off then wash my hands immediately

immediately use acetone to get the foam off my skin

using a cotton washcloth, wash the area with tepid soapy water for 15 minutes

get some KY Jelly and wipe the foam off then wash my hands immediately or using a cotton washcloth, wash the area with tepid soapy water for 15 minutes

immediately use acetone to get the foam off my skin or using a cotton washcloth, wash the area with tepid soapy water for 15 minutes

To prevent an accident with the foam, I should always

wear protective smock, gloves, and goggles

read the directions

shake the bottle with the cap pointing up away from everyone

shake the bottle with the cap pointing down inside the bag

wear protective smock, gloves, and goggles; read the directions; and shake the bottle with the cap pointing up away from everyone

wear protective smock, gloves, and goggles; read the directions; and shake the bottle with the cap pointing down inside the bag

If I get foam on a hardened surface, I should

immediately wipe it off the surface

wait until the form is finished then remove the foam

If the foam spills onto carpet or clothing, I should

immediately wipe it off the surface

wait until the form is finished then remove the foam

If I have an accident with the foam, after taking immediate steps necessary, I must

file a report with OSHA

file a report with the FDA

file an accident report with SMP

Which statement is correct?

bottle #1 contains papi, and bottle #2 contains polyol

bottle #1 contains polyol, and bottle #2 contains papi

For maximum durability with the ACMMII, I can place a 10" x 12" piece of styrofoam

inside the bag of foam

under the bag of foam

If a thick piece foam is in the path of the beam, I can

treat right through the foam

treat around the foam

cut a port in the foam with a hot wire cutter

cut a port in the foam with a serrated blade

Patient comfort and proper immobilization is not important to my palliative patients

True

False

The major concern with Alpha Cradle foam and today's treatment machines is that the foam has a significant affect on transmission

True

False

Treating through thick areas of foam will affect skin sparring

True

False

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What do FDA regulations have to do with treatment devices used in the radiation therapy field?

Federal Regulations Title 21, Part 807, 21 CFR Part 820 states that,

The FDA:

As you progress from Class I to Class III classification of medical devices, the regulatory control:

Smithers Medical Products, Inc. is registered with the FDA, as are all products, and the company received an exemplary review from an on-site inspection

MSDS stands for

The purpose of the Right to Know Law is

The Community Right to Know Law falls under the domain of the

MSDS contains valuable information

Section III, Physical/Chemical Characteristics

MSDS for foaming agents used in radiation therapy

Obtaining MSDS from one company to use for another company's similar type product is

Toxicology of chemicals (PEL) is regulated by

Toxicology of chemicals is

When an outside, independent lab tested SMP Alpha Cradle brand foam

What vapors are given off by Alpha Cradle brand foam?

What vapors may be found in other polyurethane foams?

If you use a foam outside of a medical company at your hospital on a patient

Attenuation describes

When tested with microwave radiation for one hour at temperatures up to 50ÂºC

Placement of the probes on the bottom surface of the slab detected

When tested for hyperthermia, there was a temperature gradient at the top of the slab. The bottom of the slab temperature was raised

The Alpha Cradle Advantage gives you a critical edge with

Alpha Cradle forms increase comfort and accuracy and can be used for what type of patients?

Alpha Cradle brand foam can be used by pouring the amount of foam needed from each bottle

Accordion-style bottles are used to

Alpha Cradle brand foam is the same as other foams on the market

ACMMII and ACPRS are

Differences between ACPRS and vac bags are

If there's more foam than I need for my purpose, and I just use part of the mixed foam, I should recap the remaining foam in the bottle

If the foam is shaken too long, and the bottle becomes firm or starts to expand, the bottle must be opened carefully, but immediately

If I get foam on my skin, I should

To prevent an accident with the foam, I should always

If I get foam on a hardened surface, I should

If the foam spills onto carpet or clothing, I should

If I have an accident with the foam, after taking immediate steps necessary, I must

Which statement is correct?

For maximum durability with the ACMMII, I can place a 10" x 12" piece of styrofoam

If a thick piece foam is in the path of the beam, I can

Patient comfort and proper immobilization is not important to my palliative patients

The major concern with Alpha Cradle foam and today's treatment machines is that the foam has a significant affect on transmission

Treating through thick areas of foam will affect skin sparring

Treating through the foam will release gases in the foam