331-915-0080 Approved Sterilization Standards for Tattooing

Question 1

Needles must be _____.

Answer 1

Single use, used on one client, then properly disposed of in an approved sharps container

Question 2

All non-sterilized or reusable instruments that come in direct contact with a client’s skin or are exposed to blood or other potentially infectious materials must be _____.

Answer 2

Cleaned and sterilized before use on a client or re-use on another client.

Question 3

New gloves must be worn during _____.

Answer 3

Any sterilization procedure

Question 4

The cleaning and sterilization process is not required if _____.

Answer 4

Single-use prepackaged sterilized instruments, obtained from suppliers or manufacturers, are used.

Question 5

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (a)

Answer 5

Place instruments in an ultrasonic cleaner filled with an appropriate ultrasonic solution including but not limited to, an enzymatic cleaner. The unit must be:
- Operated at 40-60 kilohertz
- Covered during use

A self-contained instrument washer may be used in place of an ultrasonic cleaner.

Question 6

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (b)

Answer 6

Remove instruments from the ultra sonic unit or self-contained instrument washer. Clean instruments by manually brushing or swabbing visible foreign matter and rinsing the instruments with warm water and appropriate detergent solution to remove blood and other potentially infectious materials.

Question 7

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (c)

Answer 7

Remove instruments from the ultrasonic unit or self-contained instrument washer. All instruments must be rinsed, air dried, and individually packaged in sterilization pouches. The date of sterilization must be applied to the pouch.
OR
Instruments sterilized in an autoclave that do not require packaging must be sterilized after use on a client, stored in a clean disinfected location, and re-sterilized immediately before performing service on a client.

Question 8

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (d)

Answer 8

Instruments must be sterilized by using an autoclave sterilizer, steam, chemical or gas, registered and listed with the FDA.

Question 9

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (e)

Answer 9

A steam sterilization integrator must be used to monitor the essential conditions of steam sterilization for each autoclaved cycle. Results must be recorded for each cycle. Each steam sterilization integrator must indicate when sterilization took place. Steam sterilization integrators must be kept for a minimum of 60 days.

Question 10

Approved cleaning and sterilization process for non sterilized or reusable instruments includes the following ordered method after each use: (f)

Answer 10

After sterilization, the sterilized instruments must be stored in individually packed sterilization pouches that include a color change indicator strip in a dry, disinfected, closed cabinet or other tightly covered container. The date of sterilization must be applied to the pouch when stored.

Question 11

Use of a biological monitoring system (“spore tests”) must be done at least _____ a month and verified through an independent laboratory, to assure all microorganism have been destroyed and sterilization achieved.

Answer 11

Once

Question 12

The ultrasonic unit must be _____ and a copy of the manufacturer’s recommended procedures for operation must be kept on file at the facility.

Answer 12

Used, cleaned, and maintained in accordance with manufacturer’s instructions

Question 13

All sterilization pouches with color change indicator strips must be _____

Answer 13

Available at all times for inspection

Question 14

Sterilization pouches with color change indicator strips and steam sterilization integrators must be _____.

Answer 14

Available at all times for inspection.

Question 15

Biological spore test results must be immediately available at all times for inspection and kept at facility for a minimum of _____.

Answer 15

2 years

Question 16

The autoclave must be _____.

Answer 16

Used, cleaned, and maintained in accordance with manufacturer’s instructions and a copy must be kept on file at the facility.

Question 17

The expiration date for sterilized instruments is _____.

Answer 17

One year from date of sterilization, unless the package integrity is compromised.

Question 18

Sterilized instruments may not be used if _____

Answer 18

The package integrity has been breached, is wet or stained, or the expiration data has passed.

Question 19

All sterilized instruments used in tattooing procedures must remain stored in _____

Answer 19

Sterile packages and in a dry, disinfected, closed cabinet or other tightly-covered container

Question 20

If a biological spore test result is positive, a licensee must discontinue the use of that sterilizer until it has been serviced and a negative spore test has been recorded. Until that happens, licensee must

Answer 20

(a) Use an alternative sterilizer
(b) Use only single-use instruments

Question 21

If a positive spore test is received, all instruments sterilized prior to the positive test must be _____

Answer 21

Repackaged and sterilized

Question 22

Following the receipt of a positive spore test, the licensee must _____

Answer 22

Notify all clients in writing stating a positive spore test has been received during the time of their tattoo and inform them of having a tattoo done with instruments that may not be sterilized