N.J. Admin. Code § 8:43A-14.5

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43A-14.5 - Care and use of sterilizers, ethylene oxide, peracetic acid, low temperature gas, plasma, and steam

(a) Biological monitoring with live spores, or an FDA approved equivalent, shall be performed as follows:

1. Ethylene oxide--in each load;

2. Peracetic acid--weekly;

3. Low temperature gas plasma--daily in the working load;

4. Steam sterilizers--weekly;

5. A biological monitor with live spores shall be performed following repair or breakdown of the above mentioned equipment; and

6. A biological monitor, or spore based enzyme, shall be used with each load containing implantables, and the implantable device shall not be used until the negative biological test is received.

(b) The biological indicator shall be applicable for the process used and shall be stored and used in accordance with the manufacturer's recommendations.

1. A rapid read out biological monitor must be incubated to obtain a spore kill reading. The length of incubation shall comply with the written instructions provided by the manufacturer of the biological indicator.

2. A chemical indicator/integrator, applicable to the sterilization process used, shall be used in the following:

i. Each package processed in steam;

ii. Each package processed in ethylene oxide;

iii. Each package processed in low temperature gas plasma; and

iv. Each load, as directed by the manufacturer, for peracetic acid.

3. A prevacuum air removal test shall be performed daily on each prevacuum sterilizer and following repair or breakdown of the prevacuum sterilizer.

4. In the event of positive biological test results on a sterilizer, effective corrective action shall be taken including retesting and recalls if indicated.

i. Documentation of actions taken shall be maintained on site.

ii. There shall be an established recall system in effect.

5. The individual responsible for reprocessing reusable medical instruments shall be certified by a national central service certification program upon hire or within two years of employment.

6. All personnel involved in the use of ethylene oxide shall have the appropriate licensure from the New Jersey Department of Environmental Protection (NJDEP).

N.J. Admin. Code § 8:43A-14.5

Repeal and New Rule, R.2004 d.299, effective 8/2/2004.
See: 35 New Jersey Register 2838(a), 36 New Jersey Register 3529(a).
Section was "Care and use of sterilizers".