N.J. Admin. Code § 8:43G-8.8

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

Section 8:43G-8.8 - Monitoring the sterilization cycle

(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; and

4. Steam sterilizers--weekly.

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

(c) A biological monitor with live spores shall be performed following repair or breakdown of the equipment in (a) above.

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

(e) A chemical indicator/integrator, applicable to the sterilization process used, shall be used in the following:

1. Each package processed in steam;

2. Each package processed in ethylene oxide;

3. Each package processed in low temperature gas plasma;

4. Each load as directed by the manufacturer for peracetic acid; and

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

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

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

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

N.J. Admin. Code § 8:43G-8.8

New Rule, R.2004 d.302, effective 8/2/2004.
See: 35 New Jersey Register 2847(a), 35 New Jersey Register 3782(a), 36 New Jersey Register 3538(a).