New Jersey dental sterilization rules: what to test, record and keep

Topic by topic

What New Jersey’s rules say, and where each answer comes from

Read the middle column first. For most topics it records silence in the state’s own text and points to the CDC guidance the state adopts.

01 · Spore tests

How often to spore test

New Jersey’s board rules set no spore-test frequency. The schedule reaches a New Jersey dental office through the state’s adoption of CDC guidance (New Jersey rule 13:30-8.5(a)2).

Monitor sterilizers at least weekly by using a biological indicator with a matching control, that is, a biological indicator and control from the same lot number (CDC, 2003 dental infection-control guidelines).

A control biological indicator, from the same lot as the test indicator and not processed through the sterilizer, should be incubated with the test indicator (CDC, 2003 dental infection-control guidelines).

Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use, at least weekly, of biological indicators (CDC, 2003 dental infection-control guidelines).

The CDC title that New Jersey’s rule names says the same in its own words: proper functioning of sterilization cycles should be verified by the periodic use, at least weekly, of biologic indicators (CDC, 1993 recommended infection-control practices for dentistry).

For sterilizers used on a part-time basis, CDC provides no separate recommendation (CDC, 2024 sterilization monitoring page for dental settings).

02 · Implant loads

What to do with a load that holds an implant

Use a biological indicator for every sterilizer load that contains an implantable device, and verify the results before using the implantable device, whenever possible (CDC, 2003 dental infection-control guidelines).

In an emergency, placing implantable items in quarantine until spore tests are known to be negative might be impossible (CDC, 2003 dental infection-control guidelines).

Recall and quarantine any implantable items and do not use them until they are shown to be sterile (CDC, 2024 sterilization monitoring page for dental settings). Ideally, implantable items should not be used until they test negative (CDC, 2024 sterilization monitoring page for dental settings).

Do not sterilize implantable devices unwrapped (CDC, 2003 dental infection-control guidelines).

Where a lapse has happened, identification of such lapses may warrant immediate consultation with the state or local health department and appropriate notification and testing of potentially affected patients (CDC, infection prevention checklist for dental settings).

03 · Every load

Per-cycle checks

New Jersey’s rules say nothing about per-cycle checks. These arrive through the adopted CDC guidance (New Jersey rule 13:30-8.5(a)2).

Monitor each load with mechanical indicators, that is, time, temperature and pressure, and with chemical indicators (CDC, 2003 dental infection-control guidelines).

Assess cycle time, temperature and pressure by observing the gauges or displays on the sterilizer and note these parameters for each load (CDC, 2003 dental infection-control guidelines).

Place a chemical indicator on the inside of each package; if the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (CDC, 2003 dental infection-control guidelines).

Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (CDC, 2003 dental infection-control guidelines).

Use mechanical and chemical indicators for each unwrapped sterilization cycle (CDC, 2003 dental infection-control guidelines).

04 · Pre-vacuum sterilizers

Air-removal tests

This test belongs to pre-vacuum sterilizers only: prevacuum sterilizers should be tested periodically for adequate air removal, as recommended by the manufacturer (CDC, 2003 dental infection-control guidelines).

If a sterilizer fails the air removal test, it should not be used until inspected by sterilizer maintenance personnel and it passes the test (CDC, 2003 dental infection-control guidelines).

05 · A positive result

What to do after a failed spore test

Remove the sterilizer from service and review the sterilization procedures, such as work practices and the use of mechanical and chemical indicators, to determine whether operator error could be responsible (CDC, 2003 dental infection-control guidelines).

Repeat the spore test immediately after correctly loading the sterilizer and using the same cycle that produced the failure, and review all records of chemical and mechanical monitoring since the last negative biological indicator test (CDC, 2003 dental infection-control guidelines).

If the repeat spore test is negative and the mechanical and chemical indicators are within normal limits, put the sterilizer back in service (CDC, 2003 dental infection-control guidelines).

If the repeat spore test is positive, do not use the sterilizer until it has been inspected or repaired or the exact reason for the positive test has been determined (CDC, 2003 dental infection-control guidelines).

Recall, to the extent possible, and reprocess all items processed since the last negative spore test (CDC, 2003 dental infection-control guidelines).

For sterilization methods other than steam, a single positive biological indicator means treating as nonsterile all items that have been processed in that sterilizer, dating from the sterilization cycle with the last negative biological indicator to the next cycle showing satisfactory results (CDC, 2008 disinfection and sterilization guideline).

Identification of such lapses may warrant immediate consultation with the state or local health department and appropriate notification and testing of potentially affected patients (CDC, infection prevention checklist for dental settings).

06 · The record

What a log entry holds

New Jersey’s own rules do not list what a sterilizer record holds. The field list reaches offices through the adopted CDC guidance (New Jersey rule 13:30-8.5(a)2).

For each sterilization cycle, record the type of sterilizer and cycle used; the load identification number; the load contents; the exposure parameters, such as time and temperature; the operator’s name or initials; and the results of mechanical, chemical and biological monitoring (CDC, 2008 disinfection and sterilization guideline).

Mechanical monitoring means checking the sterilizer gauges, computer displays or printouts, and documenting the sterilization pressure, temperature and exposure time in your sterilization records (CDC, summary of infection prevention practices in dental settings, 2016).

Packages should be labeled to show the sterilizer used, the cycle or load number, the date of sterilization and, if applicable, the expiration date (CDC, summary of infection prevention practices in dental settings, 2016).

Logs for each sterilizer cycle are current, include results from each load, and comply with state and local regulations (CDC, infection prevention checklist for dental settings).

Results of biological monitoring should be recorded (CDC, 2003 dental infection-control guidelines).

Dental Logbook will ask for exactly these fields on every load, and keep each entry as it was written, with corrections added as new entries.

07 · Retention

How long to keep records

New Jersey’s board rules are silent here: the chapter text read for this page sets no retention period for sterilizer records.

The CDC guidance the state adopts defers to other law: results of biological monitoring should be recorded, and sterilization monitoring records, that is, mechanical, chemical and biological records, retained long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines).

Maintain sterilization records in accordance with state and local regulations (CDC, summary of infection prevention practices in dental settings, 2016).

One guideline gives an example rather than a single number: retain sterilization records for a time period that complies with standards, such as 3 years, statutes of limitations, and state and federal regulations (CDC, 2008 disinfection and sterilization guideline).

Dental Logbook will keep every sterilizer record for the life of your account, delete nothing automatically, and export the whole history whenever you ask.

08 · Inspection

Who inspects, and what they may look at

New Jersey answers this in an enforcement statute that covers every board in the Division of Consumer Affairs (N.J.S.A. 45:1-18). Whenever it appears that a person has engaged in an act or practice declared unlawful by a statute or regulation administered by the board, the board, the Director or the Attorney General may inspect any premises from which a practice subject to the board’s act or regulation is conducted, and examine any record, book, document, account or paper prepared or maintained by or for a licensee in the regular course of practicing the profession (N.J.S.A. 45:1-18).

CDC sets no inspector role. Its checklist is a self-assessment, and assessment of compliance should be conducted by direct observation of personnel during the performance of their duties (CDC, infection prevention checklist for dental settings).

New Jersey’s rule also adopts OSHA’s bloodborne pathogens standard (New Jersey rule 13:30-8.5(a)1). Under that standard, the employer must make the records it requires available, on request, to the Assistant Secretary and the Director, for examination and copying (OSHA bloodborne pathogens standard, 29 CFR 1910.1030).

09 · The practice itself

What New Jersey’s own rules require of the office

Two of New Jersey’s rules are specific, and they sit alongside the records.

At least once every biennial renewal period, all licensed dentists must provide or make available infection prevention education and training to all personnel involved in patient-related sterilization, patient care and maintaining equipment (New Jersey rule 13:30-8.5A).

Dentists must complete two hours of continuing education in preventing and controlling infectious diseases and managing personnel health and safety concerns related to infection control in dental settings (New Jersey rule 13:30-5.1(e)1iii). The board’s notice gives one such period: November 1, 2023 through October 31, 2025 (New Jersey board continuing-education notice, 2024).

These rules were readopted without change and continue in effect for a seven-year period (New Jersey board readoption notice, 2024).