Pennsylvania dental sterilization rules: what to test, record and keep

Spore testing: at least weekly, and with every implant load

Pennsylvania does not name a spore-test interval anywhere in its dental rules (49 Pa. Code Chapter 33). What it does say is that failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control is unprofessional conduct for dentists, who must also ensure that auxiliary personnel and other supervisees follow these federal guidelines (Pennsylvania rule 33.211(a)(7)). Hygienists and expanded-function dental assistants carry the same duty in their own subsections (Pennsylvania rule 33.211(b)(4) and (c)(4)).

Through that rule, CDC’s recommendation reaches your sterilizer: a spore test should be used at least weekly to monitor sterilizers (CDC, 2016 dental infection-prevention summary). Each sterilizer is monitored at least weekly 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).

Every sterilizer load that contains an implantable device also gets a biological indicator, and the results are verified before the implantable device is used, whenever possible (CDC, 2003 dental infection-control guidelines). The items are quarantined until the results are known, though CDC notes that in an emergency this might be impossible (CDC, 2003 dental infection-control guidelines).

Every load: mechanical and chemical checks

Pennsylvania’s rules say nothing about per-cycle checks (49 Pa. Code Chapter 33). The CDC guidance the state adopts says to monitor each load with mechanical indicators (e.g., time, temperature, and pressure) and chemical indicators (CDC, 2003 dental infection-control guidelines).

A chemical indicator goes on the inside of each package; if the internal indicator is not visible from the outside, an exterior chemical indicator goes on the package as well (CDC, 2003 dental infection-control guidelines). Instrument packs are not used if the mechanical or chemical indicators indicate inadequate processing (CDC, 2003 dental infection-control guidelines).

Unwrapped cycles get mechanical and chemical indicators each time, and implantable devices are not sterilized unwrapped (CDC, 2003 dental infection-control guidelines).

Air-removal tests: for pre-vacuum sterilizers only

Pennsylvania sets no air-removal test (49 Pa. Code Chapter 33). The test belongs to pre-vacuum steam sterilizers, and here CDC’s two documents do not give the same instruction (CDC, 2003 dental infection-control guidelines; CDC/HICPAC, 2008 disinfection and sterilization guideline).

The 2003 dental guideline says pre-vacuum sterilizers should be tested periodically for adequate air removal, as recommended by the manufacturer (CDC, 2003 dental infection-control guidelines). The 2008 guideline says an air-removal test (Bowie-Dick Test) must be performed daily in an empty dynamic-air-removal sterilizer (CDC/HICPAC, 2008 disinfection and sterilization guideline).

That is a real difference in frequency, and this page does not pick a side between the two CDC texts (CDC, 2003 dental infection-control guidelines; CDC/HICPAC, 2008 disinfection and sterilization guideline). Whichever schedule you follow, a sterilizer that fails the air-removal test should not be used until it has been inspected by sterilizer maintenance personnel and it passes the test (CDC, 2003 dental infection-control guidelines).

After a failed spore test

Pennsylvania’s rules give no failure procedure (49 Pa. Code Chapter 33). The adopted CDC guidance does, and the steps are these (CDC, 2003 dental infection-control guidelines):

1. Remove the sterilizer from service and review the sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to find out whether operator error could be responsible (CDC, 2003 dental infection-control guidelines).
2. Repeat the spore test immediately after correctly loading the sterilizer and using the same cycle that produced the failure (CDC, 2003 dental infection-control guidelines).
3. Review all records of chemical and mechanical monitoring since the last negative spore test (CDC, 2003 dental infection-control guidelines).
4. 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).
5. If the repeat 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).
6. Recall, to the extent possible, and reprocess all items processed since the last negative spore test (CDC, 2003 dental infection-control guidelines).
7. Then rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the failure has been determined and corrected (CDC, 2003 dental infection-control guidelines).

CDC’s texts disagree about those three cycles. The 2003 dental guideline and the 2008 guideline describe empty chamber cycles (CDC, 2003 dental infection-control guidelines; CDC/HICPAC, 2008 disinfection and sterilization guideline), while CDC’s 2024 dental page says three consecutive fully loaded chamber sterilization cycles (CDC, 2024 dental sterilization-monitoring page). This page does not choose between them.

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

What a log entry holds

Pennsylvania’s chapter has no rule on sterilizer records (49 Pa. Code Chapter 33). CDC’s 2008 guideline lists what to record for each sterilization cycle: the type of sterilizer and cycle used, the load identification number, the load contents, the exposure parameters (e.g., time and temperature), the operator’s name or initials, and the results of mechanical, chemical, and biological monitoring (CDC/HICPAC, 2008 disinfection and sterilization guideline).

Results of biological monitoring should be recorded, and sterilization monitoring records (that is, mechanical, chemical, and biological) kept long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines). Packages are labelled to show the sterilizer used, the cycle or load number, the date of sterilization and, if applicable, the expiration date (CDC, 2016 dental infection-prevention summary).

One distinction matters in Pennsylvania: the 5-year rule covers patient dental records, not sterilizer records (Pennsylvania rule 33.209(b)).

A good log keeps one entry per cycle, names the sterilizer and load, and carries the spore-test result with its lot. Dental Logbook will build those entries for you.

How long to keep records

Pennsylvania’s rules set no retention period for sterilizer records (49 Pa. Code Chapter 33). CDC’s 2003 dental guideline says sterilization monitoring records (that is, mechanical, chemical, and biological) are retained long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines).

The 2008 guideline says to retain sterilization records for a time period that complies with standards (e.g., 3 years), statutes of limitations, and state and federal regulations (CDC/HICPAC, 2008 disinfection and sterilization guideline). The two texts set no single number between them (CDC, 2003 dental infection-control guidelines; CDC/HICPAC, 2008 disinfection and sterilization guideline).

Patient dental records are a separate matter, and there the state does set a period: a patient dental record shall be retained by a dentist for a minimum of 5 years from the date of the last dental entry (Pennsylvania rule 33.209(b)).

Who inspects a Pennsylvania dental office

The State Board of Dentistry, through its authorized agents, may conduct inspections of a dental office with or without prior notice (Pennsylvania rule 33.342(a)). The purpose is narrow: to determine whether the office is in compliance with the equipment and facility requirements attached to an anesthesia permit, and those lists include a sterilization area (Pennsylvania rule 33.342(a); Pennsylvania rule 33.340(a)(2)(vi)).

The rule limits the inspection to that scope (Pennsylvania rule 33.342(b)). Nothing else in 49 Pa. Code Chapter 33 sets an inspection of sterilizer monitoring or its records (49 Pa. Code Chapter 33).

This page is not legal advice; check your state board's current rules.