Fact-Checking IPAC: Why Type V Indicators and PCDs Are Non-Negotiable

Over the past week, I’ve received several emails from dental professionals asking about information they received during various IPAC sessions within the dental community, specifically around the placement and use of the Type V chemical indicator (CI).

Two common questions have emerged:

1. Is a Class IV CI in a cassette sufficient?
2. If a Class V is placed in all cassettes, is there still a need for a Type V in a Process Challenge Device (PCD)?

These questions are important. They show that people are listening, engaging, and wanting to do things right. But they also highlight why dismantling received information and fact-checking for evidence is essential in infection prevention and control (IPAC).

1. The Risk of Passive Acceptance

In the IPAC world, information travels quickly, especially when it’s shared confidently or presented with authority. However, even well-intentioned explanations can drift from evidence.

That’s why, when we encounter IPAC statements that differ from or function at a minimum of the standards, it’s our responsibility to pause, verify, and cross-check against evidence.

2. Why Context and Definitions Matter

Many of the recent questions I’ve received come down to terminology and process.

A cassette is not automatically a PCD. Several cassettes in a load are not automatically all PCDs. A cassette can serve as an in-house PCD, but only if it has been validated to represent the most challenging location for steam penetration and is consistently monitored with a Type V CI.

However, multiple cassettes in a load do not collectively act as a PCD. The critical difference lies in verification and timing:

• The PCD must be opened,
• The Type V CI must be visually verified as passed, and
• This verification is required to release the load, unless the load is being quarantined pending biological-indicator (BI) results.

This verification is not optional; it must be documented. For every load, there must be a corresponding entry on the sterilization log sheet showing that the Type V, serving as the “load leader,” has passed. This is non-negotiable.

Why? Because every load must have a complete snapshot of mechanical, chemical, and biological evidence to confirm sterilization success and maintain traceability.

If the concept of “cassettes, plural,” acting as a PCD were accepted simply because they exist within the load, then when would those cassettes be verified? At the point of use, when the clinician opens them. But by then, it’s too late. Verification must occur before point of use, confirming that sterilization has been achieved prior to releasing instruments for patient care.

3. The False Link Between Recording Devices and Type V Indicators

Suggesting that the use of a Type V CI in a PCD depends on whether the sterilizer has a recording device (mechanical indicator) is a flawed association.

A mechanical recording, such as a printout or digital log (USB or SD card), records time, temperature, and pressure, verifying the functionality of the sterilizer to physically reach the necessary parameters, as a machine. A chemical indicator, on the other hand, measures steam navigation inside the load, and the chemically engineered ink responds to the sterilization parameters, inside the sterilizer.

These are completely different quality-assurance (QA) functions, and one does not replace or diminish the need for the other.

Using a Type V CI in a PCD is not contingent on having a mechanical recorder, it is required because every load must be verified by all three QA monitoring systems:

1. Mechanical – Time, temperature, pressure (from gauges, printouts, USB, etc.)
2. Chemical – Type V CI in a PCD verifying steam contact and penetration
3. Biological – Daily BI with each cycle (not each load)

Each of these systems represents a different layer of mitigation. Relying on a recording device alone ignores one-third of the sterilization assurance equation.

4. Evidence as a Professional Compass

Fact-checking in IPAC is not about skepticism, it’s about responsibility. Let’s frame some critical thinking questions:

a. Does the use of a Type V in a PCD and in every pack align with CSA Z314:23 sterilization monitoring requirements?

The answer is unequivocally yes! CSA Z314:23 Clause 16 demonstrates that sterilization monitoring is an ongoing, multi-layered assurance process. CSA states that sterilization monitoring in Canada is based on a validated system including:

• Operational Qualification (OQ): Verifies that the sterilizer consistently achieves sterilization conditions by testing with a PCD (CSA Group, 2023).
• Routine Monitoring: Provides ongoing confirmation that every load is monitored physically, chemically, and biologically (CSA Group, 2023).

This means the use of a PCD does not stop after installation or validation, it becomes part of the routine monitoring process. If a PCD verifies sterilizer consistency during qualification, it must logically continue verifying sterilizer efficacy in day-to-day operations.

According to Clause 16.5.6 of CSA Z314:23:

The use of the word “shall” makes this a mandatory requirement, not a recommendation, establishing that every package must contain its own validated chemical indicator.

In short: every load must have mechanical, chemical, and biological monitoring, with the chemical verification performed by a Type V in a PCD.

b. What about dental regulatory bodies—what do they say about the use of Type V in every package and a Type V in a PCD?

Dental regulatory bodies in Ontario (not Alberta!) state, at minimum, a Type IV CI may be used inside instrument packages or cassettes.

This baseline requirement exists because most sterilization pouches are pre-manufactured with a built-in Type IV CI, satisfying the minimum expectation for an internal CI. In other words, if a pouch already has a Type IV, the office is meeting the regulatory minimum.

However, minimum is not the ideal to strive for when it comes to public safety.

A Type IV CI verifies that only two of the three critical parameters, time, temperature, and pressure, were achieved at a single point inside the package. In contrast, a Type V CI verifies all three parameters. This is especially important inside metal or rigid cassettes, where steam must first penetrate the cassette barriers before reaching the instruments.

From a risk-management perspective, relying on a Type IV in a closed cassette leaves an evidence gap. A Type V CI inside the cassette verifies that full sterilization conditions were achieved where it matters most, at the point of contact with the instruments.

And this is why CSA Z314:23 states a Type V is a must as an internal indicator. CSA moves beyond “minimum” expectations and defines sterility assurance as an integrated, evidence-based system that demands higher-level chemical verification. By requiring a Type V in every package, CSA ensures each sterilized item provides documented, validated proof that true sterilization parameters were achieved, not assumed.

c. What does PHO state about a Type V in a PCD and in every package?

In the IPAC Lapses – FAQ (2019b) document, PHO states:

From the IPAC Checklist for Dental Practice – Reprocessing (2019a):

Together, these statements demonstrate PHO’s position: when you cannot hold loads in quarantine pending BI results, the Type V in a PCD becomes the required verification for load release, and Type V CI inside packages provide additional assurance.

If the evidence can’t be traced back to these recognized authorities, then the claim should be verified before implementation.

5. Building a Culture of Critical Thinking

These recent emails are a reminder that dismantling received information doesn’t mean dismissing it, it means reconstructing it with evidence.

This approach strengthens professional judgment, protects client safety, and reinforces a culture of excellence in every sterilization area.

When we shift from “I heard” to “I verified and documented,” we elevate IPAC from a compliance exercise to a professional standard of care.

Key Takeaway

Each load released from a sterilizer must have documented proof that the mechanical, chemical, and biological indicators align.

The Type V in the PCD, the load leader, must be opened, verified, and recorded before instruments are released.

By striving above minimum requirements, a Type V CI becomes the package leader within each pack, providing the highest assurance of sterilization monitoring.

In IPAC, precision is protection, and evidence is our safeguard.

Michelle Aubé (Simmonds) RDH, maxill Dental Hygiene Educator

Michelle is a Dental Hygiene Speaker, Consultant and Educator with over 30 years of experience as a RDH and 4 years as a CDA. She is a professor and curriculum writer at Fanshawe College in both the dental hygiene and continuing education program sharing her knowledge in IPAC, professional practice, periodontal classification, social justice, advocacy and clinical applications. She is maxill's CE and IPAC Director and wears various IPAC hats including auditing federal correctional facilities dental clinics for IPAC standards. Michelle is ODHA's Regional Board Director and authors articles for CDHA's OH Canada professional publication and continues to practice clinically in London ON. She is a CDHO IPAC Remedial Facilitator and IPAC Expert Opinion. Her strong ethics has allowed her to serve on the Discipline Committee at Algonquin College and hold the position of a CDHO Quality Assurance Assessor for 7 years. As a lifelong learner she is completing a BA in Adult Education at Brock University. Her diverse dental background and current status as a practicing RDH offer a fulsome and realistic view of dental-related topics. As a passionate champion for the profession, she advocates for equity, professional autonomy, and systemic change, true grassroots leadership at its finest.

Michelle can be reached at [email protected]