Is the maxill u-test PCD (Process Challenge Device) a Health Canada regulated medical device?
The maxill process control device (PCD) is part of ‘Batch Monitoring’ in the quality assurance of sterilization.
Currently Health Canada does not regulate PCDs and therefore the batch monitoring PCD is not listed as a medical device.
In the US a PCD requires the FDA’s 510(k) premarket authorization.
At this point, in Canada/Ontario, the batch monitoring PCD, as the name implies serves the purpose of a challenge to the load.
As per ISO the definition of a PCD is an “item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process” [SOURCE: ISO/TS 11139, definition 2.33].
An in-office fabricated PCD used for batch monitoring satisfies this definition in the same proportion that the maxill PCD does.
Public Health Ontario would follow the direction from Health Canada.
Should Health Canada eventually change the legislation to include PCDs as medical devices then indeed the PCD would require a certificate of registration which would be fair game to provide in a Public Health inquiry.
A dental office can make their own PCD test pack with bunched instruments in a bag, again this is batch monitoring and would not be regulated by Health Canada.
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 michellea@maxill.com
