Steam Sterilization: why use a process challenge device?

July 13, 2017 Sylvia Cleaver

For medical device reprocessing department (MDRD) staff, confidence in the sterilization process is of prime importance. The results of their work can gravely affect patients, the medical staff who care for these patients, and the facilities in which these patients are being treated. Choosing the right products and methods to sterilize medical instruments is serious business.

Biological indicators (BIs) are one significant tool in the sterilization process. Process challenge devices (PCDs), also called test packs, are another.

How can these valuable tools help give you the confidence you need?

Detecting sterilization process failures

Saturated steam is a critical requirement for successful steam sterilization of medical instruments. Any air in the sterilizer chamber during the sterilization process can compromise the process.

PCDs are used to assess the performance of the steam sterilization process by providing an equal or greater challenge than the most difficult item routinely sterilized. They may use different physical designs to create a rigorous challenge to the sterilizer, but they must consistently detect sterilization process failures caused by air in the sterilizer chamber.

Canadian standards for PCD use

PCDs should be used in every sterilization cycle to provide an ongoing assessment of the efficacy of the process.

According to the Canadian Standards Association’s CSA Z314.3-14, “A biological indicator contained within a PCD shall be used to test each sterilizer with a full load every day that the sterilizer is used.” But without the right challenge, the results you get from a BI may be misleading.

CSA Z314.3-14 states that the biological indicator PCD can be either a commercially manufactured product or an in-house prepared PCD. However, achieving consistency can be problematic with manually assembled PCDs, and inconsistently or incorrectly assembled PCDs can lead to false results, potentially putting patients at risk. To provide usable data, PCDs should be consistent in their makeup and physical characteristics from test to test. The standard notes that manufacturing controls used in preparing commercially available PCDs can make them more consistent in makeup and physical characteristics than a series of in-house prepared PCDs, and recommends choosing a commercially manufactured PCD and using it consistently.

The right challenge

With more than 40 years’ use in health care facilities worldwide, 3M™ Attest™ Brand Process Challenge Devices are a trusted, proven technology with a range of options to meet customer preference.

Compared to manually assembled PCDs, these pre-assembled, single-use PCDs present a consistent, accurate challenge and help minimize the opportunity for human errors.

Each 3M™ Attest™ Process Challenge Device has a quality control external process indicator that shows that the PCD has been processed, providing additional assurance that your process is correct. Single-use test packs each have a lot number to help simplify tracking. This helps you quickly identify the source of any processing failures and recall affected instruments.

With their consistency, ease of use, traceability and ability to minimize human error in the important steam sterilization process, 3M™ Attest™ Process Challenge Devices can help you save valuable resources, time and money.

3M™ Attest Super Rapid Readout Steam Challenge Pack3M Attest™ Rapid Readout Steam Pack

Learn more about how the 3M™ Attest™ Process Challenge Devices can benefit your steam sterilization process.

 

About the Author

Sylvia Cleaver

[enBio=With education that includes a post-graduate certificate in Regulatory Affairs and Quality Assurance, Sylvia Cleaver joined 3M Canada in 2013 to provide regulatory support for the healthcare division. As part of the Sterilization and Monitoring team, she provides technical support and education across Canada, including delivering training, participating in conferences and working with sterilization professionals in all types of settings. Sylvia actively participates in standards development through work on the CSA Technical Committee for Sterilization as well as on the Standards Council of Canada Mirror Committee that delivers Canadian input to international ISO standards on sterilization.],[enJob=Professional Services Specialist, 3M Health Care, 3M Canada],[frBio=En tant que membre de l’Équipe de stérilisation et de surveillance de 3M, Sylvie offre du soutien technique et de la formation dans l’ensemble du Canada. Ses tâches consistent notamment à donner de la formation, participer à des conférences et travailler avec des professionnels de la stérilisation dans tous les types de contextes. Sylvie participe activement à l’élaboration des normes au moyen de son travail au comité technique de la CSA pour la stérilisation ainsi qu’au comité du Conseil canadien des normes qui présente les observations du Canada sur les normes internationales ISO en matière de stérilisation.],[frJob=Spécialiste des services professionnels, Soins de santé 3M, Compagnie 3M Canada]

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