Streamlining Compliance Recordkeeping:Not All Sterilizers are Created Equal

March 31, 2025

Often considered the focal point of any infection prevention (IP) program and instrument processing area, sterilizers are part of a frontline defense in keeping patients safe from contaminants, especially as more procedures move to the outpatient space.

However, when it comes to helping ensure instrument processing compliance, not all sterilizers are created equal. For instance, the next generation of Midmark M9^® and M11^® Steam Sterilizers offer new features that help make instrument processing and adherence to clinical best practices (and standards) as easy and as automated as possible.

Instrument processing is highly regulated. There are a number of organizations, including the Centers for Disease Control and Prevention (CDC) and the Association for the Advancement of Medical Instrumentation (AAMI), that provide guidelines on proper procedures for cleaning, disinfecting and sterilizing instruments to minimize the risk of infection. Compliance with these guidelines is crucial for healthcare organizations to avoid legal and ethical issues and to maintain accreditation.

Proper recordkeeping is essential to ensuring compliance.

• It offers a clear audit trail that helps ensure that all instruments are processed according to the required procedures.
• It enables facilities to trace the history of specific loads and instruments.
• It helps verify that the facility is in compliance with regulations and guidelines, reducing the likelihood of occurrences of non-compliance citations, fines or loss of accreditation.
• It serves as a quality control measure to allow investigation if an issue does arise.
• It helps ensure instruments have been properly sterilized to reduce the risk of infection or cross-contamination that can compromise patient safety.

Maintaining such records can be labor-intensive and prone to human error, creating additional challenges in ensuring the integrity and accuracy of the data. This is where having a next generation sterilizer can help, allowing care teams to gain instrument processing and documentation compliance efficiencies.

Next Generation Sterilizers Streamline Compliance

These next generation sterilizers help streamline compliance recordkeeping with step-by-step instructions. They help care teams stay audit-ready with device reminders and notifications, user authentication, unlimited storage of routine care events for the life of the sterilizer, and automated cycle recordkeeping.

The sterilizers have the capability to record, store and search documentation of the mechanical performance of every sterilization cycle. This audit-ready recordkeeping ensures the necessary data is automatically loaded, backed up and organized for safe transfer and easy access.

The CDC recommends that for each sterilization cycle, users should record 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 chemical and biological monitoring.

In case of an audit or an adverse event, having these comprehensive records of instrument processing activities can provide essential evidence to demonstrate adherence to protocols and guidelines.

Design features found on some next generation sterilizers help care teams gain instrument processing and documentation compliance efficiencies and build confidence in new staff to help reduce training time. These easy-to-use design features include:

• An intuitive user interface for ensuring completion of cycle operations
• Large touchscreen for easy viewing and operation
• Preset cycles to meet parameters commonly found in instrument manufacturer’s instructions for use

Proper Training Helps Ensure Compliance

Finally, having the right sterilizer in place is only effective if clinicians and staff are educated appropriately. They need to understand how to properly use and maintain the equipment to help ensure maximum benefits and compliance. Research has found that inadequate sterilization-process training can contribute to twice as many quality errors.

This is why the next generation of Midmark^® Steam Sterilizers were designed with intuitive instructions to simplify compliance, cycle operation, and performing and recording device care. This can help reduce transcription and documentation errors, which could account for 56 percent of sterilization errors.

The Midmark clinical education team, led by professional clinical educators who specialize in proper device use and workflow efficiency, offers an on-demand training module that focuses on the basics of the instrument processing workflow, IP area design principles and sterilizer technology.

Visit midmark.com for more information on how the next generation of Midmark Steam Sterilizers  can help balance patient care with instrument processing challenges.