Are you reprocessing your instrument containers correctly? – Part 1 Copy

While conducting a processing assessment at a healthcare facility, I noticed a steady flow of OR personnel arriving with used rigid containers. Instead of placing them in the queue for cleaning, they inverted the containers, smacked their sides, wiped them with a dry towel and placed new filters in them. After this process, the containers and their lids were stacked on a wire shelf in the assembly area. The SPD technician then retrieved these rigid containers to place newly cleaned instruments for sterilization in them.

When asked about the process, the technician stated, “If the container leaves the surgical suite before the patient comes into the suite, we don’t send the containment devices back to the SPD decontamination area for cleaning. Instead, we bring the containers directly to the clean side for instrumentation assembly and packaging. We don’t have the time or space to clean them and they’re not dirty anyway. We have been handling our containers this way for years!”

Stunned, I turned to the sterile processing manager, who immediately recognized the problem and knew corrective action was required to achieve best practices. Not only were the containers’ instructions for use (IFU) not being followed, but it was clear that staff didn’t realize they were jeopardizing patients, colleagues and the facility.

Why clean all containers every time?

Container systems, which are medical devices, protect instrumentation during and after sterilization. In the course of their use, containers may be exposed to environmental and procedural contamination. Without proper cleaning and decontamination, those contaminants can be passed on to sterile processing staff who work with the containers, potentially causing injury or illness.

Those same residual contaminants could contact instruments and shield microbes from the disinfection or sterilization process. This could result in patient exposure in the OR, which could lead to an infection. In addition, residual procedural chemicals or disinfectants transferred to instruments can injure patient tissue during the procedure, which can complicate recovery and, in some cases, cause permanent disabilities like blindness.

Injuring patients and staff can have large ramifications for the facility. For example, in addition to the personal consequences to patients and staff, both the facility and the patient can incur increased costs due to required additional treatment. Facility reputations can also suffer, which can reduce the number of elective patients and ultimately reduce revenue. Ultimately, the failure to properly follow the IFU can lead to accreditation citings and the potential of losing reimbursement status.

Instrument containers serve a critical function in the surgical department. Staff must take the time needed to properly care for them.

Guidance for manufacturers

A number of organizations provide guidance to packaging manufacturers and to users. The sources most commonly used in the U.S. are the Association for the Advancement of Medical Instrumentation (AAMI), Association of peri-Operative Registered Nurses (AORN), and International Association of Healthcare Central Service Materiel Management (IAHCSMM).

There are several different types of packaging used to maintain the integrity of sterilized medical devices. These include peel pouches, woven fabric (muslin, which is rarely used now), non-woven disposable wrap, and rigid containers. Packaging manufacturers must validate that the packaging/containers they offer ensure sterilant penetration into the contained medical devices, and that they prevent ingress of microbial contaminants and maintain instrument sterility throughout handling, storage, transport and aseptic presentation in the OR.

Manufacturers of rigid container systems turn for guidance to ANSI/AAMI ST77 Containment devices for reusable medical device sterilization. ST77 covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. Rigid container manufacturers are responsible for providing thorough IFU that include safety and effective use, routine maintenance and inspections, generalized information on their medical device validation testing, weight limitations and design characteristics, and the proper cleaning and decontamination modalities to use. For example, Section 4.3.2 – Decontamination states that containment devices and their reusable accessories need to be properly cleaned and decontaminated after each use via manual or automated processes per the manufacturer’s IFU. Section 4.5.2 – Instructions for use discusses several components needed by the end users to assist with the use of the manufacturer’s containment devices.

Guidance for container users

Users of rigid sterilization container systems typically defer to the appropriate guidance document for each sterilization method used at the facility. These include:

• ANSI/AAMI ST79: 2017. Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
• ANSI/AAMI ST41: 2008/(R)2012 Ethylene oxide sterilization in healthcare facilities: safety and effectiveness.
• ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in healthcare facilities
• AORN Guideline: Packaging Systems

These guidance documents help SPD managers establish standard policies and procedures for workflow instructions in their departments. The container manufacturers’ IFU also play a vital role in establishing care and use instructions. Before purchasing a new container system, sterile processing management should conduct a pre-purchase evaluation and request written manufacturer’s IFU to ensure that their department can follow the validated cleaning and decontamination steps required for that containment system. The validated method of cleaning containers can be very detailed and can include the required cleaning agent, manual cleaning steps, mechanical cleaning steps, and disinfection process to use before loading instrument sets for sterilization.

Both AAMI and AORN state that containers should be cleaned and disinfected as soon as possible after each use. They also advise to:

1. Follow the manufacturer’s written IFU
2. Include instructions for manual cleaning, mechanical cleaning or both
3. Use cleaning agents that don’t damage the container or its components (seals, filter retention plates)
4. Follow accepted practices for decontamination and employee safety, including wearing of PPE