Are Your Sterile Supplies Safe in Storage?

Sherry Poulos, MSN, RNC-NIC, CNL 

Healthcare acquired infections (HAI) represent a significant risk for patients and organizations. One frequent example is a surgical site infection (SSI).  

For example:¹ 

• The National Healthcare Safety Network’s (NHSN) progress report published in January 2024 identified an increase of 4% in HAI across all NHSN operative procedure categories from 2021 to 2022. 
• Surgical site infections (SSI) represent 20 percent of HAI. 
• In actual numbers, according to the CDC, inpatient surgeries in 2015 resulted in an estimated 110,800 SSI.   

One cause of SSI is critical medical equipment that contacts sterile tissues or the vascular system. How can this happen? Improper sterilization and/or storage of surgical instruments and equipment. 

You can reduce risk through proper handling and storage of sterile supplies. Align policies and practices with evidence-based guidelines from national organizations such as the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute  (ANSI), American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), Centers for Disease Control (CDC), and the Association of Perioperative Registered Nurses (AORN). 

It is extremely important to review these guidelines with each update to policy and procedure and at least annually. Knowledge advances and changes can occur at any time.

Monitoring deliveries

External shipping containers should not be brought into or unpacked in the sterile storage room due to the risk of contamination from dust, debris, and insects that may be in or on the shipping containers. Loaned instrument trays should be considered contaminated and therefore removed from the external shipping container before coming into the sterile processing area for decontamination and reprocessing. Pre-packed clean and sterile supplies that have been removed from the external shipping container may be brought directly into the sterile storage areas.² 

Location, flow, cleaning

To minimize environmental contamination of sterilized and clean supplies, ANSI/AAMI recommends locating a sterile storage system adjacent to the sterilization area with traffic restricted to authorized personnel. 

The design of the storage area should ensure that supplies are stored at least: 

• eight inches above the floor.
• five inches from the ceiling (maintaining 18 inches from sprinkler heads). 
• two inches from exterior walls. 

Air pressure should be positive relative to adjacent areas, with a minimum total air exchange rate of four air changes per hour (ACH) and minimum outdoor exchange rate of two ACH. The maximum relative humidity level is 60 percent and a temperature of 72-78 degrees Fahrenheit.^1,2,6

The flow between a central sterile department and storage should designate functionally separated decontamination areas for receiving and processing dirty items, including third-party vendor trays or bins, and a separate clean work room for packaging, sterilization, and storage of clean items. ² 

For example, in low traffic areas sterile supplies can be stored on open or wire shelves for improved air circulation, but in high traffic areas, sterile and clean supplies are better maintained in closed or covered shelves or cabinets. Wrapped packages should not be stored under rigid sterilization containers on the same shelf. They must be protected from being crushed, bent, compressed or punctured. Sterilized instruments and supplies should not be stored next to, near, or under a sink, or anywhere they can become wet.^2,4,6 

To maintain environmental cleanliness of the storage area, floors should be cleaned daily with a damp mop and the lowest storage shelves must have a solid barrier to protect against contamination when the floor is cleaned. All high contact surfaces, defined by the organization, should be cleaned using a clean, non-linting cloth following the organization’s  infection control policies and procedures.^2,3 

Shelf life

Policy and procedure should define the shelf life of items sterilized onsite, based on time or event and in compliance with the packaging manufacturer’s instructions for use. An event-related shelf-life should define issues that may contribute to a shorter shelf-life or contamination that requires reprocessing or disposal, such as the type of packaging material used, air movement, traffic, location, insects, vermin, type of shelving, or the humidity and temperature of the storage location. Items for which the manufacturer has identified a shelf-life expiration date is time-based and should not be surpassed because of possible degradation of the product or packaging. Regardless of the method used, anytime a package is past the expiration date or if the package has become wet, torn or punctured, the instrument or equipment must either be reprocessed or disposed of.^2,3,4,6 

Tips for Compliance 

Accreditation looks at the what and the how of healthcare practice. When examining sterile storage, the what and how focus on safe processes, followed consistently. These represent effective risk reduction strategies that improve patient safety and lessen the organization’s potential liability for an adverse event.

1. Make sure policies and procedures address safe storage practices and what action to take if an instrument or piece of equipment is potentially contaminated. 
2. Educate staff on storage policies and practices. Establish training updates and  competencies and monitor for adherence to policies and procedures.
3. Schedule environmental surveillance with, at minimum, an infection preventionist. Standardize surveillance to include monitoring for cleanliness of the environment, temperature, humidity, air exchanges, traffic flow, and expired and contaminated stored equipment, instruments, and supplies. 
4. Track and trend SSI rates with investigation and corrective actions implemented based on declining performance. 
5. Conduct periodic, documented risk assessments to review and evaluate evidence-based  practices in use against current evidence-based practices and recommendations.

References: 

1. Surgical Site Infection Event (SSI) National Healthcare Safety Network. 2024. Retrieved from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
2. Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AMI ST79: 2017 & 2020 Amendments A1, A2, A3, A4. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 
3. American Society of Heating Refrigeration and Air-Conditioning Engineers. Room design. In: HVAC Design Manual for Hospitals and Clinics. 2^nd ed. Atlanta, GA: ASHRAE; 2013:151-202.
4. Decontamination and reprocessing of medical devices for health-care facilities. World Health Organization. 2016. Retrieved from:  https://www.who.int/publications/i/item/9789241549851 
5. Recommendations for Disinfection and Sterilization in Healthcare Facilities. Centers for Disease Control. 2023. Retrieved from: https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/summary-recommendations.html 
6. Sterilization Practices. Centers for Disease Control. 2023. Retrieved from: https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/sterilizing-practices.html 

About the author

Sherry Poulos, MSN, RNC-NIC, CNL is Senior Standards Interpretation Specialist for acute care and critical access hospitals. Before joining ACHC, she worked as a Simulation Education Specialist and has over 20 years of experience in the Neonatal Intensive Care Unit.