Autoclaves for Orthopedic Surgery: Best Practices to Follow

In order to ensure patient safety and achieve successful surgical outcomes, orthopedic surgery centers (OSCs) need to sterilize all equipment — including implants — before use. As demand for total joint surgeries and outpatient procedures increases, so, too, does the total volume of implants, instruments, and other equipment that requires processing. Steam sterilization is one of the most effective forms of medical sterilization, offering the safety, efficiency, and affordability orthopedic surgery centers require, all without damaging important loads.

Challenges Associated with Sterilization in Orthopedic Surgery Centers

Orthopedic surgery centers face a wide variety of challenges related to sterilization, including:

• Orthopedic implants must be reprocessed before each use and may require multiple reprocessing cycles, which can affect the quality and safety of implants.
• Certain sterilization methods, such as ethylene oxide, radiation, and dry heat, are not compatible with certain implant materials. Additionally, some sterilization methods can leave chemical residuals on implants, compromising their integrity.
• Biofilm has the ability to survive common forms of sterilization for orthopedic implants, such as flash autoclaving.
• Orthopedic surgery centers have large volumes of implants and instrumentation that require sterilization before use. These volumes can lead to high throughput demand with limited sterilization resources.
• High volumes and throughput demand also call for faster, more efficient sterilization methods, as long processing turnaround times can negatively affect surgery scheduling and patient safety.
• Much of the equipment that orthopedic surgery centers need to sterilize is very small — for example, screws are a common implant — and, therefore, at risk of getting lost. As a result, orthopedic surgery centers require specialized trays to reduce the risk of items being lost or misplaced during sterilization; these trays must also be sterilized to ensure patient safety.
• Orthopedic surgery centers use unique equipment, such as saws and drills, which have different sterilization requirements than other types of instrumentation.
• Finally, space is at a premium in orthopedic surgery centers, which means processing rooms often require creative configurations in order to meet volume and throughput demands.

Steam sterilization — also known as autoclaving — solves many of these problems. Unlike other forms of sterilization for orthopedic implants, steam sterilization does not leave behind chemical residuals or biofilm and does not degrade the quality or safety of implants after multiple rounds of reprocessing. Steam sterilization is also compatible with almost all orthopedic surgery center equipment, including implants, instrumentation, and metal trays.

Sterilization on the whole is a highly efficient process, and autoclaves can process large volumes of equipment in a single cycle, optimizing throughput. Depending on the manufacturer, autoclaves can also be custom-configured to accommodate spatial constraints and can be equipped with water- and energy-saving features to reduce an orthopedic surgery center’s operating costs and environmental footprint.

How to Choose the Right Autoclave for Orthopedic Surgery

Steam sterilization may be the most effective form of sterilization for orthopedic implants and other OSC equipment, but not all autoclaves are made alike.

Before evaluating potential options, consider the following:

• What types of loads you typically sterilize
• The size and volume of a standard load
• The amount of available space in your sterile processing department
• Which utilities you require
• What your water source will be (tap or purified)
• Whether you require a steam generator
• Whether you need water- and/or energy-saving capabilities

These factors will help you determine what type of autoclave you require, what size autoclave you require, what features you require, and if you need more than one autoclave. As a general rule of thumb, most orthopedic surgery centers typically have two sterilizers — a primary sterilizer and a backup sterilizer for contingency planning purposes.

Once you’ve defined your requirements, you can begin your search in earnest. When talking to autoclave manufacturers, be sure to ask the following:

• Do your autoclaves have FDA clearance?
• Do your autoclaves comply with industry standards, such as ANSI/AAMI ST8:2013?
• Can your autoclaves be custom-configured according to your facility’s needs?
• Are replacement parts for your autoclaves proprietary or commonly available?
• Do you offer preventative maintenance plans for your autoclaves?

For a full download on how to find the right autoclave for an orthopedic surgery center, we recommend reading our eBook, “17 Questions to Ask Before Buying a Medical Autoclave.”

Steam Sterilization Best Practices for Orthopedic Implants

Given the high volume of implants and instruments in need of sterilization, orthopedic surgery centers need to optimize for efficiency. Here are some best practices to help ensure success when using autoclaves for orthopedic surgery centers:

• Plan Ahead: Review the schedule for upcoming surgeries and procedures and determine which instruments and implants you’ll need. This will help you make more informed decisions about load configuration and will maximize autoclave uptime.
• Monitor Your Autoclave: Per AAMI ST-79, every sterilization load should be monitored with a physical monitor and a chemical indicator monitor. To meet this requirement, orthopedic surgery centers should run a Bowie-Dick test after the warm-up cycle and before the first load. They should also use a biological indicator (BI) with an implantable load on a weekly — preferably daily — basis. In addition to ensuring safety, regular monitoring is a smart way for OSCs to verify that their autoclave is working properly.For additional details, refer to the screenshot from AAMI ST-79 explaining the process for monitoring devices, shown below:

13.6.1 Process Monitoring Devices

Every sterilization load should be monitored with a physical monitor and chemical indicator monitor.

Every sterilization load may be monitored with a PCD containing

• a Bl;
• a Bl and a Type 5 Cl (integrating indicator);
• a Bl and a type 5 Cl (emulating indicator);
• a Type 5 Cl (integrating indicator); or
• a Type 6 Cl (emulating indicator).

A Bl PCD should be used at least weekly and preferably daily.

• Choose the appropriate cycle for each application or load type. For example, wrapped instrument trays and fabric packs require a pre-vacuum cycle. Choosing the right cycle prevents goods from being damaged and ensures complete sterilization.
• Wear the appropriate safety equipment when autoclaving. Autoclaves achieve sterility by applying heat and pressure to goods; as such, autoclave operators should take appropriate precautions. It’s important that orthopedic surgery centers provide autoclave operators with the appropriate safety gear and that operators closely follow safety guidelines.

For more autoclaving best practices — or to find the right autoclave for your orthopedic surgery center — contact the Consolidated Sterilizer Systems team today.