Adherence to established loading techniques within Central Service that allows adequate air elimination and drainage of condensate, as per AAMI ST79 – and attention to detail in proper sterilizer cycle selection can prevent processing mistakes within CS.

One disturbing trend I see in CS is that decontamination – the work involved in cleaning and disinfecting instruments prior to assembly for sterilization – is devalued. In many departments, staff view decontamination as the undesirable work. Often, the newest, least experienced and lowest paid are assigned the ‘dirty side.’ Given how critical this work is to the overall process, this is an unfortunate approach. In my observation, the best run departments make sure that all staff works on both sides of CS. This way, each worker is aware of how important properly cleaned instruments are to the overall performance of sterile processing. If you know that inadequately cleaning instruments now only puts patients at risk, but in fact, puts your fellow employees at risk (including you), you are likely to take the job of decontamination seriously.

One of the most common mistakes in both the OR and sterile processing departments is failing to actually initiate a steam sterilization cycle and then releasing the load contents for patient use. When this happens, the load has generally been inside the sterilizer chamber for a period of time that allows the chemical indicator tape and other external chemical indicators to demonstrate an endpoint response that resembles indicators from a sterilized load. Depending on the sterilization monitoring devices used, the error may not be discovered for several hours, or even days. Ensuring adequate staff training, good quality processes, and the use of sterilization monitoring devices that provide consistent, reliable, immediate results can virtually eliminate this type of error and the need to recall a load.

I believe a common mistake CS personnel make is not getting the proper training for cleaning and decontamination of medical devices. Basic training through CS courses is critical for common devices, along with advanced training for complex devices directly from the device manufacturers validated instructions for use. Another mistake is cleaning a dirty item in the clean area rather than returning it to the decontamination area — a practice that violates best practices (AAMI ST79). CS personnel may think they area helping by cleaning the devices; however, this is poor practice as it contaminates their clean work area and does not address the poor cleaning issue on the dirty side. How can a facility address poor cleaning in decontamination (manual or mechanical) if the Prep & Pack personnel cover up the problem? Of course, this leads to bioburden being found on items in surgery as the inspection process becomes less thorough the busier Prep & Pack gets.

We believe the most common mistake made regarding sterilization is the failure to [practice] due diligence during the planning and design process. This preparation would ensure that utilities – particularly steam – fall within the manufacturer’s recommended guidelines. Improper utilities can have far-reaching implications, including wet packs; superheat; soiled wrapped trays; and extended cycle times.

What is often overlooked is educating the users [about] the meaning of the specific sterilization indicators on or in each pack or container (steam indicators or steam indicator tape, etc.). We should not assume that staff – outside of [Central Service] — understand the importance of these indicators. The integrity of the entire system relies on all users understanding the process.

There are problems with instruments not being completely disassembled according to manufacturer’s instructions prior to cleaning. Another problem relates to water quality not be periodically checked (at least twice a year, ideally). Water tables may be at different levels throughout the years. When this occurs, more or fewer minerals may be in the water. The detergent settings may need to be adjusted on automatic washers. Another problem relates to peel pouches being double-wrapped with the same size pouch inside, which results in it being folded. This can interfere with air removal and steam penetration. Inner peel pouches should never be folded. Placing peel pouches inside container systems to hold small instruments or instrument parts is another problem. A Peel pouch is a container system unto itself and hasn’t been validated to be used inside a container. Use towels to secure items or purchase validated, paper bags that can be used inside a container.

There are various modalities available to sterilize instruments. CS personnel don’t always consider the sterilization modalities that are available to them for processing instrumentation and they often continue to use whatever practice has been in place, despite the availability of new technology that would help them gain efficiency and increase productivity. For example, EtO continues to be used for heat-sensitive instruments when low-temperature gas plasma sterilization technology is available and can improve productivity, reduce costs (through smaller inventories) and enhance safety for workers and the environment.

[One problem] is the lack of understanding of sterilization as a ‘total’ process (i.e., the fact that the outcome of the sterilization process is affected by all steps in the reprocessing of medical items – cleaning, assembly, packaging, sterilizer loading, storage, and distribution). We see this often within the industry. Another problem we often see is a failure to follow medical device manufacturers’ recommended reprocessing instructions, particularly with respect to extended steam sterilization cycle recommendations.

Hughes: I believe the greatest sterilization-related advancement was the introduction of alternative processes of EtO gas. Both the STERIS System 1 peracetic acid sterilizer and the STERRAD gas plasma sterilizer offer users a safe and faster method to reprocess temperature-sensitive devices.

Basile: [I’d say] the introduction of advanced, automated equipment to clean, disinfect and sterilize instruments. Machine performance can be verified with standard, commercially-available test products and methods. This means that the quality of production is higher and more reliable. Advancements of significance include the automated instrument washers for general surgical instruments, specialized washers for unique instruments (i.e., rigid lumens and flexible endoscopes), and a variety of new sterilization methods to replace manual cold sterilization of heat-sensitive instruments.

3M Sterilization Assurance: In terms of managing the sterile processing department, the growing use of computers and software to perform functions, including instrument tracking, productivity tracking and analysis, and documentation of sterilization records including monitoring results. This has allowed CS departments to better demonstrate their value and impact within their own facilities. [Another major advancement has been] the use of Attest Rapid Readout Biological Indicators. These products allow hospitals to quarantine implants and entire loads until the biological indicator result is available.

Trattler: As surgical procedures using robotic and minimally invasive techniques have evolved, the need to turn over these costly instruments has become a priority. In the past decade, ASP has shown its commitment to helping customers turn over these instruments by introducing the new STERRAD Sterilization Systems that offer a range of capacity and cycle times. STERRAD System technology allows facilities to safely and quickly sterilize a wide variety of instruments for just in time use or to be stored as wrapped sets for future use.

Hewitt: [One advancement] is the change in guidance that AAMI has given to hospitals regarding flash sterilization and the need to biologically challenge every low temperature sterilization cycle. Now, people in the OR have a much greater awareness of the potential for improper sterilization outcomes if they flash and are generally only using flash for its intended purpose. CS departments also seem to understand that running a BI just once a day instead of in every cycle is an arbitrary guideline that leaves significant potential for a problem to go undetected until after patients have suffered harm. Additionally, I believe the introduction of ozone sterilization is among the most important advancements in sterilization in the last ten years. There has never before been a sterilization method which has simultaneously shown high efficacy; low cost to operate; environmental responsibility; ease of operation; and safety for workers and healthcare providers.

Nestman: Advancements such as low temperature alternatives to [EtO], more point of use flash sterilization containers, and sterilization monitoring devices, such as Class 5 and Class 6 integrators are improving options for SPDs. The industry has also pressured manufacturers to provide hospitals with written manufacturers’ recommended sterilization parameters, which helps provide consistent results. In addition, research being done on the effectiveness of taking sterilized loads out of the chamber after the dry time is complete, rather than cracking the door, will advance the sterile processing function.

Clement: One of the most frustrating sterilization-related challenges for sterile processing personnel is keeping up with the wide variety of sterilization parameters required by device manufacturers. Common steam sterilization cycles have become a think of the past and keeping up with all the processing instructions for the many devices in a facility, along with the need for products to monitor these cycles, has become a source of much frustration and has sent manufacturers scrambling to meet customer needs. Since medical device manufacturers are not currently required to ensure that their devices can be processed using standard sterilization cycles cleared for steam sterilizers, they may not be a solution for some time. What sterile processing personnel can do is make sure they have a copy of all manufacturers’ sterilization instructions for the devices they are processing and make sure that the instructions are followed carefully.

Nestman: The biggest challenge we are seeing is SPDs trying to meet the surgical department’s demand for rapid turnover of complex surgical trays brought in by an outside vendor. It is nearly impossible to keep up with the individual sterilization parameters required for each type of specialty instrument system. As medcial device technology progresses, the SPD is faced with the constant challenge of maintaining a balance between best practice and meeting customer demands. The use of sterilization monitoring tools, such as the Class 6 emulating indicators, will greatly assist in these types of situations.

Francis: Instrument manufacturers have a wide variance in cycle parameters for particular stets, resulting in the need for specific cycles for specific goods. This results in a greater margin for staff error and can significantly impact throughput due to the need for dedicated cycles. A suggestion for improvement is the Belimed Fast Lane system. It includes the installation of a small vertical sterilizer next to two large sterilizers. This small sterilizer can run fast cycles in situations where quick turnaround is required and eliminates the need to run partial loads in the large sterilizers for sets requiring special parameters.

Carragher: [One pressing challenge is] the coordination between medical device manufacturers and healthcare sterilizer manufacturers where there is an agreement to reduce the wide range of cycle parameters being cited across current device manufacturer’s instructions. The goal for Central Service is to help standardize extended cycle parameters (i.e., Cycle type/time/temperature) used throughout the entire healthcare system).

3M Sterilization Assurance: We see two pressing issues: management of loaner instrumentation and staff training/education and retention. Hospitals need to implement loaner policies that include a requirement that the loaner be delivered to decontamination in time to be properly processed and, if the set contains implants, to allow time for the incubation of the biological indicator. Certification is a vehicle managers can use both for staff training and to create a job ladder that may improve staff retention. The 3M Attest Sterile U Network, an objective resource of educational materials, can help managers keep their staff certified and current.

Trattler: Hospitals and ambulatory surgery centers are faced with the challenge of how to sterilize complex surgical instrumentation safely and quickly to maximize OR efficiency and facilitate case turnover. We believe education and training are critical components of the process and ASP has expert Clinical Education Consultants on staff who provide in-service training to customers on all products.

Vrancich: One of the biggest challenges faced by sterile processing departments is that they are understaffed and don’t get the resources or attention they deserve. Achieving certification in the sterile processing profession should be the goal and mission of all involved, including hospital administrators. Having certified sterile processing technicians overseeing sterilization procedures would be a great first step to correcting some of the issues facing the profession.

Hennessy: The ability to sterilize temperature-sensitive instruments has given Central Service the ability to manage many of the new instruments on the market today. This also presents the biggest challenge today with manufacturers introducing new materials and designs, which can be difficult to sterilize. Ensuring that the instrument is validated for a specific sterilization process is of utmost importance when introducing new instruments into the hospital. CS departments and infection control must ensure that the manufacturers have performed sterilization validation tests on their instruments, for the specific purpose.