Steam sterilization times have increased over the years as medical instrumentation has become more complex. Lumens imbedded in newer devices require lengthy exposure for the sterilizing media to properly decontaminate them. These instruments feature tiny tubes and crevices that are hard for steam to penetrate. The Association for the Advancement of Medical Instrumentation (AAMI) continues to adjust their guidelines and recommendations regarding cycle times for the sterilization of complex instruments. These also apply to combination loads. The Technical Information Report (TIR) 31 has been updated this year so that manufacturer recommendations for various devices requiring longer cycles are consistent.
Extended sterilization cycles of 10 to 20 minutes of exposure (or more) can seriously delay the delivery of critical surgical instruments to operating rooms. This is because many other instruments do not require lengthy processing. Devices or sets of surgical instruments that must be processed using a lengthy cycle may end up requiring a dedicated autoclave just to handle these special needs. This prevents SPD technicians from using that particular unit to run quick loads. A sterile processing and distribution scheduling nightmare can ensue.
Exposure times are set based on scientific data to ensure efficacy of the process for each particular instrument. All sterilization procedures must be documented. End users are not allowed to simply create their own standards. Instead, they must follow the guidelines and recommendations distributed by the manufacturers and the relevant associations who create publications compiling this information. However, manufacturers will listen to the complaints and concerns of their customers. Whenever possible, they will adjust standards based upon a combination of the scientific data and their client’s needs.
Of course, such changes do not occur overnight. They require good communication between vendors and end users. This also means there must be greater communication between physicians and sterilization departments. Everybody associated with or using an autoclave needs to be “on the same page”. Surgeons must be aware of the standard operating procedures at the facility where he or she practices. Understanding the entire process can prevent delays in instrument turnaround. This lessens the pressure placed on hospital personnel to use less effective flash sterilization procudures.
New Combination Products
A number of pharmaceutical and biologic delivery systems are currently being developed. These are often blood driven and may include stem cell therapy. The unique sterilization requirements of these products are currently pushing rapid invention in the autoclave field. These new and highly innovative sterilizers will require a lengthy FDA approval process
Safety is not just about being able to adequately sterilize a load. Cycle times and temperature standards must also be met so that the instruments themselves are protected from wear and tear. If materials are damaged because of the sterilization procedure, this defeats the purpose of recycling these devices. New autoclave designs must also be proven free from defects that could harm the technicians operating them.
The current poor economy has prompted manufacturers to focus on the development of near term solutions. In other words, they probably won’t worry about the long term implications of their upcoming sterilizer designs until these complex devices are actually approved for medical use.
If you are unsure about which autoclave you should purchase for a specific application, please read our report for free information.