Because quality care and patient and healthcare worker safety hinges on the availability of properly sterilized devices, it’s imperative that the sterilization process be carefully and consistently monitored to up the level of assurance that the critical steps involved were indeed accomplished. Without process challenge devices, none of that would be possible.

"A complete quality program must employ all three tools: physical monitors, biological indicators and chemical indicators," stressed medical device sterilization consultant Charles Hancock of Charles O. Hancock Associates Inc., Fairport, NY.

While there’s no way to truly validate whether a device is sterile – Hancock explained that the interpretation of the results "is a measure of the assessment of the risk of releasing a non-conforming product" — SPD and surgical services professionals are fortunate to have a wide array of process challenge devices at their disposal to give them confidence that the various sterilization parameters have been effectively met.

"We should understand that the reason we monitor the sterilization process is to identify potential failures and thereby eliminate recalls by taking immediate corrective action. The biological and chemical indicators available today are more appropriate for our intended use than ever before," assured Hancock. "The challenge for SPD and OR professionals is to understand the capabilities and limitation of the monitors available today."

To help bridge those gaps, Healthcare Purchasing News set out to create its first-ever sterilization process indicator guide. Reaching our goal took a great deal of preparation and cooperation from vendors and sterilization experts alike. A detailed product survey was sent to the various vendors for completion and the results were carefully tallied by our team. As a result of our respondents’ efforts, we were able to feature a revealing, thought-provoking question and answer segment that addresses the current and future state of the process indicator and sterility assurance segment, as well as a unique vendor-product chart that aims to provide an at-a-view glance of manufacturers’ process indicator portfolios.

We hope you find this guide useful and that it helps put you on the path to greater assurance.

To gain a clearer, more detailed per-spective on the sterility assurance and sterilization indicator market segment, HPN went straight to the source.

The following are the manufacturer and sterilization experts who weighed in regarding customer demands, product and process improvements, and both current and future challenges:

• Charles Hancock, medical device sterilization consultant, Charles O. Hancock Associates Inc.

• Ralph Basile, vice president of marketing, Healthmark Industries Inc.

• Dan Dwyer, healthcare director of marketing, Raven Biological Laboratories Inc.

• Heide Ames, product manager, sterility assurance, STERIS Corp.

• Mariann Pierce, director of sales and marketing, SPSmedical Supply Corp.

Hancock: Over the last ten years we have seen significant improvements in our ability to monitor the steam sterilization process. United States’ participation in the development of ISO standards for BIs and CIs has resulted in improvements to the quality and functionality of both BIs and CIs conforming to those ISO standards. AAMI has adopted the ISO CI manufacturers standard and dropped its own. AAMI does not provide recommendations for how to use all ISO classes of CIs. The FDA recognizes the ISO CI document, but not all classes of CIs are cleared for marketing in the USA. There is still a lot of confusion in this area.

Basile: The industry has developed a variety of new technologies to allow for more accurate and quicker prediction of a sterilization process. This has meant safer care for patients and more efficient operation for healthcare facilities. Monitoring has spread into new areas, including new forms of sterilization, improved monitoring of older technologies (including cold sterilization) and extended into monitoring other key steps in the reprocessing cycle, including cleaning.

Ames: The last five to ten years have seen the global harmonization of several guidance and standards organizations. This is bringing the standard of care througout the world closer together. The most recent development in the United States has been the recognition of the Class 6 emulating indicator. Emulating indicators have been used for several years outside the United States. The recognition of the emulating indicator in the United States by FDA and organizations like AAMI is directly due to this harmonization. FDA has already reveiwed the harmonized standard ANSI/AAMI/ISO 11140. This standard describes the performance criteria of the many classes of chemical indcators. From that review, FDA has chosen to recognize the Class 1, Class 2 and Class 6 indicators. This means that all indicators cleared by FDA in the future must meet the performance standards of one of these classes. The other classes (3,4,5) will not be recognized. Currently, the Class 6 recognition is limited to performance standards for the emulating indicators. STERIS Corporation is introducing the first cleared emulating indicator in the United States. It will not be long before organizations like AAMI will incorporate guidance on the use and application of emulating indicators. Until then, standards organizations must rely on the manufacturer to instruct hospitals on the use and application of these products.

Pierce: The sterility assurance/indicator market has come a long ways in the past five to ten years. For example, with steam sterilization alone we now have six classifications of chemical indicators, and a choice of disposable or reusable bowie-dick test packs for use with the daily air removal monitoring of pre-vacuum sterilizers. We have biological indicators with significantly reduced incubation time, and chemical indicators whose performance parallels the performance of biological. Test packs are now called process challenge devices (PCDs) and are available with a Class 5 integrator (for routine loads), or a Class 5 integrator with a BI (for loads with implants). Lastly, most large healthcare facilities have increased their routine BI testing of steam sterilizers from weekly to daily, and a growing number are testing every load.

Dwyer: The ability to monitor sterilization cycles has become of prime importance, not only to those in cental supply but to all areas of the facilities. This importance has elevated the interest in increasing technology and education. Class 5 (integrators) and Class 6 (emulators) are the latest tools designed not only to determine if sterilization conditions were met but also that they were maintained over the course of the cycle.

Ames: Customers’ overall needs have remained consistent. They desire safer products that give faster results. They desire products that give wider safety margins and final results faster. Ultimately, instruments must arrive sterile and on time. The wider the safety margin and the faster the results, the more flexibility and confidence sterile processing management has to deliver on this promise. Customers are also looking to vendors to help solve the dilemmas they face today. The most controversial of these is extended cycles. Extended cycles are sterilization cycle recommendations given by instrument manufacturers that require the user to program a longer exposure time than is validated by the sterilizer manufacturers. The problem is not in the practice but in the sterilization monitoring of these cycles. Currently, no sterility assurance products are cleared by FDA for extended cycle applications. FDA can only clear sterility assurance products that match the sterilizer cycles that were cleared for the sterilizer. Extended cycles are not part of the sterilizer’s validated and cleared cycles. Customers must run the longer cycles because of the instrument manufacturer’s instructions, but they do not have sterility assurance products that are validated for these longer cycles.

Dwyer: Customers are looking for products that will show that their cycles are effective, not only in the end result but for the entire process from start to finish. This shows an increase in education and a developed understanding of the complete sterilization process as a whole.

Basile: [Customers are demanding] better, more reliable technologies for monitoring the various sterilization processes, including technologies that are not just provide faster results, but results that are easier and clearer to interpret.

Pierce: Today’s users demand sterility assurance products that they can trust to provide accurate results — from vendors committed to supporting AAMI standards. With operator error being the number one cause of sterilizer failure, users realize the importance of selecting products that meet their specific sterilization cycles ranging from multiple modes (e.g. gravity, dynamic air removal, and flash) to extended cycle times.

Hancock: SPD/OR Managers want timely and cost effective monitoring tools with which to work. They also want assurance as to the quality and accuracy of the monitor. They want to minimize the risk of a sterilization failure.

Dwyer: I envision education increasing and the demand for more stringent indicators increasing as well. The standards will embrace the technological advances in monitoring sterilization and changes in how cycles are monitored will happen more and more quickly.

Basile: Customers will not only demand better technologies, but technologies that help them do their job better. This includes devices and test methods which related directly to the kind of reprocessing a healthcare facility has to deal with in the real world. These technologies need to encompass the entire reprocessing cycle, helping SPD to monitor a surgical instrument throughout that cycle.

Hancock: To date, there has been very little data linking patient infections with the reprocessing of medical devices. Part of the problem has been the lack of infection control information reported by the healthcare facilities. That may change dramatically. Legislation requiring reporting of infection rates will drive public opinion to take greater note of these issues. Political demands may influence greater reliance on standards and professional qualifications than in the past. Licensing and/or registration of practitioners will take place. Political expediency may be induced to fund objective solutions to what are now commercially-driven alternatives.

Ames: With the adoption of Class 6 emulating indicators, users will have a new way to monitor critical processes like sterilization loads. These products will provide imediate results and be specific for the sterilization cycle, which widens the safety net. Emulating indicator technology may prove to be a solution for many of the extended cycle dilemmas facing customers today. Only time will tell.

Pierce: Users will continue the path of demanding products that are properly validated and consistently meet their label claims.

Hancock: The challenge for the SPD/OR professional is to sort out the fact from the fiction in commercial product sales. Longer term will be the adoption of major changes in equipment and practices reflecting sound scientific practice.

Pierce: There are many challenges facing today’s SPD/OR professional; however, the ability to provide and document continuing education is certainly one of the biggest. Mandatory certification for sterile processing personnel is now required in NJ, and being proposed in many other states. Healthcare facilities must commit to increased staff education and audit departments for compliance with best practices. While this is currently being done some of the time, to combat the real and growing presence of healthcare acquired infections, we must commit to compliance of best practices all of the time.

Ames: The greatest challenge the the SPD faces today is on-time instrument delivery. Cases have become more complex, increasing the demands to coordinate several sterilization processes at one time for one case. Instrument inventories are contantly shrinking, and more and more procedures require the use of loaner sets. Improved efficiencies are required. Most improvement comes from the equipment and processes used by the SPD. However, when it comes to load release, sterility assurance products will be pushed to release faster. Healthcare-associated infections continue to be a key measurement for hospitals.

Reimbursement policies are changing, making it more difficult to gain reimbursements for infections aquired during a hospital stay. In addition, hospitals continue to become more competitive, and the public knowledge of infection rates will change the consumer mindset. Hospitals will be looking for sterility assurance products that are more accurate, provide faster results and help to prevent the possibility of an infection, not just identify when something went seriously wrong. The sterility assurance products most commonly used today require a waiting period of up to 48 hours before results are known. Some sterility assurance products have worked to reduce this wait. For example, steam biological indicators require three hours while emulating indicators provide immediate results. Other sterility assurance products require much longer.

Basile: New technologies in sterilization, decontamination and in the tools to monitor those processes has also created confusion. Standards from bodies like AAMI, AORN, etc. do their best to keep up with these developments and educate users. But ultimately it up to the device manufacturer and the user to be sure these new technologies are put to their best and proper use.

Basile: They are. But technology has advanced so rapidly in recent years, that standards bodies and users are playing a catchup game. Documents like AAMI ST79 and the new Recommended Practices from AORN (2008) are playing a key role.

Hancock: No. Objective sources are needed. Company-sponsored presentations are now the principal source of information. This bias may have to be removed by government action.

Ames: The introduction of Class 6 emulating indicator technology for steam sterilization processes is starting to address the challenges. Still, more needs to be done for the other types of sterilization processes. Sterility assurance products play a small part in reducing infection rates and increasing SPD on-time delivery. Nevertheless, these products are critical to the safety of surgical instruments and the patients on whom they are used, so they will continue to play an important role.

Pierce: These challenges are being addressed as evidenced by many SPD/OR professionals we come into contact with daily. However, there is a long road ahead and much more support is needed from the top down throughout the healthcare industry from both users and vendors.

Hancock: My ideal sterilization indicator would be a bio-electronic device which would communicate directly with independent controls to monitor, record and control the process. Such a device would provide real time response to the sterilization process and at the same time assess process lethality to a defined living organism. I believe this is doable is we understand the mechanism of kill for a given sterilization process.

Ames: Speaking from a [science fiction] perspective, the best sterility assurance product would be one that could look at the instruments and see if there were any living organisms left on them. Such a product would, in essence, prove sterility. Unfortunately, we’re not there yet. Today’s sterilization is based on probability — the chance of a surviving organism is validated and then a safety margin is added. Today’s biological and chemical indicators monitor a portion of that validated stat,e but not all of it. The next evolution in sterility assurance will be products that measure what must be delivered to ensure the desired probabability that the devices will be sterile. In a world of probability, if you were gambling with your life, wouldn’t you want the favorite horse rather than the long shot? STERIS Corporation is introducing the next best thing in sterility assurance products today: Verify SixCess chemical indicators. These products monitor what must be delivered to ensure the desired probability. They are today’s favorite horse.

Pierce: Since steam sterilization represents over 90% of medical devices processed in healthcare facilities, the best sterilization indicator is a sophisticated device capable of accurately testing all steam sterilization modes (gravity, dynamic air removal and flash). It would be capable of showing ‘immediate’ sterilization failure in a easy to read visual way (not subjective, such as a color change) whenever users error by overloading the sterilizer, used improper packaging materials, under-processed the load (e.g. improper time or temperature) and/or experienced steam quality issues (e.g. the presence of non-condensable gases). Class 5 integrators meet this definition. SPSmedical is excited to see the widespread and growing use around the world, and believes it is a critical component in the systems approach to sterility assurance.

Dwyer: Indicators that can show the effectiveness of the entirity of a sterilization cycle will become more and more in demand as we move forward. Not only will results be instant, but they will be all emcompassing, covering and monitoring every moment of sterilization.

Healthmark

Getinge

Raven

SPS Medical

STERIS

SteriTec