Up and Coming Standards:
What Every SP Professional Needs To Know
BY BECKI HARTER CST, RCST, CRCST, FEL
Every so many years it becomes time to review and look at the existing standards. Are they where they need to be to meet the needs of our patients, for protection and infection control safety issues that will always be the underlying focus of any standard or standard of practice? Have they kept up with the growing innovations of new technology arising in healthcare today? Are there standards that need to be developed to address those new technologies? Are there existing standards that need further development or clarification to address the growing needs of the healthcare environment?
These are all questions that need answers. There are organizations whose sole purpose of existence is to address these types of questions and to develop standards and regulations that meet the safety requirements for patients. The Food and Drug Administration (FDA) and a division of that branch, the Center for Devices and Radiological Health (CDRH) address regulatory requirements for medical devices to include labeling, marketing and development of devices to be used in healthcare. The office of compliance regulates and monitors requirements adjunct by the Office of Device Evaluation (ODE) within the CDRH.
At times the FDA will call for development of standards based upon regulatory safety/marketing requirements, and protocols to help healthcare and the healthcare industry comply with and understand the regulatory requirements according to standards of practice for the safest patient care. One such organization is recognized as the standards leader in the United States. This organization is often called upon by the FDA to develop standards for regulatory requirements, or is referenced to clarify current standards before development of a regulatory protocol. This organization is also referenced by healthcare end-users that will use the current standards to create guidelines, policies and practices that will best support the patient population and address safety concerns with the best possible information and practices available.
This organization meets several times a year to review and create standards, and make changes where needed to keep our patients safe and stay one step ahead of an ever- growing medical technology. The same organization welcomes input from a varied sample of the healthcare community to include; members of industry, independent consultants, and healthcare end-users, members of the FDA and its own organization or other related participants. This allows a good overview of the current practices and the effectiveness of the standards as well as the opportunity to see where further development or clarification may be needed.
The organization that takes the lead in healthcare standards of practice is the Association for the Advancement of Medical Instrumentation (AAMI). The efforts and integrity of this organization should be and are applauded because AAMI has committed itself to positive patient-care outcomes based on the best practice using the best standards available.
So what is new? What is in revision? Is there anything the healthcare community needs the heads-up on? What is in progress? How does this affect your current practices?
One of the largest areas being addressed right now is sterilization. There are new technologies that have been around for a few years but have not been included or clarified in the standard. There are new testing materials available that must be addressed in the standard as well.
Everyone knows that there are different methods of sterilization, to include: gravity displacement steam sterilization, dynamic air removal steam sterilization, EO sterilization and hydrogen peroxide plasma, not excluding Parecetic acid. There is, however, another form of steam sterilization not yet addressed in the standards, and that is steam-flush pressure pulse (SFPP). This particular steam sterilization method operates much like dynamic-air removal with a few distinct differences that warrant review and potential mention, and/or notation within a standard to include potential cycle differences that most healthcare facilities may not be aware of.
Another practice up for review and/or inclusion may be immediate read biological indicators for steam sterilization. There is, however, some investigation into the efficacy and reliability of these devices and of course, FDA approval for use, once scientific data can be acquired to support immediate readout biological indicators used as the verification method for sterilizers in clinical use instead of the current practice or in addition to the current practice for when implantable devices are used. There is a good amount of intrigue surrounding this development, as an immediate readout would allow for assurance of sterilization efficacy in a minimal amount of time. Especially where implantable devices are used, and an immediate read out would be valuable and recordable on a patients chart. Concise investigation and FDA approval practices/protocols must be maintained and carried out before this process makes its inclusion in a sterilization standard.
Verification indicators for washers, washer sterilizers, washer decontaminators and sonic machines have become an issue of controversy and a welcome innovation toward raising the standard to the next level. The premise behind the verification devices for washers, sonics and related equipment for cleaning, disinfection and decontamination is that if we can verify the parameters of our sterilizers by using scientific, data-supported devices (Biological, Dart and Bowie Dick test) that verify and document sterilization efficacy, we should verify with the same tenacity those devices that clean, disinfect or decontaminate medical devices prior to sterilization as the critical step it is in the overall processing of medical devices.
There is some trepidation by manufacturers as to how the introduction of verification devices for decontaminators and disinfection devices may affect the industry, how these devises are made and developed for testing, and if the results reliable. Some of the questions that arise are: How does it work in different manufacturers devices? What kind of liability will this incur for manufacturers? Healthcare? Is it needed? Should it be a standard?
The overall clinical response is that it makes perfect sense to verify the working parameters of any device used in the sterilization process from cleaning/disinfection, decontamination to terminal sterilization of the medical devices. The logistics of how we get there remain to be visualized, and a pathway for a standard concerning these devices will definitely raise the level on the current practice. It is one more way to measure, record and protect the safety or our patients.
There are manufacturers that have successfully developed the verification indicators for cleaning/disinfection and/or decontamination devices that are approved by the FDA, and have been found effective in verifying the process. No doubt, the jury is still out on these verification devices. However, it is coming, and whether or not these devices are included in the current standard, or tabled for future review, the practice of verifying parameters for all medical devices involved in the processing of medical devices/instrumentation is a very good modality toward the next level in the evolution of healthcare standard practices for patient safety.
As new bugs and challenges arise in our healthcare delivery systems, it will be increasingly important to be able to verify every step of the process. The manufacturers that have developed these types of devices will be one step ahead, which is where our standards of practice should always be.
Containment devices for Reusable Medical Device Sterilization is a standard under development. There is a standard for rigid container systems, but it does not include containers, organizing trays or cassettes that must be wrapped prior to sterilization for sterility assurance. The FDA requested that AAMI develop a standard that includes these devices. The key issues are:
- Labeling requirements
- Performance requirements for containment devices intended for use in sterilizing reusable medical devices in healthcare facilities.
It was recognized by the FDA that clarification was needed for these devices because there is confusion among some of the healthcare device manufacturers as to the classification, regulatory requirements and responsibility/accountability for containment devices for instrumentation to include organizing trays, cassettes or containers that need to be wrapped prior to sterilization. These devices are Class II medical devices and require the same attention to labeling and performance standards as do Class II rigid sterilization containers such as closed container systems, sterilization wrap and pouches and any other devices used to enclose and allow sterilant to penetrate and or maintain sterility of medical devices/instrumentation and equipment.
Items included in the discussion and development of the inclusive standard are:
- General considerations: durability, compatibility with the sterilization process, corrosion resistance, heat transfer, and biocompatibility.
- Design consideration: decontamination, perforations, stacking, gaskets, filters, valves, handles, lid/base, latching mechanisms, tamper evident closure and attention to recommended sterilizer manufacturers for weight, distribution and configuration.
- Sterilization requirements: documentation, drying, sterilant residual (if applicable), sterility maintenance, device markings, instructions for use to include sterilization cycles available and achievable in healthcare.
- Testing requirements: biocompatibility, gaskets, filters, valves, sterilization methods, test configurations, load configurations, cycle operations, standard drying times, sterilant residuals (if applicable) and sterility maintenance.
This standard is being developed largely for manufacturers to use as a guideline for containment device production/manufacturing. This standard will not cover the end-users purchasing practice, but will be available to end-users as a tool for choosing containment devises or systems for instrumentation, medical devices and equipment to be placed into a sterilization process.
This is not to say that all manufacturers of containment devices are not doing what is needed or required; however, there are manufacturers that are not on the same page as the standard and/or regulatory protocols concerning these devices, and therefore, need further direction and guidance to get there, to include classification, and standard recommendations for these devices.
This standard will be a tool, guideline and recommendation for that purpose as well as an additional link in the overall chain of patient safety directives.
What can healthcare practitioners do in the meantime?
- Insist upon Class II 510(K) FDA-approved containers/container systems, organizing trays or cassettes that adhere to the FDA Premarket notification/labeling and classification requirements for such devices and meet the necessary standard healthcare requirements for: weight, configuration and density.
- Published standard sterilization cycles available in healthcare according to the sterilizer manufacturer(s) recommended validated cycles to include standard recommended dry times ¡ Research and purchase systems that meet the needs of the device placed in them and the validated sterilization cycles according to the healthcare standard, without deviation.
This also includes and applies to manufacturers and distributors that provide packaging with their instrumentation (i.e., orthopedics: total systems, implantable devices and instrumentation, and neurological instrumentation/ equipment and implants).
These are just a few of the things that are on the ballot, so to speak, that the healthcare industry needs to be aware of, but certainly not limited to. It would be difficult to comment on all the practices under review in one article, but these are some of the key topics under the magnifying glass.
Central service departments will find the changes, clarifications, developments and adjustments of special interest in that these departments are major key components of the infection control process certainly because the infection control arena begins and ends in CPD/CS departments. Infection control, risk management departments and directors of departments where sterilization processes occur or sterile items are received, returned or distributed, will also hold a candle of interest in the coming years as standards are upgraded, developed or maintained.
There will never be a time when standards are not under review at one time or another or developed, as practices and technologies will always be changing, and innovations created to meet the demands of an ever-changing patient nomenclature will undoubtedly continue for centuries to come. Professional organizations, healthcare facilities and regulatory bodies committed to patient safety will assure that the proliferation of the best practice according to the best standards available will be a constant legacy and banner for the safest healthcare possible without exception.
Getting involved in the process for standards development has been an education all by itself. Because of the participation in the various committees that are among my scope of practice, a greater understanding and respect for those that have committed themselves to the hard work of protecting patients has been heightened, along with the awareness of what must be done along side my colleagues and peers. Encouraging involvement in professional standards organizations is paramount in every aspect of a patient advocates walk. The need for more clinical participants is greater now than ever. Take the time to get involved, make a difference and be a part of the overall process to which we are governed and aspire to and our patients depend on.
Becki Harter, CST, RCST, CRCST, FEL, is president/CEO of Indianapolis-based Sterilization by Design and 2003 winner of the Becton Dickinson Career Achievement Award.