Raising the Standard to the Standard
By Becki Harter, CST, RCST, CRCST, FEL
Too many times in recent years, I have discovered that there are deviations to the standards of practice. It seems in some instances that a nomenclature standard has emerged to take the place of the current standards. Healthcare systems are replacing best-practice standards with common-practice standards because they are unable to make concession with the varied medical device requirements that seem to ignore the universally accepted standards designed to protect patients, not industry. The use of substandard practices in an attempt to make all-over-the- chart sterilization cycles and weight configurations fit into a healthcare environment is rampant.
For the most part, segments of industry have been allowed to ignore the patient-safety needs of the healthcare systems they serve. This is not to say that all manufacturers are at fault, but it is surprising to see that some manufacturers routinely ignore standards of healthcare practice, and in fact, vehemently oppose the acquisition of clarified regulatory protocols that will help them get back to and or raise the standard so that patients are duly served and protected.
There is a strong opposing voice by some in the orthopedic industry who have expressed their disdain for raising the standard to the standard. This voice of opposition largely stems from the fiscal fact that it is going to require further testing and in some cases the implementation of testing for the first time of many of the current devices being used in healthcare to include sterilization packaging systems, all of which will cost time and money.
Not all orthopedic manufacturers feel this way; however, there is a proportionate number who do. These manufacturers have gone to great lengths to undermine the standards and to negate existing regulatory protocols concerning orthopedic systems and the provided packaging systems they are shipped, organized and sterilized in. These opponents have written letters to the Food and Drug Administration (FDA) positioning themselves against positive patient-safety directives and have told the healthcare industry that these protocols and recommendations/regulations are erroneous and not needed.
These manufacturers have threatened the standards body as well as the FDA. Orthopedic device manufacturers that agree with this stance create the most risk for your patients, and should receive a clear message form healthcare that we will accept nothing less than the best for our patients. Nothing says what we must have other than purchasing practices that exclude any manufacturer that will not adhere to the standards and regulatory protocols put in place to provide safe effective devices to patients. If it cost too much to do the right thing it will cost even more to continue to do the wrong thing if healthcare bodies refuse to allow these manufacturers in their facilities until the appropriate work has been done and universal standards, regulatory protocols and device guidelines are met. The cost incurred by orthopedic manufacturers falling outside of the protocols to get on the same page is by far less than injury that may pass to patients, including potential for deathno price can measure the value of a life or the quality of that life.
What can we do? Healthcare has got to take a stand. We have got to stand behind the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) standards. Deviation from best practices according to the best standards cannot be allowed to exist in our facilities. We must be the driving force that helps industry understand that we take our patients safety seriously. Healthcare must adhere to and completely understand the universal standards, and insist upon nothing less from their facilities and from the healthcare device manufacturers they choose to assist their patients on the road to good health. As a unified force, we must start asking questions and insisting upon the right answers. We have got to stop allowing manufacturers to dictate or manipulate the standard to fit their products, leaving healthcare to clean up the mess that creates.
What are the issues?
- Universal published healthcare sterilization cycles need to be strictly cleaved to. What are the universal published standard sterilization cycles? This cycle information is readily available in the owners manual of your sterilizer. It is also true that deviation of sterilization cycles away from the sterilizer manufacturer recommendations can void warranties and if not validated using AAMI ST8 (healthcare cannot validate but verify), can find the healthcare facility in violation of federal and local/state laws, and can cause such a facility to lose accreditation for insurance carriers if discovered. This information is also available for review in your sterilizer manual.
- Adhering to recommended weight limits by sterilizer manufacturers that have tested for sterility assurance levels (SAL) using test configurations weighing 16 to 20 pounds that will best support the SAL. While it is true that SAL can be achieved in weights exceeding 16 to 20 pounds, it is also true that your sterilizer manufacturer will not stand behind this and it is more difficult to stay within the universally available standard sterilization cycles to include dry times when this practice is allowed. Ergonomic considerations, being secondary, cannot be dispelled, as workman comp claims will rise as the recommended weight limit continues to be largely ignored. Variable cycles and configuration requirements place undue stress on already time-constrained departments trying to make productivity levels, sterilization requirements and customer service demands work when there are many times that an entire load that could contain up to 18 sets has one set in it; this is because the sterilization requirements are outside of the universally recommended standard for healthcare.
- The key proponent issue is the use of Class I organizing trays, cassettes container and container systems inside of a sterilization process that does not have test data to support efficacy nor SAL the argued point being that because these devices do not maintain sterility the Class II 510 (k) requirement does not apply. However, these devices are accessories to the sterilization unit and can have a positive or negative impact on the ability of the sterilization unit to penetrate all surfaces of the containment device as well the medical devices contained with in them. Thus, they are indeed Class II medical devices and are held to the regulatory protocols for such devices to include:
- Cleaning /disinfection
- Sterilization methods as proven by manufacturer to include use of universally available cycles and parameters
- 510(k) Pre market approval
- Ignoring the standard will not make it go away but it will adversely affect the outcomes of your patients health.
Many manufacturers and healthcare providers agree that the return to universal standards is long overdue. The purpose of standards is so that best practices can be achieved universally. This is why it is called a standard. To expect yo-yo, all-over-the-map instructions for use, sterilization cycles, crazy weight limits and unrealistic device designs to ever support positive patient care outcomes, is not prudent. Some manufacturers will say that there is no way to meet the device demands with such limitations, but this is largely untrue manufacturers that support patient safety achieve this every time they develop a new device or upgrade a pre-existing one to include containment devices (sterilization trays, cassettes, containers and container systems) within the universal healthcare standard.
This information is not meant to tread on any one facility or manufacturer, but to recognize that a very real problem needs to be actively addressed considering the importance it has upon patient safety. We cant act as is everything is OK when there are some very serious and potentially life-threatening practices going unchecked or uncorrected within our system, which includes device manufacturers.
Many device manufacturers have recognized the need to upgrade their protocols and have made great strides in maintaining and raising the standard to the standard. Healthcare facilities are becoming more aware and increasingly more involved in the standards process, but we need everyone to get involved, either in practice or in process. Our patients cannot afford for us to turn a blind eye or to continue with a this is the way it has always been attitude. The truth is, in some cases, it is poised the way it has been done, but not the way it was supposed to have been done according to the standard.
We simply must raise the standard back to the standard. Getting something through regulatory is not half as important as making sure the results are universally achievable and repeatable in healthcare. Never lose sight of who we are really working for. We are not trying to save industry time and money; if manufacturing practices are done properly the first time, interest on both sides can be achieved and fiscally tolerable. We are not trying to get things done as fast as possible without consideration to patient safety. Our sole driving purpose should be to provide the best care, reaching the best results for, the No. 1 reason for doing what we do our patients.
Becki Harter, CST, RCST, CRCST, FEL, is president and CEO of Indianapolis-based consulting firm Sterilization By Design.