Learning Objectives:
- Discover the importance of the previously-issued HAN 00382 and its regulatory impact on the SPD reprocessing work for which SPD leaders are responsible.
- Discover various challenges to achieving best practices in SPD departments.
- Discover the renewed need to overcome these challenges by cultivating a culture of best practices and Instructions for Use (IFU) compliance within SPD departments and among SPD technicians.
Introduction:
On September 11, 2015 the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) jointly issued HAN 00382---"Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices." This advisory states that all healthcare facilities that reprocess reusable medical devices should immediately assess their reprocessing activities to ensure that all cleaning, disinfecting, and sterilization activities are being done in accordance with the recommendations of medical device manufacturers as well as in accordance with current standards and guidelines. In fact, HAN 00382 recommends that all healthcare facilities involved in medical device reprocessing should immediately arrange for a “healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures” to ensure that they are safe, current, and valid. Included in this advisory is a recommendation that SPD technicians receive training upon hire, annually thereafter, and whenever new devices are introduced into the facility. One crucial focus in this advisory is that all healthcare facilities should "ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer." Such an emphasis on manufacturers’ recommendations and compliance with FDA-cleared Instructions for Use is not new to the SPD world as this has long been a feature of ANSI/AAMI ST79. What is new in the current day is that this is now being spoken of directly from a regulatory perspective by the CDC as well as the FDA.
The 21st century has brought many changes to the SPD world. Never before has there been such an intensive focus on compliance to FDA-cleared Instructions for Use, issued by the manufacturer, which prescribes how a given medical device is to be reprocessed. Compliance with these manufacturers' recommendations is an obligation that all healthcare facilities now must fulfill. Compliance with these manufacturers' recommendations has also become the essence of achieving best practices. No longer can SPD leaders allow their technicians simply to clean, disinfect, and/or sterilize medical devices following the general practices of the past. Instead, SPD leaders and technicians now must always ask, check, and verify how a medical device is to be reprocessed. Healthcare facilities today are under more pressure, and possess a weighty obligation to ensure, that best practices are being practiced and cultivated in their facilities in behalf of their patients and staff members. SPD leaders and technicians play a crucial role in achieving best practices in regards to medical device reprocessing.
Given the introduction above, one might think that it would be a straightforward thing to achieve best practices in the SPD world as anything else would be negligent and substandard. Anything else would endanger patient safety. Anything else would be immoral, unethical, and potentially illegal. However, this is not a straightforward matter in that there are many challenges to achieving best practices in the current healthcare setting. The purpose of this lesson is to highlight various challenges to achieving best practices in the SPD world in the 21st century and to focus on how SPD leaders can help to overcome these challenges in their departments.
Challenge #1: Rest Practices---Relying on doing things the way that they have been done in the past---Resting on Past Practices.
Whenever SPD professionals seek to solve a problem, or overcome a challenge, it is frequently best to look in the mirror to make sure that they are not contributing to the problem or failing to appreciate the challenge before them. This author has been sterilizing surgical instruments for more than 20 years. Looking back, the unfortunate fact is that best practices and manufacturers’ recommendations sometimes were rarely spoken of. Instead, SPD department leaders and technicians frequently spoke of simply how---we do it here (without regard for or consideration of what the manufacturer of the device actually recommends). This mentality/situation can be called rest practices as reliance on how things have been done in the past is seen. If SPD leaders and technicians are willing to simply settle for how things were done 20 years ago there is almost no chance that best practices are being implemented or practiced in those healthcare facilities.
According to ANSI/AAMI ST79 those people who are responsible for medical device reprocessing are to be certified to perform this function. Also, ANSI/AAMI ST79 states that SPD department leaders are to be certified as leaders (not as technicians) in the field of sterile processing. If technicians are certified to be technicians and leaders are certified to be leaders, then resting on past practices will not be seen as an option. Instead a culture of asking questions as to what the medical device manufacturer actually recommends will develop which will enhance a department's ability to perform their cleaning, disinfecting, and sterilizing functions in a safe and legal manner. On the contrary, if these questions are not asked, and if SPD leaders and technicians are not willing to go out of their way to verify the validity of their practices, then it is possible that these SPD professionals are simply settling for rest practices instead of pursuing best practices. Such a practice is no longer valid in the SPD world from a regulatory perspective.
The following is a list of what can be called rest practices:
- Placing past facility practice and custom before current IFU requirements
- Not devoting time and energy to verifying that facility practice satisfies IFU requirements
- SPD leaders not allowing their technicians to ask questions and to ensure that current facility practice satisfies IFU requirements
Challenge #2: Rust Practices---Settling for working with outdated protocols, equipment, supplies, and policies.
Another challenge to achieving best practices in the SPD world relates to protocols, equipment, supplies, and policies that are/can be extremely outdated. As the current regulatory focus on IFU compliance requires SPD leaders and technicians to be more and more aware of manufacturers' recommendations, this can be a difficult challenge as these documents can be extremely detailed and intricate. As SPD department leaders review their reprocessing protocols, they will likely find that many of those protocols, some of their equipment, some of their supplies, and many of their policies are outdated/no longer valid. In fact, this situation will require SPD department leaders to rewrite policies, retrain staff members, and consider the purchase of new equipment and supplies. This will be a challenging task that SPD leaders must face and overcome. It is a task that will require interaction with, and support from, facility management and administration. Especially support from Infection Control/Epidemiology departments. This is a task for which both time and money will need to be allocated in order to ensure that reprocessing activities are being done correctly.
All SPD department leaders face limitations as to their ability to properly reprocess the medical devices entrusted to their care. Facilities are built with different designs, have different staffing levels, and have very different budget allowances. In spite of these limitations, all SPD department leaders at this time are under a fresh mandate to review their reprocessing activities, retrain their staff members, and update their reprocessing protocols, equipment, supplies, and policies. Failure to do this will result in medical device reprocessing being done with rusty/old/outdated equipment and protocols which will not meet the current mandate to reprocess all of these devices according to the FDA-cleared Instructions for Use which are issued by medical device manufacturers. The required updating of department policies and protocols will be time consuming and difficult. Yet, this is the---only way forward---for SPD leaders to ensure that their technicians are performing their reprocessing work according to legitimate, current, and legal standards.
The following is a list of what can be called rust practices:
- Unwillingness to spend the needed time and resources to review department policies and procedures to ensure that manufacturers’ recommendations are being complied with
- Unwillingness to spend the needed time and resources to retrain staff members according to updated policies, procedures, and protocols
- Unwillingness to seek updated equipment and supplies in order to enhance the effectiveness and legitimacy of reprocessing activities
Challenge #3: Rush Practices---Simply Doing Everything as Fast as Possible to Meet the Needs of the Operating Room.
At this point, this lesson reaches a difficult topic in that the concept of rushing SPD reprocessing work comes into view. In the previously-issued HAN 00382 by the CDC and the FDA referred to above, mention is made specifically that “Healthcare facilities should allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturer.” Indeed, the CDC even warns that “Considerations should be made regarding scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing.” To be sure, the goal of most Operating Rooms, and surgeons, is to do as many cases as possible on a given business day. Equally certain is that the purpose of SPD departments is to support this process. The challenge lies in how this can be done while still developing a culture of best practices and compliance with manufacturers’ recommendations for reprocessing. Also important here is the staffing level of the SPD department. Adequate numbers of staff members are essential in the development of a department committed to the cultivation of best practices and compliance with manufacturers’ recommendations for reprocessing. In some cases, SPD departments can be viewed as slow, obstructive, and non-responsive to the needs and demands of the Operating Room. This does not need to be the case as appropriate communication with the Operating Room and sound prioritization within SPD departments can help to meet the needs of the Operating Room---while still adhering to a culture of best practices.
Having said this, the following list is just a sampling of what can be considered rush practices:
- Scheduling surgical procedures that exceed instrument inventories and turnover times
- Rushed or abbreviated cleaning processes (shortened manual cleaning protocols, lack of sonication, lack of automated washing and disinfection practices)
- Forcing SPD technicians to work in a chronically short-staffed department
- Reliance upon Immediate Use Steam Sterilization
- Release of implants for patient use prior to biological test results
- Use of shortened sterilization cycles
- Delivery of items still hot, or warm, to the Operating Room for patient use
- Failure to send the items to the SPD department for appropriate reprocessing
Conclusion:
It is likely that many SPD professionals experience the challenges referred to above frequently, if not daily. It is likely that many SPD professionals routinely encounter situations in which individuals, departments, or institutions are either unmotivated (rest practice), untrained (rust practice), or simply unable (rush practice) to perform their reprocessing activities in accordance with manufacturers’ recommendations and best practices.
Yet, this should not be a discouraging thing to SPD professionals as this is the challenge that is now set before them as they move forward into the 21st century. Compliance with manufacturers’ recommendations is not an option. It serves as the regulatory framework in which medical device reprocessing now occurs. Just how this compliance with manufacturers’ recommendations for reprocessing will occur will differ from place to place and facility to facility as different facilities have different designs, protocols, equipment, supplies, and policies. As SPD departments work to ensure the validity of their reprocessing activities the customers that they serve will need to be included in that conversation. Indeed, collaboration and communication can go a long way here in order to enable SPD departments to meet the needs of the busy Operating Rooms that they serve while still developing a culture of best practices and IFU compliance in SPD departments. Beyond that. SPD departments can share information with, and learn from, other SPD departments, and industry experts, in such a way that the best possible practices and outcomes can be provided for the patient whose care has been entrusted to the reprocessing activities of SPD professionals!