Following guidelines necessary for pressure-cooker reprocessing

As sterile processing professionals grapple with understanding and complying with manufacturer instructions-for-use (IFUs) to reprocess reusable medical/surgical devices, questions linger about whether new or updated guidelines and regulations must be enacted or current guidelines and regulations would work just fine if enforced.

Rob Cripe, Vice President, North American Sales and Marketing, Integrated Endoscopy, Rancho Santa Margarita, CA

One of the challenges in focusing on enforcement of existing guidelines or creating new regulations is that IFUs for reprocessing endoscopes often are lengthy and complex — and becoming more so. While some recent infection outbreaks have occurred after endoscopes were reportedly reprocessed according to guidelines, most outbreaks linked to endoscopes have been associated with documented breaches of reprocessing.

A number of audits have demonstrated lack of compliance with guidelines. A “human factors” study published in Gastroenterology Nursing also identified several issues reported by reprocessing staff, including physical discomfort and health problems associated with the time spent on reprocessing activities. Even with automated high-level disinfection and sterilization systems, steps such as bedside pre-cleaning must be effectively completed every time, with no room for human error, in order to minimize risk of infection transmission.

As a result, interest in single-use endoscopes is increasing, part of a trend toward use of disposable instruments in operating rooms and ambulatory surgery centers. Advances in optical technology are opening the door to development of low-cost, single-use endoscopes to eliminate the need for reprocessing, as well as the cost associated with reprocessing equipment and materials, staff training, and documentation. Other important goals are to prevent costly OR delays and downtime by ensuring the availability of patient-ready scopes, and eliminating the risk of healthcare-associated infections due to lapses in reprocessing.

Dan Gusanders, President, Pure Processing

I believe the way to move the industry towards better patient care is we need to enforce guidelines and regulations. How effective is a guideline if we can’t or don’t follow it? Enforcing guidelines would shine a light on how many SPDs are lacking appropriate resources. Short term, this would require investments into staff, higher wages, better internal education and possibly infrastructure. With this type of financial commitment it would  require administration and infection control to be more involved with SPD as well. Long-term benefits could far outweigh investment by driving cost and liability out of the operation. I recently was in a meeting with numerous SPD managers. I was actively part of a conversation regarding a very important guideline. The conversation got awkwardly heated because of the elephant in the room: They did not have the necessary staff to fully execute the guideline.

Richard W. Schule, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, Director, Clinical Education, STERIS Corp.

Quality management systems provide the guidance organizations need to ensure applicable regulatory guidelines and standards are followed. In 2011, Mary Logan, President of AAMI, stated, “No one group can do this alone, and the answer is not as simple as “more standards” or “more regulations.”

We need consistency of knowledge from our credentialing surveyors. A surveyor’s role is not to dictate to their customer what product to use; rather they should be auditing on the objectives set forth by the organization in their quality manual. In a quality management system (QMS) environment there are credentialed surveyors who are trained on the requirements of the quality management systems and it is through this QMS organizations can implement and ensure the effectiveness of their processes.

Donna Swenson, President and CEO, Sterile Processing Quality Services Inc., Stickney, IL

I think enforcement of the current guidelines is needed. Currently, we do not have a consistent way of enforcing cleaning of medical devices in the healthcare setting. Accreditation with The Joint Commission or any of the other accrediting agencies is voluntary. Many hospitals are not accredited and they are not required to be. There are also inconsistencies between how current standards and guidelines are enforced. Even if a healthcare facility is accredited by one of the accrediting agencies it does not necessarily mean that the facility would be able to pass accreditation by one of the other agencies. Right now only The Joint Commission is using ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities as a guide for evaluating sterile processing departments. I think there needs to be consistency in how current and future updates/additions to guidelines are enforced. At the present time we do not have that in the area of reprocessing of medical devices.

Stephen Kovach, Director of Education, Healthmark Industries, Fraser, MI

We are in a dynamic environment, which is in constant flux and change. So yes, standards, guidelines and practice will continue to change. Those who understand this and can adapt, will be the high-performing departments. Standards and guidelines help give departments a roadmap to success. Yet as these standards and guidelines are constantly updated, they need to be followed and kept up with. Make sure you are following the latest version of your applicable standard and professional society guideline.

Brianne Flesher, Flexible Scope Division Manager, Mobile Instrument Service & Repair Inc., Bellefontaine, OH

We’re not big fans of external enforcement as it is a one-time event that breeds a defensive attitude on the part of staff. Routine internal audits are needed as is routine refresher training and reminders for staff. The reason is simple, the implication of lapse in protocol can be life threatening.

J. Hudson Garrett Jr., Ph.D., MSN, MPH, FNP-BC, PLNC, VA-BC, IP-BC, FACDONA, Global Chief Clinical Officer, Pentax Medical-Hoya Corp.

According to estimates from the Centers for Disease Control and Prevention, healthcare facilities fully implement relevant evidence-based recommendations to reduce healthcare-associated infections about 40 percent of the time, meaning that there is an opportunity for improvement across the continuum of care. It is important to conduct a facility assessment of compliance of evidence based practices and then ensure that sufficient resources and staff are available to achieve success and the established goals. In addition, more collaboration versus enforcement is helpful as the punitive approach can limit success. Great tools such as TeamSTEPPS and Just Culture are available widely to improve communication and collaboration.

Accountability questions

Because manufacturers actually provide IFUs to sterile processing departments, why shouldn’t they be held at least partially liable and responsible for end user noncompliance?

“Everybody has a part in the equation,” Healthmark’s Kovach emphasized. That includes manufacturers, independent testing labs, regulatory agencies, reviewing/accrediting agencies and medical facilities. “Not just one department, but the whole medical facility,” he continued. “Yes, the C-suite too! They hold the money for any change and the tone to bring about a real change in the facility. Each has a stake in the issue. If one does not do their part, you have problems. It is that simple.”

Mobile Instrument’s Flesher called for a balanced approach for the ultimate protection.

“We need a better balance between a usable IFU and IFUs that are really designed so the manufacturers can say they warned the end user about every nuance in the device,” she asserted. “As it stands now, the latter approach seems to be accepted, and the complexity in the IFUs is more than most end users can digest and implement effectively. Manufacturers are responsible for all training when equipment is purchased and first installed by the end user.

“Oftentimes the equipment is received with IFUs in written form in SPD,” she continued. “This leaves all steps necessary for proper cleaning open to interpretation of the end user. When equipment is sold, it should be mandatory that thorough hands-on training be provided to the purchaser and all SPD staff. Ongoing training should be received through the manufacturer and care and handling practices through the contracted service providers. Despite the opinion of the manufacturer, if a third party is providing repair service, original manufacturers should still engage and support their customers with reprocessing guidance and refresher classes. There are many third-party service providers in the industry performing repairs to this equipment, and in doing so, they are not changing any original designs or altering the endoscopes functionality.”

Ryan Klebba, Vice President, Endoscopy Sales Division, STERIS Instrument Management Services, IMS/Synergy Health, a subsidiary of STERIS plc, Birmingham, AL, cast blame squarely on “overly complex and lengthy IFUs, increasingly more complex design of devices, improper training or infrequent training by the OEMs on their devices, and contradictions from OEM representatives versus what is stated in the IFU.”

Lisa Wakeman, CHL, CIS, CRCST, MBTI, National Director of Education, Circle of Care, Fresno, TX, urged manufacturers to follow through with their customers, the end users.

“Manufacturers could make more efforts to standardize their instructions-for-use by considering the implications that such a free range of play imposes upon healthcare professionals to meet stringent guidelines,” Wakeman said. “Published specifications covering aspects of care and handling only back up what a manufacturer has actually validated. Questions that must be brought into consideration are: How validation tests are administered, how is it determined which validation tests are trialed verses others, and even more so, what variables contribute to why some tests fail. Compliance with manufacturers’ IFUs can often be a two-edged sword. While compliance to validated tests is extremely important for best care practices, are companies actually discouraging this when their IFUs are too complicated or variant from a standard of work?”

Wakeman credited those reps who deliver.

“There are some company reps who know their manufacturer IFUs and are prepared to provide them when expecting sterile processing services from a facility,” she indicated. “However, many of the reps I have worked with do not readily know them and only provide them when asked. This leaves a bulk of the responsibility on the sterile processing professional to seek out IFUs in order to ensure compliance with the validation metrics detailed by the manufacturer.”