Dissecting the Dirty Instruments Issue in Healthcare Facilities

By Nancy Chobin, RN, CSPDM, with contributions from Sue McManus, RN, CSPDM; Teckla Maresca, LPN, CSPDM; Karen Swanson, LPN, CSPDM; and Nora Wikander, RN, CSPDM

The recent attention to dirty instruments is interesting, as this is not a new issue. For years, sterile processing professionals have been dealing with issues surrounding reprocessing of reusable medical devices and surgical instrumentation. One of the major reasons certification programs were developed for sterile processing personnel was to be able to verify competencies for personnel performing the critical functions of cleaning, high-level disinfection and sterilization.
For the past 20 years, the Certification Board for Sterile Processing and Distribution, Inc. (CBSPD) has seen the dramatic changes in the profession. Yet, not much has changed in terms of job descriptions, salaries and requirements for the positions.
So what are the issues?

Processes
According to Karen Swanson, LPN, CSPDM, we need to take a look at:
- The complexity of surgical instrument design has drastically changed over the past 25 years and continues to change.  Compared to basic surgical instruments, there are many hard to reach areas which make cleaning challenging and difficult.  Even when the manufacturers written instructions are followed, one cannot be sure all hidden soil is being removed.
- Manufacturers' instructions are not consistent, not easily obtained and are hard to read. Once obtained, it is difficult to make them easily accessible to personnel performing the reprocessing functions, especially the cleaning.
- Some complex instrumentation cannot be disassembled for cleaning and inspection.
- Loaner instrumentation is frequently brought in without consideration  for in-servicing SPD staff on the recommended cleaning and sterilization.
- Loaner instrumentation, in many instances, does not arrive in sufficient time for adequate processing prior to use.
- Failure of facilities to consult with the sterile processing manager regarding potential purchases of instruments and devices to determine if the facility can comply with the IFUs (instructions for use).
- Lack of sufficient instrument inventory forces quick turnaround (taking short cuts) and immediate use sterilization.

People
My personal feelings are that unless we raise the qualifications and requirements for sterile processing technicians, we will have major difficulties delivering what we and the customer want.  Many CS/SPDs have inferior conditions, inadequate space, insufficient or improperly working processing equipment, and insufficient instrumentation -- all of which can affect the departments ability to work efficiently and effectively. It is important for CS/SPD managers and supervisors to communicate to the administration the needs of the department.

 
On the other hand, administrators need to understand that you cannot have operating rooms performing sophisticated surgical procedures unless you have the support services of an SPD that is provided with the necessary staff, that the staff is thoroughly trained and educated, and that they have the equipment, instruments and physical design/layout to function effectively and efficiently.

Every CS/SPD manager and supervisor should create an environment of teamwork, quality, and pride so that quality products are produced each and every time.
For sterile processing, the first consideration is that CS/SPD is one of the youngest professions in healthcare. In fact, it is just beginning to be recognized as a profession. Few people tell their children, When you grow up I want you to be a sterile processing technician. There is nothing wrong with CS/SPD, its just that the profession has no identity outside healthcare facilities. Recruitment is difficult because of the woefully low salaries. Although the responsibilities have changed dramatically over the past 10 years, salaries are nowhere close to being commensurate with the level of those responsibilities.

According to Teckla Maresca, LPN, CSPDM, and Nora Wikander, RN, CSPDM, The big push seems to be for staff certification when, in fact, management certification is equally important. The manager needs to be able to demonstrate proficiency in the technical aspects of sterile processing as well as the managerial aspects of budget, labor relationships and leadership. How can a manager manage unless they have a clear understanding of the job and what is involved?  Its similar to the television show 'Undercover Boss' ... once the 'boss' gets in the trenches they have a clearer understanding and greater appreciation for the job. We need to concentrate on the SPD manager as well as the technician with regards to not just certification but ongoing competency. Daily, the CBSPD office receives questions from technicians who obviously are working for managers who dont know or understand the job. Its even more concerning when managers are questioning the very basic principles upon which practice in the SPD is based.

 
Many people think increasing staff is the answer to all of our woes. In fact, time is one of our biggest enemies not bodies. Increased pressure to turn instrumentation around more quickly, sometimes from one case to the next, does not allow the time necessary to clean the instruments as they should be. This is where administrative support becomes a major concern.

 
There also needs to be an understanding that although the number of surgeries may not have increased significantly the complexity of the surgery and instrumentation being used has and more time may be needed to do the job well. As a result staff cannot necessarily be cut. This also leads to the necessity for the right equipment in SPD to do the job. We are faced with an ever increasing number of specialized instrumentation requiring special sterilization cycles and modalities putting a strain on our existing sterilizers. There are many different components of the SPD processes that other departments/managers are unaware of. What we do is taken for granted and until a problem arises no one pays attention.

 
It is the responsibility of the SPD manger to educate the surgeons, OR, administrators, infection prevention nurses about what we do, how it needs to be done, and most importantly, how it relates to the care of the patient.  Everything SPD does every day has a direct impact on the patient. Even though the patients never see us and do not know we exist, we play a key role in their recovery. Administrators and other departments need to understand this as well.
Sue McManus adds, "Certification is only part of the answer.  We must have supervisors and managers that are knowledgeable, educated and certified in CS/SPD.  If they dont know the basics, how can they develop, maintain, and verify  the competencies required for staff to perform the cleaning, disinfection and sterilization of these complicated devices?  Just because the managers are nurses or have bacherlors, masters or doctorate degrees does not mean that they know anything about cleaning, decontamination, disinfection or sterilization.  Running SPD as a business is a small part of the department."

Can the issues be addressed quickly?  There is no quick fix, it takes time to educate and train staff, develop competencies and evaluate the individuals performing these tasks.  It is also important to make time for their continued education to keep them competent.   We must  educate staff, get them credentialed, raise their pay and hold everyone accountable for maintaining their credential just like we do any other credentialed employee.

All of us agree that the SPD is at this point today because of:
- Cost reductions fewer dollars for equipment and staffing.
- Financial constraints sterile processing is not a revenue producing department so they are often the last to receive funds for education and equipment.
- Poorly paid technicians and high turnover rates.  If people can get higher paying jobs with just a high school education, why would they want to work in a position of such responsibility for less money?
- Rushed orientations and training, or lack of either altogether, due to staff shortages.
- In many facilities there are no financial incentives or recognition for technicians to certify, so they dont bother.
- Managers are not providing ongoing education for staff.
- Poorly paid technicians do not have the personal funds to pay for certification, ongoing education and recertification.
- There are not many clinical ladder programs in sterile processing departments,  therefore many good people are lost to other professions / jobs where there is room to grow.

How do we approach resolving these SPD-related concerns?
1. Continue to collaborate with AAMI, FDA and medical / surgical equipment manufacturers to develop IFUs that are easy to understand  The FDAs concern with human factors in understanding IFUs is a good step forward.
2. While it would be wonderful for device manufacturers to design complex instrumentation  in a way that allows for easy disassembly for cleaning and inspection, this is not always possible,  however, at least if the IFUs were clear and concise this would help.
3. Instructions for use must be written for the country in which the equipment  will be sold.  IFUs for use in the U.S. do not need to have the European cycle information.  This causes confusion and opens the door for misinterpretation and errors.
4. Manufacturers' sales reps must be thoroughly trained in care and handling of their product.  They should also be certified in CS/SPD so they understand our processes.  They should also be required to provide hands-on in-servicing of their products.
5. Certification on a national level for all who work in or lead sterile processing departments.
6. SPD managers should be consulted and their opinions respected before the purchase of any equipment that will need to be reprocessed.
7. SPD managers must make administration aware of the needs and administration needs to listen and give what is needed.
8. Sterile processing departments need to be built with room for expansion to accommodate cleaning, processing and storage of new instrument technologies.
9. Certification is only the first step, though it is an excellent method of learning.  Certification does not guarantee best performance of individuals. 
10. There must be a push for ongoing, mandatory education for all managers of sterile processing.
11. There must be recognition of the importance of the reprocessing functions and respect for those who perform this job.
12. Ensure adequate staffing based upon SPD work volumes so that employees do not have to take short cuts.
Much of this is not new but now may be the time to get each SPD manager to step up to the plate and coordinate an effort at their facility to ensure that best practices are a way of life and that patient safety is never compromised.

Nancy Chobin is the AVP of sterile processing services for the Barnabas Health System, West Orange NJ and the executive director of the CBSPD, Inc. Sue McManus is the director of Medisource for Mission-Health in Asheville, N.C. and board member emeritus of the CBSPD. Karen Swanson is the CS manager at Connecticut Childrens Medical Center in Hartford, Conn. and chair of the CBSPD Item Review Committee and co-executive director of the CBSPD. Teckla Maresca and Nora Wikander are retired SPD directors; both serve as co-chairs of the CBSOPD Continuing Education Committee.