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Instrument Processing in the Ambulatory Surgery Setting
By Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT

In the last 30-plus years, healthcare has had a major shift from the acute, inpatient hospital setting to ambulatory settings. Today, more than 3/4 of surgical procedures are performed in outpatient settings such as freestanding or hospital-based ambulatory surgery centers (ASC), physician offices, and other dedicated settings.

Any patient having surgery or an invasive procedure has a right to efficient and safe care, including surgical instrument reprocessing, no matter where that care is provided. Unfortunately, evidence-based best practices in reprocessing reusable medical devices are not always followed. Reprocessing has become a big focal point for regulatory and accreditation surveys. One of the major focuses of the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) is prevention of healthcare-associated infections. The Joint Commission’s National Patient Safety Goals include implementing evidence-based practices for preventing surgical site infections.

Recently, there have been many reports in the media of patients in jeopardy of serious infection resulting from reusable medical devices that were inadequately cleaned, sterilized, or disinfected. According to reports in the media, the majority of outbreaks appear to not be in hospitals, but rather ambulatory settings. 

Reports have cited many lapses in instrument and equipment reprocessing, which include:  

  • Single-use devices inappropriately being reprocessed
  • High-level disinfectants (HLD) not prepared, tested, or replaced appropriately
  • Instruments not precleaned prior to sterilization or HLD
  • Monitoring devices (chemical and biological indicators) not appropriately used in sterilizer loads, among other things.

Reprocessing areas differ in their physical design, location, equipment, and in the level of personnel expertise, competence, and training. Smaller facilities, such as ASCs, often find it challenging to meet all these big regulations with their limited resources. Ambulatory surgery centers and other ambulatory care, such as office-based surgical settings, do not always have sufficient or dedicated resources to support infection prevention and surveillance activities. However, it is recommended that every outpatient setting have at least one individual with training as a dedicated infection preventionist (IP).

The IP should be employed by or regularly available to the facility. The IP should be involved in the development and ongoing improvement of IP policies (including medical device reprocessing policies) that are based on regulations, evidence-based guidelines, and national published standards.  

Every IP, operating room, and reprocessing professional should have access at least to these regularly updated evidence-based standards and guidelines:

  • Guidelines for Perioperative PracticeDenver, CO, AORN
  • ST79:2017: Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI
  • ST91:2015: Flexible and semi-rigid endoscope processing in health care facilities, ANSI/AAMI
  • ST58:2013: Chemical sterilization and high-level disinfection in health care facilities, ANSI/AAMI

These documents reflect the most current research and expert opinions resulting in best practices, so it is critical that the most current editions are obtained. It is essential that all reprocessing policies and procedures be developed and referenced using the most current published recommended standards and guidelines.

As a consultant, I have been told many times that a facility may not always follow AORN, AAMI, or CDC standards because they are recommendations or guidelines and not the law. However, in most cases, these recommendations are considered the minimal standard of care and, if not followed, could be considered malpractice in a court of law. Published guidelines are built on sound principles, research, scientific data, and opinions of experts in the field, making them best practices. My response is always, “Don’t you want best practices for your patients, not just run of the mill practices? What if the patient was you or one of your loved ones?”  

Sterilization and decontamination duties should only be performed by competent personnel with demonstrated knowledge and documented competences in all aspects of reprocessing: decontamination, preparation, packaging, sterilization, sterile storage, and handling of sterile items. Competencies should be documented and performed at least annually. 

Sterilization is a complex process requiring environmental controls, appropriate equipment, and supplies; adequate space; qualified, competent personnel who are provided with ongoing training and personal protective equipment (PPE); and monitoring for quality assurance. The Joint Commission standard LD.04.01.11 says, “The leaders provide for equipment, supplies, and other resources.” Therefore, it is up to the leadership of the facility to ensure all of these resources are available for the staff.

In an effort to improve processes and reduce risks to patients, ASCs should:

  1. Follow the basics for cleaning and disinfection/sterilization,
  2. Have the right tools (IFU, cleaning implements, and equipment)
  3. Create a multidisciplinary committee (review issues and set a plan)
  4. Share lessons learned (learn from other facilities)
  5. Write policies and procedures built on published best practices
  6. Know the current standards
  7. Consider reprocessing issues and concerns before purchasing reusable items
  8. Create standardized job descriptions for those that are responsible for reprocessing activities
  9. Train, train, and retrain
  10. Do assessment to check for compliance routinely.  

Every patient has the right to efficient and safe care in any setting. Established evidence-based best practices for reprocessing should be consistently followed. As with any facility, ASCs should ensure the validated manufacturer’s IFUs are available and constantly followed and that the staff reprocessing these devices are competent in their duties. It only takes one negligent mistake to make a big change in a patient’s life. Remember, safety isn’t expensive—it’s priceless!

 

 

 

 

Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, is president/CEO of Seavey Healthcare Consulting and formerly the director of the SPD at The Children’s Hospital of Denver. Rose served on the AORN board of directors and is a past president ASHCSP. She received numerous awards and was named as one of the Who’s Who in Infection Prevention by Infection Control Today. Ms. Seavey is the author of Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys, published by AAMI. She serves on several AAMI committees helping to write national standards.

 

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