Karen Owens, MSN, RN, CRCST, CIS, CER, CHL, FCS, CQIA, is a seasoned health care leader with 39 years of nursing, management, and operational experience, including more than a decade in central sterile management and 5 years as a system director overseeing sterile processing across 11 hospitals. 

Recognized nationally for her expertise, she blends clinical insight with lean methodologies to drive operational excellence, earning distinctions such as “Who’s Who in Infection Prevention” and guiding her teams to award‑winning performance.

Karen Owens, MSN, RN, CRCST, CIS, CER, CHL, FCS, CQIA

Figure 1. Specialized cycles and equipment reduced the manual processing

steps needed to clean robotic-assisted surgical instrumentation.

Over the past 30 years, the field of medical device reprocessing has undergone a remarkable transformation, driven by infection‑related crises, the rapid expansion of health care services, and the introduction of increasingly complex medical technologies. In response to these mounting pressures, sterile processing teams have continuously evolved—standardizing practices, modernizing workflows, and embracing innovation—to safeguard patient care and meet the ever‑rising demands of modern medicine.

Foundations of Modern Reprocessing (Mid-1990s to Early 2000s)

The early years were marked by a heavy reliance on manual cleaning processes and analog documentation. The equipment used for processing was simple, relying heavily on manual cleaning and technician performance. These factors led to higher process variability and the potential of residual soils, which can interfere with subsequent disinfection and sterilization steps.

The link between ineffective processing and patient infections was just coming into focus, leading to the establishment of important standards and regulations still relied on today. The Association for the Advancement of Medical Instrumentation (AAMI) published, for the first time, standards focused on improving medical device reprocessing, including the following:

AAMI ST46, Good Hospital Practice: Steam Sterilization and Sterility Assurance (1993)

AAMI ST8, Hospital Steam Sterilizers (1994)

AAMI ST55, Table-Top Steam Sterilizers (1997)

The Food and Drug Administration (FDA) also began focusing on device reprocessing and published numerous guidance documents. The most significant of these was the "Guidance Document for Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices” by the FDA Center for Devices and Radiological Health, which established the regulatory definitions and expectations for performance of automated cleaning equipment used to clean medical devices.

At the same time, instrument tracking systems became a widely adopted practice to electronically track surgical equipment and instrument trays as they progressed through the multiple stages of reprocessing. Instrument tracking enabled better planning and asset utilization, with the most advanced systems managing device maintenance, inspections, and repairs.

Standardization and Quality Systems Take Hold (Early 2000s to Mid-2010s

In the 2000s, the mindset around medical device reprocessing and the roles of those responsible for it began to shift. Rapid growth in system-wide protocols for cleaning, decontamination, and sterilization was driven by new best practices grounded in clinical evidence, increased decontamination requirements, and education from The Joint Commission.

Quality took center stage as infectious outbreaks caused by ineffectively cleaned and disinfected endoscopes made headlines. Use of quality management system practices expanded, with many facilities adopting Lean practices, Six Sigma, and quality management standards, such as ISO 13485.

 Cleaning indicators, residual soil detection kits, and borescopes became essential quality control tools in the battle against residual soil.

Figure 2. The ATLAS.WAV is an advanced, dynamic system that automates
loading and unloading, washer selection, and load prioritization.

Workforce Professionalization and Culture Change (2005-2025)

Through the concerted efforts of the Healthcare Sterile Processing Association, Certification Board of Sterile Processing and Distribution, and other professional organizations, reprocessing of medical devices became recognized as a specialized health care profession. The need for competent decontamination technicians became clear as ongoing research linked processing errors and skipped steps to key contributors to many infectious outbreaks during this period. This led New Jersey to mandate certification of sterile processing personnel.

 Mandated certification has since grown to 7 additional states, with more considering similar legislation.

Recognition of the specialized skills and education required for reprocessing drove a desire to retain skilled professional technicians. Facilities focused on ergonomics, workforce safety, mental health, and professional advancement to entice and retain reprocessing professionals. Sterile processing departments (SPDs) now boast adjustable-height sinks and preparation tables and enforce weight limits for instrument sets and containers. Many facilities have clear clinical ladders that provide visibility into professional advancement.

Acceleration of Automation and Digital Transformation

The mid-2000s marked the beginning of the largest migration of workers into retirement. As the baby boomer generation aged, demand for health care services increased significantly. Procedure growth in hospitals and ambulatory surgical centers exceeded 30%,

 requiring SPDs to increase capacity quickly.

Adoption of advanced automated cleaning and decontamination equipment helped. High-capacity washer-disinfectors, like the AMSCOTM 7053HP Washer-Disinfectors, could increase washing throughput by 50% compared to standard single-chamber washer/disinfectors.

 Advanced ultrasonic cleaners self-fill, clean, and rinse devices, freeing technicians to do other tasks.

Special validated cleaning cycles combined specific cycle parameters with validated cleaning chemistries to reduce the time needed to clean instrumentation.

Instrument tracking systems soon evolved to support this faster-paced environment. Workflow management systems developed reporting tools that helped departments identify processing bottlenecks and determine how to reduce them.

New portable processing solutions also entered the market. These SPDs and mobile gastrointestinal reprocessing centers kept departments fully functional during expansions and renovations, with some facilities using them to expand capacities without changing the department.

Validated third-party reprocessing grew as facilities sought to supplement, and in some cases replace, medical device reprocessing.

Advances in Device Design and Material Science

Amidst the growth of procedures, medical device manufacturers continued to innovate. The increasing complexity of surgical instruments and flexible endoscopes has driven demand for validated, device-specific cleaning protocols.

Medical device manufacturers partnered with reprocessing equipment manufacturers to create automated solutions that reduced complex reprocessing steps and met the stringent requirements of the FDA. The STERIS RAS 12 washer disinfector rack was designed in partnership with Intuitive Surgical to mechanically clean, rinse, and disinfect up to 12 soiled da Vinci EndoWrist X/Xi, S/Si, or single-site instruments, reducing manual cleaning steps. It was the first type of these racks to receive clearance under the new FDA requirements.

3D printing of medical devices allowed hospitals to create patient-specific devices, including cranial implants, surgical guides, and anatomical models. Singular, unique, and manufactured by the hospital, these devices often lacked detailed instructions for cleaning and sterilization. Through collaboration among 3D printer manufacturers, radiologists, and sterilizer manufacturers, a specialized sterilization cycle was developed and approved for the V-PRO maX 2 Low-Temperature Sterilization System. The validated cycle provided SPDs with a validated process for preparing and sterilizing surgical guides and anatomical models.

Infection Prevention Intensifies as a Driving Force

Several high-profile US duodenoscope-associated outbreaks led to FDA oversight, product redesigns, and supplemental reprocessing measures reshaping endoscope reprocessing practices. Research studies published during this time revealed insufficient cleaning, leaving residual soil and moisture after drying.

 New evidence-based reprocessing guidelines were issued, leading to the publication and subsequent revision of the American National Standards Institute/AAMI ST91, Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.

Changes to endoscope reprocessing guidelines included the following:

Special cleaning instructions for endoscopes when cleaning did not begin within a specified time frame

Use of borescopes to visualize the long channels found within endoscopes following cleaning

Sterilization of high-risk endoscopes prior to patient use

Implementation of a storage cabinet capable of a positive pressure atmosphere using an instrument or high-efficiency particulate air (HEPA)-filtered air

The focus led to a surge in systematic audits and enhanced surveillance, which promoted closer collaboration among infection prevention, reprocessing, and clinical engineering. The Joint Commission surveys conducted in 2022 indicated that 53.64% of hospitals and 39% of ambulatory care facilities were noncompliant with IC.02.02.01 EP 2.7. This governs infection prevention and control activities during intermediate disinfection, high-level disinfection, and sterilization. Additionally, this led to the development and publication of the 2023 guidance, 

The Joint Commission Guide to Reprocessing Reusable Medical Devices

Looking Ahead: The Next Era of Innovation

The road ahead for sterile processing is both challenging and full of possibilities. As baby boomer retirements accelerate, the widening shortage of skilled reprocessing professionals will push departments to rethink long‑standing workflows and reduce reliance on labor‑intensive manual tasks.

Looking forward, the next 30 years may usher in a new era of intelligent automation: artificial intelligence–driven tracking systems, automated quality validation, robotics capable of assembling and packaging surgical trays, and equipment that loads and unloads itself with minimal human intervention. These advances won’t replace the profession; they will expand it.

The future of sterile processing is poised not just to evolve, but to excel, propelled by innovation, shaped by necessity, and strengthened by the professionals who continue to move it forward.

Da Vinci is a trademark of Intuitive Surgical, Inc

AMSOC, V-PRO, and ATLAS are trademarks of STERIS

Guidance for Industry and FDA Staff: Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices.

 US Food and Drug Administration. Published May 2007. Accessed May 7, 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-washers-and-washer-disinfectors-intended-processing-reusable-medical-devices

ISO 13485:2016: medical devices—quality management systems—requirements for regulatory purposes. International Organization for Standardization. 2016. Accessed May 1, 2026. 

New Jersey mandates certification of central service professionals. News release. 

https://www.infectioncontroltoday.com/view/new-jersey-mandates-certification-central-service-professionals

Kozak LJ, Owings MF. Ambulatory and inpatient procedures in the United States, 1995. 

US surgical procedure volumes (SPV) database. Life Science Intelligence. Accessed March 27, 2026. 

https://www.lifesciencemarketresearch.com/procedure-volumes/united-states-surgical-procedure-volumes-database

AMSCO 7052HP & 7053HP washer/disinfectors. STERIS. Accessed March 27, 2026. 

https://ww1.steris.com/onbDocs/V571/0/4738075.pdf

510(k) clearance letter for RAS-12 rack, RAS 12 long rack; RAS cycle of AMSCO 7052HP/7053HP single chamber washer/disinfector. FDA. August 21, 2019. Accessed March 27, 2026. 

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190081.pdf

Sterilize 3D printed materials in the V-PRO maX 2 low temperature sterilization system. STERIS. Accessed March 27, 2026. 

https://www.steris.com/healthcare/products/v-pro-sterilizers/sterilize-3d-printed-medical-devices

Thaker AM. Duodenoscope-related infections: will history repeat itself? American Gastroenterological Association. Published November 22, 2021. Accessed March 27, 2026. 

https://scopeinnovation.gastro.org/duodenoscope-related-infections-will-history-repeat-itself/

Articles

Over the past 30 years, as infection outbreaks, rapid service expansion, and increasingly complex medical devices transformed the landscape, sterile processing rose to the challenge by standardizing, modernizing, and innovating to keep patients safe.

Karen Owens, MSN, RN, CRCST, CIS, CER, CHL, FCS, CQIA

Articles

Crisis, Innovation, and Professionalism: Reflecting on 30 Years of Progress in Medical Device Reprocessing