Leadership Challenge in Sterile Processing

𝗪𝗵𝘆 𝗖𝗮𝘀𝗲 𝗠𝗶𝘅 𝗠𝗮𝘁𝘁𝗲𝗿𝘀 𝗠𝗼𝗿𝗲 𝗧𝗵𝗮𝗻 𝗖𝗮𝘀𝗲 𝗖𝗼𝘂𝗻𝘁

By Noushad Valiyakath Registered Nurse (RN) & Central Sterile Supply Department (CSSD) Specialist Educator | Expert in Sterile Processing & Infection Control | Founder of HealthPro

𝗔𝗯𝘀𝘁𝗿𝗮𝗰𝘁 – 𝗧𝗵𝗲 𝗛𝗶𝗱𝗱𝗲𝗻 𝗦𝗽𝗱 𝗪𝗼𝗿𝗸𝗹𝗼𝗮𝗱

In Sterile Processing Departments (SPD), productivity is often measured using surgical case count, defined as the total number of procedures performed in a set period. This method is convenient for administrators but fails to reflect the real workload of sterile processing.

Not all surgical procedures generate the same burden.

• A general surgery such as a laparoscopic gallbladder removal may produce only one tray, processed in 15 minutes.
• A complex orthopedic revision may generate 12–15 trays, each requiring extended decontamination, assembly, inspection, functional testing, packaging, and sterilization.

This article highlights the leadership challenge of replacing case count with case mix as the true indicator of productivity. Case mix accounts for the complexity, diversity, and instrument intensity of cases. By using complexity-based measures such as trays per Full-Time Equivalent (FTE), Turnaround Time (TAT), and Defects per Million Opportunities (DPMO), leaders can advocate for fair staffing, protect patient safety, and maintain compliance with standards such as:

• Association for the Advancement of Medical Instrumentation (AAMI) ST79 and ST91
• International Organization for Standardization (ISO) 17665
• Healthcare Sterile Processing Association (HSPA) CRCST Technical Manual

𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 – 𝗪𝗵𝘆 𝗖𝗮𝘀𝗲 𝗖𝗼𝘂𝗻𝘁 𝗜𝘀 𝗠𝗶𝘀𝗹𝗲𝗮𝗱𝗶𝗻𝗴

Case count is the number of surgeries performed in a given day or shift. It is quick to extract from Operating Room (OR) scheduling systems and often used as a hospital productivity metric.

However, this does not reflect SPD workload. The sterile processing workflow includes many labor-intensive steps:

• Point-of-use treatment in the OR or clinic
• Transport to the decontamination area
• Manual cleaning, brushing, flushing
• Washer-disinfector or ultrasonic cycles
• Inspection and functional testing
• Assembly and packaging
• Sterilization in steam or low-temperature cycles
• Cooling, storage, and distribution

The time and resources required for these steps vary widely depending on the case mix-the diversity and complexity of surgeries.

For example:

• Ten laparoscopic gallbladder surgeries may produce about 15 trays, requiring three hours of SPD work.
• Six orthopedic or neurosurgical procedures may generate over 70 trays, consuming more than 20 hours of SPD work.

On paper, “10 cases vs. 6 cases” appears similar. In practice, SPD workload differs by a factor of seven.

𝗖𝗮𝘀𝗲 𝗖𝗼𝘂𝗻𝘁 𝗩𝗲𝗿𝘀𝘂𝘀 𝗖𝗮𝘀𝗲 𝗠𝗶𝘅 – 𝗔 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗟𝗲𝘀𝘀𝗼𝗻

Case Count (Simplified Metric)

• Easy to calculate.
• Measures only the number of surgeries performed.
• Ignores how many trays, sets, or instruments are involved.

Case Mix (True Indicator of Workload)

• Includes the number of trays per procedure.
• Recognizes specialty differences (general vs. ortho vs. cardiac).
• Considers implants, loaner sets, and robotics.
• Captures time, skill, and testing requirements.

Example : A day of 12 cases may sound simple. If 8 are general surgeries (16 trays total) and 4 are complex orthopedic/neuro cases (54 trays total), the SPD must process 70 trays. The workload is exponentially greater than the raw case count suggests.

𝗜𝗻𝘀𝘁𝗿𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗧𝗶𝗺𝗲

Different tray types require vastly different processing times:

• Peel Packs: A few simple instruments. 3–5 minutes for cleaning, inspection, and sealing.
• Standard Trays: 10–15 minutes for full decontamination, inspection, lubrication, assembly, and packaging.
• Complex Orthopedic Trays: 45–60 minutes. Involves heavy multi-layered trays, implant verification, torque-testing, and lubrication.
• Rigid Endoscope Trays: 20–25 minutes plus leak testing, brushing lumens, enzymatic flushing, and drying.
• Loaner Sets: 60–90 minutes each. Require sorting, cross-checking against count sheets, reviewing Instructions for Use (IFUs), and sometimes double sterilization.

Example for human clarity:

• 200 peel packs sent from a clinic in one day may consume 10 hours of work.
• One orthopedic knee revision may also consume 10 hours-just from 12 to 15 trays.

Both appear small in case count, but SPD sees the reality.

𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗖𝘆𝗰𝗹𝗲𝘀 𝗮𝗻𝗱 𝗛𝗶𝗱𝗱𝗲𝗻 𝗕𝘂𝗿𝗱𝗲𝗻𝘀

• Steam Sterilization: Standard wrapped trays run 30–40 minutes. Complex orthopedic trays may require up to four hours of drying due to weight and density.
• Loaner Instruments: Frequently arrive less than 24 hours before surgery, violating AAMI ST79’s recommendation of 24–48 hours advance. Many require two complete sterilization cycles.
• Washers and Disinfectors: Each cycle lasts 35–45 minutes, but rack capacity is the limiting factor. High-volume days mean repeated cycles, delaying assembly.
• Complex Devices: Flexible endoscopes, robotic arms, and lumen instruments often require low-temperature sterilization methods (hydrogen peroxide gas plasma, vaporized hydrogen peroxide, or ethylene oxide).

Leadership must emphasize that SPD’s work continues long after OR finishes.

𝗦𝘁𝗮𝗳𝗳 𝗖𝗼𝗺𝗽𝗲𝘁𝗲𝗻𝗰𝘆 𝗶𝘀 𝗠𝗼𝗿𝗲 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗧𝗵𝗮𝗻 𝗛𝗲𝗮𝗱𝗰𝗼𝘂𝗻𝘁

Staffing must be based on competency, not just numbers.

• Junior Technicians: Manage peel packs and general surgery trays but need supervision on high-risk sets.
• Senior Technicians: Handle orthopedic, neuro, and cardiac trays. Perform functional testing such as insulation checks for laparoscopic instruments and sharpness testing for scissors.
• Endoscope-Trained Technicians: Required for flexible scopes. AAMI ST91 requires documented annual validation.

Scenario:

• A day of hernia and cholecystectomy cases (20 trays) can be managed by junior staff.
• A day of orthopedic and spine cases (70 trays including loaners) requires senior specialists and additional QC time.

𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗦𝗣𝗗 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁

1. Adopt Data-Driven Metrics
2. Plan Staffing by Case Mix
3. Communicate Transparently with OR Leadership
4. Ensure Compliance with Standards
5. Apply Lean Six Sigma Methodology

𝗖𝗮𝘀𝗲 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗖𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 – 𝗔 𝗗𝗮𝘆 𝗶𝗻 𝗧𝘄𝗼 𝗦𝘁𝗼𝗿𝗶𝗲𝘀

• Day A (General Surgery): Ten procedures. About 15 trays. Three hours SPD workload.
• Day B (Orthopedic/Neuro): Six procedures. Seventy-plus trays. Over 20 hours SPD workload.

Fewer cases can mean far greater SPD effort. This misunderstanding is at the heart of many OR-SPD conflicts.

𝗗𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻 – 𝗧𝗵𝗲 𝗟𝗲𝗮𝗱𝗲𝗿’𝘀 𝗥𝗼𝗹𝗲

When case count is used blindly:

• Staff are under allocated.
• Technicians face burnout.
• Errors rise, threatening patient safety.

Leadership must advocate for case mix-based measurement. Education of administrators, surgeons, and nurses is key. Metrics and evidence-not assumptions-must guide staffing and resourcing.

𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻 – 𝗖𝗮𝘀𝗲 𝗖𝗼𝘂𝗻𝘁 𝗩𝘀. 𝗖𝗮𝘀𝗲 𝗠𝗶𝘅

• Case count represents surgical activity.
• Case mix represents the true SPD reality.

By adopting case mix as the measure of productivity, SPD leaders can ensure:

• Safer outcomes for patients.
• Fair workloads for staff.
• Compliance with accreditation standards.
• Sustainable operations.

In sterile processing, case count tells only half the story. Case mix tells the truth.

𝗥𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀

• AAMI ST79:2017 – Comprehensive guide to steam sterilization.
• AAMI ST91:2021 – Endoscope processing in healthcare.
• ISO 17665-1:2016 – Sterilization of healthcare products (moist heat).
• HSPA Central Service Technical Manual (9th Ed.).
• George et al. (2005). Lean Six Sigma Pocket Toolbook.