1.4 Policies, Procedures, Safety Data Sheets (SDS) & Standard Precautions

1.4 Policies, Procedures, Safety Data Sheets (SDS) & Standard Precautions

Quick Answer: Administrative governance in Sterile Processing relies on written Policies (what to do) and Procedures/SOPs (how to do it), derived from manufacturer Instructions for Use (IFU). Chemical safety is managed through Safety Data Sheets (SDS) formatted into 16 standardized GHS sections. Technician protection relies on Standard Precautions and strict Personal Protective Equipment (PPE) donning and doffing sequences to prevent occupational exposure.

Operating a compliant Sterile Processing Department requires translating regulatory laws and professional standards into day-to-day departmental documentation and safety behaviors.

Departmental Policies, Procedures, and Manufacturer IFUs

Every sterile processing department must maintain accessible, up-to-date written administrative and operational documents.

1. Policies vs. Procedures (SOPs)

• Policy: An official administrative directive that defines institutional rules, objectives, and compliance requirements ("What is required and why"). Example: "All reusable flexible endoscopes must undergo leak testing prior to manual cleaning."
• Procedure / Standard Operating Procedure (SOP): Step-by-step instructions specifying the exact sequence of actions, equipment, chemical concentrations, and technical steps required to execute a policy ("How, when, and by whom"). Example: "Attach leak tester, pressurize scope to 160 mmHg, submerge completely in clean water, observe for 30 seconds for continuous bubble streams."

2. Manufacturer Instructions for Use (IFU)

Federal law dictates that medical devices and cleaning chemicals must be processed according to the manufacturer's validated Instructions for Use (IFU). Technicians must never improvise cleaning methods or sterilization cycles. If a device manufacturer's IFU conflicts with a sterilizer manufacturer's IFU, the device IFU takes precedence, or the facility must contact both manufacturers for written resolution.

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Safety Data Sheets (SDS) and Hazard Communication

Under OSHA's Hazard Communication Standard (29 CFR 1910.1200), employers must maintain a Safety Data Sheet (SDS) for every hazardous chemical present in the workplace (e.g., enzymatic detergents, disinfectants, sterilants, ultrasonic solutions, lubricant sprays).

Access Requirements

SDSs must be immediately accessible 24/7/365 to all technicians in their work areas. They cannot be locked in an office or stored behind password-protected computer systems that technicians cannot access instantly during an emergency spill or exposure.

Standardized 16-Section SDS Format (GHS Alignment)

OSHA mandates a standardized 16-section format. Technicians must be familiar with key sections for exam and workplace safety:

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Standard Precautions and Infection Prevention

Standard Precautions represent the foundation of infection prevention in healthcare. Standard Precautions combine the concepts of Universal Precautions (treating all human blood and body fluids as containing bloodborne pathogens like HIV, HBV, and HCV) and Body Substance Isolation (BSI).

Technicians must apply Standard Precautions to ALL items entering Decontamination, regardless of whether the patient was known to have an infectious disease. Organisms like Clostridioides difficile, Methicillin-Resistant Staphylococcus aureus (MRSA), and Hepatitis C cannot be visually detected on surgical instruments.

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Personal Protective Equipment (PPE) Protocols in Decontamination

Because decontamination involves scrubbing, flushing, and ultrasonic cleaning of biohazardous items, liquid splashing and aerosolization are constant risks.

Mandatory Decontamination PPE

1. Fluid-resistant gown or apron with long sleeves and liquid barrier protection.
2. Fluid-resistant surgical mask combined with full eye protection (eye goggles or full-face shield). Standard prescription glasses are unacceptable; eye protection must feature side shields.
3. Heavy-duty nitrile or butyl decontamination gloves with long cuffs extending up the forearm. Thin examination gloves are prohibited.
4. Fluid-resistant shoe covers or dedicated washable rubber boots.

Donning and Doffing Sequences (CDC / AAMI)

Technicians must follow strict step-by-step sequences when putting on (donning) and taking off (doffing) PPE to prevent self-contamination.

[DONNING SEQUENCE (Putting On)]
  1. Gown (Tie securely at neck and waist)
  2. Mask or Respirator (Secure ties/straps, fit nose piece)
  3. Goggles or Face Shield (Fit over eyes/face)
  4. Gloves (Pull cuffs over gown sleeves)

[DOFFING SEQUENCE (Taking Off)]
  1. Gloves (Remove glove-in-glove or peel off turning inside out)
  2. Goggles or Face Shield (Remove from back headband without touching front)
  3. Gown (Unfasten ties, peel down from shoulders turning inside out)
  4. Mask or Respirator (Grasp bottom ties then top ties, remove without touching front)
  5. Hand Hygiene (Wash hands immediately with soap and water for 20+ seconds)

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Sharps Safety and Exposure Incident Protocols

Occupational exposures to sharps (scalpel blades, suture needles, bone hooks) present severe risk for bloodborne virus transmission.

Sharps Prevention

• Operating room staff are responsible for removing disposable blades and sharps prior to transport to SPD.
• Technicians in Decontamination must never reach blindly into wash basins or sinks filled with opaque soapy water. Instruments must be arranged in perforated mesh trays.

Post-Exposure Protocol

If a technician suffers a needle stick, sharp injury, or chemical splash:

1. Immediate First Aid: Wash sharps wounds thoroughly with soap and water. Flush chemical splashes to eyes/skin at an emergency eyewash station for a full 15 minutes.
2. Report Immediately: Notify the department supervisor immediately.
3. Medical Evaluation: Report to Occupational Health or Emergency Department for baseline blood testing (technician and source patient for HBV, HCV, HIV) and initiation of Post-Exposure Prophylaxis (PEP) within hours if indicated.