WORKFLOW, PEOPLE FLOW, TRAFFIC CONTROL

  • Work Flow: Work progresses through the department starting from dirty in the decontamination moves to the clean preparation and packaging area, where items are inspected, assembled, and packaged for sterilization.

  • People Flow: Technicians must remove all PPE (including head and shoe covers) and wash hands before moving to clean areas to prevent contamination. Proper people flow ensures that contamination from soiled areas does not spread to clean or sterile areas.

  • Traffic Control: Access to the SPD should be restricted to departmental employees and authorized personnel to maintain the sterile environment and control infection risks. This includes controlling the movement of staff, visitors, and equipment through the department.

DISASTERS

  • Supply Responsibility: The SPD is crucial in providing necessary supplies and equipment for disaster response, following protocols set by the Joint Commission.

  • Patient Confidentiality: SPD technicians must handle patient information accessed through OR schedules, computerized records, equipment issuing, and charge systems with strict confidentiality, complying with HIPAA regulations.

  • Employee Safety: Technicians must report noncompliance with PPE use, reprocessing protocols, and other safety policies to ensure a safe working environment and adherence to ethical standards.

REGULATIONS, STANDARDS, AND RECOMMENDED PRACTICES

  • Regulations: Mandatory rules set by agencies such as the EPA, FDA, OSHA, and state health departments. Compliance with these regulations is legally required.

  • Standards: Established norms from organizations like AAMI, which set benchmarks for good practices in sterile processing. While not always legally required (only in New Jersey), these standards are widely recognized and followed.

  • Recommended Practices: Guidelines from professional organizations like SGNA and AORN. These reflect sound principles of practice based on scientific data and expert opinion, although compliance is not legally required.

GOVERNMENT AGENCIES

  • EPA: Regulates environmental disinfectants, air/water emissions, and the manufacture and sale of EO gas. Ensures that pesticides meet federal safety standards before being marketed.

  • OSHA: Regulates occupational safety, including exposure limits for chemicals, bloodborne pathogens, and hazard communication. Ensures that workplace hazards are communicated to employees from day one.

    • Mandates proper labeling of all chemical containers to provide essential safety information.

U.S. Food and Drug Administration (FDA)

  • Ensures medical devices are safe and effective.

  • Requires reporting of device-related deaths and serious injuries.

Regulates medical device manufacture, sterilants, disinfectants, packaging, sterilizers, biological indicators, and single-use devices.

FDA Medical Device Classification:

  • Class I: Low-risk devices - with general controls.

    • e.g. hand-held surgical instruments, hospital beds, and ultrasonic cleaners.

  • Class II: Moderate-risk devices- with performance standards and specific guidelines. 

    • e.g. most types of sterilization equipment, Bls, chemical indicators CIs, wraps, etc.

  • Class III: High-risk devices - requiring premarket approval.

    • e.g. heart valves, pacemakers, and other life-sustaining devices.


INSTRUCTIONS FOR USE (IFU)

All new instruments must include written IFUs from the manufacturer when they arrive, detailing proper cleaning and sterilization methods.

  • Validation: Manufacturers perform validation to ensure processes meet predetermined specifications consistently, providing documented procedures for this.

  • User Verification: Facilities perform user verification to ensure processes meet specifications within the user environment, ensuring that devices are cleaned and sterilized according to manufacturers' instructions.

EMERGENCY EYEWASH STATIONS

  • Requirements:  Must provide at least 0.4 gallons/min for 15 minutes, be hands-free, wash both eyes simultaneously, and be located within 10 seconds' travel time (approx. 55 ft) of chemical use areas. Regular testing is required to ensure functionality at least weekly.

NFPA DIAMONDS

  • Hazard Labeling: Color-coded for health (blue), flammability (red), instability (yellow), and special information (white), with numerical ratings (0-4) indicating severity. Essential for identifying chemical hazards.

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

  • Device Classification (AKA SPAULDING CLASSIFICATION):

    • Critical: Direct contact with bloodstream/sterile areas (e.g., surgical instruments, implants) and must be sterilized.

    • Semicritical: Contact mucous membranes/nonintact skin (e.g., endoscopes, catheters) and should be sterilized or undergo high-level disinfection if sterilization is not feasible.

    • Noncritical: Contact intact skin (e.g., face masks, BP cuffs) and require cleaning with detergent and water (usually disinfectant wipe).

ACCREDITING AGENCIES

  • The Joint Commission (TJC): Come unannounced and evaluate healthcare facility performance affecting patient care ensuring employee competency. Facilities must pass TJC inspections every three years to maintain accreditation and receive insurance payments. Kown formally as JCAHO.

PROFESSIONAL ORGANIZATIONS

  • AAMI: Develops standards for decontamination, disinfection, sterilization, and related equipment. Recognized as best practices in the industry and coordinates international standards development.

  • AORN: The Association of periOperative Registered Nurses (AORN) provides guidelines that recommend practices for maintaining a sterile environment and ensuring patient safety during surgical procedures.

POLICIES AND PROCEDURES

  • Facility Policies: Apply to all departments within a healthcare facility (e.g., attendance policy).

  • Departmental Policies: Specific to SPD (e.g., loaner instruments receiving and processing).

Standard Precaution 

Involves using appropriate barriers to lower the risk of spreading pathogens and applies to all patients, regardless of their diagnosed condition or assumed infectious status.

SPECIAL CONSIDERATIONS FOR LOANED INSTRUMENTS

  • Reprocessing: All loaned instruments are considered contaminated and must be reprocessed according to facility protocols, ensuring they are safe and sterile for use.

  • Weight Limit: All instrument sets, including their containers, should not exceed 25 LB as per AAMI recommendations to ensure proper sterilization and prevent injuries.

CLASSIFICATION OF FIRE EXTINGUISHERS

  • Class A: Combustibles like cloth, wood, and paper.

  • Class B: Flammable liquids/gases.

  • Class C: Electrical equipment.

  • Class D: Combustible metals.

  • Class K: Cooking oils/fats in commercial kitchens.

FIRE SAFETY

  • Fire Triangle: Combustion elements include: 

    • An ignition source, fuel source, and oxygen source.

  • PASS: 

    • Pull pin

    • Aim nozzle

    • Squeeze handle

    • Sweep base.

  • RACE: 

    • Remove/rescue

    • Alarm

    • Contain

    • Extinguish

ELECTRICAL SAFETY

  • Equipment Checks: All new portable electrical equipment that arrives must be checked by biomedical engineering for safety and compatibility. Regular checks for damaged cords and missing prongs ensure safety.

  • Electrical Equipment: Workers should check electrical equipment for frayed cords and connections during cleaning and ensure any damaged items are reported and sent for repair to maintain safety.

DECONTAMINATION, SHARPS, AND BLOODBORNE PATHOGEN SAFETY

  • PPE: Mandatory use of PPE to protect against bloodborne pathogens.

  • Sharps Disposal: Proper handling and disposal of sharps in puncture-proof, leak-proof containers typically red or labeled as biohazard, to prevent injury and contamination. Do not reach blindly into containers; use sponge forceps to remove instruments.

OTHER SAFETY CONSIDERATIONS

  • Chemical Safety: Follow SDS instructions for chemical use to prevent exposure and injury; as regulated by OSHA.

  • Ergonomics: Back injuries are the most common injury for SPD workers. Use good body mechanics to AVOID injuries from lifting above the shoulders, pulling, pushing heavy objects, and storing heavy instruments on bottom shelves. 

  • Burns: Avoid injuries from steam sterilizers and heat sealers. Use PPE such as heat-resistant gloves for protection.

  • Slipping/Tripping: Maintain dry, organized areas. Report wet floors immediately to prevent accidents.

  • Dress Code: Compliance with attire to prevent contamination and injury, including appropriate use of PPE and adherence to hygiene standards.

INCIDENT REPORTS

  • Documentation: Report any injury immediately (within 24 hours) to ensure proper documentation and coverage under workman’s compensation.

DRESS CODE AND PERSONAL HYGIENE

  • Warm-Up Jackets: Recommended to prevent bacterial shedding from bare arms and contain skin squames.

  • Personal Cloth Head Coverings: Are permissible if laundered after each use at the facility to prevent contamination.

  • No jewelry to maintain hygiene and safety in the SPD including Lanyards. 

  • Nails: should be short, with tips no longer than 2 millimeters (0.08 inches), and free from artificial enhancements to ensure thorough cleaning and prevent glove punctures.

  • Avoid loose-fitting clothing as it can catch on things and cause injury, but ensure personal clothing is contained within scrub attire to prevent contamination.

ENVIRONMENTAL SANITATION

  • SPD Staff: Responsible for cleaning horizontal work surfaces (workstations, countertops, shelving) to avoid contamination during the handling and preparation of sterile items.

  • Other Departments: Environmental Services, Engineering, or designated cleaning crews handle specialized cleaning tasks such as floors, walls, vents, ceiling fixtures, cabinets, and high-touch areas.

    • Daily Cleaning: Wet-mop floors daily during operations to remove dust, debris, and contaminants; this needs to be documented.

QUALITY ASSURANCE AND CONTINUOUS QUALITY IMPROVEMENT

  • Monitoring: Continuously assess and improve work quality through regular evaluations and competency assessments. Provide ongoing education and training to maintain high standards in sterile processing.