SPD REVIEW: Regulations, Standards, and Practices

Work Flow

The flow of work through the SPD department: from Decontamination → Prep/Pack → Sterile Storage

People Flow

How people move through the department: from clean areas (Prep/Pack, Sterile Storage) → to the Decontamination area (clean to dirty)

Regulation

A principle, rule, or law that is mandatory. Examples: FDA, EPA, OSHA

Standard

An established norm determined by opinion, authority, research, and/or theory. Examples: CDC, AAMI

Recommended Practice

Statements of sound principles of practice based on scientific data and opinions. Examples:AORN, HSPA

Ethics

Dealing with what is good and bad with moral duty and obligation

EPA (Environmental Protection Agency)

Registers and regulates environmental disinfectants, controls air emissions, evaluates pesticides, and regulates manufacture/sale of EtO gas

FDA (Food and Drug Administration)

Regulates food, drugs, cosmetics, all medical devices, sterilizers, chemical/biological indicators, and chemical disinfectants. Requires IFUs from all manufacturers.

Medical Device Reporting

FDA requires all HCFs to report to the manufacturer: patient deaths, serious injuries, and malfunctions of medical devices

Validation

Performed by Manufacturers to confirm a process works

Verification

Performed by the HCF to confirm a process works in their setting

OSHA

Regulates employee exposure to airborne contaminants, bloodborne pathogens, and communication of workplace hazards. Standards communicated on the 1st day of work.

Safety Data Sheets (SDS)

Sections 1-8: Chemical ID, hazards, composition, safe handling, emergency controls. Sections 11-16: Physical/chemical properties, toxicology, exposure controls, date of preparation/last revision.

Eye Wash Stations

Provide 0.4 gallons/min continuously to both eyes for 15 minutes; hands-free; within 10 seconds of travel; tested weekly; water temp 60-100°F

NFPA Diamond - Blue

Health hazard

NFPA Diamond - Red

Flammability

NFPA Diamond - Yellow

Instability

NFPA Diamond - White

Special hazard information

NFPA Number 4

Vaporizes and readily burns at normal temperatures

NFPA Number 3

Ignited at ambient temperatures

NFPA Number 2

Must be heated or high ambient temperatures to burn

NFPA Number 1

Must be preheated before ignition can occur

NFPA Number 0

Will not burn

State vs. Federal Regulations

Whichever is stricter has precedence

CDC (Centers for Disease Control)

NOT a regulatory agency. Publishes widely respected guidelines on hand hygiene, infection control, disinfection, sterilization, and emerging diseases.

Spaulding Classification - Critical

Devices exposed to normally sterile areas of the body; must be sterilized

Spaulding Classification - Semicritical

Devices exposed to intact mucous membranes; can be sterilized or High Level Disinfected

Spaulding Classification - Noncritical

Devices that touch skin; can be cleaned with low-level disinfectant or soap and water

The Joint Commission

Independent nonprofit that accredits healthcare facilities. Accreditation lasts 3 years. Uses "Tracer Methodology" during unannounced surveys.

AAMI

Primary US organization that develops consensus standards for decontamination, disinfection, and sterilization. Standards are considered law in New Jersey.

Policies vs. Procedures

Policies define what must be done. Procedures define the steps to comply with the policy.

Loaner Instrumentation

Must be delivered 48-72 hours before surgery, must include IFUs, and must be completely reprocessed before use.

PASS (Fire Extinguisher)

Pull the pin, Aim the nozzle, Squeeze the handle, Sweep the base of the fire

RACE (Fire Emergency)

Remove/Rescue, Alarm, Contain, Extinguish

Fire Class A

Cloth, wood, paper, rubber, plastics

Fire Class B

Gas, alcohol, oil, flammable gases

Fire Class C

Energized electrical equipment

Fire Class D

Combustible metals (magnesium, sodium, titanium)

Fire Class K

Vegetable oils, fats, cooking appliances

Sharps Safety

SPD techs should only reach into contaminated instruments if contents are visible, or use a sponge stick. OSHA requires PPE for protection from bloodborne pathogens.

Latex Allergy Signs & Symptoms

Skin rash/hives, flushing, itching, nasal/eye/sinus symptoms, asthma, shock

Ergonomics in SPD

Use height-adjustable surfaces, carts with low rolling wheels, sit/stand stools, anti-fatigue mats; keep elbows close to the body

Incident Reports

Must be made immediately, no more than 24 hours after the incident. Any injury, no matter how slight, must be documented.

Dress Code - Scrubs

Provided and laundered by the facility. Cannot be worn outside the building.

Dress Code - Shoes

Clean, non-skid soles, closed-toed, and sturdy

Dress Code - Hair/Nails

Complete hair coverage required (including facial hair). No artificial nails. Natural nails trimmed to ¼ inch from fingertips. No jewelry.

Quality Assurance (QA)

Random audits, monitoring compliance with policies; leads to fewer errors, increased satisfaction, better patient outcomes, and lower costs

Orientation Duration

3 to 18 months; includes mentors, "return demonstration" for each task. Joint Commission recommends evaluating competencies every 3 years.

Microbiology - Gram Staining

Gram negative = stain red/pink. Gram positive = stain blue/purple.

Bacteria Shapes

Cocci (round), Bacilli (rod-shaped), Spiral

Spore

Hardest type of bacterial structure to kill; surrounds some bacteria

Capsule

Slimy outer covering on some bacteria; easier to kill than a spore

Gram Positive Examples

Staphylococcus aureus, Streptococcus, Clostridia, Enterococcus, B. mycobacterium

Gram Negative Examples

E. coli, Salmonella, Shigella, Pseudomonas, Legionella, N. gonorrhoeae, H. influenza

MRSA

Multi-drug resistant Staphylococcus aureus; major cause of nosocomial infections

C. difficile

Gram positive, spore-forming; proliferates with antibiotic overuse causing diarrhea; a common HAI

Viruses

Require a living host to multiply. Responsible for rabies, AIDS, smallpox, measles, Ebola, hepatitis, herpes, influenza, Zika.

Prions

Responsible for TSEs (Transmissible Spongiform Encephalopathies) such as Mad Cow Disease and CJD. Have an affinity for brain, eye, and spinal cord tissue.

HAI / Nosocomial Infection

An infection acquired in a healthcare facility

Direct Contact Transmission

Patient's blood or body fluid directly enters a caregiver's body through mucous membranes or breaks in skin (e.g., staph, Hep A, measles, HIV)

Indirect Contact Transmission

Via inanimate objects (fomites) such as dirty needles, cups, tissue; or from healthcare worker hands

Droplet Transmission

Respiratory droplets traveling less than 3 feet (e.g., influenza, SARS, coronavirus, meningitis, pertussis)

Airborne Transmission

Transmitted over 3 feet via air currents; requires AIIRS (e.g., TB, rubeola/measles, varicella/chickenpox)

Vector Transmission

Transmitted by insects/animals: Malaria (mosquito), Lyme disease (tick), Zika (mosquito), typhus (lice), plague (fleas)

Handwashing

Wash for 20 seconds with soap and water. Waterless hand sanitizers are 60-95% effective.

Contact Precautions

For MRSA, VRE, C. diff, scabies, draining wounds (direct or indirect contact)

Droplet Precautions

For influenza, Mycoplasma pneumonia, strep pharyngitis, meningitis, pertussis

Airborne Precautions

For TB, SARS, Ebola, chickenpox, measles; requires N95 mask and AIIR room

Medical Waste

Placed in leak-proof orange bags or puncture-proof sharps containers; includes lab waste, blood products, sharps contaminated with blood

Cleaning (Definition)

Removal of contamination from an item to the extent necessary for further processing

Decontamination (Definition)

Use of physical or chemical means to remove, inactivate, or destroy BBP so items are no longer capable of transmitting infectious particles

Decontamination Temperature & Humidity

Temperature: 60-65°F; Humidity: 30-60%

PPE - Donning Order

Shoe covers → Gown → Mask → Goggles/Face Shield → Gloves

PPE - Doffing Order

Shoe covers (dirtiest) → Gloves → Goggles/Face Shield → Gown → Mask

Transporting Contaminated Items

Gross soil removed at point of use with wet towel or enzymatic foam (no saline). Transported in a closed cart. No soaking (prevents biofilm).

Ultrasonic Cleaner - Cavitation

Transducer emits sound waves through solution that collapse inward, dislodging soil. Cleans but does NOT disinfect.

Ultrasonic Cleaner - Degassing

Must be done before use; tap water contains air that interferes with cleaning

Ultrasonic Cleaner - Metal Rule

No mixing of metals; instruments no higher than 3 inches from top of tray

Water - Utility

Tap water; used for washing, flushing, and first rinse

Water - Critical

Distilled, deionized, or reverse osmosis; used for final rinse

Detergent Temperature

109-140°F (too hot destroys enzymes; too cold makes them sluggish)

Proteolytic Detergent

Breaks down blood, mucus, feces, and albumin

Lipolytic Detergent

Breaks down fats, bone marrow, adipose tissue

Amylase Detergent

Breaks down carbohydrates and starches

Principles of Cleaning

Every surface must contact solution; hinged instruments open; multi-part items disassembled; delicate instruments on top; don't mix metals

Lumen Cleaning

Use correct-size brush; brush from smaller to larger end (reverse flushing); ensure lumens are clear of debris

TASS (Toxic Anterior Segment Syndrome)

Acute inflammation of anterior eye chamber after cataract surgery; linked to inadequate cleaning, gram negative bacilli in ultrasonic baths, and residual detergents

Flexible Scope - Leak Test

Done before pre-cleaning; wet test uses tap water (no detergent) so air bubbles from sheath damage are visible; scope must be "insufflated" before testing

Flexible Scope Storage

Hung vertically, no coils, in a dust-free, closed, well-ventilated cabinet; should not touch the bottom; 14-day storage limit then must reprocess

HLD - Glutaraldehyde

14-28 day shelf life; rinse at least twice; use butyl rubber gloves; dispose with continuous running water, 20 minutes at a temperature of 20°C (68°F)

HLD - Ortho-phthalaldehyde (OPA)

HLD in 12 minutes (5 min in AER); stains tissue blue; discard after 14 days; requires 3 separate rinses; neutralize with glycine for disposal

MEC Testing

Test strips used to verify Minimum Effective Concentration of HLDs; if solution fails MEC, must be changed; document all results

Bowie-Dick Test

Used ONLY for prevacuum/dynamic air removal sterilizers; detects air leaks, inadequate air removal, and steam penetration issues; run in first load of the day in an empty chamber for 3-3.5 min at 270°F

Sterilization Monitoring - Physical

Charts, gauges, and printouts

Sterilization Monitoring - Chemical

External indicators (Type 1), Bowie-Dick (Type 2); placed inside every package

Sterilization Monitoring - Biological

Measures lethality of sterilization using spore tests; most definitive method

Chemical Indicator Type 1

Indicator tape (external); reacts to specific sterilization process

Chemical Indicator Type 2

Bowie-Dick test (prevacuum sterilizers only)

Chemical Indicator Type 3

Reacts to only one variable (e.g., temperature)

Chemical Indicator Type 4

Reacts to two or more variables