Infection Control: New York State Mandatory Training

Element V, Con't.

Introduction

Element I

Element II

Element III

Element IV

Element V

Element VI

Conclusion

Resources

References

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Recent Changes in Disinfection/Sterilization Reflected in the 2008 Guidelines

1. Formaldehyde-alcohol has been deleted as a recommended chemical sterilant or high-level disinfectant because it is irritating and toxic and not commonly used.
2. Several new chemical sterilants have been added, including hydrogen peroxide, peracetic acid and peracetic acid and hydrogen peroxide in combination.
3. Three percent phenolics and iodophors have been deleted as high-level disinfectants because of their unproven efficacy against bacterial spores, M. tuberculosis, and/or some fungi.
4. Isopropyl alcohol and ethyl alcohol have been excluded as high-level disinfectants 15 because of their inability to inactivate bacterial spores and because of the inability of isopropyl alcohol to inactivate hydrophilic viruses (i.e., poliovirus, coxsackie virus).
5. Reiteration/clarification of the need to high-level disinfect items such as vaginal endoscopes and ENT scopes between each patient use even if a protective sheath is used.
6. A 1:16 dilution of 2.0% glutaraldehyde-7.05% phenol-1.20% sodium phenate (which contained 0.125% glutaraldehyde, 0.440% phenol, and 0.075% sodium phenate when diluted) has been deleted as a high-level disinfectant because this product was removed from the marketplace in December 1991 because of a lack of bactericidal activity in the presence of organic matter; a lack of fungicidal, tuberculocidal and sporicidal activity; and reduced virucidal activity.
7. The exposure time required to achieve high-level disinfection has been changed from 10-30 minutes to 12 minutes or more depending on the FDA-cleared label claim and the scientific literature. A glutaraldehyde and an ortho-phthalaldehyde have an FDA-cleared label claim of 5 minutes when used at 35 degrees C and 25 degreesC, respectively, in an automated endoscope reprocessor with FDA-cleared capability to maintain the solution at the appropriate temperature.
8. Many new subjects have been added to the 2008 Guideline. These include inactivation of emerging pathogens, bioterrorist agents, and bloodborne pathogens; toxicologic, environmental, and occupational concerns associated with disinfection and sterilization practices; disinfection of patient-care equipment used in ambulatory and home care; inactivation of antibiotic-resistant bacteria; new sterilization processes, such as hydrogen peroxide gas plasma and liquid peracetic acid; and disinfection of complex medical instruments (e.g., endoscopes). For more detailed information about disinfection/sterilization of specific medical equipment, or other topics related to this content consult the complete Guideline at http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf.

OSHA's Bloodborne Pathogens Standard

OSHA's Bloodborne Pathogens Standard is aimed at eliminating or minimizing occupational exposure to bloodborne pathogens. One component of Standard is that all equipment and environmental and working surfaces be cleaned and decontaminated with an appropriate disinfectant after contact with blood or other potentially infectious materials. Even though the OSHA standard does not specify the type of disinfectant or procedure, the OSHA original compliance document suggested that a germicide must be tuberculocidal to kill the HBV. To follow the OSHA compliance document a tuberculocidal disinfectant (e.g., phenolic, and chlorine) would be needed to clean a blood spill. However, in February 1997, OSHA amended its policy and stated that EPA-registered disinfectants labeled as effective against HIV and HBV would be considered as appropriate disinfectants ". . . provided such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended."

When bloodborne pathogens other than HBV or HIV are of concern, OSHA continues to require use of EPA-registered tuberculocidal disinfectants or hypochlorite solution (diluted 1:10 or 1:100 with water). Studies demonstrate that, in the presence of large blood spills, a 1:10 final dilution of EPA-registered hypochlorite solution initially should be used to inactivate bloodborne viruses to minimize risk for infection to healthcare personnel from percutaneous injury during cleanup.

Potential for contamination is dependent upon:

• Type of instrument, medical device, equipment, or environmental surface.
• Potential for external contamination (e.g., presence of hinges, crevices).
• Potential for internal contamination (e.g., presence of lumens).
• Physical composition, design, or configuration of the instrument, medical device, equipment, or environmental surface.
• Frequency of hand contact with instrument medical device, equipment, or environmental surface. Potential for contamination with body substances or environmental sources of microorganisms.

Level of contamination is dependent upon:

• Types of microorganisms
• Number of microorganisms
• Potential for cross-contamination

Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas

• Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions.
• Do not use high-level disinfectants/liquid chemical sterilants for disinfection of either noncritical instruments and devices or any environmental surfaces; such use is counter to label instructions for these toxic chemicals.
• Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment.
• In the absence of a manufacturer's cleaning instructions, follow certain procedures:
  • Clean noncritical medical equipment surfaces with a detergent/disinfectant. This may be followed by an application of an EPA-registered hospital disinfectant with or without a tuberculocidal claim (depending on the nature of the surface and the degree of contamination), in accordance with germicide label instructions.
  • Do not use alcohol to disinfect large environmental surfaces.
  • When using a pre-moistened/pre-mixed detergent/disinfectant wipe, use enough sheets to ensure that the surface area remains visibly wet for the contact time required for that product.
  • Use barrier protective coverings as appropriate for noncritical surfaces that are:
  • touched frequently with gloved hands during the delivery of patient care;
  • likely to become contaminated with blood or body substances; or
  • difficult to clean (e.g., computer keyboards).
• Keep housekeeping surfaces (e.g., floors, walls, tabletops) visibly clean on a regular basis and clean up spills promptly.
• Use a one-step process and an EPA-registered hospital detergent/ disinfectant designed for general housekeeping purposes in patient-care areas where:
  • Uncertainty exists as to the nature of the soil on the surfaces (e.g., blood or body fluid contamination versus routine dust or dirt); or
  • Uncertainty exists regarding the presence of multidrug resistant organisms on such surfaces.
• Detergent and water are adequate for cleaning surfaces in nonpatient-care areas (e.g., administrative offices).
• Clean and disinfect high-touch surfaces (e.g., doorknobs, bed rails, light switches, and surfaces in and around toilets in patients' rooms) on a more frequent schedule than minimal-touch housekeeping surfaces.
• Clean walls, blinds, and window curtains in patient-care areas when they are visibly dusty or soiled.
• Do not perform disinfectant fogging in patient-care areas.
• Avoid large-surface cleaning methods that produce mists or aerosols, or disperse dust in patient-care areas.
• Follow proper procedures for effective uses of mops, cloths, and solutions:
  • Prepare cleaning solutions daily or as needed, and replace with fresh solution frequently according to facility policies and procedures.
  • Change the mop head at the beginning of each day and also as required by facility policy, or after cleaning up large spills of blood or other body substances.
  • Clean mops and cloths after use and allow to dry before reuse; or use single-use, disposable mop heads and cloths.
• After the last surgical procedure of the day or night, wet vacuum or mop operating room floors with a single-use mop and an EPA-registered hospital disinfectant.
• Do not use mats with tacky surfaces at the entrances to operating rooms or infection-control suites.
• Use appropriate dusting methods for patient-care areas designated for immunocompromised patients (e.g., HSCT patients).
  • Wet-dust horizontal surfaces daily by moistening a cloth with a small amount of an EPA-registered hospital detergent/disinfectant.
  • Avoid dusting methods that disperse dust (e.g., feather-dusting).
• Keep vacuums in good repair and equip vacuums with HEPA filters for use areas with patients at risk.
• Close the doors of immunocompromised patients' rooms when vacuuming, waxing, or buffing corridor floors to minimize exposure to airborne dust.
• When performing low- or intermediate-level disinfection of environmental surfaces in nurseries and neonatal units, avoid unnecessary exposure of neonates to disinfectant residues on these surfaces by using EPA-registered germicides in accordance with manufacturers' instructions and safety advisories.
  • Do not use phenolics or any other chemical germicide to disinfect bassinets or incubators during an infant's stay.
  • Rinse disinfectant-treated surfaces, especially those treated with phenolics, with water.
  • When using phenolic disinfectants in neonatal units, prepare solutions to correct concentrations in accordance with manufacturers' instructions, or use premixed formulations.

Reprocessing

Universal Principles

Instruments, medical devices and equipment should be managed and reprocessed according to recommended/appropriate methods regardless of a patient's diagnosis except for cases of suspected prion disease.

Special procedures are required for handling brain, spinal, or nerve tissue from patients with known or suspected prion disease (e.g., Creutzfeldt-Jakob disease [CJD]). Consultation with infection control experts prior to performing procedures on such patients is warranted.

Industry guidelines as well as equipment and chemical manufacturer recommendations should be used to develop and update reprocessing policies and procedures.

Written instructions should be available for each instrument, medical device, and equipment reprocessed.

Steps of Reprocessing

• Pre-cleaning Removes soil, debris, lubricants from internal and external surfaces; to be done as soon as possible after use
• Cleaning
  • Manual (e.g., scrubbing with brushes)
  • Mechanical (e.g., automated washers) " Appropriate use and reprocessing of cleaning equipment (e. g., do not reuse disposable cleaning equipment)
• Frequency of solution changes
• Disinfection- requires sufficient contact time with chemical solution
• Sterilization- requires sufficient exposure time to heat, chemicals, or gases

Choice/Level of reprocessing sequence

• Based on intended use (see Definitions):
  • Critical instruments and medical devices require sterilization.
  • Semi critical instruments and medical devices minimally require high level disinfection.
  • Noncritical instruments and medical devices minimally require cleaning and low level disinfection.
• Based on manufacturer's recommendations
  • Compatibility among equipment components, materials, and chemicals used
  • Equipment heat and pressure tolerance
  • Time and temperature requirements for reprocessing

The effectiveness of reprocessing instruments, medical devices and equipment is dependent on:

• Cleaning prior to disinfection
• Disinfection
  • Selection and use of disinfectants-use of surface products or immersion products
  • Presence of organic matter
  • Presence of biofilms
  • Monitoring, including activity and stability of disinfectant, contact time with internal and external components, record keeping/tracking of instrument usage and reprocessing
  • Post-disinfection handling and storage
• Sterilization
  • Selection and use of methods
  • Monitoring - biologic monitors, process monitors (tape, indicator strips, etc.), physical monitors (pressure, temperature gauges), record keeping and recall/tracking system for each sterilization processing batch/item
  • Post-sterilization handling, packaging and storage (event-related criteria)

It is important to recognize potential sources of cross-contamination in the healthcare environment:

• Surfaces or equipment which require cleaning between patient procedures/treatments
• Practices that contribute to hand contamination and the potential for cross-contamination
• Consequences of reuse of single-use/disposable instruments, medical devices or equipment

At any point in reprocessing or handling, breaks in infection control practices can compromise the integrity of instruments, medical devices or equipment. Some specific factors have contributed to contamination in reported cases of disease transmission include:

• Failure to reprocess or dispose of items between patients " Inadequate cleaning "
• Inadequate disinfection or sterilization
• Contamination of disinfectant or rinse solutions
• Improper packaging, storage and handling
• Inadequate/inaccurate record keeping of reprocessing requirements

Provider Practice Setting and Need for Detailed Reprocessing Information

The individual healthcare provider's area of professional practice setting and scope of responsibilities determines the need for more information regarding infection control and disinfection/sterilization.

For professionals who practice in settings where handling, cleaning, and reprocessing equipment, instruments or medical devices is performed elsewhere (e.g., in a dedicated Sterile Processing Department), it is important to understand core concepts and principles of infection control, including:

• Standard and Universal Precautions (e.g., wearing of personal protective equipment);
• Cleaning, disinfection, and sterilization described in Sections III and IV above;
• Appropriate application of safe practices for handling instruments, medical devices and equipment in the area of professional practice;
• Designation and physical separation of patient care areas from cleaning and reprocessing areas is strongly recommended by NYSDOH;
• Verify with those responsible for reprocessing what steps are necessary prior to submission regarding pre-cleaning, soaking, etc.

For professionals who have primary or supervisory responsibilities for equipment, instruments or medical device reprocessing (e.g., Sterile Processing Department staff or clinics and physician practices where medical equipment is reprocessed on-site):

• Understand core concepts and principles
  • Standard and Universal Precautions
  • Cleaning, disinfection, and sterilization described in Sections III and IV above
  • Appropriate application of safe practices for handling instruments, medical devices, and equipment in the area of professional practice
  • Designation and physical separation of patient care areas from cleaning and reprocessing areas is strongly recommended by NYSDOH.
• Determine appropriate reprocessing practices and the selection of appropriate methods, taking into consideration:
  • Antimicrobial efficacy
  • Time constraints and requirements for various methods
  • Compatibility among equipment/materials, including factors such as corrosiveness, penetrability, leaching, disintegration, heat tolerance and moisture sensitivity.
  • Toxicity, including occupational health risks, environmental hazards, abatement methods, monitoring exposures, potential for patient toxicity/allergy
  • Residual effect, including antibacterial residual, patient toxicity/allergy
  • Ease of use, is there a need for specialized equipment or are there special training requirements
  • Stability, concentration, potency, efficacy of use, rffect of organic material
  • Odor
  • Cost
  • Monitoring frequency For more information regarding FDA regulations for reprocessing single use devices refer to the FDA web site at: http://www.fda.gov/cdrh/reprocessing

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