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This document outlines detailed guidelines for infection control practices, decontamination processes, and sterilization procedures to ensure compliance with medical devices regulations. Topics covered include cleaning instruments, use of washer disinfectors, ultrasonic cleaning, manual cleaning, and sterilization methods.
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Infection control • Practices require registration with CQC. Cleanliness and inf control requirement • Decontamination processes should be audited every 6 months (DH audit tool) (prev 3/12) • Aim to achieve reprocessed device fully compliant with medical devices regs 2002 • Special precautions for prion transmission not necessary • Training essential (5 hours per CPD cycle)
Infection control policy • Written policy updated every 2 years • Blood borne transmission and sharps • Decontamination and storage • Procedures for cleaning, disinfection and sterilization of instruments • Management and disposal of clinical waste • Hand hygiene • Reusable instruments and single use • PPE • Disinfectants-use, storage, disposal • Spillage procedures and COSHH • Environmental cleaning • training
Transport of instruments • ASAP to avoid risk of drying (can immerse in water or gels/sprays) • Containers should be • Leak proof • Easy to clean • Rigid • Able to be closed securely • Robust to prevent instrument damage • Clearly marked • Transport outwith surgery for decon. requires noted consignment • Domiciliary visits require record of date and vehicle used
Cleaning instruments • Essential prerequisite before sterilization • Best practice with WD • ASAP after use • New instruments cleaned & sterilized before use, unless supplied as sterile • Cleaning practices should be validated
Washer disinfector • Flush –remove gross contamination <45oC • Wash-detergent • Rinse-remove detergent • Thermal disinfection-80oC for 10 mins or 90oC for 1min • Drying • Crucial to load correctly-open hinges, no overlapping, attach to irrigation • Inspect afterwards under lighting and magnification
Ultrasonic cleaning • Can be used prior to WD esp. for hinged instruments • Should be immersed in cold water with detergent first • Place instruments in basket, fully immersed • Do not overload, overlap or place on floor • Close lid and set timer • After cycle drain basket before rinsing in a dedicated sink or bowl • Change solution when visibly contaminated or at end of every session
Manual cleaning • Wash hands • Wear PPE • Prepare sinks, equipment and setting down area • Fill the sink to level (marked on edge of sink) with water and detergent • Ensure temp <45oC • Fully submerge and keep under water to prevent aerosols • Scrub using long handled brush with soft plastic bristles • Drain water • Rinse in separate sink (potable/RO/distiller water) • Drain (and dry if to be wrapped) • Visually inspect
Sterilization • Saturated steam under pressure at the highest temperature compatible with the product • Records required for every cycle • These should be copied as print outs fade over time • All steam sterilizers subject to Pressure Vessels Systems Safety Regulations 2000-must be examined periodically by a competent person
Sterilizers • Type N: non-vacuum • Type B: vacuum • Type S: specific load Must be: Compliant with safety requirements Installed, commissioned , validated and maintained Operated according to manufacturers instructions
Sterilizers • Reservoir should be filled at least daily with distilled or RO water • Should be cleaned, drained and left empty with door open at end of day • Testing required to ensure performance • Each sterilizer should have a logbook in which the following are recorded: • Maintenance • Validation • Faults • Modifications • Routine tests
Sterilizers • Before carrying out tests the user should: • Clean door seal • Check chamber for cleanliness • Fill reservoir • Turn power source • Daily tests consist of • Automatic control test • Steam penetration (vacuum) helix or Bowie-Dick
Packaging • Instruments should be cleaned and dried before wrapping • With steam displacement (type N) instruments should be wrapped after sterilization • With Type B instruments should be wrapped prior to sterilization • Instruments should be dried using disposable non-linting cloths • Instruments can be stored for up to 12 months • First in - first out principle helpful • Date should be marked on package
Storage • Wrapped instruments may be stored for up to 1year • Unwrapped instruments in the clinical area 1 day (must be dry and protected from contamination eg in cupboard). These instruments should be reprocessed at the end of day or next morning even if not used • Unwrapped instruments in a non-clinical area 1 week • Wrapped instruments should be date stamped/marked
LDU • Dirty to clean workflow, clearly separated • Decluttered • Sealed, easily cleaned work tops • Should be wiped down after each decontamination cycle • Air flow from clean to dirty • Dirty zone receives instruments • Washing sinks should be next to receiving area. • Ultrasonic cleaner next and then WD • After the cleaning/disinfection area should be an inspection area • Sterilizer should be well away from other activities • Set down clean area adjacent to this • Separate wash hand basin for hand washing
Hand hygiene • Crucial to prevent spread of infection and decontamination • Should be carried out: • Before and after each treatment session • Before and after removal of PPE • Following washing of dental instruments • Before contact with instruments that have been steam sterilized • After cleaning or maintaining decontamination devices • After toilet visits • Before and after contact with food
Hand hygiene • Mild soap should be used, not bar soap. • Apply soap to wet hands • Dry with disposable paper towel • Hand cream (water based) should be used at the end of session • Rings, bracelets and watches should be removed • Fingernails should be kept clean and short with no polish • The basin used should not have a plug or overflow • It should have a mixer tap-lever or sensor operated • Taps shouldn’t discharge directly into the drain (to prevent aerosols) • A cleanable poster dictating hand wash method should be displayed above every clinical wash hand basin
PPE • Infection control policy should specify when PPE should be worn and changed • Gloves: • Protect hands from contamination, chemicals and to minimise cross infection risk • Glove integrity can be damaged by isopropanol or ethanol, therefore alcohol rubs shouldn’t be used with gloves • Domestic household gloves, if used should be washed with detergent and hot water and left to dry
PPE • Plastic single use aprons should be worn during all decontamination processes • Face masks are single use • Visor or face shield should be worn • Footwear should be enclosed • Clinical clothing should not be worn outside the practice • Short sleeves should be used (can wear disposable sleeves) • Uniforms should be washed at hottest temperature suitable for fabric • Clean uniform should be worn every day
Removal of PPE • Items should be removed in the following order • Gloves first • Plastic apron • Face and eye protection • Face mask • Wash hands thoroughly
Maintenance and testing Sterilizer DAILY • Steam penetration B • Automatic control test B & N WEEKLY including daily tests plus • Air leakage B • Residual air test N QUARTERLY (by engineer) • Thermometric tests ANNUALLY (by engineer) • Thermometric tests - Small load, Large load • Dryness tests - Small load, Large load
Maintenance and Testing WD Validation is needed for new equipment at installation and annually thereafter. Also after any repairs DAILY • Remove and clean strainers and filters - Ensures filters and strainers are clean • Cleaning efficacy - Visual examination of all load items WEEKLY including daily tests plus: • Protein residue test - Confirms that cleaning process retains the capability of removing protein • Safety checks - Check condition of door seal QUARTERLY • Safety checks • Automatic control test • Cleaning efficacy test • Chemical dosing • Thermometric disinfection test ANNUALLY • Completion of all validation tests above
Maintenance and Testing Ultrasonic Validation is needed for new equipment at installation and annually thereafter. It will also be necessary to validate equipment after any major repairs have been carried out DAILY • Remove and clean strainers and filters - Ensures filters and strainers are clean • Drain machine at end of day/ session • Cleaning efficacy - Visual examination of all load items WEEKLY • Safety checks - Check condition of door-seal • Protein residue test QUARTERLY • Automatic control test • Verification of calibration • Cleaning efficacy test • Ultrasonic activity test ANNUALLY • Completion of all validation tests above
Blood spillages • The use of hypochlorite at 1000 ppm available chlorine is recommended. Hypochlorite should be made up either freshly using hypochlorite-generating tablets or at least weekly in clean containers. Contact times should be reasonably prolonged (not less than five minutes). • A higher available chlorine concentration of 10,000 ppm is useful, particularly for blood contamination. The process should be initiated quickly and care should be taken to avoid corrosive damage to metal fittings etc. The use of alcohol within the same decontamination process is not advised.
Sharps Regulations • Needles must not be recapped after use unless the employer’s risk assessment has identified that recapping is itself required to prevent a risk (eg to reduce the risk of contamination of sterile preparations). In these limited cases, appropriate devices to control the risk of injury to employees must be provided. For example, needle-blocks can be used to remove and hold the needle cap and so allow safe one-handed recapping.