Standard of Practice: IPC and MDR for Dentistry (Alberta) - Comprehensive Notes

Introduction

• The Standard of Practice: Infection Prevention and Control Standards and Risk Management for Dentistry is issued by the College of Dental Surgeons of Alberta (CDSA). It sets IPC and risk management requirements for all dental offices in Alberta.
• Origin and scope:
  • In effect since January 1, 2011, with updates and alignment to CSA standards and Alberta Health guidelines.
  • Applies to all clinical, laboratory, and medical device reprocessing areas in dental settings.
  • All sterilizers must record cycle parameters (printer or electronic data recorder). If a sterilizer lacks this feature, adaptation or replacement was required by January 1, 2023.
• Key references and standards:
  • Alberta Health and Government of Alberta Reusable & Single-Use Medical Devices Standards (CSA Z314-18 family).
  • CSA standards for medical device reprocessing and related guidelines.
  • Spaulding Classification System for classifying devices and surfaces.
• Terminology and definitions: Many terms are defined in the Definitions section (see page 26). Review definitions when reviewing the Standard.
• Organization of content: The standard covers written policies, patient evaluation, hand hygiene, PPE, laundering, MDR considerations, pre-cleaning, cleaning, disinfection, sterilization, storage, education, environmental controls, waterlines, single-use devices, occupational health and safety, ethics, and quality management.

1.0 Written Policies and Procedures

• 1.1 IPC policies must exist in writing and include:
  • 1.1.1 Reporting structure for IPC and risk management policy development, approval, monitoring, and maintenance.
  • 1.1.2 Hand hygiene policy and procedure (indications, agent selection, ABHR management, hand lotion, ABHR use, monitoring/compliance audits).
  • 1.1.3 Policies for selection, acquisition, transportation, receiving, handling, processing, and disposal of dental instruments/devices (new, loaned, shared, leased).
  • 1.1.4 Manufacturer’s Instructions for Use (MIFU) regarding maintenance and reprocessing.
  • 1.1.5 Sterilization processes following IPC principles per CDSA Standards.
  • 1.1.6 Personnel protection and safety per Alberta OHS Act.
• 1.2 DHCP awareness and compliance with IPC and OHS documentation.
• 1.3 Annual review of policies by the clinic owner and dentists; IPC training/CE per CDSA Standards.

2.0 Patient Evaluation

• 2.1 Dentist must perform medical history for every patient with point-of-care risk assessment at every interaction to determine IPC measures beyond routine practice.
• 2.2 Vigilance for signs, symptoms, and epidemiology of communicable diseases (e.g., blood-borne pathogens, MRSA, C. difficile, VRE, TB, SARS-CoV-2, influenza-like illnesses).
• 2.2 Additional (transmission-based) precautions in specific situations:
  • 2.2.1 Airborne Precautions in addition to Routine Practices for influenza-like illnesses or TB.
  • 2.2.2 Contact Precautions (e.g., gowns) for MRSA, C. difficile, or VRE colonization or infection.
• 2.3 Respiratory protection plan required, based on a point-of-care risk assessment prior to each task.

3.0 Hand Hygiene

• 3.1 Required hand hygiene for all DHCP:
  • Before/after contact with patients, body substances, contaminated items; before invasive procedures; before handling/serving/consuming food; after assisting with personal care; before donning and after doffing gloves and PPE; after personal functions; when hands contact secretions/blood; before handling clean supplies.
• 3.2 Hands must be washed with soap, water, and disposable towels at start, after meals, after restroom use, and when contaminated.
• 3.3 Antisepsis with soap and water or ABHR containing 60\% - 90\% alcohol with Health Canada DIN or NPN, prior to patient treatment, before donning gloves, between patients after glove changes. ABHR only when hands are not visibly soiled.
• 3.4 Soap/ABHR dispensers must be cleaned and dried before refilling; preferred to use cartridge systems.
• 3.5 DHCP must not wear hand jewelry during hand hygiene or clinical treatment; remove during invasive procedures except smooth metal bands.
• 3.6 No artificial nails; nails short (< 3-4 mm) with no chipped polish.
• 3.7 Do not use a standing basin of water to rinse hands.
• 3.8 Use disposable hand towels to dry hands after hygiene.
• 3.9 Do not use non-alcohol-based hand antiseptics.

4.0 Personal Protective Equipment (PPE)

• 4.1 Use new single-use exam gloves for patient care; sterile gloves for invasive surgical procedures (gingival/mucosal flaps, bone cutting, surgical decisions).
• 4.1.2 Use chemical resistant, puncture-proof utility gloves for instrument reprocessing; PPE must protect appropriately with sufficient dexterity.
• 4.2 Surgical mask covering nose and mouth during procedures; replace if contaminated or wet or per MIFU.
• 4.3 Protective eyewear (safety glasses, goggles, face shields) as determined by point-of-care risk assessment during procedures with possible splashes.
• 4.4 PPE removed before leaving patient care area.
• 4.5 PPE (gloves, gowns, eyewear, masks) worn during instrument decontamination and removed after.
• 4.6 A face shield does not replace a mask.

5.0 Laundering for Onsite Linens and Reusable PPE

• Laundry may be onsite or via offsite service; maintain hygiene and PPE usage to minimize transmission.
• 5.1 Handling of soiled linens:
  • 5.1.1 Appropriate PPE (gloves, long sleeves) when sorting soiled laundry;
  • 5.1.2 Remove PPE after placing soiled laundry into bag; minimize agitation; wash hands after PPE removal;
  • 5.1.3 Do not require gloves to transport laundry bag to laundry area.
• Washing soiled linen:
  • 5.1.4 Wash and dry linen per routine standards; avoid overloading;
  • 5.1.5 Use detergent/disinfectant appropriate for load/soil; follow detergent and water temperature guidelines; complete wash/rinse/dry cycles;
  • 5.1.7 If using low-temperature cycles, use a chemical suitable for low-temperature washing at proper concentration;
  • 5.1.8 Run empty washer with 1 chlorine disinfectant tablet (equivalent to 1 cup chlorine bleach) between loads after heavily soiled loads or Additional Precautions; store chlorine tablets securely;
  • 5.1.9 After loading, disinfect high-touch washer surfaces; leave washers/dryers empty at end of day;
  • 5.1.10 Wash hands after handling soiled linen;
  • 5.1.11 Maintain and clean washing machine/dryer per manufacturer; keep a maintenance log.
• Handling and storing clean linen:
  • 5.1.12 Dry linen promptly; remove from washer to minimize biofilm;
  • 5.1.13 Hand hygiene before removing clean linen from washer;
  • 5.1.14 Fold linen on clean surfaces with clean hands;
  • 5.1.15 Store clean linen in a clean, dry place (dedicated linen storage room or shelf/cart);
  • 5.1.16 Do not store linen in patient care rooms; unused linen left after discharge is considered contaminated; any linen entering a patient room should exit in a soiled linen bag.

6.0 Purchasing and Assessing Dental Instruments and Devices and Products for Disinfection or Sterilization Processes

• 6.1 Dentists must ensure all instruments and devices are licensed under Health Canada Medical Devices Regulations; suction units also require Health Canada license.
• 6.1.1 Do not purchase or trial reusable devices lacking valid medical device licence.
• 6.2 Instrument manufacturers must identify at least one approved reprocessing method; SFPP and pre-vacuum are recognized dynamic air removal cycles.
• 6.2.1 If manufacturer instructions specify pre-vacuum (e.g., 4 minutes @ 270°F/132°C or 3 minutes @ 275°F/135°C), SFPP with equivalent times may be substituted.
• 6.3 DHCP must comply with OHS requirements.
• 6.4 The clinic must obtain from manufacturers: device design information, use manuals, device-specific cleaning/reprocessing recommendations, training materials, and monitoring recommendations.
• 6.5 Newly purchased non-sterile critical/semi-critical instruments must be inspected and processed per MIFU before use.
• 6.6 For low-risk neurological tissue (e.g., dental pulp) from high-CJD risk patients, disposal or decontamination per Health Canada/PHAC guidelines.
• 6.7 Non-critical devices should have validated MIFU for reprocessing; if not, develop SOP with IPC/MDR input; may require external expertise.
• 6.8 Before purchasing new reusable critical/semi-critical devices, confirm there is written confirmation that MIFU for reprocessing has been validated.
• 6.9 MDR leadership must review MIFU to ensure device-specific disassembly, cleaning, sterilization/disinfection cycles are appropriate and feasible.
• 6.10 If MIFU lacks required information, contact manufacturer; report gaps to Health Canada if unresolved.
• 6.11 Before purchasing reprocessing equipment, obtain technical data and ensure space and utility requirements can be met.

7.0 Selection of Products and Processes for Reprocessing

• 7.1 All reusable devices must have written device-specific manufacturer cleaning, decontamination, disinfection, wrapping, and sterilization instructions.
  • 7.1.1 Reprocessing products must be compatible with each other and the device.
  • 7.1.2 Reprocessing choices must align with Spaulding Classification based on intended use.
  • 7.1.3 If disassembly/reassembly is required, MIFU must include detailed instructions/diagrams.
• 7.2 Dentist remains ultimately responsible for selection of reprocessing products/processes; delegation to competent staff only after demonstrated competency.
• 7.2.1 Staff training on disassembly/reassembly/reprocessing before use.

8.0 Environmental and Structural Requirements for a Medical Device Reprocessing (MDR) Area

• 8.1 MDR area designated and physically separated from clinical care areas; activity limited to MDR.
• 8.2 MDR space requirements:
  • 8.2.1 Adequate space for cleaning and storage of equipment/supplies
  • 8.2.2 Separate decontamination areas from clean/disinfected/sterile handling areas
  • 8.2.3 Easy access to hand hygiene facilities
  • 8.2.4 Surfaces non-porous, seamless, cut-resistant; easy to clean
  • 8.2.5 One-way instrument flow dirty -> sterile; if physical separation is not possible, establish spatial separation and one-way workflow
  • 8.2.6 Adequate air changes, temperature, humidity as per MIFU
  • 8.2.7 Adequate lighting
  • 8.2.8 New construction/renovation should provide separate MDR room with one-way flow
  • 8.2.9 If two adjacent sinks are not possible, provide a dedicated basin for rinsing; future MDR areas should meet these standards
• 8.3 Water supply must be potable and tested; sterile water/saline for irrigation in open vascular sites or bone cutting
• 8.4 Forward-venting handpieces are not to be used for surgical/invasive procedures
• 8.5 Written contingency plans for loss of potable water or boil-water advisories
• 8.6 DHCP must not touch non-barrier surfaces with contaminated gloves
• 8.7 Premises must be neat, clean, and free of exposed waste

9.0 Pre-Cleaning, Transportation and Handling of Contaminated Dental Instruments and Devices

• 9.1 Dispose of disposable sharps in approved sharps containers at point of use or during transport; label and dispose per local regs
• 9.2 DHCP must be aware of biomedical waste and hazardous materials handling
  • 9.2.1 Heavily blood-soaked gauze/tissue to be disposed in biohazard containers per regulations
• 9.3 Pre-clean reusable devices immediately after use and before transport; keep organic matter from drying
  • 9.3.1 Remove single-use sharps into sharps container at point of use
  • 9.3.2 Do not allow organic matter to dry; keep moist with foam/spray/gel per MIFU
• 9.4 Handling must minimize exposure and environmental contamination
• 9.5 Contaminated items taken directly to MDR area; initial disassembly if needed
• 9.6 Transport in covered, leak-proof containers or closed carts; separate containers for sterile vs soiled
• 9.7 Clearly label contaminated items not yet reprocessed (color coding or tagging)
• 9.8 Intra-operative sharpening of hand/dental instruments allowed with conditions (sterilize stones per MIFU; wipe instruments after sharpening)

10.0 Preparation and Cleaning Reusable Dental Instruments and Devices

• 10.1 Remove debris/bioburden from all reusable instruments/devices before disinfection/sterilization
• 10.2 Process includes sorting/disassembly (if needed), cleaning, manual cleaning, automated cleaning, rinsing, drying, reassembly, inspection
• 10.3 Inspect and sort contaminated devices prior to reprocessing; apply appropriate cleaning to each device
• 10.4 Disassemble multi-component devices per MIFU
• 10.5 Thorough cleaning of each device prior to disinfection/sterilization
• 10.6 Cleaning methods per MIFU; match device type/soil load
• 10.7 Prefer automated cleaning for critical/semi-critical devices; manual cleaning only per MIFU
• 10.8 If manual, follow MIFU specs (detergent type, water type, temperature, methods)
• 10.9 Immersible devices must be fully submerged during cleaning; non-immersible per MIFU
• 10.10 Automated washers/ultrasonic cleaners used per MIFU; daily testing of automated systems per MIFU; log results
• 10.11 Ensure device compatibility of cleaning process conditions with the MDR equipment
• 10.12 Rinse to remove chemical residues; final rinse may be in automated step; otherwise manual rinse
• 10.13 Dry devices as per MIFU; dry exterior surfaces manually if not automated
• 10.14 Reassemble in clean/dry area; apply corrosion reduction/lubrication per MIFU
• 10.15 Visually inspect cleaned devices for cleanliness, damage, integrity, functionality; re-clean if visibly soiled
• 10.15.1 Damaged/poor-condition devices must be removed from service and segregated
• 10.16 Most non-critical items can be decontaminated at point of use; use Low-Level Disinfectant (LLD) per MIFU for cleaning and disinfecting non-critical items
• 10.17 Reusable instruments must be cleaned with instrument detergent/enzymatic product as per MIFU; discard after each use
• 10.18 Automated cleaning equipment must be operated/maintained per MIFU; document
• 10.19 Cleaning accessories (brushes, etc.) must be disposable or cleaned and disinfected/sterilized between uses; inspect before use
• 10.20 Reprocessed items from opened/compromised packages must be reprocessed prior to use
• 10.21 (Note) This section includes sequencing: sorting, disassembly, cleaning, rinsing, drying, reassembly, inspection

11.0 Disinfection of Reusable Dental Instruments and Devices

• 11.1 Heat-sensitive semi-critical instruments/devices must be disinfected per MIFU using high-level disinfection (HLD) or pasteurization
• 11.2 Disinfection must follow the MIFU for the device and the disinfection process/equipment/products
• 11.3 Only chemical disinfectants with Health Canada DIN/MDL may be used for disinfection
• 11.4 Do not use disinfectants beyond expiry or in-use shelf life
• 11.5 Reusable liquid chemical disinfectants must be clearly identified with expiry; stored/disinfected/dried properly; keep container covered when not in use
• Non-critical devices (11.6): disinfect between patients with intermediate-level disinfectant (ILD) or low-level disinfectant (LLD); wipes must wet surface completely for required contact time
• Semi-critical medical devices (11.7): if cannot sterilize, high-level disinfect between patients
• 11.8 MEC (Minimum Effective Concentration) testing for HLD must be performed daily at start and per cycle for automated HLD; ensure test strips are within expiry; ensure MEC test passes
• 11.9 Manual disinfection of semi-critical devices requires complete contact with HLD, removal of air bubbles from contact surfaces, and measured contact time/temperature from first contact
• 11.10 Automated disinfection systems must provide cycle parameter records
• 11.11 After chemical HLD, rinse thoroughly with sterile or bacteria-free water; manual rinsing requires multiple rinses (three minimum unless specified by HLD MIFU)
• 11.12 After HLD and rinsing, dry the device per MIFU
• 11.13 DHCP must document/maintain records for HLD solution details, test strips, MEC results, cycle parameters, device name, etc.
• 11.14 Devices not easily disinfected (e.g., endoscopes) must be cleaned/disinfected/sterilized per MIFU

12.0 Sterilization of Reusable Dental Instruments and Devices

• 12.1 A reusable critical device must be sterilized between each patient use
• 12.2 Semi-critical devices compatible with heat/moisture must be steam sterilized between patients
• 12.3 Sterilization must follow the device MIFU and the sterilization process MIFU
• 12.4 Prohibited sterilization methods: boiling, UV, glass bead sterilization, ovens designed for food prep, microwave ovens
• 12.5 Installation Qualification (IQ) of sterilizers must be documented per MIFU
• 12.6 Operational Qualification (OQ) at installation
• 12.7 Annual or post-repair relocation changes require requalification (OQ) per MIFU; includes changes to steam supply/pressure
• 12.8 OQ/RQ testing must verify cycle performance; process uses PCD with BI for short exposure times; fully loaded chamber for table-top sterilizers
• 12.9 Performance Qualification (PQ) uses loads representative of dental office; documents must show loading, packaging, and cycle validation; update when new materials/conditions are introduced
• 12.10 Packaging/labels (sterile barrier systems) validated; loads identified with sterilizer number, load number, and date
• 12.12 Labeling for pouches/wrapping; outer/visible indicators on packaging
• 12.13 Loading/unloading: ensure air removal/penetration; avoid contact with interior chamber walls; proper spacing between items; allow drying
• 12.14 Cool to room temperature before handling
• 12.15 Inspect packages during unloading for integrity, dryness, labeling, external indicator change, seal integrity, contamination
• 12.16 Sterilization processes require ongoing QA/maintenance per MIFU; document
• 12.17 Use mechanical/electronic failure alarms; document cycle parameters
• 12.18 Use both internal and external chemical indicators with each package; Type 1 external indicator; Type 5/6 internal indicators
• 12.19 Dynamic air removal sterilizers require daily Bowie-Dick/Dart air removal tests
• 12.20 Biological indicators (BI) within a Process Challenge Device (PCD) for each cycle type; daily testing; BI results tracked
• 12.21 Implantable devices: BI used for each load containing implants; quarantined until BI results are known; no early release unless urgent and documented; assess 5/6 indicators and cycle parameters if BI not ready
• 12.22 Documentation of sterility assurance includes cycle parameter printout/record, load contents, and indicator results
• 12.23 Procedures to recall/reprocess loads if indicator test fails
• 12.24 Immediate-use Steam Sterilization (IUSS) allowed only in emergencies with no other option; not for convenience; devices sterilized with IUSS must be used immediately and not stored
• 12.25 IUSS not used for implantable devices except as strictly required
• 12.26 IUSS packages should be used immediately; inspect integrity at point of use
• 12.27 In case of sterilization failure, investigate, document actions, recall loads if needed
• 12.28 Loaned/shared instruments must be reprocessed on receipt according to MIFU before patient use

13.0 Storage and Use of Reprocessed Dental Instruments and Devices

• 13.1 Labeled sterile packages; include sterilizer number, load number, and reprocessing date
• 13.2 Maintain sterile condition until point of use; if packaging integrity compromised, do not use and reprocess
• 13.3 Storage areas must be dedicated and designed to prevent damage and allow easy label reading; adequate lighting; follow cleaning schedules
• 13.4 Protect reprocessed devices from contamination (FIFO, off floors, away from water/hazardous materials)
• 13.5 Inspect contents upon opening; validate internal chemical indicator results before use

14.0 Education and Training

• 14.1 Ensure all personnel involved in reprocessing are educated and trained for their duties
• 14.2 Maintain records of education, training, orientation, and competency assessments for reprocessing staff

15.0 Environmental Infection Prevention and Control Practices

• 15.2 Clean and disinfect all clinical contact surfaces between patients
• 15.3 If surface covers are used:
  • 15.3.1 Covers must protect entire surface including edges
  • 15.3.2 Covers must be moisture-impervious
  • 15.3.3 Applied with clean hands or clean gloves
  • 15.3.4 Removed and discarded between patients with single-use gloves; inspect surface for contamination and disinfect if needed
• 15.4 If covers not used:
  • 15.4.1 Clean and disinfect clinical surfaces between patients
  • 15.4.2 Use hospital-grade LLD per MIFU for cleaning/disinfection of clinical surfaces
• 15.5 Components permanently attached to dental unit water lines must be disinfected after each use
• 15.6 Radiographic equipment must be cleaned/disinfected between patients

16.0 Dental Unit Waterlines

• 16.1 Purge all waterlines at start of each workday: flush for at least 2\ \text{minutes} with water
• 16.2 Purge waterlines for at least 20\ seconds after patient care
• 16.3 Follow MIFU for daily/weekly maintenance of closed water systems or other water delivery systems
• 16.4 Suction lines must be aspirated with water or disinfectant compatible with the evacuation system between patients
• 16.5 Suction lines cleaned weekly with enzymatic cleaner compatible with evacuation system

17.0 Single-Use Instruments and Devices

• 17.1 Do not reuse single-use items; discard after use unless MIFU validates reprocessing
  • 17.1.1 Examples include syringe needles, disposable syringes, prophylaxis cups/brushes, implant parts, temporary anchorage devices, bone grafting materials, some orthodontic components
  • 17.1.2 Packaged bone graft materials are single-use, for one patient/day; discard after use
  • 17.1.3 Single-use devices must be discarded after a single patient use/day
• 17.2 Medications from multi-use vials:
  • 17.2.1 Use a new needle and syringe for each entry into a multi-dose vial; date opening
  • 17.2.2 Discard multi-dose vials 28 days after opening (per product MIFU)
  • 17.2.3 Clean vial septum with a new disinfectant swab prior to each entry
  • 17.2.4 Use a new needle and syringe for each vial entry; do not reuse across patients
  • 17.2.5 Do not administer drugs to more than one patient from the same syringe/IV system
  • 17.2.6 Inspect multi-dose vials for contamination before use

18.0 Occupational Health and Safety Requirements

• 18.1 Clinic must comply with Alberta Occupational Health and Safety Act, Regulation, and Code
• 18.1.1 Conduct written hazard assessment identifying physical, biological, chemical, and radiation risks; repeat as needed
• 18.1.2 Reprocessing area restricted to reprocessing activities; no eating, drinking, etc.
• 18.1.3 Adequate air handling to protect personnel from toxic vapors
• 18.1.4 Chemicals stored per MIFU; SDS available per WHMIS
• 18.1.5 DHCP handling contaminated instruments must wear PPE
• 18.1.6 Immunizations required for DHCP; assess Hep B immunity and provide vaccination if required
• 18.1.7 AED must be on site and serviced per MIFU
• 18.1.8 Latex allergy readiness and plan
• 18.1.9 Work practice controls for exposure to blood/fluids, chemicals, sharp injuries
• 18.1.10 Policies for sharps, syringes, safety-engineered syringes (SES)
• 18.1.11 Policies for immediate response to chemical exposure
• 18.1.12 Policies for post-exposure management of blood/body fluid exposure
• 18.1.13 Eye-wash station/eye wash bottle readily accessible
• 18.1.14 Policies for exposure to sharps
• 18.1.15 Ventilation to remove toxic vapors from cleaning/disinfecting agents

19.0 Ethical Responsibilities

• 19.1 DHCP must not refuse care based on patient seropositivity (HIV, HBV, HCV)
• 19.2 If a dentist has a blood-borne infection, inform CDSA immediately
• 19.3 Legal obligation to report to Medical Officer of Health for threats to public health per Health Professions Act
• 19.4 Adherence to CDSA standards; non-compliance may constitute unprofessional conduct

20.0 Quality Management

• 20.1 Clear accountability for MDR and single-use device usage
• 20.2 Written policies/SOPs meeting/exceeding provincial and national standards; cover all MDR aspects
• 20.2.1 All MDR steps per MIFU; 20.2.2 IQ/OQ/RQ requirements per MIFU; 20.2.3 Regular inspection and preventive maintenance per MIFU
• 20.2.4 Actions after a failed sterility indicator or parameter change per MIFU
• 20.2.5 Management of limited-use (reposable) devices per MIFU
• 20.2.6 Recall procedures
• 20.2.7 Management of loaned/shared devices per MIFU
• 20.3 Policy on single-use devices aligned with section 17
• 20.4 OH&S and IPC practices; storage/transport/distribution of devices per MIFU
• 20.5 Regular review of policies and SOPs; update after incidents or changes in practice
• 20.6 Recordkeeping for MDR activities per facility policies and legal requirements
• 20.7 MIFU must be maintained in printed or electronic format and accessible; updated as required
• 20.8 Subcontractors must comply with these Standards if reprocessing is performed externally
• 20.9 Policies for handling high-risk tissues (CJD/prion diseases) per Health Canada/PHAC guidelines
• 20.10 Monitoring of compliance with these standards; document results

21.0 (Definitions and Appendices)

• The Definitions section provides standardized terms used throughout the document, including but not limited to:
  • Accountability, Additional Precautions, Aerosol, ABHR, Antiseptic, Aseptic Technique, Automated Instrument Washer, Bead Sterilizer, Bioburden, Biological Indicator (BI), Biomedical Waste, CSA, Chemical Indicator (CI), High-Level Disinfectant (HLD), Immunization, Immunity, Implantable Device, In-Use Shelf Life, Infection Prevention and Control (IPC), Intermediate-Level Disinfectant (ILD), Manual Cleaning, Medical Device, Medical Device Reprocessing (MDR) Area, MRSA, MEC (Minimum Effective Concentration), MIFU (Manufacturer’s Instruction for Use), MDL (Medical Device License), MDR, Non-Critical Medical Device, OHS (Occupational Health and Safety), PPE, Spaulding Classification, Process Challenge Device (PCD), Prion, Reusable Medical Device, Reprocessing, Routine Practices, Semi-Critical Medical Device, Sharps, Single-Use/Disposable Medical Device, Spatter, Sterilization, Sterile/Sterility, Sterile Barrier System, Type 1/5/6 indicators, and many more.
• The appendices also include Spaulding Classification charts, patient care items, environmental surfaces, and an extensive reference list of national/international guidelines and standards.

Spaulding Classification and Managing Contaminated Surfaces (Charts)

• Spaulding Classification defines three risk categories for devices/surfaces and corresponding reprocessing levels:
  • Critical: devices that penetrate soft tissue or bone; high risk of infection; sterilization required for reusable items; single-use disposables must not be reprocessed. Examples include air/water syringe tips, anaesthetic syringes, endodontic instruments, handpieces, implant components, etc.
  • Semi-Critical: touches intact mucous membranes or non-intact skin; moderate risk; high-level disinfection or sterilization required; many items may be stored unwrapped in a clean area but heat-sensitive items require HLD; examples include articulating ribbon holders, cotton rolls, crown removers, impression trays, lab burs, mouth mirrors (non-surgical use), etc.
  • Non-Critical: contacts intact skin; low to intermediate/low disinfection required; examples include blood pressure cuffs, curing lights, face bows, intra-oral cameras, radiograph sensors, etc.
• Environmental surfaces are categorized into Clinical Contact Surfaces (direct contact with DHCP hands, patient care items, or patient skin) and Housekeeping Surfaces (inadvertent contact; periodic cleaning). Clinical surfaces should be barrier-protected or tuberculocidal low-level disinfected if contaminated; housekeeping surfaces receive periodic cleaning or low-level disinfection as needed.

Patient Care Items – Modified Spaulding Classification

• Examples and handling mirror Spaulding categories above, with specific reprocessing levels and handling practices for common dental items (e.g., instruments, handpieces, trays, mirrors, suction tips, radiographic items).

References

• The standard cites multiple references from Alberta Government, Health Canada, CSA, AHS, PIDAC, IPAC Canada, CPSA, CPSO, and other national/international guidelines. These references provide the underpinning for infection prevention, device reprocessing, and safety practices used in this Standard of Practice.

Key Formatted Equations and Numerical References (LaTeX)

• Temperature guidelines for hot-water laundering: 70^\circ\mathrm{C} ( 160^\circ\mathrm{F} ) for at least 25 minutes.
• Alcohol-based hand rub effectiveness: 60\% - 90\% alcohol concentration.
• Barrier and disinfection timing: appropriate contact times are defined in MIFU for various disinfectants (no single fixed number here; follow MEC, contact times, and cycle parameters as specified by the MIFU).
• Filtration/airflow references: for environmental controls, ventilation should meet MIFU-driven specifications (no fixed numeric value provided in the text beyond these guidelines).

Quick reference summary

• Policy and governance: written IPC policies; annual review; staff training
• Clinical care: risk-based approach to IPC; additional precautions for airborne and contact-transmissible pathogens
• Hygiene and PPE: strict hand hygiene, no jewelry/nails; mask/eye protection; gloves for procedures; PPE donning/doffing rules
• Laundry/linens: proper handling, washing at specified temperatures, chemical disinfection options, and proper storage of clean linen
• MDR readiness: licensing, MIFU validation, staff training, one-way workflow, designated MDR area, water quality, and contingency planning
• Pre-cleaning and handling: do not dry organic matter; maintain moist conditions; leak-proof transport; labeling and segregation of contaminated items
• Cleaning, disinfection, sterilization: adhere to device-specific MIFU; use validated disinfectants; MEC testing; proper packaging; sterility assurance documentation; IUSS only for emergencies
• Storage and use: sterile storage, labeling, FIFO, and integrity checks
• Education/quality: ongoing training; records; policy reviews; external/commercial reprocessors must comply
• Ethics/health and safety: non-discrimination; immunizations; AED availability; exposure response plans
• Documentation: keep logs of maintenance, testing, and reprocessing cycles; ensure traceability to patients

Notes on usage

• Use these notes as a comprehensive study guide to replace or supplement the provided Standard of Practice document. Pay particular attention to the sections most relevant to your exam focus, such as Spaulding classification, MDR area requirements, and disinfection/sterilization protocols.
• If you need a concise checklist for a practical exam, I can generate a separate, compact checklist version.