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Vanity Skin Laser

170 - 159 Carrington Plaza NW Calgary AB T3P 0C9 · Personal Services

4 inspections

  1. Monitoring Inspection

    4 infractions

    • 20. Is reusable equipment disinfected properly?
      • Operator was disinfecting the re-usable comedone extractor instruments with PREempt RTU/wipes. - Comodone extractors are considered semi-critical equipment and must be disinfected using a high level of disinfectant at a minimum. Operator did not a supply of CS20 and HLD5 but indicated that she will stop using the equipment going forward.
    • 21. Is equipment that is intended to be sterile maintained sterile at the point of use?
      • When using the Dr. Pen system, the operator had single-use microneedling cartridges which did not contain the sterility assurance documentation required on the packaging. These cartridges were missing information such as manufacturer and lot number. - Operator has agreed to stop using this pen and the cartridges. Ensure all microneedling cartridges are sterile and meet the following sterility assurance documentation requirements:o lot numberso manufacturer or company name and contact information. If this information is only found on the box/container, operators are expected to keep them for their records.o method of sterilization. Most common methods include ionizing radiation (beta and gamma rays) and ethylene oxide (EtO/EO gas)o process indicators that may be on or in the packaging. Indicators arerecommended but not required for pre-sterilized equipmento expiry dates, determined by the manufacturer, based on shortest projected useful lifeo sterilization dates. Operators should follow first in first out storage principles when there is only a sterilization date and no expiry date.
    • 25. Are the equipment manufacturer's instructions for use of specific equipment available and followed?
      • Mirror present in treatment room where a class 4 energy emitting device is intended to be used. - Please remove the mirror and ensure to follow the manufacturer's instructions.
    • 32. Are general nuisance conditions, other than those noted in other violations, being prevented at this personal services facility (Critical)?
      • Operator was using a Dr. Pen M8 system which has reported safety concerns flagged by Health Canada and does not have a medical license for use in Canada. When using the Dr. Pen system, the operator had single-use microneedling cartridges which did not contain the sterility assurance documentation required on the packaging. These cartridges were missing information such as manufacturer and lot number. - Operator has agreed to stop using this pen. Ensure to purchase a microneedling device that is approved for use in Canada. Additionally ensure all microneedling cartridges are sterile and meet the requirements.
  2. Risk Management Inspection

    0 infractions

  3. Demand Inspection

    0 infractions

  4. Initial Inspection

    0 infractions