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Initial Report

Premise/Facility under investigation.

(Please include name and full address)

Guaranteed Hair Transplant Clinic
1291 Wyandotte Street East,
Windsor, N9A 3K6


Type of Premise/Facility.

(e.g., clinic, personal service setting)

Hair Transplant (Hair Follicle Extraction method)


Date Board of Health became aware of IPAC Lapse.

10/31/2018


Date of initial report posting.

11/23/2018


Date of initial report update(s), if applicable.

 


How the IPAC lapse was identified?

A complaint forwarded by College of Physician and Surgeon Ontario (CPSO)


Summary description of the IPAC lapse.

During the inspection it was observed that the cleaning, disinfection and sterilization of the medical devices on site did not follow the Provincial Infectious Disease Advisory Committee (PIDAC) Best Practice Standards for medical device reprocessing and infection control in a clinical office setting.


IPAC Lapse Investigation

Did the IPAC lapse involve a member of a Regulatory College?

Yes


If Yes, was the issue referred to the Regulatory College?

The complaint was made to CPSO by a member of the public.


Were any corrective measures recommended and/or implemented?

Yes


Please provide further details.

It is recommended that:
  • The staff assigned to reprocess medical equipment/devices must complete education and training in reprocessing if reprocessing is to continue.
  • The operator should have ongoing audits with documentation of competency of staff involved in reprocessing medical devices.
  • The reprocessing room must have a one-way work flow from dirty to clean area to prevent cross-contamination.
  • The reprocessing room counter surfaces must be non-porous and easily cleanable.
  • The reprocessing room must have a dedicated hand wash sink.
  • The sink for equipment cleaning should not to be used for hand washing.
  • The reprocessing room must have a sharps container.
  • The reprocessing room must have an eye wash station at the point of use.
  • The reprocessing room must have a regular environmental cleaning schedule
  • The reprocessing room must have PPE at the point of use.
  • The ultrasonic cleaner must be tested for efficacy at least weekly or according to the manufacturer’s recommendations. 
  • The operator must maintain the record of the sterilizer mechanical print out checked and signed for each cycle by the person sterilizing the instruments.
  • The operator must maintain the record of physical parameters such as time/temperature/pressure of the autoclave.
  • The operator must maintain the record of external, internal chemical indicators and biological indicators (BI).
  • The operator must recall and reprocess instruments in case of a failed BI test.
  • The operator must have a process for receiving and disseminating medical device alerts and recalls originating from manufacturers or government agencies.

Date any order(s) or directive(s) were issued to the owners/operators. (if applicable)

On November 10, 2018, a Public Health Inspector issued an Order under Sec. 13 of the HPPA to the operator to stop the sterilization of the medical devices immediately. He was advised to recall and re-sterilize all the medical devices according to the PIDAC best practices for cleaning, disinfection and sterilization of medical devices.


Initial Report Comments and Contact Information

Any additional comments:(do not include any personal information or personal health information)

On Nov. 13, 2018 WECHU was notified that the operator had ceased operations as an out of hospital facility and had removed the sterilizer and instruments from the premises.

Nov. 15, 2018 a re-inspection was carried out and verified that the health hazard has been eliminated. Therefore, the Sec. 13 Order was rescinded.


Contact Information

Name/Title

Windsor Essex County Health Unit- Environmental Health Department


Email address


Phone number

(519) 258-2146 ext. 4475


Final Report

Date of final report posting.

11/23/2018


Date any order(s) or directive(s) were issued to the owners/operators. (if applicable)

11/13/2018


Brief description of corrective measures taken.

The operator has ceased the operation and has removed all sterilizing equipment. Records were not available for clients for contact tracing. 


Date all corrective measures were confirmed to have been completed.

11/15/2018


Final Report Comments and Contact Information

Any additional comments: (do not include any personal information or personal health information)

N/A


Name/Title:

Windsor-Essex County Health Unit- Environmental Health Department


Email address:


Phone number:

(519) 258-2146 ext. 4475

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