Registrants progress through several stages in POMDRA from the initial contact with a pre-assessment questionnaire (PAQ) to the final assessment report provided after the assessment visit.
Preparing for the assessment
Registrants are encouraged to review the following, which may help their clinical office prepare for a POMDRA assessment:
- information on current standards
- educational opportunities
- sample record keeping documents
Registrants who currently use a steam sterilizer in their clinical office can use the POMDRA assessment tool for steam sterilization as a useful self-assessment exercise to help prepare for an upcoming assessment. This tool is used by POMDRA to assess clinical offices who reprocess semi-critical and/or critical medical devices using a steam sterilizer.
Pre-assessment questionnaire (PAQ)
Registrants selected for an assessment are required to complete the PAQ. The PAQ is reviewed for deficiencies related to the reuse and reprocessing of medical devices in the clinical office.
If reprocessing deficiencies are identified, recommendations for improvement are provided to the registrant in an MDR action plan. The MDR action plan will include guidance on how the deficiencies should be corrected.
MDR action plan
Registrants must correct deficiencies identified in the MDR action plan and return it to POMDRA for review. Our assessors will review the submitted action plan and schedule a final site assessment.
The time allotted to correct a deficiency depends on the level of risk. High-risk deficiencies that require immediate attention may require the office to cease reprocessing immediately until the matter is corrected. During this time, the registrant may be required to obtain disposable devices in order to continue performing procedures. Some offices may opt to permanently switch to disposable medical devices.
Current MDR standards state that the reprocessing of reusable medical devices must occur in a dedicated physical space. While smaller clinical offices may not have dedicated space for reprocessing, reprocessing can take place in a dual-purpose or multi-purpose room with some requirements. For example, a patient exam room is acceptable provided no patients are present when the steps of reprocessing occur. The staff kitchen and washroom are not appropriate areas for reprocessing due to the potential for cross-contamination.
Final site assessment and report
An assessor conducts the site assessment. The site assessment allows the assessor to gather detailed information on the physical set-up for reprocessing, sterile storage practices, and sterilizer function. Clinic staff are encouraged to ask questions during these site assessments.
The site assessment may identify further deficiencies and requirements for improvement that must be addressed by the registrant. A completed copy of the report is returned to POMDRA once those deficiencies are resolved. This is the final step of the assessment process.
Our goal is to:
- identify deficiencies in reprocessing practices
- provide guidance
- support physicians in making any necessary changes to continue providing safe services to their patients
We do not close clinics based on reprocessing deficiencies.