Following is a compilation of questions and answers on key concepts related to medical device reprocessing (MDR) for the community-based physician office setting.
General
With the launch of POMDRA, has the College rolled out new practice standards?
How does POMDRA choose participants?
Does the College have the authority to assess registrants on their medical device reprocessing practices?
Can a registrant refuse to participate?
Can a physician fail the assessment, and if so, how does that impact his/her practice and office procedures?
Will the College shut down a physician's practice if it identifies some deficiencies in reprocessing?
How much time will I have to make POMDRA required changes to my reprocessing practice?
Medical Devices
What is a medical device?
Why is it important to know what type of medical devices I have in my practice setting?
Why is it important to know what type of medical devices I have in my practice setting?
What if a physician doesn’t have a dedicated physical space for reprocessing reusable medical devices?
What are MIFUs and why are they important?
When is a medical device considered contaminated?
Reprocessing
What is reprocessing?
Why is the cleaning of reusable medical devices the first and most important step of reprocessing?
What products can I use during the cleaning step of my reusable medical devices?
Why do semi-critical reusable medical devices need to be steam sterilized like reusable critical medical devices?
Why do my reusable semi-critical medical devices have to be packaged in preparation for steam sterilization?
Sterilization
What is sterilization?
What type of sterilizer should I have for my clinical office?
What is sterilization monitoring?
What do I do if there is an unsuccessful outcome or breach during sterilization of reusable medical devices?
I have an arrangement with a physician/dentist in the same building to have my reusable medical devices sterilized by their sterilizer. Is this permitted?
I have an arrangement with a physician/dentist in the same building to have my reusable medical devices sterilized by their sterilizer. Is this permitted?
References
- British Columbia Ministry of Health. Best practice guidelines for cleaning, disinfection and sterilization of critical and semi- critical medical devices in BC health authorities [Internet]. Victoria: British Columbia Ministry of Health; 2007 [revision 2011 Dec; cited 2017 Feb 15]. 136 p. Available from: http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelines-cleaning.pdf
- Ontario Agency for Health Protection and Promotion (Public Health Ontario), Provincial Infectious Diseases Advisory Committee. Infection control for clinical office practice [Internet]. Toronto: Queen’s Printer for Ontario; 2013 [revision 2015 Apr; cited 2017 Feb 15]. 116 p. Available from: http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf
- Canadian Standards Association; Standards Council of Canada. Canadian medical device reprocessing. Toronto: CSA Group; 2018. 375 p. CSA Standard No.: CAN/CSA-Z314-18.