Dear Editor:
An open letter to Peter Sovran, director of education with the Upper Grand District School Board (UGDSB).
I am a parent and taxpayer who’s very concerned about the UGDSB’s redistribution of the government’s SARS-CoV-2-testing devices (otherwise known as rapid test kits).
In a Jan. 14 interview for CBC.ca, you stated that “We have a number of staff beginning the process of taking apart those 25 per package and reassembling them into single units so that we can get them out to the schools…”
According to the Government of Canada, COVID testing devices are labeled as a Class IV In-Vitro Medical Device. Everything from the licensing of such devices to the packaging is strictly regulated at the federal level.
Part 1, Section 16 (b) of the Medical Devices Regulations states, “The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including: (b) presence of a contaminant or chemical or microbial residue.”
Section 17 goes on to state, “A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated.”
Validation, according to regulations, means, “Confirmation by examination and the provision of objective evidence that the requirements for a specific intended use have been fulfilled, as set out in the definition validation in section 2.18 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance-Vocabulary…”
Prior to the Christmas break, my children’s school provided the box of five SARS-CoV-2 rapid test kits. Both boxes were sealed and all the subsequent pieces of the test kit (minus the tube stand, package insert and Procedure Card) were in their own sealed bags within the sealed box.
I guess my questions to you, Mr. Sovran, are:
1. How is your board guaranteeing a sterile environment when you are opening a sealed medical testing device and redistributing them to the families that support this board?
2. What appropriate controlled sterile conditions are you and your staff adhering to?
3. Who is validating/overseeing said sterile conditions from the federal government?
4. How are you guaranteeing there is no contaminants being added to rapid test kits?
If Part 1, Section 16 (b) of the Medical Devices Regulations states that the whole point of packaging and sealing the rapid test kits is to minimize risk to a patient, user or other person from reasonably foreseeable hazards such as contaminants, how does it make sense for school boards to break that seal, repackage the medical device using “a number of staff” and then hand it out to students to take home?
Any medical professional will tell you that if a seal is broken – especially on a medical device that deals with biologicals (in-vitro), you should not use it. From what I can see, this is no different.
If I am interpreting this wrong, I would welcome an explanation.
Paul Johnson,
Ariss