A reused instrument that wasn't properly reprocessed is a direct route to patient harm — and it's also the part of a compliance review where the most findings show up. In 2025, 158 Alberta medical clinics completed medical device reprocessing (MDR) compliance reviews with CPSA's Infection Prevention and Control (IPAC) program, and CPSA published the recurring deficiencies it saw across that pool. The encouraging part: these are the kinds of gaps a clinic can correct during routine monitoring. The honest part: the same ten keep coming up. Here's each one in plain language — why it matters, and the concrete fix.
A quick scope note before we start. This article is about community medical clinics assessed by CPSA's IPAC program — not accredited non-hospital surgical facilities (NHSFs), which are held to a separate, more demanding CPSA accreditation standard. If you run a surgical facility, see Reprocessing & sterilization in an NHSF instead. We flag where the two diverge at the end.
How CPSA assesses MDR in Alberta clinics
CPSA's review is anchored in two of its own documents: the Infection Prevention and Control (IPAC) Requirements for Medical Clinics, and the Reusable and Single-Use Medical Device Requirements for Medical Clinics (effective January 1, 2022). Those Requirements are in turn built on three external authorities you'll see referenced throughout the deficiencies below:
- Alberta Health's Reusable and Single-Use Medical Devices Standards (2019) — the provincial standard.
- CSA Z314 (the Requirements cite the 2018 edition, CAN/CSA-Z314-18) — the national medical device reprocessing standard.
- PHO/PIDAC's 2013 best practices for cleaning, disinfection and sterilization.
One principle runs through all of it: the manufacturer's instructions for use (MIFU) for each device is the controlling document. Where the MIFU is more stringent than a general standard, you follow the MIFU. CPSA frames the "why" plainly — meeting these requirements reduces infection risk and protects patients, and the highest-leverage moves are regular training, proper documentation, and MIFU compliance.
The Top 10 group naturally into five areas. We'll take them in that order.
Group 1 — Written policies and your quality management system
The first three deficiencies are all about the documents that govern how reprocessing happens at all.
MDR policies and procedures. Your clinic needs documented reprocessing procedures that at least match the applicable Alberta and Canadian standards and walk staff through the full reprocessing lifecycle — receiving, cleaning, inspection, packaging, sterilization, storage, and recall — not sterilization alone. The fix: build these from CPSA's Developing Policies and Procedures guidance, and obtain and review each device's MIFU so your written procedures actually match how the manufacturer says the device must be reprocessed.
Single-use device policy. You need a written policy on single-use medical devices, consistent with Part A of CPSA's Reusable and Single-Use Medical Device Requirements. Part A is strict: a single-use device is used on a single patient for a single procedure and then discarded; it isn't used past the manufacturer's expiry; it's kept sterile until the point of use; and if a package is opened but the device goes unused, it's discarded — unless a validated MIFU exists for reprocessing it. The fix: put that policy in writing and make "single-use means single-use" the default, with reprocessing of a single-use device allowed only where the manufacturer validates it.
Scheduled, dated reviews. Policies drift. CPSA wants all of your written MDR policies and procedures reviewed on a schedule, and the policy dated with the review date so a reviewer can see it's current. CPSA recommends reviewing at least once a year, or whenever equipment or a process changes — whichever comes first. The fix: set a review cadence, record the date on each document, and trigger an off-cycle review whenever you buy a new sterilizer or change a workflow.
Group 2 — Staff training and competency documentation
Education, training and competency. This has two halves, and clinics commonly do one without the other. First, you need a written policy that lays out your training requirements. Second — and this is where most findings land — you have to document and retain records of education, training, orientation, and competency assessments for the personnel who reprocess critical and semi-critical devices.
There's an important nuance for staff who do reprocessing without being hired specifically as MDR technicians. For them, two things are required together: they have to be trained — either through a recognized formal MDR program or through thorough in-house instruction — and they have to clear a competency check. Sitting through the training alone doesn't satisfy it; their competence has to be tested and the result written down.
The fix: CPSA publishes an MDR Staff Training Log Template and an MDR Staff Competency Assessment Template. Use them, keep them current as staff change, and retain them. A binder that proves who was trained, on what, and when they were last assessed as competent closes this finding cleanly.
Group 3 — Qualifying your sterilizer
Two deficiencies cover proving the sterilizer works — at install, and on an ongoing basis. These get technical, so read your equipment's MIFU alongside this.
Operational and requalification testing (OQ/RQ). Beyond install, you have to test and verify the sterilizer at least annually — and also after major repairs, after relocations, after an unexplained sterility failure, and (for steam units) after any steam-supply disruption or steam-pressure change. The result has to be recorded.
The method matters here, and it's a common place to get it wrong. OQ/RQ verifies each cycle your clinic actually uses, per the testing MIFU, by running three back-to-back cycles with process challenge devices (PCDs) that hold biological indicators. Those three cycles run in an unloaded chamber — except for table-top steam sterilizers, which are tested with the chamber packed to a full load. If you run a dynamic-air-removal (pre-vacuum) sterilizer, you also need air-removal and leak-rate testing, plus three consecutive Bowie-Dick-type air-removal runs in an otherwise empty sterilizer. The fix: schedule annual OQ/RQ, trigger it after the events above, follow the empty-vs-loaded rule for your sterilizer type, and keep the records. CPSA's Qualifying Sterilizers guidance and IQ/OQ/RQ template walk through it.
Installation qualification (IQ). Sterilization equipment has to be installed and documented per the manufacturer's specifications — and the same documentation requirement is triggered if you relocate the unit to another spot in the clinic. Relocating a sterilizer is not a neutral act; it requires re-qualification. The Requirements extend IQ to large-chamber, table-top steam, and chemical sterilizers. The fix: keep the IQ documentation on file, and re-run IQ any time the unit moves.
Group 4 — Daily biological-indicator testing in a PCD
Daily BI in a PCD. Every day a sterilizer is used, you run a biological indicator (BI) inside a process challenge device (PCD) — for each cycle type the sterilizer runs. Place the BI-in-PCD at the cycle's shortest exposure setting, run it in a fully loaded chamber, and do this every day the sterilizer is used. If one sterilizer runs both a dynamic-air-removal and a gravity cycle, each type gets its own daily test. CPSA provides a how-to and a video on building a BI PCD.
Why a spore test and not just the printout? Because no single check proves sterility on its own. CPSA layers three kinds of sterility-assurance monitoring — physical, chemical, and biological — plus a daily air-removal (Bowie-Dick) test on pre-vacuum sterilizers. You need all of them:
- Physical — the printout or electronic cycle record, confirmed each cycle. (Alberta clinics' sterilizers have been required to have a printer or electronic cycle record since January 1, 2023.)
- Chemical — internal and external chemical indicators on each package. If you release a package based on the physical record plus the internal CI, that internal CI must be Type 5 or Type 6.
- Biological — the BI in a PCD, as above.
- A daily air-removal (Bowie-Dick) test on pre-vacuum sterilizers — a separate requirement, not part of the physical/chemical/biological triad.
The BI is the only test that confirms actual microbial kill. That's why it's the layer clinics can't skip — and why "we run a chemical indicator" is not a substitute. (A note on timing: how long you hold a load while a BI incubates, and rapid-readout versus 24–48-hour results, comes from IPAC and indicator-vendor guidance rather than the CPSA documents themselves — follow your BI manufacturer's MIFU for the specifics.)
Group 5 — Documentation that proves it happened
The last three deficiencies are about evidence. You can do everything right and still fail the review if you can't show it.
MIFU accessibility. The MIFUs for your devices, equipment, and supplies have to be readily accessible to the staff who reprocess — kept in a binder or electronically — and kept up to date. The Requirements say MIFU may be printed or electronic, must be accessible to those who need it, and must be updated as required. The fix: maintain a single, current MIFU library that reprocessing staff can reach at the point of work.
Sterility-assurance records. You have to keep enough detail to prove a particular load came out sterile. For every cycle, four things have to be on file: the cycle-parameter trace (the printout or its electronic equivalent), the load control label, a record of what was actually in the load, and the matching chemical- and biological-indicator results. The fix: use a consistent per-load record. CPSA supplies a Sterilization Log Sheet, a Sterilizer Maintenance Log, and an Endoscope Reprocessing Tracking Log to standardize it.
Record retention. Reprocessing records have to be kept as long as your own clinic policy and the relevant legislation require, and must include (at minimum) preventative maintenance of reusable devices and equipment; the results of installation, operational qualification and requalification testing; and routine testing of reprocessing equipment and products. CPSA doesn't set a single fixed number of years — your retention period comes from your own policy and the applicable law, so define it and stick to it.
A practical fix checklist
Turning the Top 10 into a routine that holds up between reviews:
- Write (or update) MDR procedures that cover the whole lifecycle and at least meet Alberta and Canadian standards, plus a single-use-device policy aligned to Part A.
- Put a dated annual review cycle on every policy — and review off-cycle on any equipment or process change.
- Keep a training-and-competency binder for everyone who reprocesses critical or semi-critical devices, with competency assessed, not just delivered.
- File IQ documentation, and re-qualify whenever a sterilizer moves.
- Run OQ/RQ annually and after repairs, relocations, sterility failures, or steam disruptions — empty chamber, or fully loaded for table-top units.
- Run a BI-in-PCD daily, per sterilizer, per cycle type, at the shortest exposure setting in a full load — alongside physical, chemical, and (for pre-vacuum) Bowie-Dick monitoring.
- Keep MIFUs current and reachable; keep per-load sterility-assurance records; retain everything as long as your written policy and the law require.
Before your next review, run your clinic through CPSA's Self-Assessment Tool: Reusable and Single-Use Medical Device Requirements — it walks each requirement line by line, so the gaps surface on your terms instead of an assessor's.
Most of these aren't hard tasks — they're hard to keep consistent by hand. That's where the failures come from: a missed log on a busy day, a policy that never got its review date, a competency assessment that was done but never recorded. For the bigger picture of what a CPSA visit covers beyond MDR, see our CPSA IPC inspection checklist for clinics.
How Zosimos helps
We help Alberta clinics turn these requirements into a system that stays ready, not a scramble before a review. That means the written policies and SOPs the Requirements ask for, the training and competency records, sterilizer qualification and biological-indicator logs, a current MIFU library, and the evidence trail that ties it all together.
Two tools are built for exactly this, both launching soon:
- PolicyHUB, our electronic policy library, keeps your controlled MDR policies, SOPs, and device MIFUs version-controlled, dated, and findable — so the review-date and accessibility deficiencies stop happening.
- Compliance Tracker holds the operational records the standard runs on: training and competency records, sterilizer-testing schedules with IQ/OQ/RQ reminders, daily BI logs, policy-review reminders, and corrective actions to close findings and prevent recurrence.
See our CPSA IPC & MDR compliance support for clinics, or — if you run a surgical facility — our NHSF accreditation support. Either way, get in touch if reprocessing records are where you feel exposed.
Where surgical facilities differ
Because the line gets blurred a lot: the Top 10 above apply to CPSA members in independently operated medical clinics. Accredited non-hospital surgical facilities are governed by CPSA's separate NHSF IPC/MDR accreditation standard, which raises the bar — it references the newer CSA Z314-23 (2023 edition), requires reprocessing personnel to hold certification from a recognized program, requires a BI in every implant load with the load quarantined until the result is known, and prohibits flash/immediate-use sterilization for convenience. If you operate both kinds of setting, treat them as two different programs. Our deeper dive lives in Reprocessing & sterilization in an NHSF.
None of this replaces the source documents. For binding interpretation, work from the CPSA Requirements and your device MIFUs, and contact CPSA's IPAC program directly at ipac@cpsa.ab.ca or 780-969-5004. This article is compliance guidance, not medical or legal advice.
References & further reading
- CPSA — Using & Reprocessing Medical Devices (MDR program hub) — the Requirements, the Top 10 resource, and CPSA's downloadable templates.
- CPSA — Self-Assessment Tool: Reusable and Single-Use Medical Device Requirements (PDF) — work through it to check your clinic against each requirement before a review.
- CSA Group — CSA Z314, Canadian medical device reprocessing — the national standard. The CPSA Requirements cite the 2018 edition (CAN/CSA-Z314-18); the page now carries the current 2023 edition (Z314:23).
- Alberta Health — Reusable & Single-Use Medical Devices Standards (2019) — the provincial standard behind the Requirements (PDF available from the publication page).
- PHO/PIDAC — Best Practices for Cleaning, Disinfection and Sterilization (PDF) — one of the three foundational documents, covering monitoring, PCDs, and IQ/OQ.
- Health Canada — Information to be provided by manufacturers for reprocessing and sterilization of reusable medical devices — federal grounding for validated MIFUs.
- IPAC Canada — Reprocessing of Critical and Semi-Critical Devices in the Community (position statement, PDF) — national corroboration that clinics meet the same reprocessing bar.