Medical Device Reprocessing Audit Form
Use this form to document and review the reprocessing of medical devices, record compliance checks across each stage, and capture audit findings and corrective actions.
Audit Context
Audit Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Audit Time
*
Hour Minutes
AM
PM
AM/PM Option
Facility / Department Name
*
Auditor Name or Role
*
Audit Type
*
Routine
Follow-up
Spot Check
Post-Incident
Other
Audit Reference / Batch Identifier (if applicable)
Device and Reprocessing Details
Device Name / Type
*
Device Identifier / Asset Tag
*
Manufacturer
Reprocessing Cycle Number / Batch
Reprocessing Location / Unit
*
Please Select
Central Sterile
Operating Room
Endoscopy Unit
Dental Clinic
Outpatient Clinic
Other
Reprocessing Procedure Review
Cleaning / Pre-cleaning
*
Rows
Compliant
Non-compliant
Not applicable
Cleaning / Pre-cleaning
1
2
3
Disassembly (if applicable)
Rows
Compliant
Non-compliant
Not applicable
Disassembly (if applicable)
4
5
6
Manual Cleaning
*
Rows
Compliant
Non-compliant
Not applicable
Manual Cleaning
7
8
9
Ultrasonic / Automated Cleaning (if applicable)
Rows
Compliant
Non-compliant
Not applicable
Ultrasonic / Automated Cleaning (if applicable)
10
11
12
Inspection
*
Rows
Compliant
Non-compliant
Not applicable
Inspection
13
14
15
Packaging
*
Rows
Compliant
Non-compliant
Not applicable
Packaging
16
17
18
Sterilization / High-level Disinfection Method
*
Rows
Compliant
Non-compliant
Not applicable
Sterilization / High-level Disinfection Method
19
20
21
Drying, Storage, and Transport
*
Rows
Compliant
Non-compliant
Not applicable
Drying, Storage, and Transport
22
23
24
Sterilization and Monitoring
Sterilization/Disinfection Method Used
*
Steam Sterilization
Ethylene Oxide
Hydrogen Peroxide Plasma
Low-Temperature Steam Formaldehyde
High-Level Disinfection
Other
Cycle Parameters or Run ID
*
Indicator Verification Completed
*
Chemical Indicator
Biological Indicator
Mechanical Monitoring
Other
Load Released
*
Released
Held for Review
Rejected
Monitoring Results and Anomalies
Rows
Compliant
Anomaly Noted
Cycle parameters within validated range
25
26
Indicator results acceptable
27
28
Load release documentation complete
29
30
Any deviation or anomaly observed
31
32
Findings and Corrective Actions
Deficiencies Observed
*
Risk Level / Severity
*
Please Select
Low
Moderate
High
Critical
Immediate Containment Action Taken
Corrective Action Required
*
Responsible Person / Department
*
Target Completion Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Audit Outcome and Sign-Off
Overall Audit Result
*
Pass
Conditional Pass
Fail
Auditor Comments
Follow-Up Required
*
Yes
No
Auditor Confirmation
*
Submit Audit
Submit Audit
Should be Empty: