Switching Serial Numbers on Repaired Medical Devices

I

ISObsessed

#1
We outsource the repair of our medical devices (Infusion pumps, monitors, etc.) and I believe that the repair facility we use may be switching the serial #s of our units onto those of their inventory to get our "units" back in a timely manner. It was my understanding that the traceability of the unit in regards to the DHR would be compromised if our units are actually their units with our serial # label on them? Not that i think it matters but our permission for this to occur is not solicited.

What is the FDA regulation on this and do I have any responsibility to take action here?
 
Elsmar Forum Sponsor
A

ascherp

#2
Just to make sure I understand you correctly: the units you are receiving back from the repair service are actually not yours but equivalent ones made by some other manufacturer, with your serial number on them?
 
M

MIREGMGR

#3
I'd guess that you're exposed to possible FDA action for failure to implement 21CFR 820.50 Purchasing Controls so as to prevent your vendor from acting in such a way as to defeat your obligation for some of your equipment...for instance, possibly including infusion pumps...to implement 21CFR 820.65 Traceability.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
Marc BP Slashes Its Oil Exploration Team by 85%, Starts Switching to Renewables World News 11
A ISO 2859-1 - 9.3.3.2 Switching score - Sampling Plans and PPM AQL - Acceptable Quality Level 0
M Switching (Migrating) to a new QMS Software Package Document Control Systems, Procedures, Forms and Templates 14
S Change notice while switching to injection molding technique for manufacturing EU Medical Device Regulations 1
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D Switching Master Product in EO (Ethylene Oxide) Other Medical Device Related Standards 5
A Attribute Sampling Plans with Switching Rules - Software Recommendations Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Long Range OC Curves - Acceptance Sampling Switching Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
I Microbiological Monitoring for Surfaces - Switching from Swab to Contact Plates Other Medical Device Related Standards 2
S Switching 510(k) product from Prescription to OTC US Food and Drug Administration (FDA) 2
R Switching Power Supplies Certified to IEC 60601 3rd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Reference Voltage for Switching Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
R Windings Temperature exceeds the Limit - Overload Test of Switching Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Switching to a new Quality Management software - Seeking recommendations Quality Assurance and Compliance Software Tools and Solutions 4
G Customer Notification requirements when Switching Facility APQP and PPAP 10
W ANSI Z1.4 Switching Rule Applications Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Switching over to Management - Is the MBA an Asset? Career and Occupation Discussions 10
R Sampling Plans - ISO 2859-1: 1999 - How to calculate the switching score? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Is it acceptable to use a Sampling Plan and not use the Switching Rules? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Switching to new problem solving methodology Quality Tools, Improvement and Analysis 7
E ISO 2895/3951 Switching Inspection Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
C BS6001 sampling tables - Seeking software with Alert for switching rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T PPAP and Raw Material - Is a PPAP required when switching raw material suppliers? APQP and PPAP 4
Marc Registrar Comparisons - We're thinking of switching registrars Registrars and Notified Bodies 6
Marc Switching Registrars (A 'Life Long' Relationship?) and Problems for Auditors Registrars and Notified Bodies 16
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JoshuaFroud Serial numbers and labelling when sharing device components ISO 13485:2016 - Medical Device Quality Management Systems 1
C FDA Medical Device Label Requirements - serial numbers Other US Medical Device Regulations 2
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
M Are model# and Serial # required on a calibration cert? General Measurement Device and Calibration Topics 4
T Policy or Good Guidance for a Traceability Decision Tree (Serial and Batch Numbers) Misc. Quality Assurance and Business Systems Related Topics 4
S Requirements relating to Serial Number and Lot Number Other US Medical Device Regulations 6
knightarmourus Initial Samples with dimensional deviation in Serial Production Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
P Serial Testing of Bioburden for Medical Devices Other Medical Device Related Standards 2
M Systems for Serial Numbers, Batches and Catalogue Numbers Other Medical Device Related Standards 3
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
K Serial Numbers on Authorised Release Certificates AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Off the Shelf Parts - Serial to USB adapter for a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Off the shelf Serial to USB Adapter Impact on 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W What does "Release of Purchased Serial Products" mean? IATF 16949 - Automotive Quality Systems Standard 7
P Control of Serial Number Label in Medical Device CE Marking (Conformité Européene) / CB Scheme 7
R Linking a Gage Manufacturer by Serial Number Quality Manager and Management Related Issues 5
G Should Serial # of all Measurement Instruments (Calipers,etc) be in Control Plans? FMEA and Control Plans 7
G Requirement to follow Control Plan for serial production in a PPAP run APQP and PPAP 4
O Simple process for providing Serial/Lot Numbering for our product Document Control Systems, Procedures, Forms and Templates 5
L Serial Number labeling for Class IIa Medical device packaged in multi-pack EU Medical Device Regulations 2
A Repairs vs. Scrapping for Parts and Serial Numbers ISO 13485:2016 - Medical Device Quality Management Systems 4
F Manufacturing date on serial number plate? ISO 13485:2016 - Medical Device Quality Management Systems 16
M Serial Numbers for Product - Common sense? Optical Components for Telecommunications Manufacturing and Related Processes 9
S Device History Records (DHR) Component Traceability / Serial Number Requirements ISO 13485:2016 - Medical Device Quality Management Systems 16

Similar threads

Top Bottom