Handling of contaminated medical equipment

#1
Hi All,

I am currently working with a company who have some gaps in their processes when it comes to the handling of contaminated medical equipment and was looking to get some advice and perhaps how some other companies handle such issues.

To provide some background:

Currently, when a user suspects a medical device is contaminated, the company requests the customer to reprocess the device according to the instructions for use and then bioburden test the device to see if it is still contaminated. If the device is still contaminated and the CFU counts > 100, we ask them to also conduct further identification tests to confirm what the device is contaminated with prior to it being sent back to us.

On most occasions, customers only agree to do bioburden testing and no identification tests as the guidelines in the UK don't require identification testing unless CFU counts are greater then 100. This however, causes issues with transport as we have to send the device to Germany for testing. We have a despatch team, who says they will not agree to exporting any device suspected of being contaminated, unless we can categorically confirm what the device is contaminated with as under the ADR regulations (and IATA for the case), they need to ensure that the device is not contaminated with a category A infectious substance, otherwise it needs specialist packaging. Unfortunately, this specialist packaging is not readily available and needs to be tested etc, hence it causes great delay in our repair and complaints procedure.


Keen to hear how other companies deal with such situations? Specifically, if anyone has experience with sending contaminated medical equipment by Air.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
V Handling deviations during analytical method validations Qualification and Validation (including 21 CFR Part 11) 4
C Handling in-Process Defect Repairs Nonconformance and Corrective Action 31
T Is handling chemically treated parts safe? RoHS, REACH, ELV, IMDS and Restricted Substances 18
N Handling B-Grade Products within the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
G Handling Unpacked (Additive Chemical) Product For Automotive Applications IATF 16949 - Automotive Quality Systems Standard 3
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 10
J KPIs or Metrics to Measure a New Complaint Handling Process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
Jimmy123 Handling nonfunctional requirements in DFMEA FMEA and Control Plans 5
F Component Molding and Over-molding - Handling Resin Inventory Manufacturing and Related Processes 2
Q Handling Off-the-Shelf Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Handling open points in design reviews 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
P HVAC System vs Air Handling Unit (AHU) - Differences Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L GMDN code wanted - Software for handling records Service Industry Specific Topics 9
leftoverture Handling Sort/Return Requests Customer Complaints 8
S Document Handling during an Audit General Auditing Discussions 6
S Handling Cost of Sales requests for Customer Quality Manager and Management Related Issues 2
Q AS9100/AS1180-1 - Handling of Equipment and Calibration Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M Complaint Handling Responsibilities for a Design Partner - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
S Merging Post Market Surveillance and Complaint Handling ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 9001 Ergonomics and Manual Handling Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Suggestions requested on handling batch record papers exposed to hormonal products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
A Production and Post-Production and Complaint Handling ISO 14971 - Medical Device Risk Management 2
C What's Your Process for handling rush jobs, urgent or priority orders ? Manufacturing and Related Processes 6
A Medical Device Handling AFTER the device's specified lifetime has expired 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Handling of Obsolete Material Work Instruction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Risk Management, complaint handling and CAPA system ISO 14971 - Medical Device Risk Management 5
W Aerospace Materials Handling Training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
V Handling decomissioned line/equipment during 1st time product-based inspection US Food and Drug Administration (FDA) 1
D Complaint Handling Call Centers ISO 13485:2016 - Medical Device Quality Management Systems 7
W Contract Initial Importer and Order Handling for a Class I Medical Device Service Industry Specific Topics 2
W SOP on Handling of HCl (Hydrochloric Acid) Document Control Systems, Procedures, Forms and Templates 5
A Handling Normal Capacitor Production Fallout AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Procedure for Handling of Customer Supplied Material (AS9100 Requirements) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Procedure for Handling Customer Return Part (Defective Part Return) IATF 16949 - Automotive Quality Systems Standard 1
M Manufacturer's handling of Distributor's Historical Complaint Records US Food and Drug Administration (FDA) 5
C Anyone have experience handling Feed Safety Management System (GMP+B2)? Other ISO and International Standards and European Regulations 1
V ISO10002:2004 (Guidelines for Handling Customer Complaints) Self Assessment Checklist Customer Complaints 5
V Ensuring Improvement and Handling Change FMEA and Control Plans 4
S Handling Out-of-Specification Results: FDA's guidance for the industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 12
M Internal Warehouse Handling - A Reverse Logistic Case! Process Maps, Process Mapping and Turtle Diagrams 6
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
S PCB Handling Requirements - What to do if we drop a PCB during the assembly Manufacturing and Related Processes 4
M Raw Material Handling & Mixing in Plastic Injection Moulding Manufacturing and Related Processes 5

Similar threads

Top Bottom