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
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 1
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 7
J KPIs or Metrics to Measure a New Complaint Handling Process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
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 9100, Nadcap and related Aerospace 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
L 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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace Standards and Requirements 2
K Procedure for Handling of Customer Supplied Material (AS9100 Requirements) AS9100, IAQG 9100, Nadcap and related Aerospace 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
Mikael 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
C Safe Handling of Non-Device Refurbished Medical Equipment US Food and Drug Administration (FDA) 3
Y Handling of Potentially Biohazard Material - Alcohol Cleaning Procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
R Use of Automated Liquid Handling Robot for a PCR based Assay CE Marking (Conformité Européene) / CB Scheme 2
R Storage Procedure per NQA 1 Storage and Handling Requirements Document Control Systems, Procedures, Forms and Templates 6
Michael Malis What is the best Complaint Handling system? Customer Complaints 16
M Suggestions for Handling Quality Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Seeking a Sample Procedure for Handling Potentially Unsafe Food Products Food Safety - ISO 22000, HACCP (21 CFR 120) 1
R Handling Quality Self-Audits on Outsourced Products Misc. Quality Assurance and Business Systems Related Topics 5
Similar threads


















































Top Bottom