Medical devices used in surgeries or other procedures (in the field) are the subject of a complaint, are required to be rendered safe for evaluation.
All medical device companies need a Decontamination facility they can depend upon to offer quick, quality driven services. C.G. Laboratories understands that the clock begins ticking the minute a complaint is submitted. We are ISO 13485:2016/MDSAP and FDA certified with fully trained technicians to safely decontaminate your contaminated devices.
C.G. Laboratories offers numerous types of decontamination services to fit your device specifications. In house validations are performed to support the decontamination method. We are experts in both!
- Your Staff Safety – to render your devices safe to perform post-use investigation
- Regulatory Requirements – the FDA requires medical device manufactures to have procedures in place for receiving, investigating, and evaluating complaints
Over 50% of warning letters issued by FDA to Medical Device manufacturers relate to complaint-handling deficiencies. Many of which are due to inadequate procedures for receiving, investigating and evaluating complaints.
- Peace of Mind – it’s fast, easy, and cost effective
- Compatibility – to confirm that the chosen method is compatible with your device and will not interfere with the investigation
- Due diligence – confirmation of effectiveness of the method (safe handling), and reduce audit findings exposures
- Shipping regulations – OSHA, CDC, DoT
Why use C.G. Laboratories?
- We’ve been a leader in the Decontamination of medical devices since 1998
- Decontaminated over 1 million devices including hundreds of device families (including electronics and battery powered devices)
- Fast turnaround times
- Customizable services including integration directly into your systems, photography, measurements, weight
- We provide services to all companies, from start-up to fortune 500 companies.
- CISS (AAMI Certified Sterilization Specialist) on staff
How does it work?
Your contaminated devices (including cadaver trays) can be shipped directly from a hospital or sales representative to C.G. Laboratories. We have all the equipment necessary for decontamination including autoclaves, ethylene oxide sterilizers and biohazard safety hoods (cabinets). Your medical devices, including paperwork, are rendered safe using the appropriate, validated decontamination method. C.G. Laboratories maintains a validated Tracking Software System that monitors each shipment from the moment it arrives until it leaves our facility.
Available Decontamination Methods:
- Ethylene Oxide
- Liquid (Cidex OPA and other options)
- Gamma Radiation
- Custom options
We are experts in developing and validating methods of decontamination for even the most challenging or complex devices.
We provide all the equipment and the expertise, saving you valuable time, money and inconvenience.
When the full cost of maintaining a bloodborne pathogen program, space, equipment (biohazard hoods), regulations, training, employees and management is considered: OUTSOURCING DECONTAMINATION IS THE LOWER COST OPTION