IoMT Solutions’ secure process provides: 

• Documented termination of regulatory device tracking requirements
• Regulatory and industry environmental compliance standards for disposal 
• Assurance against unauthorized and uncontrolled re-marketing of your devices 
• Destruction of all sensitive data that might be recorded on your device 
• Disposal vendor due diligence: qualified, experienced, capable, and responsible

Documented termination:

Medical device manufactures are required by the FDA to maintain up-to-date tracking records on certain medical devices.  It is in the manufactures best interest to have explanted, defective, surplus or obsolete devices permanently destroyed and recycled with UDI tracked destruction certification. The FDA CFR Title 821.25, 3, viii – Medical Device Tracking Requirements states a manufacturer must maintain the following records: “If and when applicable, the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.”
IoMT Solutions, a division of Back Thru The Future, destroys all medical devices sent to our facility by both disassembly and shredding. We are a certified secure destruction facility and provide certificates of destruction with detailed listings of the devices destroyed.

Environmental disposal compliance:

IEC medical device manufacturing standard 60601-1-9 requires that manufacture’s provide instructions with their device to minimize the environmental impact of the product during normal usage and must include information for the proper disposal at the end of life.
ISO 14971 deals with the influence medical devices have on the environment and the management of the associated environmental risk. Proper end of life disposal is part of the standard’s environmental sustainability objectives.
ISO 14001 includes guidance on implementing processes for managing environmental concerns throughout the medical device’s lifespan.
Federal EPA and State regulations governing the proper disposal and recycling of materials included in the manufacturing of medical devices.
Back Thru the Future is ISO 14001 certified and is a US EPA and NJ DEP licensed Universal Waste destination facility for the processing and handling of electronics and batteries. We are R2 (Responsible Recycling) certified.  We provide environmental compliance certificates that are valid in all 50 states.

Documented control of medical device disposal: 

All electronic medical devices are destroyed in our certified, secure mobile shred vehicles or at our Northern NJ DEP licensed recycling facility. Destruction is accomplished by both disassembly and shredding. Back Thru The Future Computer Recycling has been providing certified secure data destruction services to the IT industry for over 10 years. We track individual device manufacturer’s serial numbers and asset tags numbers which are analogous to UDI coding.  All compliance documentation including secure tracking information is stored in our secure cloud based “Compliance Library” document archive. These detailed records are available to you 24/7/365 through a unique password protected web portal.

Control unauthorized resale: 

Back thru the Future never resells used medical devices. We provide detailed certificates of destruction for all devices received.

Destroy sensitive recorded data: 

As electronic medical devices become increasingly more technically complex with the introduction of new communications and AI technologies, manufacturer’s data privacy responsibilities under HIPAA are expanding rapidly.  The US Department of Health and Human Services requires that all Protected Health Information (PHI) must be controlled and protected at all times. Manufacturers will be held responsible for building in protection both through hardware and software to provide auditable proof that your devices do not pose a threat to collected and stored PHI. Back Thru The Future specialize in providing HIPAA compliant PHI data destruction to the health service industry. We provide  HIPPA data privacy compliance certificates as well HiPAA Business Associate Agreements.