Using Policies and Procedures to Mitigate Liability Concerns for AT Recycling Programs
Jessica Brodey
JMB Policy Consulting
Consultant to Pass It On Center
January 31, 2008
Agenda
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What are Policies and Procedures?
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How can Policies and Procedures Mitigate Liability
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FDA Regulation and AT Recycling
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Checklist for Policies and Procedures
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Question & Answer Period
Types of Reutilization Programs
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Device exchange in which organizations facilitate the transfer of a device from a consumer who does not need the device to a consumer who could use the device without the organization taking possession of the device at any time.
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Device reassignment in which an organization accepts devices from donors and stores them until they can be given or sold to new owners.
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Device refurbishment in which an organization takes the additional step of repairing or restoring used devices to original manufacturer specifications before giving or selling the device to a new owner.
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Device remanufacturing in which an organization alters or enhances devices before giving or selling the device to a new owner.
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Device recycling in which an organization accepts devices from donors and breaks the devices down into component pieces for recycling and disposal.
What are Policies and Procedures?
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Policies are guidelines and principles the overarching standard for handling activities, systems, and problems.
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Procedures are far more specific the step-by-step list of actions and steps that should be taken to implement or address a particular activity, system, or problem.
Using Policies and Procedures to Mitigate Liability
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In organizational activities, there is always a degree of liability risk
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Injuries
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Employees
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Dissatisfied consumers
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Misinformation
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Policies and Procedures set the standard for how things SHOULD be done
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Most liability issues occur because of lack of forethought/attention
Using Policies and Procedures to Mitigate Liability (cont)
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Policies and procedures force organizations to plan and consider possible problems
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Offer some protection from liability to the extent that practices adhere to these policies and procedures
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Practices are planned and intended
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Potential defense shows lack of intent to do harm and often can be defense to negligence
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FDA
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The Food and Drug Administration (FDA) has jurisdiction over the manufacture and distribution of medical devices, as defined in the Food, Drug, and Cosmetic Act, as amended (the Act)
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Some AT devices may fall within the definition of a medical device.
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Section 201(h) of the Act, a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
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recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
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intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
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intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
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Regulation of Medical Devices
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Registration
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Device listing
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Premarket notification or approval
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Investigational device exemption for clinical studies
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Quality system regulation
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Labeling
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Medical device reporting
Application of FDA Regulations
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Relevant to any entity using a medical device in a commercial activity.
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May include manufacturing, remanufacturing, distributing, redistributing, packaging, repackaging, labeling, relabeling
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Most activities of AT reutilization do not qualify as regulated activities
Prescription Medical Devices
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Approved only for dispensing under the supervision of a licensed practitioner
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Follows the DEVICE
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Important to AT programs that distribute devices that may require a prescription
Recommendations re: FDA regulations
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Know Inventory: Understand inventory, and be aware of all of the different types and brands of products available in your inventory.
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Identify Prescription Devices: Using available FDA resources, identify prescription medical devices within inventory.
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Licensed Practitioner Assistance: If distributing prescription medical devices, establish relationships with licensed practitioners and policies and procedures for obtaining appropriate supervision to dispense prescription medical devices.
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Consider Partnering: Work closely with local vendors vendors can be a great asset both in identifying prescription medical devices, seeking supervision from licensed practitioners and tracking FDA recalls and reporting medical device incidents.
Recommendations re: FDA Regulations
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Sanitize Devices: Clean or sanitize the devices according to the manufacturers specifications.
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Monitor Recalls and Maintain Records: Medical devices continue to be subject to any warnings, bans, or recalls issued by the FDA. Keep ordinary business records regarding inventory and consumers. Such records would be important in the event of a recall or warning issues about a device. Know whether or not a particular type of device passed through the program, what repairs or services were performed on the device, which consumer possesses the device and how to contact that consumer to inform him/her of the recall or warning.
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Report Adverse Events: The FDA does not require that reutilizers report incidents of serious injury or death involving a device to the FDA or to the device manufacturer. However, programs should keep records of any complaints or reports of such incidents.
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Understand and Apply State Statutes and Regulations: Some states have chosen to regulate the reutilization of medical devices. Programs should consult the applicable state statutes and regulations to be sure they are in compliance with state or local law.
Recommendations re: FDA Regulations
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Restore Devices to Manufacturer Specifications: Reutilization programs that refurbish devices should ensure that the device functions the way the manufacturer intended. The overriding concern is the safety of the device. Refurbishers may not modify devices to different safety or performance specifications. If the device was not meant to be used for a purpose as originally designed and marketed by the manufacturer, it may not be modified for that purpose by a refurbisher.
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Appropriately Inform Consumers: Reutilization programs should consider whether the safe operation of the device involves providing the manufacturers specifications, instructions, or owners manual to the consumer. Additional training on the device may also help the consumer to safely operate the device and obtain the greatest benefit from the device. Refurbishers may not market a device as a new device. Consumers should be aware that the device they are being given or sold was previously used.
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Use Qualified Technicians: If the manufacturers specifications indicate that a repair or an adjustment must be done by a qualified technician, unless the specifications indicate the technician must have a specific certification, a qualified technician is taken to mean someone with experience refurbishing that type of device. Unless specified otherwise, a qualified technician is a person who can be trusted to safely service or repair the device.
Recommendations re: FDA Regulations
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Programs that engage in remanufacturing could be subject to the FDA regulations. Because of the complexities involved in remanufacturing, we encourage AT reutilization programs to avoid remanufacturing.
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If a program is disposing of recycled parts, be aware and comply with its states solid waste and e-waste laws and regulations.
Purpose of Checklist
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Devising a checklist of policies and procedures to aid organizations in creating appropriate systems and practices
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Checklist is expansive looks at every possible liability issue that may occur
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Not every organization will find every policy/procedure relevant
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Most organizations will not have all policies and procedures written
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Rubric for developing and writing policies and procedures for the organization over time
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Work-in-progress
Organizational Structure
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Legal Entity with Proper Licenses to Operate
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Church Group
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Mom & Pop
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All-volunteer
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Employee based
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Hybrid
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Investigation of Legal Liability for Activities Organizational Structure
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Employees Written Employee Handbook
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Volunteers Volunteer Forms, Written Handbook
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Advisory Committee Organizational Documents Specifying Role/Function
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Board Corporate Documents Specifying Role/Function
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Directors & Officers Liability Insurance
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Key Person Insurance
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Liability Coverage/Insurance for Employees
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Volunteer Liability Coverage/Insurance
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Liability for Driving/Picking Up/Insurance
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Written Policies/Procedures for Services to be Provided, and Standard Operating Procedures for providing services (what, who, how)
Intake of Clients
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Written Policies and Procedures for Client Intake by Phone (Screening)
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Written Policies and Procedures for Client Intake in Person
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Written Eligibility Guidelines for Service (and requirements for types of services provided)
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Written Referral Policies and Procedures (and current lists/Resources)
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Written Policies and Procedures for Keeping/Storing Client Information
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Privacy Policy for Data Collection/Use of Information Share with Clients (Intake Forms/Contract for Services)
Web Site
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Privacy Policy
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Comply with Federal and State privacy collection laws
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Is it accessible (all components back pages, services offered)
Subcontractors
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Written contracts with subcontractors that consider liability and responsibility and warranties for products/services
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Written contracts with subcontractors that identify who owns equipment/property/work product
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Appropriate releases from liability or warranties from subcontractors
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Agreements to keep client information confidential/not sell or disclose private information
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Insurance may be taken care of contractually
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either the program can extend their insurance to cover the subcontractor
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or state in the contract that liability insurance is the contractors responsibility
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Volunteers
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Written Training Manual
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Clear Written Standards for Activities Volunteers May Perform
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Clear Written Standards for Activities Volunteers Must NEVER Perform
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Volunteer Management System
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Hard to find insurance for all volunteer programs.
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Workers Comp. wont cover volunteers
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Need record checks
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Church groups how is their liability coverage
Services
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If evaluate individuals, proper qualifications?
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Written policies and procedures for when evaluate internally, when refer to outside professionals.
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Written policies and procedures if you evaluate/recommend equipment
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Consider including a referral policy that lets vendors/consumers know that other products exist
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May want include a waiver
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Recommendations imply an increased level of involvement (Are you just an exchange program, or do you do more?)
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Insurance for transportation? Drivers?
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Driving organizations vehicle or driving their own?
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Driving on business time?
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Exchange Programs
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Web Sites
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Written Policies and Procedures posted (and accepted by members) outlining permissible uses of the exchange web site
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If money exchanges are handled through web site, security measures in place to protect against fraud and theft
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Best practices/tips for consumers to help them navigate the process, ensure they are acquiring good equipment
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Ensure that:
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Seller owns the equipment he/she is selling/donating
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May want to ask if equipment purchased with VR funds
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Privacy Policy that addresses use of information, and registration for use of online exchange
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Add notice that program will report abuse
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Include agreement checkbox
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Verify insurance policies cover these activities, or set aside money for claims.
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Disclaimers for each online exchange (if completed via web site) releasing organization from any liability (effectiveness may vary depending on State laws)
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Buyer beware warranty language before transactions completed
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Include waiver check box
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Rating system for frequent sellers
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Exchange Programs
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Products
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Means to track recalled/dangerous products
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Provide information to consumers about how to identify fraudulent products listed
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Check VIN Numbers
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May be able to check if they are still usable with manufacturers
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Provide a Checklist for consumers
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Reporting System
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Means to report sellers that fail to deliver as promised
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Means to report illegal/inappropriate equipment that should not be available for exchange
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Reassignment
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Sanitization
Refurbishment
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Products
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If refurbishing computers:
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Must have appropriate data scrubbing software
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Licensing???
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Liability for refurbishing product
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Warranties? Certification?
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Communicate with users
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Matching issues
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State that you accept no liability
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Insurance (both for products carried and services)
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Value depends on situation and state law
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Recycling
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Products
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Do you own the computer and the licenses to all the software?
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Do you have licenses in place?
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Written policies for how will you license and install software
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Standards for proper removal of private information
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When you distribute computers, clear about what you are warranting, and who is liable if the computer fails/breaks, or the software does not behave as expected
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If you are labeling, be sure NOT to remove original manufacture labels
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E-Waste
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Does your state currently have regulations governing e-waste?
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Is your state *considering* regulations?
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What are the ramifications for recyclers?
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Can you deposit e-waste as a business in your states repositories
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Must you pay the business fee for disposal of E-Waste
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Can you negotiate a non-profit rate
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Will your recycled products be assessed in the state processes
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140 countries to which we cannot send waste are your downstream recyclers complying with Federal and International law www.ban.org/country_status/country_status_chart.html
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