Pass It On Center
FDA Webinar
Jessica M. Brodey
March 25, 2008
Agenda
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Introduction
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Policy Series
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FDA Regulations
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Guidelines for Reassignment, Refurbishment and Recycling
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Guidelines for Exchange
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Considerations for Remanufacturing
Introducing: Policy Series
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Many questions about policies/procedures
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What are they?
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How do we write them?
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New series of webinars to address these questions!
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Coaching sessions
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Discuss structure for good policies/procedures
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Provide step-by-step information/guidance on how to write and what we need
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Share and discuss existing policies/procedures
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Policy Series, Cont
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Organizational Structure, Governance, Insurance
April 22, 2008
Topics will include: Legal Status, Staffing Model, Board of Directors, Advisory
Committee, Management, & Range of Insurance Policies
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User Services
May 13, 2008
Topics will include: Client Intake, Equipment Matching, Training & Technical
Assistance, Delivery, Follow Up, & Website Operations.
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Program Operations
June 17, 2008
Topics will include: Facilities, Acquisition/Donations, Inventory Management,
Evaluation, Repairing/Refurbishing, Sanitization, Storage,
Distribution/Transportation of Equipment, Disposal/Recycling, Website Operations
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.
FDA
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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
Basic Guidelines
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Created a set of guidelines to help reutilization programs navigate the pitfalls
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Three categories:
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Device Reassignment, Refurbishment and Recycling Reutilization Activities
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Device Exchange Reutilization Activities
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Device Remanufacturing
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Aide to understanding steps to take to avoid liability
Inform Consumers
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Warn buyers about the risks of acquiring reutilized devices
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Clarify what warranties, if any, are offered with the devices
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Create and post a list of best practices for consumers acquiring reutilized devices to educate consumers and protect reutilization programs.
Know your inventory
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Be aware of all of the different types and brands of products available for through your program
Address Sanitization Guidelines
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Devices distributed by reutilization programs should be sanitized according to the manufacturers specifications.
Track Class 1
FDA-issued warnings, bans, or recalls
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Know whether devices in inventory are subject to warnings, bans, or recalls.
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Subscribe to FDA alerts of medical device recalls or FDA email notifications at:
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Recalled or banned medical devices should be immediately removed from inventory.
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Those who refurbish, remanufacture and recycle may be able to fix the problem identified in the recall to the manufacturers specifications or may simply recycle parts not affected by the recall.
Maintain business records of inventory and customers
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AT Reutilization programs should keep ordinary business records of inventory and customers. A flexible database with search capacity will allow program staff to locate medical devices that have been recalled that you suspect may be in your inventory. This search capacity will enable a designated staff or volunteer to:
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search for medical devices that appear on the FDA medical device recall alerts
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notify customers who may have received such devices about the FDA alert
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advise customers about appropriate steps they can take (i.e., stop using device immediately, disposal, contact manufacturer, etc.)
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Comply with Prescription Use Practices
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If programs are reutilizing prescription medical devices, they should ensure that they are only dispensing those devices under the supervision of a licensed practitioner.
Use Qualified Technicians for Reassignment, Refurbishing and Recycling Activities
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All repairs or adjustments made to devices should be conducted by a qualified technician.
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Unless the manufacturer specifications indicate the technician must have a specific certification, a qualified technician is taken to mean someone with experience refurbishing that type of device, with proper skills and training to understand the manufacturer specifications and conduct the repairs as specified.
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Qualified technician is a person who can be trusted to safely service or repair the device.
Report Adverse Events
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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, reutilization programs should keep records of any complaints or reports of such incidents.
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If a faulty device design causes a serious injury or death it is important that the manufacturer becomes aware of the danger.
Understand and Apply State Statutes and Regulations
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Some states have chosen to regulate the reutilization of medical devices.
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Consult the applicable state statutes and regulations to be sure they are in compliance with state or local law.
Consider Partnering
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Work closely with local vendors vendors can be a great asset in identifying prescription medical devices, seeking supervision from licensed practitioners and tracking FDA recalls and reporting medical device incidents.
End of Life Recycling
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If a program is recycling parts in order to use them to refurbish or remanufacture devices, a program should be aware and comply with its states solid waste and e-waste laws and regulations when disposing of those parts that cannot be reutilized.
Basic Guidelines for Exchange Programs
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Slight differences for Exchange Programs because they do not directly distribute to consumers.
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Focus is on educating consumers of risks.
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Devices made available for exchange continue to be subject to any warnings, bans, or recalls issued by the FDA. Therefore, a program that facilitates the exchange of a device subject to a warning, ban or recall may be subject to liability.
Inform Consumers
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Warn buyers about the risks of acquiring reutilized devices, and to clarify what warranties, if any, are offered with the devices.
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A list of best practices and/or Buyer Beware guidelines for consumers.
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Request that sellers clarify what warranties, if any, are offered with the device, and should encourage consumers to ask about warranties and user guides.
Know Inventory
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Be aware of all of the different types and brands of products available for exchange through your program and whether any of them are subject to warnings, bans, or recalls.
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If a program is aware of that a banned device is available for exchange, that device should be removed.
Address Sanitization Guidelines
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Device exchange programs should inform buyers and sellers about appropriate steps they should take to sanitize devices.
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Programs should request that sellers sanitize all devices exchanged, and should post sanitization guidelines.
Track Class 1
FDA-Issued Warnings, Bans, or Recalls
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Medical devices continue to be subject to any warnings, bans, or recalls issued by the FDA. The FDA does track some medical devices from the manufacturer to the consumer in order to notify consumers and recall devices should a device pose a serious health risk. The FDA does not track medical devices intended for repeated use, often the devices used by reutilization programs. Exchange Programs should encourage consumers to verify whether the devices they may be acquiring are subject to any FDA recalls or bans at: .
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Exchange programs should have a mechanism for removing medical devices from their listings if notified that the listed product is recalled or banned.
Maintain Business Records of Inventory and Customers
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Keep ordinary business records regarding their inventory and their consumers.
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Such records would be important in the event of a recall or warning issues about a device.
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Exchange programs should know whether or not a particular type of device passed through the program, which consumer possesses the device and how to contact that consumer to inform him/her of the recall or warning.
Comply with
Prescription Use Practices
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Exchange programs should inform consumers that prescription medical devices, should only be dispensed under the supervision of a licensed practitioner.
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Exchange programs should ask those listing products for sale to verify that the device being listed is not a prescription device.
Report Adverse Events
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The FDA does not require reutilizers to report incidents of serious injury or death involving a device.
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Reutilization programs should keep records of any complaints or reports of such incidents.
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If a faulty device design causes a serious injury or death it is important that the manufacturer becomes aware of the danger.
Understand and Apply State Statutes and Regulations
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There may be no applicable FDA regulations or statutes governing reutilization activities, but some states have chosen to regulate the reutilization of medical devices.
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State statute and regulations may govern contract relationships and warranty promises for contractual exchanges made through the Exchange program website. Exchange programs should understand how these laws may impact exchanges, and inform consumers of these laws.
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Reutilization programs should also consult the applicable state statutes and regulations to be sure they are in compliance with state or local law.
Guidelines for Device Remanufacturing
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Programs that engage in remanufacturing could be subject to the FDA regulations.
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Because of the complexities involved in remanufacturing, we encourage AT reutilization programs to avoid remanufacturing.
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If a program chooses to remanufacture, it will be critical to identify and comply with the FDA regulations for remanufacturers, including registration, device listing, premarket notification or approval, labeling, quality system regulation, and reporting.
Next Webinar
Organizational Structure, Governance,
and Insurance
April 22, 2008
2:00 3:30 pm ET
Link to Pass It On Center Webinar Room
http://conference321.com/masteradmin/room.asp?id=rs21c4e11226b6
Contact Information
Jessica Brodey
(301) 770-1127
jbrodey@jmbpolicy.com