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Rehabilitation Engineering Part 2 > L18 Funding and Standards > Flashcards

L18 Funding and Standards Flashcards

1
Q

Who funds assistive and rehabilitation technology?

A
  • Federal and State Programs
  • Medicare/Medicaid
  • VA
  • Advocacy Groups
  • Organizations
  • Grants
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2
Q

MediCARE (Only)

A
  • Federal Insurance Program
    *Paid by a Trust Fund funded with Payroll Taxes
    *Same Program nationwide
    *Benefits people over the age of 65
    *Participants pay deductibles and for part of coverage
    *Divided into 4 parts: A, B, C, D
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3
Q

MedicAID

A
  • Federal & State Assistance Program
  • Paid for by Federal, State, and Local Taxes
  • Program differs State by State
  • Benefits people with low incomes
  • Participants pay very little or no part of coverage
    *Participants receive regular Dental and Vision exams
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4
Q

MediCARE and MedicAID

A

*Benefits people with disabilities
* Prescription Drug Coverage
* Outpatient Hospital Care
* Inpatient Hospital Care

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5
Q

Medicare - More

A
  • durable medical equipment (DME) equipment that is medically necessary, able to withstand repeated use, and is generally not useful to someone in the absence of illness or injury
  • DME includes items like wheelchairs, walkers, scooters, and hospitals beds.
  • does NOT pay for any assistive equipment that is not strictly medically necessary.
  • does NOT pay home modifications (like the installation of a stairlift or grab bars near the toilet or tub)
  • does NOT pay assistive devices (like large-button telephones or flashing doorbell signals for the hard of-hearing)
  • 20% co-pay typically required
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6
Q

Medicare Coverage for Durable Medical Equipment (DME)

A
  • Pressure reducing beds and mattresses
  • Blood sugar monitors
  • Blood sugar (glucose) test strips
  • Canes
  • Commode chairs
  • Continuous Passive Motion (CPM) Machines
  • Crutches
  • Hospital beds
  • Infusion pumps and supplies
  • Manual wheelchairs and mobility devices
  • Nebulizers and some nebulizer medications
  • Oxygen equipment and accessories
  • Patient lifts
  • Sleep apnea and CPAP machines
  • Suction pumps
  • Traction equipment
  • Walkers
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7
Q

Medicare: Power Mobility Device (PMD)

A
  • PMD primarily used in the home
  • Assessment Tool for Determining Eligibility for PMDs
  • Face-to-Face Examination and Prescription Required
  • Advanced Determination of Medical Coverage (ADMC)
  • Co-payment Responsibility: 20%
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8
Q

Organizations

A

Disability specific organizations may help fund technology

  • National Multiple Sclerosis Society

*American Council of the Blind

  • United Spinal Association
  • United Cerebral Palsy of Tampa Bay
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9
Q

Advocacy

A
  • Self advocate
  • Professional Organizations: AAOP, AOPA,
  • RESNA:
  • Legislators
  • Florida: Governor’s Commission on Disabilities, Governor’s ADA Working Group
  • Patient specific groups: SCI, blind, MS, CP
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10
Q

Florida Division of Vocational Rehabilitation

A

Vocational Rehabilitation (VR) is a federal-state program that helps people who have physical or mental disabilities get or keep a job. VR is committed to helping people with disabilities find meaningful careers.

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11
Q

Examples of VR Services

A
  • Medical and Psychological Assessment
  • Vocational Evaluation and Planning
  • Career Counseling and Guidance
  • Training and Education After High School
  • Job-Site Assessment and Accommodations
  • Job Placement
  • Job Coaching
  • On-the-Job Training
  • Supported Employment
  • Time-Limited Medical and/or Psychological Treatment
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12
Q

RESNA’s goal

A

To maximize the health and well being of people with disabilities through technology.”

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13
Q

RESNA

A

Rehabilitation Engineering and Assistive Technology Society of North America)

  • professional organization dedicated to promoting the health and well-being of people with disabilities
  • increasing access to technology solutions.
  • certification, continuing education, and professional development
  • developing assistive technology standards
  • promoting research and public policy
  • sponsoring forums, conferences for the exchange of information and idea
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14
Q

National Institute of Disability, Independent Living
Rehabilitation Research (NIDILRR)

A
  • Part of U.S. Department of Education
  • 2015 became part of the Administration for
    Community Living , Dept. of Health and Human
    Services

NIDILRR is a federal government grants-making agency that sponsors grantees to generate new disability and rehabilitation knowledge and promote its use and adoption

  • Promotes the use and adoption of new disability and rehabilitation knowledge
  • Helps people with disabilities to perform activities in the community
  • Provides full opportunities and accommodations for its citizens with disabilities
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15
Q

What are Standards?

A
  • Standards serve as rules to measure or judge capacity,
    quantity, content, extent, value, and quality
  • Some standards take the form of an actual item:
  • The atomic clock serves as the reference for measuring
    time throughout the world
  • Other standards set criteria for use and practice in industry
    and for products in everyday life
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16
Q

How are Standards Developed?

A

The International Standards Organization (ISO) coordinates standards worldwide
Representatives Organizations from many countries: American National Standards
Institute (ANSI) coordinates national technical standards organizations.

There are about 210
organizations designated
as Standard
Development
Organizations (SDOs)

17
Q

Standard

A

A document that defines the characteristics of a
product, process or service, such as dimensions, safety
aspects, and performance requirements

18
Q

Code

A

Laws or regulations that specify minimum standards to
protect public safety and health

19
Q

Specification

A

A set of conditions and requirements of precise
and limited application that provide a detailed description of a procedure, process, material, product, or service for use in procurement and manufacturing

20
Q

Purpose of Standards

A
  • Communication tool that allows all users to speak the same language when reacting to products or processes
  • Taught and applied globally
  • Designed to protect the public from questionable designs, products and practices
21
Q

A medical device is …

A
  • Section 201(h) of the Food, Drug and Cosmetic Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or by being
    metabolized.
  • A simple as a tongue depressor or a thermometer
  • As complex as robotic surgery devices.
22
Q

Regulations of Medical Devices

A
  • more regulation for devices that pose greater risk
  • Implanted devices (pacemakers etc.) are typically designated class III
  • Investigational devices are typically exempt
23
Q

Class I (General controls):

A

-Low Risk General controls

-50% of medical devices

-Manufacturers are required to perform registration, premarketing notification, record keeping, labeling,
reporting of adverse experiences and good manufacturing practices

-EXAMPLES: bandages, tongue depressors, disposable gloves, stethoscope, non-electric wheelchair

24
Q

Class II (Performance standards)

A

-Medium Risk

-40% of medical devices

-General and special controls
800 standards needed to be met

-EXAMPLES: catheters, syringes, contact lenses, pregnancy tests, powered/electric wheelchairs, myoelectric prosthesis

25
Q

Class III (Premarketing approval)

A

-High Risk

-10 % of medical devices

-General controls and premarket approval
Manufacturers have to prove the safety of these devices prior to market release

-EXAMPLES: defibrillators, pacemakers, breast implants and implanted prosthetics

26
Q

Center for Devices and Radiological Health (CDRH)

A
  • Part of U.S. FDA
  • Responsible for protecting and promoting the public health
  • Assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting
    products.
27
Q

CDRH Mission

A

Get safe and effectie medical devices to market as quickly as possible while ensuring that medical devices currently on the market remain safe and effective

Help the public get science-based accurate information about medical devices and radiological products needed to improve health

28
Q

International Organization for Standardization (ISO)

A
  • ISO is an independent, non-governmental international organization with a membership of 161 national standards bodies.
  • Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based,
    market relevant International Standards that support innovation and provide solutions to global challenges.
29
Q

ISO 13484 – Medical Devices

A
  • ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of
    medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
  • Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard,
    and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
30
Q

American National Standards Institute

A

To enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and safeguarding their integrity.

Rehabilitation Engineering Part 2 (11 decks)

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