HGMT310 UMUC Not All Medical Devices Are Constructed Safely. Patients and Providers Rely on Their Safety.

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hgmt310

University of Maryland University College

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Topic: Not all medical devices are constructed safely. Patients and providers rely on their safety.

  • Assignment #2- Policy Implementation (16 points)Build on Assignment #1. You will cover the same health problem and the same policy unless otherwise indicated by your instructor.Some remedial action on Assignment #1 may be required in order for students to proceed to Assignment #2. Complete the following using the format provided. Except for titles, the narrative format is expected with complete sentences. The table should be single-spaced maximum 2.5 pages. Also, include a cover page and a reference page in APA Format.
    HGMT 310 Assignment #2
    Student Name:Type your name here.
    Assignment #2 Title:Provide the title of your topic in this section and the official title of the legislation
    Agency Responsible for Implementation:Identify the agency and subunit (such as a bureau or office) responsible for implementing the policy. If multiple agencies are involved indicate who is responsible for what.
    Agency Responsible for Enforcement:What federal or state agency is responsible for enforcement? What are the key areas for enforcement (provider, payer, producer, patient)?
    Implementation:How is the legislation implemented? Discuss any programs that were implemented as a result of this policy. What federal or state agency is charged with its implementation? Are local public health departments involved? Are collaborating organizations engaged to achieve the aims of the policy? Are citizen’s involved? Health providers or organizations? Are grants awarded to organizations to execute the policy (i.e. FDA, CDC, etc)?
    Impact on Health Service Organizations:What does a Health Care Manager need to know about this legislation? Does the implementation of this policy impact how Healthcare Managers deliver services? Include five bullets on how this legislation impacts health services organizations operating in your home state.
    Resource:What internet resources are available to health organizations to find updates on programs implemented as a result of the policy you described?
    All sections of Assignment #2 are required.The grading rubric for this assignment appears below if you opened the Assignment in the Assignment Folder. It can be opened by clicking on the 'Written Assignment rubric" tab in the lower right corner of the screen if you opened the Assignment in Content.

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Explanation & Answer

Attached.

Running Head: MEDICAL DEVICES

1

Medical Devices
Name
Institution

MEDICAL DEVICES

2
Assignment #2

Name of Student
Title:

Not all medical devices are constructed safely. Patients and providers rely
on their safety.
Safe use of Medical devices. The Food, Drug, and Cosmetic Act. Bill

Assignment #2 Title:

number 3095.
The Implementation of the FD&C Act is the responsibility of the U.S Food
Drug and Administration agency. The FDA established some requirements
and regulations that manufacturers and users of medical devices must
comply with. The FDA works in collaboration with other agencies and
institutions to ensure the health of the citizens is promoted and that the
people are protected from defective devices (FDA, n.d).
The Food Trade Commission is also an independent agency that is tasked

Agency Responsible

with ensuring that competition in the manufacture and distribution of

for Implementation: medical devices remain fair by protecting and eliminating deceptive
practices. The FTC is also tasked with advertisement and promotion of
medical products, including drugs and medical devices in the international
markets.
Additionally, the FDA contracted with the IOM (Institute of Medicine) to
ensure the study and oversight of the implementation of certain provisions
in the Act especially those that deal with chemical goods and products

Agency Responsible The FDA is also responsible for the enforcement of the FD&C Act. The
Center for Devices and Radiological Health (CDRH) also regulates
for Enforcement:
manufacturing, importation, and repackagin...


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