Background Information:

The Moreno Medical Center is partnering with the Food and Drug Administration’s MedSun Project to improve patient safety by reporting problems with medical devices and ensuring compliance with reporting requirements. MedSun grants of $25,000 are available to fund research designed to improve medical device safety in clinical and operational processes.

Assignment:

Write a 1,750- to 2,450-word paper in which you detail a needs assessment and proposal for utilizing MedSun grant funds to improve the medical device policies, procedures, and processes at the Moreno Medical Center.

Your proposal needs to include the following elements:

• Proposal goal and objectives
• Assessment related to the Safe Medical Devices Act (SMDA) of 1990
  • Compliance with Medical Device Reporting requirements*

• Organization policies
• Summary of identified deficiencies
• Plan for addressing each of the identified deficiencies to include:
  • Deficiency
  • Proposed intervention
  • Timeline for completion
  • Budgeted Grant Funds
• Evaluation
  • Description of evaluation process
  • Criteria to include:
    • Achievement of proposal goals and objectives
    • Correction of deficiencies
    • Use of grant funds
    • Compliance with established timeline

Research primary and secondary sources of information related to medical devices and methods to improve adverse event reporting and patient safety.