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Related Concept Videos

Types of Reports II: Incident or Occurrence Report01:21

Types of Reports II: Incident or Occurrence Report

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An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
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Data Reporting and Recording01:24

Data Reporting and Recording

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Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
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Introduction to Documentation and Reporting01:20

Introduction to Documentation and Reporting

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Documentation is the systematic process of formally recording, maintaining, and communicating information.
Nursing documentation records essential information and details regarding a patient's care and treatment in written or electronic form. It is a critical aspect of nursing practice that involves documenting assessments, interventions, outcomes, and other relevant details about a patient's health status.
Documentation maps the patient's health journey by creating a comprehensive...
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Healthcare Associated Infections II: Preventive Measures01:22

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Essential infection prevention measures are based on the knowledge of the infection chain, the modes of transmission in healthcare settings, and the use of the best practices in all healthcare settings. Compulsory public reporting of healthcare-associated infection rates is needed to allow individuals and the community to make informed choices regarding selecting a healthcare facility.
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Methods of Documentation VII: EMR01:30

Methods of Documentation VII: EMR

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Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
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SBAR II: Application of SBAR01:14

SBAR II: Application of SBAR

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SBAR is an effective communication tool used by healthcare professionals to communicate patient information accurately. SBAR stands for Situation, Background, Assessment, and Recommendation. For a better understanding, an example is given below.
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
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The application study of harmonization code in medical device adverse event reporting.

Soo Jeong Choi1,2, Sooin Choi3,4, Songhyeon Park5

  • 1Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea. crystal@schmc.ac.kr.

BMC Health Services Research
|November 15, 2024
PubMed
Summary

Medical device adverse event (MDAE) reporting shows varied code application among regulators. Most participants used broad codes, indicating a need for improved standardization in post-market surveillance.

Keywords:
Adverse eventIMDRFInternational medical device regulators forumMedical devicesPost-market surveillanceSafety management

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Area of Science:

  • Regulatory Science
  • Medical Device Safety
  • Post-Market Surveillance

Background:

  • Adverse event reporting is crucial for medical device (MD) post-market surveillance and safety signal detection.
  • Standardized codes for medical device adverse events (MDAE) were implemented by international regulators due to global occurrences and public health crises.
  • This study evaluates the practical application of MDAE terminology and coding systems.

Purpose of the Study:

  • To assess the application of International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes.
  • To identify patterns and variations in code selection during medical device adverse event reporting.

Main Methods:

  • An online survey was administered to participants of the MD Training Program for Regulatory Authorities.
  • The survey included six virtual medical device adverse event (MDAE) cases for participants to code.
  • Participants' code selections were analyzed for patterns and variations.

Main Results:

  • Regulators predominantly selected broad (Level 1) codes over detailed (Level 2 or 3) codes for MDAE reporting.
  • While code selection varied, over 50% of responders selected intended codes for a specific case (Case 6).
  • Codes related to device problem, components, and health effects were frequently chosen for cause investigation.

Conclusions:

  • Diversification in terminology and code selection was observed in medical device adverse event (MDAE) reporting.
  • Findings suggest potential challenges in consistent application of standardized MDAE coding systems.
  • Further refinement or training may be needed to enhance uniformity in MDAE reporting.