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Calibration of Medical Devices Training

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Training on Calibration of Medical Devices

Medical devices are health technologies that help diagnose, treat, prevent, monitor, and rehabilitate patients. They are used in hospitals, clinics, and at home. Medical devices calibration is the process of verifying the accuracy of medical equipment to ensure it provides reliable and precise measurements. Proper calibration is critical in healthcare settings to maintain patient safety, comply with regulatory standards, and ensure the accuracy of diagnostic and therapeutic procedures.

FARE Labs, an accredited laboratory as per ISO/IEC 17025:2017 for the Calibration of Medical Devices, offers comprehensive training programs in Medical Device Training Course. The training includes hands-on experience with sophisticated instruments, allowing participants to gain practical skills essential for the calibration of medical devices. FARE Labs’ state-of-the-art calibration laboratory is accredited as per ISO/IEC 17025:2017 in various disciplines, including biomedical devices.

Objectives

The primary objective of medical equipment calibration training is to ensure the accuracy, reliability, and safety of medical equipment. Key objectives of the Medical Devices Calibration Course include:

  1. Accuracy Assurance: Ensuring that medical devices provide correct and reliable measurements.
  2. Compliance: Meeting regulatory requirements and industry standards for medical device performance.
  3. Patient Safety: Reducing risks associated with inaccurate readings that could impact patient care.
  4. Device Longevity: Maintaining optimal performance and extending the operational life of medical equipment.
  5. Quality Control: Supporting consistent quality management practices to ensure reliable medical outcomes.

Regular calibration of medical devices is essential for maintaining trust in medical procedures, meeting legal obligations, and ensuring the highest level of patient

What is to learn?

Training will be provided on selected parameters from the list below:

1. Fundamentals of Calibration

  • Definition of Calibration: Comparing measurement outputs of a medical device against a known reference standard.
  • Traceability: Ensuring calibration is linked to national or international standards (e.g., NIST, ISO).
  • Standard Operating Procedures: Understanding the process of calibration.

 

2. Regulatory and Quality Standards

  • ISO 13485: Quality management for medical devices.
  • ISO 17025: Calibration and testing laboratory competence.
  • IEC 60601: Electrical safety and performance of medical devices.

 

3. Calibration Process

  • Pre-Calibration Check:
    • Review device manuals and calibration intervals.
    • Check for physical damage or prior malfunctions.
  • Reference Standards:
    • Use Standard Simulators / Analyzers.
    • Maintain traceable records to national standards.
  • Calibration Procedure:
    • Follow manufacturer guidelines and calibration SOPs.
    • Record all inputs, outputs, and deviations.
  • Post-Calibration:
    • Apply calibration stickers and update documentation.
    • Issue calibration certificates with key details (e.g., uncertainty).

 

4. Measurement Uncertainty & Tolerances

  • Measurement Uncertainty: Evaluating errors in calibration results.
  • Tolerance Levels: Understanding acceptable limits for device performance.
  • Risk Assessment: Assessing the impact of inaccurate readings on patient safety.

 

5. Calibration Schedules & Records

  • Frequency of Calibration: Based on manufacturer recommendations and usage.
  • Documentation:
    • Calibration certificates.
    • Equipment history records.
    • Non-conformance reports (if out-of-tolerance).

 

6. Common Medical Devices (Group wise) for Calibration

  • Discharge Equipment/Devices (Suction Pump, Flow meter with Humidifier, Pressure Gauge of Oxygen Cylinder, BP Apparatus, Nebulizer, Syringe Pump, Infusion Pump, CPAP, Bi-PAP, Boyles Apparatus, Anaesthesia machine)
  • Patient Conditioning / Maintenance (Baby Incubator, Autoclave, Defibrillator, Ventilator, ElectroSurgical Unit/Diathermy machine/Cautry Machine, External Pacemaker, Electronic Tourniquet, Dialysis Machine, Heart Lung machine, Patient Warmer, OT Table., Radiant Warmer, Phototherapy Unit)
  • Monitoring Unit (Patient Monitor, Fetal Monitor, Weighing Scale, Semi-Auto Analyzer)
  • Imaging/Plotters (Trans Illuminator Light Source, EEG, Fetal Doppler, ECG Machine).

1. Accredited Calibration Laboratories

  • ISO/IEC 17025 accredited labs ensure compliance with international standards.
  • Examples:
    • National Metrology Institutes (NMI)
    • Local ISO 17025-certified calibration labs

2. Medical Device Manufacturers

  • Many original equipment manufacturers (OEMs) offer in-house calibration services.
  • Contact the device manufacturer for certified calibration.

3. Third-Party Calibration Service Providers

  • Independent companies specialize in multi-brand calibration and servicing.

4. Hospitals and Healthcare Facilities

  • Large hospitals may have biomedical engineering departments for calibration.

5. Government and Regulatory Bodies

  • National calibration services provided by public health agencies.

6. Biomedical Equipment Maintenance Companies

  • Provide calibration as part of preventive maintenance contracts.

7. University Research Facilities

  • Academic institutions with medical research programs may offer calibration services.
  1. Adherence to Safety Protocols: Strictly follow all laboratory safety guidelines and protocols to prevent accidents and ensure the well-being of all participants.
  2. Active Participation: Engage actively in all training sessions, discussions, and practical exercises. Complete all assigned tasks and projects on time.
  3. Respect for Equipment and Facilities: Handle all laboratory equipment and materials with care. Report any damages or malfunctions to the instructor immediately.
  4. Collaboration and Teamwork: Work collaboratively with fellow participants, sharing knowledge and supporting each other’s learning.
  5. Integrity and Accuracy: Maintain a high standard of integrity in all testing procedures and documentation. Ensure that all results are accurate and reliable.

Commitment to the Program: Participants must demonstrate a commitment to the training program by attending all scheduled sessions, completing all assignments, and actively participating in practical exercises. A signed commitment agreement may be required before the start of the program.

Health and Safety Compliance: Participants must comply with health and safety regulations, including wearing appropriate personal protective equipment (PPE) and adhering to all safety protocols. A medical clearance or proof of immunizations may be required for certain training programs.

 

Designation: Medical Devices Calibration Trainee

Section: Training

Qualification: Ph. D./ M. Tech./ M. Sc./ B. Tech./ B. Sc.

Fees:  As Per Industry Standards

Experience: Freshers / Professionals

Employment Type: Short Term / Long Term

Location: Gurugram, Haryana

 

Note:

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