BMET- Regulations in a hospital environment

Module 3

What does “AHJ” stand for?

Authorities Having Jurisdiction

What is an incoming inspection?

A series of checks done on a medical equipment before it is placed in service or on a patient

What is included in an “incoming inspection”

• Electrical safety checks

• Operational checks

• Functional checks

• Documentation into CMMS

What is an Electrical safety test

• A series of assessments performed to ensure that the device operates safely and does not pose electrical hazards to patients, operators, or other equipment

• aligns with international safety standards, such as IEC 60601

What are the key tests in the Electrical safety?

1. Ground Continuity Test

2. Leakage Current Test

3. Insulation Resistance Test

4. Line Voltage Test

What is done in an Ground Continuity Test

Ensures that the grounding connection in the device is intact and capable of safely carrying current in case of a fault.

What is done in Leakage Current Test

Measures the small electrical currents that may escape from the device's circuitry to ensure they are within safe limits.

What is done in an Insulation Resistance Test

Quality of the insulation between electrical components to prevent short circuits or accidental current flow is verified

What is done in a Line Voltage Test

device can handle normal operating voltages without compromising safety is confirmed.

What is an Operational Check?

• a process performed to ensure that a medical device is functioning as intended according to its design specifications (just for basic performance)

• typically performed during routine maintenance, before deploying a new device, or after repairs

What are the key components of an Operational Check?

1. Functional Testing

2. Performance Evaluation

3. Self-Tests

4. Accessories and Connections

What is done in Functional Testing?

Verification that all controls, displays, and outputs of the device are working correctly (e.g., buttons, alarms, and screens)

What is done in Performance Evaluation?

Ensuring the device performs its primary functions, such as delivering accurate readings or treatments (e.g., infusion rates for a pump or ECG waveform accuracy).

What is done in Self-Tests?

Running built-in diagnostic routines or calibration programs that many devices perform automatically.

What is done in Accessories and Connections?

Checks if all necessary accessories (e.g., cables, sensors, or tubing) are properly connected and operational

What is a functional check?

• A process to verify that a medical device operates according to its intended purpose and performance specifications.

• Crucial during routine maintenance, after repairs, or before placing the device into service

What are the key components of a Functional Check?

1. Performance Testing

2. Simulated Use

3. Calibration Verification

4. Functional Features: Checks specific operational elements such as alarms, displays, buttons, and system settings to ensure they work as designed.

What is done in Performance Testing?

Ensures the device performs its primary functions, such as delivering accurate measurements, doses, or treatments (e.g., infusion rates for pumps, ECG waveform accuracy for monitors).

What is done in Simulated Use?

Simulators are used (e.g., patient simulators or infusion pump testers) to replicate real-world conditions and validate the device’s responses.

What is done in Calibration Verification

Confirms if the device is properly calibrated and meets the manufacturer’s specifications

What is done in Functional Features?

Checks specific operational elements such as alarms, displays, buttons, and system settings to ensure they work as designed.

What kind of info should be documented into a CMMS to ensure proper tracking, maintenance, and compliance?

1. Acquisition Details:

   • Purchase date and cost

   • Vendor or supplier information

   • Warranty start and end dates

   • Purchase Order Number

2. Location and Assignment:

   • Physical location in the hospital (e.g., department or room number)

   • Assigned department or unit (e.g., ICU, OR)

3. Planned Maintenance (PM) Schedule:

   • Frequency of required maintenance (e.g., monthly, annually)

   • First PM due date and required procedures

4. Regulatory and Compliance Data:

   • Risk classification (e.g., high-risk or life-support equipment)

5. Documentation:

   • Attach or link user manuals, technical service manuals, and training materials

   • Warranty and purchase order documents

6. Initial Testing and Inspection:

   • Record results of initial performance and safety tests (e.g., electrical safety tests or functional checks) through a separate Work Order linked to the device's asset record.

When are BMETs supposed to refer to OEMs?

Corrective and planned maintenance activities