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Biomedical device safety program

The Medical Center has thousands of electronic devices that support clinical care and research.  Biomedical Engineering provides inventory control, installation, safety testing, calibration, preventive maintenance and repair services for this equipment.

What counts as a biomedical device?

Biomedical devices range from infusion pumps to hospital beds.  At the most general level, the category includes devices that provide direct life support, gather diagnostic information or monitor physiologic condition, control body functions, deliver drugs or require invasive connection. They may or may not be electrical.

Every department that has "ownership" of biomedical devices must designate one or more persons to be responsible for device control.  Everyone that uses a biomedical device in the course of their work is part of the safety process too.  Here's how:

New biomedical devices

Every new device must be added to the biomedical equipment database, so it can be scheduled for initial safety testing, calibration, and calendared for preventive maintenance.  Devices that come in through normal receiving channels, like Materials Management, are routinely added. 

However, if you receive a device directly via a commercial shipper (e.g., FedEx or DHL) or from a vendor representative, you are responsible for this step.  Call Biomedical Engineering at 305-243-5999 (option #2) to initiate the process.

Devices cannot be put into service until completion of an initial safety test.  And they cannot stay in service if they are past due for preventive maintenance or inspection. 

How can you tell if a device has been appropriately entered into inventory and is "current"?   It should have an inventory sticker and a maintenance sticker.  (Click on those links to see an image of each.)

If you find a device without both of these -- or one where inspection or maintenance is past due -- you must do two things:

  • Attach a red tag to indicate that the device is not usable.
  • Remove the device from service (move it to a location where no one will be tempted to use it).
  • Call Biomedical Engineering at 305-243-5999 (option #2) to request inspection/maintenance.

Old biomedical devices in new settings

When a device is transferred to another department, or even just a new location within the same department, its inventory record must be updated to reflect the new circumstances.  It's a very big medical campus, and it's very difficult to keep up with devices if the inventory records are not kept current. 

Contact us at 305-243-5999 (option #2) to report such changes.

Devices that aren't working properly

The process is the same as with a device that is past due for inspection or preventive maintenance:

  • Attach a red tag to indicate that the device is not usable.
  • Remove the device from service (move it to a location where no one will be tempted to use it).
  • Call Biomedical Engineering at 305-243-5999 (option #2) to request repair service.

Prompt reporting ensures that we can schedule a repair visit to put the device back in service as rapidly as possible.

Old biomedical devices being retired

The device database must also be updated when equipment is retired from service.  Again, contact us at 305-243-5999 (option #2) to report retirements.

We will schedule a visit to remove the inventory and maintenance tags, and perform any other necessary device "processing" prior to removing it from service.

Non-biomedical devices used in patient areas

Biomedical Engineering will perform initial electrical safety tests on equipment that is not used for patient care, but is present in patient care areas.  Examples include computers, printers, microwave ovens, etc.

Questions and additional information

Contact the Biomedical Engineering group.