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Electrical Safety on Non-Biomed Devices

Electrical Safety Inspection of Medical Devices
Not Managed by PBME
Some medical devices at MGH are managed by departments other than Biomedical Engineering. There are 12 Designated Technology Management Groups (DTMGs) at MGH. Biomedical Engineering is one of them. Vascular, Radiology and Endoscopy are other examples.

Biomedical Engineering is sometimes asked to perform electrical safety inspections on other DTMGs’ devices. This is usually because the other DTMGs have their devices serviced by vendors who do not always check electrical safety during their scheduled maintenance procedures. Even though Biomedical Engineering is not responsible for those devices, we typically perform this check because it is best for patient safety.

However, this can cause confusion because now two groups are handling the same device, and there are no rules on how to deal with control numbers, inspection stickers, etc. The MGH Medical Equipment Management Plan does not cover what to do in this scenario.

The longer term solution is for the DTMGs to decide how to deal with this situation and possibly revise the Medial Equipment Management Plan. In the short term, when someone asks Biomedical Engineering to check electrical safety on a device that is not ours, this is how we will proceed:

1. We will NOT issue a control number or put a control number sticker on the device. A control number is a unique identifier, so only the managing DTMG should have a control number on the device.

2. We will NOT put an inspection sticker on the device. Our inspection stickers imply a full SM, and that is not the case here. Even if the full SM is just electrical safety, that is for the other DTMG to decide, not us. We are providing a specific service - an electrical safety inspection - and we do not have a sticker for that.

3. We will NOT put any other stickers, labels or markings on the device because we do not manage the device.

4. We will document the work by creating an unclassified work order with Customer Request as the work order type, and record in the Comment field the device’s control number (issued by the other DTMG), serial number, manufacturer, model, and whether the device PASSED or FAILED.

5. We will give a printout of the work order to the person who requested the work, with the reminder that they should give it to their DTMG representative (listed on the PBME website), since the representative is responsible for keeping track of the device’s history. The work order is basically a receipt for their records.

6. If the device fails electrical safety, we will inform the person that they should not use the device. We can suggest using an isolation transformer, but they will be responsible for obtaining one.

7. Because the other DTMG manages the device, not us, it is their responsibility to keep track of SM intervals and due dates.

8. If the ownership of a device is in doubt - if you and the other person are not sure if BME or the other DTMG owns the device - take the issue to your team leader before doing any work.

9. We will not go back and modify any devices that were handled differently than this until the DTMGs reach an agreement on this situation. We will leave them “as is” for now.

10. If another DTMG’s device is on a regular care unit, it is still their responsibility first, not ours.


MGH Medical Equipment Management Plan

MGH Medical Equipment Management Committee (DTMG representatives)

Created: May 15, 2008
Added to site: May 27, 2008
Source: Michael Cusack, PBME
Document owner: Michael Cusack

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This page was last updated on 11/3/2014