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Posted by / 04-Sep-2019 03:53

Validating a manufacturing process for a pacemaker

Minimum required personnel for pacemaker implantation consist of implanting physician, scrub nurse, and circulating nurse or technician.

Scrub nurse is required to help the implanter throughout the procedure.

Antimicrobial flush and saline for pocket irrigation should be available.

If venography is to be performed, an appropriate intravenous contrast agent must be available.

The pacemaker implantation can be performed in electrophysiology (EP) laboratory, catheterization laboratory, or operating room [1].

The need for lifelong follow-up should be emphasized and patient should be informed about the generator change and possible lead replacement in the future.

Currently available permanent pacemakers contain a pulse generator and one or more pacing leads.

Early in the era of pacemaker implantation, this procedure was only performed by the cardiac surgeons because of the initial mandate for epicardial lead implantation.

Before pacemaker implantation, an informed consent should be obtained.

Any anticipated risks and benefits should be honestly discussed with patient or the patient’s family.

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Our routine practice is to give 1 gram of cefazolin or vancomycin (in penicillin-allergic patients) one hour before the procedure.

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