Validating a manufacturing process for a pacemaker

15-Jan-2021 06:23

Many of the patients requiring a pacemaker may be on oral anticoagulant [3].Perioperative management of these patients is often challenging and needs special experience.Recently, there has been an increasing interest in performing the pacemaker implantation without reversal of the anticoagulant.This practice was associated with lower risk of pocket bleeding and shorter hospital stay [3, 5-7].All device trainees will require basic skills in pacemaker implantation.However, first step is to identify whether a patient needs a permanent pacemaker.Further advancements in the pacing hardware and percutaneous venous catheterization simplified the implantation technique and made it feasible to implant the transvenous leads.

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Suture materials include both nonabsorbable material for lead and device anchoring and absorbable material for pocket closure.

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

Pacemaker implantation by interventional electrophysiologist in EP lab or catheterization laboratory resulted in a significant reduction in medical cost and hospital stay [2].

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.