Validating a manufacturing process for a pacemaker get dating magazine


14-Feb-2020 14:55

Any physical or occupational restrictions related to the pacemaker implantation including rules regarding the driving should be discussed in detail with the patient.

Routine pre-implant lab tests are 12-lead ECG, chest x-ray, complete blood count, prothombin and partial thromboplastin times, serum electrolytes, blood urea nitrogen, and serum creatinine.

Infiltration of skin and subcutaneous tissue at the implant site with 1-2% lidocaine provides sufficient local anesthesia for the majority of implant procedures.

However, to obtain optimal anesthesia, conscious sedation in the form of carefully titrated IV midazolam and fentanyl is recommended.

The indication for pacing should be thoroughly described to the patient.

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.

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

validating a manufacturing process for a pacemaker-3

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Fluoroscopy and electrocardiography (ECG) are necessary equipments in every device implant.Antimicrobial flush and saline for pocket irrigation should be available.If venography is to be performed, an appropriate intravenous contrast agent must be available.In the past, standard practice was to discontinue warfarin 48 hours before the procedure, bridge with intravenous heparin, and then reinitiate warfarin the day of the procedure or even the night before.

This practice has been associated with higher risk of hematoma formation compared with that encountered in unanticoagulated patients (up to 20%) [4].

Before pacemaker implantation, an informed consent should be obtained.



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