Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables
This level 2 guidance concerns the applicability of the Performance Standard for Electrode Lead Wires and Patient Cables (Code of Federal Regulations, Chapter 21, Part 898) to active leads used with electrosurgical devices.
The performance standard was established to prevent unintended electrical connections between patients and electrical power sources. The performance standard applies to electrode lead wires and patient cables intended for use with a medical device.
There are two types of leads that are used with monopolar electrosurgical devices, one for the active electrode and one for the dispersive electrode. The active electrode lead is that part of the device that delivers the RF current to the patient for therapeutic effect. The active electrode is under direct control of the surgeon when it is in contact with the patient. This is not the case with the dispersive electrode, which is attached to the patient. Lead wires used with dispersive electrodes are subject to the Performance Standard for Electrode Lead Wires and Patient Cables. This is consistent with Section 220.127.116.11 of the AAMI/ANSI Standard HF18, Electrosurgical Devices.
The active electrode lead wire (both for monopolar and bipolar systems) is not subject to the Performance Standard. This is consistent with the IEC 60601-2-2 International Standard. Under Section Ten clause 56.3, active electrodes are specifically exempted from the requirement that any neutral connector be constructed such that no conductive connection which is remote from the patient can contact conductive parts of fixed mains socket outlets and mains connectors. (See IEC 60601-2-2 Section 10 Clause 56.3 for the full requirement.) The rationale given for this exemption is as follows, “The situation with electrosurgical APPLIED PARTS is quite different, because this kind of EQUIPMENT is intended to be used only under the control of a doctor or trained medical staff.”
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.