An electrocardiograph electrode is an electrode applied directly to the patient's skin to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram. An electrocardiograph electrode is not intended to deliver therapy to the patient.The FDA is announcing the proposal to designate special controls guidance and to exempt this device type. Designation of this guidance document as a special control will mean that manufacturers of ECG electrodes will need to address the issues identified in this special controls guidance document. However, a manufacturer need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness.
Thus, persons who intend to market a device of this type do not need to submit a 510(k) to FDA and receive agency clearance prior to marketing the device if they follow the recommendations in this special controls guidance document. If a manufacturer does not follow the recommendations in this guidance document but instead chooses to use alternative means to address the issues covered in this guidance, then it will not be exempt from the requirements under section 510(k) and will need to submit a 510(k) and receive clearance for its device prior to marketing.
This draft guidance document reflects the FDA's careful review of what we believe are the relevant issues related to ECG electrodes and what we believe would be the least burdensome way of addressing these issues.
An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The FDA considers both pre-gelled and bare (non-pre-gelled) electrodes to be included in this classification.
FDA has identified the following risks associated with electrocardiograph electrodes - adverse tissue reactions to the skin/contacting electrode materials and misdiagnosis.
The skin-contacting materials, such as the electro conductive gel, adhesives, and electrodes, should be biocompatible for their intended use. The FDA recommends testing the electrodes under the intended conditions of use, e.g., duration of application.
The electrodes should not cause toxic or electrolytic effects that could produce an irritating, sensitizing or cytotoxic effect upon the skin or allow irritating sensitizing, or cytotoxic materials to enter the skin by iontophoresis. However, due to the electrolytic composition of some electro conductive gels that contain high levels of saline, a positive cytotoxicity result may not be a correct indication that the hydro gel is truly cytotoxic. In these circumstances, evaluation using other tests specified in the standard may be appropriate.
Electrical Performance will be judged on AC impedance, DC offset voltage, combined instability and internal noise, defibrillation overload recovery, and bias current tolerance.
The design of the electrode should ensure it will adhere to the patient's skin for duration of use compatible with the intended use of the device. FDA recommends testing adhesive performance to show it meets specifications of the design and meets user needs.
FDA recommends testing the device's shelf life and storage conditions.
If the electrodes are not limited to single-patient use, FDA recommends the labeling include instructions for handling, transport, cleaning, and biological decontamination. For reusable ECG electrodes, FDA recommends evaluating the potential for skin reactions and disease transmission.
Electrode Lead Wires and Patient Cables - FDA recommends documenting the length(s), construction, materials, and connections between the ECG recording device and the electrodes. The electrode lead wires and patient cables intended for use with a medical device are subject to the performance standard set. Your documentation should contain information sufficient to demonstrate conformance to this performance standard.
The package insert should advise users of cautions and precautions, adverse reactions, and limitations.
If products are unsafe, they can alter become the subject of litigation. If you suspect you were injured by defective lead wires from your heart device, please contact our lawyers.
