Dear All
The Food and Drug Administration (FDA) issues the guidance document entitled "Class II Special Controls Guidance Document: Electrocardiograph Electrodes." The special controls identify the following risks to health associated with electrocardiograph electrodes: Adverse tissue reaction to the skin-contacting electrode materials, misdiagnosis and electrical shock.
The guidance document provides information on how to mitigate these risks and recommends testing such as biocompatibility, electrical performance, adhesive performance, shelf life, sterility testing if the product supplies as sterile disposable ECG electrode and so on..
Also, this guidance document recommends to use following labeling information’s on the packaging insert.
Cautions
The package insert should advise users of the following:
• CAUTION: Federal law restricts this device to sale by or on the order of a physician.
• ECG electrodes should only be used by or in consultation with a health care provider familiar with their proper placement and use;
• ECG electrodes may damage the skin if removed carelessly;
• ECG electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected, or inflamed areas); and
• ECG electrodes should be properly disposed of if they are disposable by design or they are reusable but cannot be fully cleaned between uses.
This guidance document describes a means by which electrocardiograph electrodes may comply with the requirement of special controls for class II devices.
To access the aforesaid FDA guidance document please refer here.
Regards
S.Subramaniam
The Food and Drug Administration (FDA) issues the guidance document entitled "Class II Special Controls Guidance Document: Electrocardiograph Electrodes." The special controls identify the following risks to health associated with electrocardiograph electrodes: Adverse tissue reaction to the skin-contacting electrode materials, misdiagnosis and electrical shock.
The guidance document provides information on how to mitigate these risks and recommends testing such as biocompatibility, electrical performance, adhesive performance, shelf life, sterility testing if the product supplies as sterile disposable ECG electrode and so on..
Also, this guidance document recommends to use following labeling information’s on the packaging insert.
Cautions
The package insert should advise users of the following:
• CAUTION: Federal law restricts this device to sale by or on the order of a physician.
• ECG electrodes should only be used by or in consultation with a health care provider familiar with their proper placement and use;
• ECG electrodes may damage the skin if removed carelessly;
• ECG electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected, or inflamed areas); and
• ECG electrodes should be properly disposed of if they are disposable by design or they are reusable but cannot be fully cleaned between uses.
This guidance document describes a means by which electrocardiograph electrodes may comply with the requirement of special controls for class II devices.
To access the aforesaid FDA guidance document please refer here.
Regards
S.Subramaniam
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