The Food and Drug Administration (FDA) has published a safety communication dedicated to the use of the cold-therapy mode of water-circulating hot/cold therapy devices. The document is intended to remind the users of the aforementioned devices about the importance of following the instructions for use supplied with the devices in order to ensure safety and effectiveness.
Hot/Cold Therapy Devices in Brief
It is important to outline the medical devices covered by the scope of the FDA safety communication. In particular, the document is dedicated to the medical devices are being used to create the flow of the hot or cold water through the tubing system for the purpose of providing hot or cold therapy to the particular parts of the body. Due to the specifics of construction, some of the devices could be used only to provide cold treatment, while some of the devices could provide both types. Some of the devices also have additional functions, such as compression applicable during the hot or cold therapy or separately. Depending on the design and construction, the water-circulating hot/cold therapy devices could also have programmable time and temperature settings or automated deactivation function. In general, medical devices of this type are intended to be used to provide the patient with the temporary relief of pain. These devices could be used at home or in healthcare institutions.
Grounds for the FDA Safety Communication
The Agency states that within four consecutive years starting from 2015, it has received 15 adverse event reports describing injuries caused by the water-circulation hot/cold therapy devices operating in a cold therapy mode. According to the information available to the FDA, in certain cases, the patients required additional medical intervention to treat the consequences of these side effects. Thus, the Agency states that all modes the devices could work in are associated with certain inherent risks, mostly in the form of tissue injuries and/or pain appearing when the device is being used in a compression mode.
FDA Recommendations for Patients
In order to mitigate the risks associated with the use of hot/cold treatment medical devices, the FDA provides certain recommendations the patients shall follow. These recommendations include, inter alia, the following ones:
- Before using the device: considering the main points, including the particular type of therapy to be applied, the frequency and duration of the therapy, as well as the duration to breaks, the overall time of treatment.
- Taking into account specific preconditions that could impact the use of the device and its outcomes, such as diabetes, conditions impacting the skin sensation, circulatory disorders, or certain medications that could affect negatively when combined with the hot/cold therapy.
- When using the device: an additional barrier should be placed between the device wrap and the skin of the patient in a way prohibiting the wrap from contacting the skin during the whole period of using the device. The wrap should not be placed too tight. The treatment site should be dry during the whole period of treatment.
- Suspending the use of the water-circulating hot/cold therapy device in case if the patient faces any of the adverse reactions (e.g. pain, swelling, discoloration, or burning).
FDA Recommendations for Healthcare Professionals
Besides the recommendations for the patients, the FDA safety communication also contains the recommendations for healthcare professionals applying hot/cold therapy medical devices during health care and treatment procedures. While being less detailed than the previous ones, the recommendations for healthcare providers describe the particular points to be considered when applying water-circulating hot/cold therapy medical devices. First of all, the FDA refers to the precautions and warnings indicated in the labeling of the medical device describing the way the device should be used safely. Healthcare professionals should use the devices in accordance with the instructions for use provided by the manufacturer of a medical device. As an additional safety measure, healthcare professionals should also apply patient screening to identify the potential risk factors.
The FDA declares that it will continue its ongoing monitoring activity to ensure the safety of medical devices allowed to be marketed and used in the US. The Agency will duly publish important information related to the safety issues associated with the water circulating hot/cold therapy medical devices. Moreover, the authority encourages all the parties involved in operations with medical devices to report any and all adverse events and safety issues. In particular, the user of the device facing side effects could use the MedWatch Voluntary Reporting Form or submit a report in accordance with the internal reporting procedures (in case of side effects identified by healthcare professionals working in the appropriate institution).
General Reporting Procedures
Nowadays the medical device adverse event reporting is established under the FDA Safety Information and Adverse Event Reporting Program, and could be conducted in two ways:
- By submitting the report via an online reporting portal, or
- By submitting the filled FDA Form.
The Agency states that healthcare professionals should use Form 3500, while individual customers/patients should use another Form – 3500B. Once started, the reporter will be able to complete the report within 3 days from the date the reporting process has been commenced. In case of any doubts regarding the way the information should be provided, the reporter can provide contact details and ask for additional clarifications.
Under the general rule, the scope of the information to be reported covers:
- Adverse events or side effects appearing when using the medical device,
- Issues related to the quality of medicinal products,
- Issues associated with the use of the products (e.g. choosing the wrong product due to the labeling issues),
- Inappropriate performance of a medicinal product (therapeutic failure).
In accordance with the appropriate adverse event reporting guidelines, when submitting the report, the reporter shall provide the following information:
- Details about the issue itself,
- Name of a medical device in question,
- Name of the reporter.
It is stated that additional details could be included to simplify and accelerate the review of the adverse event report, but only the points above are mandatory. It will take approximately 20 minutes to fill in the reporting form, providing that all necessary information is in place. Textual information provided by the reporter could be also accompanied by the images (if necessary). The reporter may also ask the authority not to disclose its name to the medical device manufacturer.
The filled report could be also printed by the reporter to be saved for the records. All information provided when filing the adverse event report is protected by the Secure Socket Layer (SSL) and Pretty Good Protection (PGP) encryption measures.
Summarizing the information provided here above, the FDA safety communication on water-circulating hot/cold therapy medical devices describes the most common risks associated with the use of the devices of this type depending on the particular model, and also outlines the recommendations to be considered by healthcare provides and patients.
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