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In addition to work done throughout the medical device approval process, the Home Health Care Committee reviews what has been done to address problems when devices are used in the home and recommends further actions to ensure consumers can use the devices safely and effectively. Not all medical devices require a prescription; however, many medical devices do require a prescription . Home use tests are intended to help you with your health care, but they should not replace periodic visits to your doctor.Most tests are best evaluated together with your medical history, a physical exam, and other testing.
Moreover, it is also important to ensure that all the information necessary to ensure the use of the device safely and efficiently is duly communicated to its intended users. For this purpose, the authority provides detailed recommendations regarding the way such information should be communicated to ensure its proper interpretation. In summary, the present FDA guidance highlights the key points related to the human factors to be considered concerning medical devices intended for home use. The authority outlines the matters that require special attention due to the risks arising when medical devices are used by non-professionals outside clinical settings. First of all, the party responsible for a medical device intended to be marketed and used in the US should take all the necessary measures to ensure the customers have access to technical assistance they may reasonably need when using the device for its intended purposes. This includes, inter alia, the assistance provided via phone, email, or online in any other form.
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Detect specific conditions when there are no signs so that you can take immediate action (i.e. pregnancy testing). Detect possible health conditions when you have no symptoms, so that you can get early treatment and lower your chance of developing later complications (i.e. cholesterol testing, hepatitis testing). The Caregiver Action Network to gain a more fully formed picture of the challenges faced by family caregivers in the home.
As further explained by the FDA, the key points here are performance, error detection, control, and recovery. The authority also mentions that special attention should be paid to software updates to ensure they will not adversely impact the safety and performance of the device operated by the software. In all cases, the approach applied should be based on the lowest risk to a person using the device, and the least burden for the manufacturer.
Additional Resources on Home Use Devices
Device manufacturers to take initial steps to make the labeling for home use devices available to the public on the Internet. The FDA and device manufacturers conducted a pilot program to address public Internet access to product labels. The above factors are to be taken into consideration to ensure the overall safety and effectiveness of home-use medical devices. The document further provides references to the respective manual containing detailed instructions to be followed by the party responsible for a medical device when preparing and submitting a report on the adverse event on the device in question. Apart from this, the authority also refers to the respective guidelines on reporting, which describe the particular way it should be undertaken. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally.
The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new requirements the parties involved should follow. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
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In particular, the authority mentions that medical device manufacturers should always take into account the expected knowledge and abilities of potential users of the device. For instance, it could be difficult for users to understand multiple steps, or operate the device without additional training. Users could also fail to understand numerous warnings and precautions to be considered when using the device for its intended purpose. Apart from this, users may not realize the importance of proper maintenance, cleaning, and calibration of the device for ensuring its safety and effectiveness. In some cases, proper training is vitally important for ensuring safety during the use of the device.
Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash. Evaluate information from multiple sources, including medical device adverse event reports to identify safety issues with home use devices.
Thus, the need for training potential users should undergo should be determined based on the complexity of the device and the way it should be used, and other device-specific factors. The authority also encourages medical device manufacturers to validate the actual effectiveness of the training program developed. The pilot ended in December 2015 and provided industry and CDRH staff the opportunity to evaluate the submissions process and system, and usability of the database. The pilot confirmed that it is possible to use the FDA’s existing Registration and Listing system to receive electronic labeling information. Next steps would include making the submitted labeling accessible to the public through an FDA-managed or partner Internet website.
The new article provides an overview of the human factors considerations related to home use of medical devices. You may also wish to contact your pharmacist, nearest hospital, solid waste company, or state or local government for additional information about proper disposal. It is important to note because the FDA’s scope of work is to regulate the medical device industry, the FDA cannot and does not recommend specific medical devices for use in any setting. Review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population. Collaborate with clinicians involved in home care to understand their experiences and needs with medical device labeling. The new article describes in detail the approach to be applied to design considerations for home use medical devices.
The authority additionally emphasizes that in the case of life-supporting or life-sustaining medical devices such assistance should be available 24 hours a day. Furthermore, it is stated that all the data collected in the course of provisions of such assistance should be subject to a rigorous assessment, as it constitutes a valuable source of information regarding the actual safety and performance of a medical device. As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions.
The Food and Drug Administration , the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices intended to be used in a home environment. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. In particular, the guidance highlights the most important aspects resulting from the specific nature of home use devices, the intended use environment, and potential users. The scope of the guidance also covers the aspects related to the design considerations for home-use products. The Food and Drug Administration , the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices intended for home use.
The FDA developed this guidance with input from manufacturers, the health care community and other stakeholders, most of which came from a May 4, 2010 public workshop and written comments received on the draft guidance. Included in the guidance are steps that manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions for home care recipients, consumers, and caregivers. The guidance is intended to improve the design and quality of home use devices to reduce errors that may occur during use. It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling. Another important aspect addressed in the guidance is related to the maintenance of the device in terms of hygienic requirements.
In this respect, the authority also refers to the guidance on reprocessing medical devices in health care settings. Home care recipients, consumers and caregivers need immediate and easy access to information on medical devices used in the home. Health care professionals also need ready access to labeling that may not always accompany a medical device. We then worked with those manufacturers that participated to identify the best approach to foster the development of a labeling repository. The abovementioned factors should be taken into consideration by medical device manufacturers at all stages of the design and development process.
In summary, the present FDA guidance outlines the main design considerations for home use medical devices reflecting the specific nature of the intended use environment. The document describes the approach to be followed by medical device manufacturers to ensure their home use products would fit the intended purpose, and would not expose users or patients to additional risks. The document also describes in detail the aspects related to user training and certification.
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