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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.
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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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.
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.
Digital Health Center of Excellence
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.
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.
FDA Guidance on Home Use Devices: Postmarket Considerations
In particular, the guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to achieve and sustain compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new requirements. Moreover, an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
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.
Additional Resources on Home Use Devices
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.
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.
Also check the store’s return policy and customer support statement before you place an order. Changes in health care have moved care from the hospital environment to the home environment. A self-service collection of disaster medical, healthcare, and public health preparedness materials, searchable by keywords and functional areas.
In this respect, the manufacturer may refer to the applicable FDA-recognized voluntary consensus standards the device is subject. In summary, the present FDA guidance addresses the main points related to the labeling for home-use medical devices. The document outlines the scope of information to be communicated to potential users to ensure the device will be used safely and efficiently. A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home.
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.
The maintenance procedures themselves should be easy enough to perform so that lay persons having no proper qualification or training be able to complete them properly. CDRH held a public meeting in April 2013 to discuss any comments or questions the public had about making medical device labeling available online, as well as soliciting input on what information medical device users want and need in labeling, and how they would prefer to access it. CDRH surveyed caregivers and health care professionals in separate research studies to understand how they use and access medical device labeling. Should the device be designed in a way ensuring its portability for frequent change of use locations, the manufacturer should pay additional attention to the potential impact of external factors the device may face during normal use. According to the guidance, devices should have a minimal number of parts that could be detached or fall off and present an inhalation, swallowing, or tripping hazard. Under the general rule, the mechanical strength should be enough to ensure the device withstands the impact of factors that are common to the intended use environment, which is outside the clinical setting.
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