Globally, there were over 420 million cases of cardiovascular disease in 2015, with the top three most widespread and severe arterial diseases being deep vein thrombosis (DVT), peripheral artery disease (PAD), and coronary artery disease (CAD) ( Roth et al., 2017). By reducing physical and financial encumbrances, the device presented in this work may better enable patients to treat cardiovascular diseases and aid in recovery from cardiac surgeries.Ĭardiovascular disease is the top global cause of unnatural deaths, and has accounted for the largest increase in deaths since the year 2000 ( World Health Organization, 2020). Furthermore, our textile-stacking method, inspired by conventional fabrication methods from the apparel industry, along with the lightweight fabrics used, allows the device to be worn more comfortably than other SCT devices. Our open-source, low-profile, and lightweight (140 g) device costs $62, less than one-third the cost the least expensive alternative and one-half the weight of lightest alternative approved by the US Food and Drug Administration (FDA), presenting the opportunity to more effectively provide SCT to socioeconomically disadvantaged individuals. Expanding on concepts from the field of soft robotics, textile sheets are thermally bonded to form pneumatic actuators, which are controlled by an inconspicuous and tetherless electronic onboard supply of pressurized air. Here, we present a low-cost wearable device to administer SCT, constructed using a stacked lamination fabrication approach. Meanwhile, sequential compression therapy (SCT) offers a low-risk alternative, but is currently expensive and unwieldy, and often requires the patient to be immobilized during administration. Treatment with long-term administration of medication can adversely affect other organs, and surgeries such as coronary artery grafts are risky. In 2020, cardiovascular diseases resulted in 25% of unnatural deaths in the United States. Department of Mechanical Engineering, Rice University, Houston, TX, United States.This website will provide safety information and resources about medical products used in the home environment geared for a variety of audiences – consumers, patients, healthcare providers and manufacturers.Mark Schara † Mingde Zeng † Barclay Jumet* ‡ Daniel J. What information does this website provide? Accrediting bodies (Private or governmental bodies that grant recognition that an institution has met certain standards or requirements).To be successful, the government agencies involved in home care need to collaborate with relevant stakeholders: What can CDRH do?ĬDRH wants to decrease the number of problems that occur in the home environment but the issues are complex. CDRH has been receiving an increasing number of adverse event reports about medical devices that are used in the home. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.ĬDRH regulates medical devices however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions. In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.Īs 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. Why is FDA's Center for Devices and Radiological Health (CDRH) interested?Ĭhanges in health care have moved care from the hospital environment to the home environment. A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.This includes devices intended for use in both professional healthcare facilities and homes. What information does this website provide?Ī home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility.Why is FDA's Center for Devices and Radiological Health (CDRH) interested?.
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