Medical devices in the home: a unique challenge for the FDA.

OBJECTIVE: With the rising numbers of elderly populations and those with chronic diseases, the Home Healthcare field has inevitable expanded within the United States. Patients, more specifically home-bound patients, are becoming increasingly dependent on medical technology to help sustain and improve their quality if life. Often times, home care patients, or care recipients, depend on a properly functioning medical device for recovery. As efficient as this method may be, home healthcare also comes along with many challenges involving use and management of medical devices. Difficulties regarding device function, use, the environment, and human factors can all serve as factors to jeopardize patient safety. FDA recognizes that devices need to be safe and capable of meeting needs in an uncontrolled home environment. PARTICIPANTS: Major stakeholders such as manufacturers, distributors, human factor specialists, professional health organizations, healthcare professionals, patient/caregivers, and other government agencies. RESULT: FDA would assure that manufacturers are designing and testing devices for the home, that proper training and education to use the device are available and completed, and the public knows how to report problems with their devices. METHODS: FDA launched the Medical Device Home Use Initiative in April 2010 which proposed different methods that can support safety and safe use of medical devices in the home environment. CONCLUSION: FDA faces many challenges in assuring safe usage of medical devices in the home. FDA hopes that stakeholders can also become actively involved in working with us to address a total life cycle approach on device safety.

Lymphatic/Blood endothelial cell connections at the capillary level in adult rat mesentery.

Analyses of microvascular networks with traditional tracer filling techniques suggest that the blood and lymphatic systems are distinct without direct communications, yet involvement of common growth factors during angiogenesis and lymphangiogenesis suggest that interactions at the capillary level are possible. To investigate the structural basis for lymphatic/blood endothelial cell connections during normal physiological growth, the objective of this study was to characterize the spatial relations between lymphatic and blood capillaries in adult rat mesenteric tissue. Using immunohistochemical methods, adult male Wistar rat mesenteric tissues were labeled with antibodies against PECAM (an endothelial marker) and LYVE-1, Prox-1, or Podoplanin (lymphatic endothelial markers) or NG2 (a pericyte marker). Positive PECAM labeling identified apparent lymphatic/blood endothelial cell connections at the capillary level characterized by direct contact or direct alignment with one another. In PECAM labeled networks, a subset of the lymphatic and blood capillary blind ends were connected with each other. Intravital imaging of FITC-Albumin injected through the femoral vein did not identify lymphatic vessels. At contact sites, lymphatic endothelial markers did not extend along blood capillary segments. However, PECAM positive lymphatic sprouts, structurally similar to blood capillary sprouts, lacked observable lymphatic marker labeling. These observations suggest that nonlumenal lymphatic/blood endothelial cell interactions exist in unstimulated adult microvascular networks and highlight the potential for lymphatic/blood endothelial cell plasticity.