Single Use Medical Devices

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Pursuant to a congressional request, GAO reviewed the practice of single-use device (SUD) reprocessing in the United States, focusing on the: (1) extent of SUD reprocessing; (2) health risks associated SUD with reprocessing; (3) cost savings from reprocessing; and (4) Food and Drug Administration's (FDA) oversight of SUD reprocessing. GAO noted that: (1) while some health care institutions have chosen to reprocess and reuse some kinds of SUDs, accurate and comprehensive information about the number of facilities that use reprocessed SUDs and the types of SUDs that are reprocessed is not available; (2) surveys by professional associations and other groups have found that approximately 20 to 30 percent of American hospitals reported that they reuse at least one type of SUD and that at least one-third of the hospitals that do so contract with third-party reprocessing companies; (3) most hospitals using reprocessed SUDs reuse only a few types of devices; (4) it is likely that some hospitals do not report their use of reprocessed SUDs, and the estimates do not fully include ambulatory surgery centers or physicians' practices that also may reuse SUDs; (5) although SUD reprocessing does pose theoretical health risks, clinical evidence shows that certain devices can be reprocessed safely; (6) some infection control experts told GAO that the careful reprocessing of appropriate SUDs has not been demonstrated to be a public health risk; (7) GAO found that several reports of patient adverse events allegedly due to SUD reprocessing that GAO identified were inaccurate or not relevant to the debate; (8) however, this does not mean that SUD reprocessing is always safe; (9) current surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs; (10) FDA, device manufacturers, and third-party reprocessors generally agree that many types of SUDs cannot be safely cleaned and sterilized, and even for devices that usually can be reprocessed, some models are impossible to clean and sterilize effectively; (11) substantial cost savings can be achieved by reprocessing SUDs; (12) independent reprocessing firms charge hospitals approximately one-half the price of a new device for a reprocessed device, while the in-house cost of reprocessing some devices can be less than 10 percent of the price of a new device; (13) under FDA's revised framework for SUD reprocessing, independent reprocessing firms and hospitals will have to obtain FDA's approval before they can reprocess many devices labelled for single-use; and (14) the revised regulatory framework will give FDA more information about SUD reprocessing and strengthen its oversight of reprocessing.

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.