Safe Medical Devices for Children (2006) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 17-45
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 17... ...
Notably, in addition to improved sanitation and nutrition, the development of vaccines to prevent common childhood diseases and antibiotics to treat infections have saved the lives of countless children. Although medical devices such as syringes, intravenous infusion equipment, and infant-sized catheters have played supporting roles in immunizations and antibiotic therapy, devices have figured most prominently in other areas of pediatric health care.
|
From page 18... ...
To cite another example, children who once would have died from congenital heart conditions today survive with the aid of implanted devices such as mechanical heart valves, pacemakers, devices that close holes in the heart, and artificial tubes used to bypass malformed heart valves. The surgical procedures associated with these and other treatments typically require additional sophisticated equipment, including cardiopulmonary bypass systems (heartlung machines that oxygenate and circulate the blood while the heart is stopped for surgery)
|
From page 19... ...
. This report examines the regulation and surveillance of a wide range of medical devices used with children.
|
From page 20... ...
Although still plagued with problems of infection and blockage requiring surgical repair, cerebrospinal fluid shunts allow more than half of children with hydrocephalus to avoid brain damage and develop mental delay caused by prolonged increased spinal fluid pressure on the brain (Casey et al., 1997)
|
From page 21... ...
. In many cases, medical devices used to help children have been initially developed for, tested with, and most frequently employed to treat adults, who constitute a much larger market for medical devices and medical treatments than children, who are, overall, a healthier segment of the population.
|
From page 22... ...
105115) and the Medical Device User Fee and Modernization Act of 2002 (P.L.
|
From page 23... ...
It is appropriate to put a high priority on keeping unsafe and ineffective medical devices and other products from entering the market in the first place. It is also reasonable to ask whether the system of postmarket surveillance established under the Federal Food, Drug, and Cosmetic Act provides adequate safeguards for the use of medical devices once the devices have been approved for marketing.
|
From page 24... ...
The migration of care out of the hospital into patient homes has brought many benefits, but it also presents risks as families and patients have taken on many roles in the operation, maintenance, and troubleshooting of complex medical devices that were formerly performed by health care professionals. In addition, for complex devices now used in the home, the opportunity and responsibility for identifying and reporting possible device-related adverse events has shifted, in considerable measure, to patients, families, officebased physicians, home care nurses, home health agencies, and even school personnel.
|
From page 25... ...
. The study was also to examine · the FDA's monitoring and use of adverse reaction reports, registries, clinical studies, and other postmarket surveillance activities; · the adequacy of FDA's monitoring of commitments for further clinical studies made by manufacturers at the time of approval of specific medical devices; · the adequacy of postmarket surveillance studies to evaluate how children's active lifestyles may affect failure rates and longevity for implanted devices; and · the length of postmarket surveillance studies of implanted devices, including whether studies continue long enough to evaluate the impact of children's growth and development given the expected length of time that a child will have an implant.
|
From page 26... ...
Chapter 2 examines the rationale for particular attention to the special characteristics of children when medical devices are designed, evaluated, regulated, and used. The regulatory framework for postmarket surveillance is reviewed in Chapter 3.
|
From page 27... ...
Pediatric Population, Children Pediatrics refers to the health care of children. As part of guidance on premarket assessment of pediatric medical devices, FDA's Center for Devices and Radiological Health (CDRH)
|
From page 28... ...
) , a medical device is: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any com ponent, part, or accessory which is: · recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; · intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or · intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
|
From page 29... ...
. In an earlier directive, an "active implantable medical device" ("active" meaning, essentially, that the device depends on electrical energy)
|
From page 30... ...
in the United States and the Global Medical Device Nomenclature (GMDN) , which is owned by the European Standards Organization (Lumpkin, 2004)
|
From page 31... ...
A harm is a hurtful outcome of an event or action. A hazard is a potential BOX 1.2 Categories of Medical Devices for Purposes of FDA Scientific Review Anesthesiology Hematology and Pathology Cardiovascular Immunology and Microbiology Clinical Chemistry and Clinical Toxicology Neurological Dental Obstetrical and Gynecological Ear, Nose, and Throat Ophthalmic Gastroenterology and Urology Orthopedic General and Plastic Surgery Physical Medicine General Hospital and Personal Use Radiology SOURCE: 21 CFR 862892.
|
From page 32... ...
The charge to the committee refers to adverse reactions, but FDA refers to adverse events. This report follows FDA usage.5 Adverse events are sometimes defined to include events that have the potential to cause harm, such as close calls or near misses that could have resulted in harm but did not.
|
From page 33... ...
. Because errors in the use of medical devices may reflect flaws in the design of the devices and because reference to user errors may contribute to a counterproductive culture of blame within health care organizations, FDA tends now to refer to use error rather than user error.
|
From page 34... ...
. Broadly, then, postmarket surveillance of medical devices refers to programs that seek to protect public health by systematically collecting, analyzing, and communicating information about events involving or potentially involving legally marketed medical devices.
|
From page 35... ...
A major tool of FDA postmarket surveillance is an adverse event reporting system for collecting and analyzing information about product failures or harms related to or potentially related to medical products. For medical devices, the emphasis is on the reporting of device failures and malfunctions and device-related deaths or serious injuries.
|
From page 36... ...
. FDA first received authority to regulate medical devices in the 1938 Federal Food, Drug, and Cosmetic Act.
|
From page 37... ...
Required facilities using medical devices to report incidents related to a death, serious illness, or serious injury to FDA or manufacturers. Provided for mandatory Postmarket Surveillance by manufacturers for implanted or life-supporting devices that might cause death or serious harm.
|
From page 38... ...
2002 Medical Device User Fee and Modernization Act. Provided for user fees for premarket reviews of medical devices.
|
From page 39... ...
, recommended that regulation of devices be tailored to characteristics of devices rather than essentially copying provisions established for drugs. For example, the committee recommended that device regulation be keyed to the variability in the risks presented by different kinds of devices (Study Group on Medical Devices [Cooper Committee]
|
From page 40... ...
The legislation also authorized additional appropriations for postmarket surveillance activities, but Congress did not appropriate these funds. Other FDA regulations set forth requirements for the protection of human participants involved in research on medical devices and other medical products.
|
From page 41... ...
This increase has many causes, including the stimulus to scientific and engineering innovation provided by World War II, the postwar acceleration of public and private investments in biomedical and bioengineering research, the growth of academic medical centers, and the expansion of public and private health plans that pay for medical treatments. Today's medical devices constitute an extremely varied category of medical products -- some as simple and low risk as an infant cap, others as complex and high risk as a cardiac pacemaker.
|
From page 42... ...
To the extent that drugs and devices differ, the differences may warrant adaptations in regulatory and evaluation strategies. Still, the public should expect medical devices to be safe and effective and should expect FDA to fulfill its responsibilities in this regard.
|
From page 43... ...
One theme of this report is that government regulation of medical devices cannot by itself safeguard children or adults who use medical devices. The availability of safe and effective medical devices and their safe and effective use depends on the knowledge, skill, creativity, and integrity of many individuals and organizations on the frontlines of clinical care and device development and production.
|
From page 44... ...
That requires looking beyond FDA policies to, for example, the research priorities of NIH, the coverage and reimbursement policies of Medicare and other health plans, and the patient safety initiatives of public agencies such as the Agency for Healthcare Research and Quality and private agencies such as the Joint Commission on the Accreditation of Healthcare Organizations. It also requires an understanding of the processes of device innovation and the characteristics of the device industry, and an appreciation of the potential for policies to have unintended and unwanted effects.
|
From page 45... ...
In response to the particular shortfalls in the knowledge base for pediatric care and in the availability of medical products evaluated for use with children, Congress, FDA, NIH, and others have sought to create a mix of incentives and requirements to expand pediatric research and reduce barriers to the development of drugs, devices, vaccines, and other medical services that improve children's health and well-being. The next chapter describes why children's needs and characteristics warrant special attention and pose challenges to those developing, evaluating, and monitoring medical devices.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.