Vital and Health Statistics Advance Data From Vital and Health Statistics: Numbers 191–200 Series 16: Compilations of Advance Data From Vital and Health Statistics No. 20 Data in this report from health surveys present statistics by age and other variables on national hospital discharge; selected medical device implants; fecundity and infertility; AIDS knowledge and attitudes; cohabitation, marriage, marriage dissolution, and remarriage; office visits by adolescents; and characterktics of persons by limitation of activity, The reports were originally published in 1990 and 1991, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention National Center for Health Statistics Hyattsvllle, Maryland May 1995 DHHS Publication No, (PHS) 95-1879 Copyright information All material appearing in this report ia in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated. Suggested citation National Center for Health Statistics. Advance data from vital and health statistics: numbers 191–200. National Center for Health statistics. Vital Health Stat 16(20). 1995. National Center for Health Statistics Jack R. Anderson, Acting Director Jennifer H. Madans, Ph.D., Acting Deputy Director Jacob J. Feldman, Ph.D., Associate Director for Analysis, Epidemiology, and Health Promotion Gail F. Fisher, Ph.D., Associate Director for Planning and Extramural Programs Peter L. Hurley, Associate Director for Wtal and Health Statistics Systems Robert A. Israel, Associate Director for International Statistics Stephen E. Nieberding, Associate Director for Management Charles J. Rothwell, Associate Director for Data Processing and Services Monroe G. Sirken, Ph.D., Associate Director for Research and Methodology Use of Selected Medical Device Implants in the United States, 1988.. No. 191 Fecundity and Infertility in the United States, 1965-88 . No. 192 MDS Ihowledge and Attitudes for January-March 1990 Provisional Data From the National Health Interview Survey . No. 193 Cohabitation, Marriage, Marital Dissolution, and Remarriage: United States, 1988 Data From the National Survey of Family Growth . No. 194 AIDS Knowledge and Attitudes for April-June 1990 Provisional Data From the National Health Interview Survey . No. 195 Office Vkits by Adolescents . No. 196 Disability and Healti Chmactefistim of Pemonsby Limitation of Activi& ad&essed Health Shtis, Ufited States, 1984-88 . No. 197 AIDS Knowledge and Attitudes for July-September 1990 Provisional Data From the National Health Interview Survey . No. 198 1989 Summary: National Hospital Discharge Survey . No. 199 AIDS-Related Knowledge and Behavior Among Women 15-44 Years of Age: United States, 1988. No. 200 ... Ill Number 191 ● February 26, 1991 Advance Data From Vital and Health Statistics of the National Center for Health Statistics Use of Selected Medical Device Implants in the United States, 1988 by Abigail J. Moss, Division of Health Interview Statistics, National Center for Health Statistics; Stanford Hamburger, D. D. S., M. P. H., Roscoe M. Moore, Jr., D.V.M., M. P.H., Ph. D., and Lana L. Jeng, M. D., M. P. H., Food and Drug Administration; and L. Jean Howie, Division of Health Interview Statistics, National Center for Health Statistics Introduction biocompatibility, durabili~, and The report also includes estimates efficacy of medical device implants are for several details about these devices, During the past few decades, a continuing concern of the Food and such as length of time the current there have been great increases in the Drug Administration (FDA), the implant has been in use, implant numbers of manmade materials and medical profession, the device replacement, implant problems, and devices introduced to the medical manufacturers, and, most importantly, reason(s) for the origimd implant. All profession for implantation into the patients (3–12). Unfortunately, estimates are shown by the following humans. The search for replacement sufficient scientific documentation and sociodemo&aphic and health status of natural body parts began in ancient literature presently are not available to indicators: age, sex, race, Hispanic times. Dental implants are traceable to assess the success of many of these origin, famiIy income, poverty status, early Egyptians and to Central and medical device implants. This report education, geographic region, place of South American cultures (l). The first presents previously unavailable residence, activity limitation, and pacemaker was invented in the 1950’s, baseline estimates of medical device respondent-assessed health status. the first artificial heart valve was implants in an attempt to address implanted by Hufnagel in 1952, and in some of these concerns. Background 1954 Charnley performed the first Included are estimates from the Under the Federal Food, Drug, artificial hip replacement (2). National Center for Health Statistic’s and Cosmetic Act, as amended, FDA Despite the many advances made National Health Interview Survey to date in research and development is responsible for the approval and (NHIS) of the percent of persons in regtdation of new and existing medical of medical device implants, it remains the United States with one medicd devices (13). This act defines a unclear whether there is or ever will device implant or more. Estimates of mediczd device, inciuding any be an implant device suitable for every the total number of artificial joints, component part, as any article clinical situation. In addition, the long- fixation devices, intraoctdar lens term effectiveness and safety of the implants, pacemakers, artificial heart (a) intended for use in the diagnosis most widely used implants have yet to valves, and ear vent tubes are also of disease or other conditions; be definitively established. presented. The technical notes to this (b) intended for use in the cure, All medical device implants are report include definitions of these mitigation, treatmen~ and prevention complex in design, materials, and of diseasq or (c) intended to affect medical devices. implementation procedures. The the structure and/or function of the ,uncz*.o U.S. DEPARTMENT OF HEALTH AND HUMAN SERVK%B **Q@“+ g Public Health Sem”ce s Centers for Disease Control -@ National Center for Health Statistics cm ‘%.> Manning Feinleib, M. D., Dr. P.H., Director 2 Advance Data No. 191 ● February 26, 1991 human body, Implants are classified as agencies, and individuals, however, for each type of medical device medical devices under this act. should also benefit from data implant: the number, type, and body FDA’s Center for Devices and generated from the MDI Survey. For location of each device reported; the Radiological Health (CDRH) example, the medical device industry dates of the original and most recent currently utilizes several sources of could use the estimates for marketing, replacement implantation; the medical device implant data to assess research, and development of new and frequency of replacement and reasons the use, safety, and effectiveness of improved medical device implant for the most recent replacement; the specific classes of implanted medical products. Other Government agencies, length of time in use of the implant; devices. Some of the sources used by such as the Centers for Disease and the types and onset of adverse CDRH to monitor medical device Control, the National Institutes of effects or complications that occurred implants provide a count of the Health, the Health Resources and with each implant, such as healing number of implant procedures Services Administration, and the problems, pain, infection, or performed in any given year but do Health Care Financing mechanical failure. A limited number not provide any accompanying Administration, may also utilize these of other questions unique to each historical information on the patients data for ongoing research, for specific implant type were also who received the implants (14). Other developing program objectives for included. A facsimile of the MDI sources provide information that is health personnel and health service Survey questionnaire is provided in generated from either mandatory delivexy to populations or subgroups Current Estimates from the National reports of device-related deaths and of populations, for aiding in activities Health Interview SurvqY: United States, serious injuries or voluntary and concerning complications related to 1988 (17). anecdotal reports of device utilization special devices, and for developing Persons with a medical device experience (15). Manufacturer data on programs and policies for standards implant were first identified through a medical device implants are primarily and quality. series of “screener” questions sales data (16). administered to the NHIS adult household respondent(s). The detailed These information sources lack Data and methods denominator data needed for proper questions about medical devices asked cIinical evaluations. Furthermore, they NHIS is a continuous, in response to the screener replies, have limitations that restrict their use cross-sectional survey representing the however, were administered directly to for future epidemiologic studies. household population of the United those adult family members with the Prevalence estimates generated from States. Each year in NHIS basic health actual medical device implant. If the these combined data are based on and demographic information is person with the medical device was mathematical models rather than