Tampons
A few years later, in May 1980, investigators reported to the US Centers for Disease Control and Prevention CDC at that time the agency was called the Center for Disease Figure 14.1 Dalkon Shield poster from the 1970s. Courtesy of the FDA History Office Figure 14.1 Dalkon Shield poster from the 1970s. Courtesy of the FDA History Office Control 55 cases of toxic shock syndrome TSS , a newly recognized illness characterized by high fever, sunburn-like rash, desquamation, hypotension, and...
Contents
2 Medical device regulation in the USA 5 Thomas P. Gross, Celia M. Witten, and Casper Uldriks 3 Medical device epidemiology 21 Features of medical devices that are relevant to epidemiology study design 26 Study designs for medical device epidemiology 35 4 Surveillance of adverse medical device events 43 Surveillance based on adverse event reports 47 Surveillance based on registries 52 Necessary conditions for effective surveillance 54 Ideal AMDE surveillance program 55 5 The Medical Product...
Preclinical studies
Preclinical or 'nonclinical' testing consists of bench or laboratory testing and sometimes animal testing. Bench tests are conducted to provide valid scientific evidence that the medical device is ready to be tested in animals, in the clinical setting, or in both Table 10.2 . The types and depth of studies performed depend on the intended use of the product and the risk involved in its use. For example, a mechanical product will have different test requirements than an electrical device or an...
Mechanical heart valves
The mechanical heart valve was first implanted in the early 1950s. Over the years, there have been various mechanical designs. The mechanical heart valves have progressed from caged-ball valves in the 1960s, disk valves in the 1970s, to bileaflet valves in the 1980s Caged-ball valve. The caged-ball valve has a small ball held by a metal cage in order to limit the blood flow to a single direction. The Starr-Edwards caged-ball heart valve was the first commercially available heart valve in the...
Data mining
Data mining is a statistical technique for extracting meaningful, organized information from large complex databases. There has been increasing interest in the use of data-mining technology to enhance the FDA's ability to monitor the safety of products after they have been approved for use. The software attempts to detect strong, consistent associations that occur at higher than expected frequencies. The Center for Devices and Radiological Health CDRH receives more than 100 000 adverse event...
Introduction Ccb
At first glance, a federal medical device regulatory program would be an unlikely academic resource and, indeed, academic functions of education and training are not a formal part of the Center for Devices and Radiological Health CDRH of the Food and Drug Administration FDA . However, to succeed in its mission to improve the performance and safety of medical devices requires scientific experience and new knowledge. These are derived from scientific methods, continuing education, and research,...
The MAUDE database
The MAUDE database consists of reports of device-related deaths, serious injuries and device malfunctions - the three major types of adverse medical events reported to the FDA. The database includes both voluntary and mandatory reports. The section on 'Postmarket Surveillance' of Chapter 2 in this book gives a brief historical perspective on voluntary and mandatory medical device reporting, describes the reporting requirements for manufacturers, user facilities and importers, and defines...
Device description
The EFM obtains two channels of information and records them continuously on a moving strip chart recorder see e.g. Figure 30.1 . For the display of the fetal heart rate actually the fetal heart rate pattern , the monitor, by means of either internal or external transducers, determines the interval between consecutive heart beats. For each interval that it detects, the monitor calculates and then plots a 'rate', as if all intervals in one minute were exactly the same as the detected interval....
Hemodialysisrelated outbreaks
In the USA, more than 340 000 patients are on dialysis or have a kidney transplant, with costs estimated at 17 billion per year 31 . The invasive nature of hemodialysis lends itself to outbreaks. Infection is the major cause of death in 15-30 of dialysis patients, with vascular access-related infections being a contributing cause 32 . There have been numerous disease outbreaks originating in hemodialysis centers, as described below Table 17.3 . In hemodialysis, a dialysis machine and a special...
Hesha J Duggirala and Thomas P Gross
US Food and Drug Administration, Rockville, MD, USA David E. Kandzari Duke Clinical Research Institute, Durham, NC, USA In April 2003, the US Food and Drug Administration's FDA approval of the first drug-eluting stent DES was followed by widespread adoption of this novel therapy for percutaneous coronary revascularization. Drug-eluting stents are a good example of the epidemiology of break-through technologies and implantable devices. Break-through technologies a transform the standard of care...
History and evolution of coronary stents clinical perspective
Each year, over 1 million percutaneous coronary interventions are performed worldwide, surpassing the annual number of coronary artery bypass operations. Coronary stents are generally permanently placed to keep the treated vessel open after angioplasty. In the USA, use of coronary stents in interventional procedures increased from 10 in 1994 to over 90 by 2002 1 . Compared with balloon angioplasty, stents significantly reduce recurrent ischemia, restenosis, and revascularization. Nevertheless,...
References Xtg
1. Marvick C. Implant recommendations news . J Am Med Assoc 2000 283 269. 2. Brown SL, Bright RA, Tavris DR. Medical device epidemiology and surveillance patient safety is the bottom line. Expert Rev Med Devices 2004 1 89-90. 3. Shatin D, Bright RA, Astor BC. Databases for studying the epidemiology of implanted medical devices. In The Bionic Human Health Promotion for People with Implanted Prosthetic Devices, Johnson FE, Virgo KS eds . Totowa, NJ Humana, 2005 115-132. 4. Bright RA....
References Pkv
1. Thylefors B, Negrel AD, Pararajasegaram R, Dadzie KY. Global data on blindness. Bull World Health Org 1995 73 115-121. 2. Rahmani B, Tielsch JM, Katz J, Gottsch J et al. for the Baltimore Eye Survey. The cause-specific prevalence of visual impairment in an urban population. Ophthalmology 1996 103 1721-1726. 3. The Eye Diseases Prevalence Research Group. Prevalence of cataract and pseudophakia aphakia Among Adults in the United States. Arch Ophthalmol 2004 122 487-494. 4. Leske MC, Chylak LT,...
Council for International Organizations of Medical Sciences CIOMS guidelines
Adopted in 2002, these are the third biomedical research ethical guidelines issued by CIOMS since 1982. This document consists of 21 guidelines with commentaries. It also provides lists of items to be included in the research protocol submitted for scientific and ethical review and clearance. Appendices include also the World Medical Association's Declaration of Helsinki. The guidelines discuss the following topics ethical justification and scientific validity of research ethical review...
Cochlear implant description
Cochlear implants are electronic device systems designed to provide functional hearing to those who have severe to profound hearing loss. The cochlear implant has both external and implanted components see Figure 26.1 . The external components include a speech processor body-worn or ear-level , headset, and cables. The speech processor receives sound waves through a microphone and converts the acoustic signal into a radio frequency signal, which is transmitted across the skin to the implanted...
Study designs for medical device epidemiology
Epidemiology is 'the study of the occurrence of illness' and causes that can explain that occurrence 59 . In this chapter, 'epidemiology' is used to refer to stand-alone descriptive studies or investigations of hypotheses. The usual types of study designs are discussed in great depth in major textbooks. This chapter will give examples of the major types, with references to medical device examples in the literature and other chapters in this book. The choice of study type depends on the study...
References Bfp
1. Medical device regulations global overview and guiding principles. World Health Organization, 2003 2. Kojic EM, Darouiche RO. Candida infections of medical devices. Clin Microbiol Rev 2004 17 255-267. 3. Garver D, Kaczmarek RG, Silverman BG, Gross TP, Hamilton PM. The epidemiology of prosthetic heart valves in the United States. Texas Heart Inst J 1995 22 86-91. 4. American Society of Plastic Surgeons. Procedural statistics http www.plasticsurgery.org public_education 2004Statistics.cfm...
Governmentsponsored registries
New Approaches to Coronary Interventions registry In 1990, the National Heart, Lung, and Blood Institute NHLBI funded a multicenter voluntary registry, New Approaches to Coronary Intervention NACI 43 . This registry was essentially the continuation of the original 1977-1981 44 and second 1985-1986 45 percutaneous transluminal coronary angioplasty PTCA registries in evaluating the initiation and evolution of conventional PTCA. The NACI registry prospectively collected patient and lesion...
Global Medical Device Nomenclature GMDN
In 1993, the European Committee for Standardization CEN initiated an effort to develop a pan-European medical device nomenclature primarily for the exchange of regulatory information. The International Organization for Standardization ISO joined the effort in 1996, widening its scope of application, and the following year the project that led to the creation of the GMDN began with the aim of creating a single, internationally-developed, global nomenclature for medical devices. The GMDN was...
Surgical instruments used to transplant tissues known to have transmitted prion
Surgical instruments that are used to transplant or surgically implant or explant tissues that have been associated with CJD transmission are also of concern. For instance, there have been several cases of CJD transmitted via corneal transplant 18,21 and there is also a theoretical risk of contaminating surgical instruments used to harvest corneas from cadavers or transplant them to recipients. Cross-contamination of harvested corneas by using contaminated instruments is of concern for the...
References Xvo
1. Blot WJ, Ibrahim MA, Ivey TD et al. Twenty-five-year experience with the Bjork-Shiley convexoconcave heart valve a continuing clinical concern. Circulation 2005 111 21 2850-2857. 2. Kao HL, Wang SS, Chen WJ, Huang SK, Lee YT. Migration of a fractured retention wire in the pulmonary artery from an active fixation atrial lead. Pacing Clin Electrophysiol 1995 18 10 1966-1967. 3. Saliba BC, Ardesia RJ, John RM, Venditti FJ, Schoenfeld MH. Predictors of fracture in the Accufix Atrial 'J' lead. Am...
FDA surveillance systems
The US Food and Drug Administration FDA maintains a database containing data on device-related adverse event reports see Chapter 2 . This database is currently known as the Manufacturer and User Facility Device Experience Database MAUDE . Presently administered as part of the FDA's MedWatch program, the program accepts information voluntarily submitted to the FDA by healthcare providers and consumers 7 . In 1973, the FDA began a voluntary reporting program for adverse events associated with...
Acupuncture needles
The line between alternative and complementary medicine may shift over time. An example of this, involving a medical device, is acupuncture. At one time in the USA, acupuncture was viewed as an alternative practice, but it is now used as a complementary treatment. Acupuncture is part of a tradition of ancient Chinese healing practice that inserts needles at specified acupuncture points to redirect and reposition the flow of energy see Figure 21.1 . This practice is used to relieve pain, such as...
Results
A total of 550 reports meeting our initial criteria were retrieved. Figure 20.2 presents the distribution of the reports and how they were classified. After reading all reports, 116 21 were determined either to be not related to EMI 13 or the information needed to even tentatively ascribe the adverse event to EMI was inadequate 8 . Twenty-nine 5 reports involved a magnetic resonance imaging MRI device and a metal object or another medical device. There are several concerns besides EMI that...
Device description 1
This device was designed to continuously measure fetal oxygen saturation FSpO2 in the presence of a nonreassuring fetal heart rate FHR pattern. It was not to be used as a primary form of surveillance. A specialized sensor is inserted through the dilated cervix after the membranes have been ruptured and positioned against the fetal face, permitting measurement of FSpO2 during labor. The stated and implied benefits of the technology include a reduced cesarean section rate for so-called...
Epidemiologic assessment Uxa
A clinical trial used to support device approval included 1010 women with labors complicated by nonreassuring FHR patterns that were randomly assigned to either EFM alone or EFM plus continuous fetal pulse oximetry 51 . In this randomized clinical trial there was indeed a reduction in cesarean delivery rates for 'nonreassuring fetal heart rate patterns', from 10.2 to 4.5 p 0.007 , but there was no difference in the immediate neonatal outcomes or the overall cesarean delivery rates the latter as...
Agency For Healthcare Research And Quality. Patient Safety Reporting Systems
1. United States General Accounting Office. Medical Devices Early Warning of Problems Is Hamperedby Severe Underreporting. United States Government Publication GAO PEMD 87-1, 1987. 2. United States General Accounting Office. Medical Devices Early Warning of Problems Is Hampered by Severe Underreporting. United States Government Publication GAO-T-PEMD 87-4, 1987. 3. The Safe Medical Devices Act of 1990, Public Law 101-629, signed 1990. 4. Safe Medical Devices Act of 1990 Report. US House of...
Epidemiology of contact lens ulcers and public policy
Millions of people wear contact lenses safely. However, contact lens wear is not without serious complications contact lens-related corneal ulcers pose a risk of significant vision loss. A corneal ulcer is a localized area of tissue erosion associated with inflammatory cells in the cornea. Corneal ulcers can be either infectious or noninfectious 14 . When infectious, the disease is clinically referred to as 'microbial keratitis' MK . Infectious corneal ulcers are more serious than sterile...
Http Www.fda.gov Bbs Topics Answers Ans00667.html
1. Monstrey S, Cristophe A, Delanghe J, De Vriese S et al. What exactly was wrong with the trilucent implants A unifying hypothesis. Plast Reconstr Surg 2004 113 847-856. 2. US FDA breast implant consumer handbook http www.US FDA.gov cdrh breastimplants indexbip.html 3. Sherman LA. Looking through a window of the Food and Drug Administration US FDA's advisory committee system. Preclinica 2004 2 99-102. 4. TDA and polyurethane breast implants http www.US FDA.gov bbs topics ANSWERS ANS00667.html...
External insulin infusion pumps
Continuous subcutaneous insulin infusion pumps CSII are small programmable devices, about the size of a pager, with a reservoir filled with insulin. Insulin is delivered through a catheter, inserted under the abdomen, to the subcutaneous tissue. The device allows programming of different pre-selected rates basal rate as well as bolus doses. CSII allows the user to program different pre-selected basal rates of insulin infusion based on patterns of perceived needs. The device also allows the...
Medical device regulation in the USA
Thomas P. Gross, Celia M. Witten, and Caspar Uldriks US Food and Drug Administration, Rockville, MD, USA The US Food and Drug Administration FDA is first and foremost a public health and consumer protection agency. It regulates products worth over 1 trillion, accounting for one-fourth of all dollars spent annually by American consumers 1 . The agency is responsible, through enforcement of the Federal Food, Drug, and Cosmetic Act 'the Act' and several related public health laws, for ensuring...
Br J Radiol 2000 73 994-998
1. Kainz W, Neubauer G, Alesch F, Schmid G, Jahn O. Electromagnetic compatibility of electronic implants - review of the literature. Wien Klin Wochenschr 2001 24 903-914. 2. Silberberg JL. Performance degradation of electronic medical devices due to electromagnetic interference. Compliance Eng 1993 10 5 25-39. 3. Silberberg, JL. What can reports of medical device electromagnetic interference tell us Compliance Eng 1997 Annual Reference Guide D17-D23. 4. Sykes S ed. . Electromagnetic...
Two types of vascular hemostasis devices
There were two main types of vascular hemostasis devices marketed by the end of 2003 only devices marketed by the end of 2003 are discussed in this chapter because there is currently insufficient postmarket data on devices marketed after that time suture devices and collagen plug sealant devices. In addition, although topical sealant devices may also be used, it should be noted that none of these devices have been approved by the FDA for femoral artery closure, and it is recommended in the...
Classification names for medical devices and in vitro diagnostic products
The US Food and Drug Administration FDA 's medical device classification was the first of its kind 8 . In 1969, President Nixon, in his consumer affairs message to Congress, directed the Department of Health and Human Services HHS Secretary to determine the scope and nature of additional legislative controls needed to protect the public against unreasonable risk of illness or injury from medical devices. About 2 years later, the HHS Secretary requested that the FDA Commissioner develop an...
Closed loop systems artificial mechanical pancreas
In the DCCT, the rate of hypoglycemia was three times more in the treatment MDI group when compared to the control conventional group 6 . Intensive and conventional insulin management require frequent daily finger sticks to monitor blood glucose levels. Diabetes management via needle injections results in poor quality of life, poor compliance, and increased incidence with disease transmission and problems with needle disposal. Though the benefit of tight blood glucose control in limiting the...
Acknowledgments
We owe a debt of gratitude to the many authors who contributed to this book. Each of the manuscripts for this book went through a review process. The reviewers are so important because their discussions with the authors helped to clarify and strengthen the chapters. The reviewers were from both inside and outside the Food and Drug Administration. FDAreviewers include Samie N. Allen, Karen Baker, R.N., Helen J. Barr, M.D., Patricia A. Bernhardt, Ashley B. Boam, M.S.B.E., Barbara D. Buch, M.D.,...
Future medical devices for the management of diabetes Implantable insulin pumps
The long-term implantable insulin pump LIIP is a high risk, Class III device. It is currently limited to investigational use in the United States. This device has received approval for marketing in the European Community. The LIIP is implanted into the anterior abdominal cavity and a catheter implanted through the abdomen into the peritoneal wall. Like the external pump, the device is comprised of a pumping mechanism, drug reservoir, and a programmable microprocessor. As opposed to the external...
Jet injectors
Pain is a problem with any traditional method of insulin delivery where needles are involved. Thus, jet injectors have been touted as needleless systems, and no needles'' is often interpreted as no pain. Jet injectors have been used extensively since 1947, and have provided a parenteral delivery system not dependent on a needles and syringes 12 . Jet injectors can deliver vaccines or drugs subcutaneously, intramuscularly, or intra-dermally. Some injectors employ high pressure and low volume...
References Wgl
1. ECRI. Guide to Constructing Terms. Plymouth Meeting, PA ECRI, 1997 16 pp. 2. Chute CG, Cohn SP, Campbell JR. A framework for comprehensive health terminology systems in the United States development guidelines, criteria for selection and public policy. J Am Med Inform Assoc 1998 5 6 503-510. 3. International Organization for Standardization ISO . International Standard ISO 704. Terminology Work - Principles and Methods. Geneva, Switzerland ISO, 2000 38 pp. 4. Cimino JJ. Desiderata for...
Data sources and selected methodological issues to consider in epidemiologic
Epidemiologic research has provided much of the clinical trial data used to evaluate the efficacy and safety of orthopedic devices and to build the body of scientific knowledge we have about these devices, but the full potential of the clinical trial and other epidemiologic research designs to expand our knowledge of the long-term effectiveness of orthopedic devices and improve clinical practice has yet to be realized. This section describes data sources available for use in epidemiologic...
Cochlear implant hermeticity failures
During 2003-2004, FDA identified a hermeticity problem with the COMBI 40 Cochlear Implant System, hereafter referred to as the COMBI 40 , manufactured by MED-EL Corporation, Innsbruck, Austria. Specifically, the hermetic integrity of the implant case i.e. its 'air-tightness' against intrusion of foreign liquids gases was failing over time. Consequently, device reliability was being compromised by moisture intrusion, which affected the functionality of the electronic circuitry. The COMBI 40 has...
Contributors
Shewit Bezabeh, MD, MPH Medical Officer, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd, HFZ-480, Rockville, MD 20850, USA. Email Shewit.bezabeh fda.hhs.gov Michele G. Bonhomme, PhD Epidemiologist, Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health,...
Underreporting of adverse medical device events
Most reports are from manufacturers and are based on reports from their sales staff or product complaints they have received from their customers who may be healthcare providers or patients . Relatively few reports come to FDA directly from healthcare providers or patients, despite renaming and publicizing the voluntary reporting program as 'MedWatch' 41 . Healthcare facilities may feel no tie to FDA and mistakenly believe that FDA regulates their every move, although FDA's only regulatory...
International vigilance surveillance system
A process for the global exchange of vigilance reports between National Competent Authorities NCAs has been established through the Global Harmonization Task Force GHTF , which was established in 1992. Standardized reports about potentially high-risk issues for which action is to be taken are submitted electronically to a shared listserver. The GHTF is a voluntary international consortium of public health officials, responsible for administering national medical device regulatory systems...
Medical device epidemiology
US Food and Drug Administration, Rockville, MD, USA S. Lori Brown US Food and Drug Administration, Bothell, WA, USA In this overview chapter, medical devices are defined, examples of devices given, and the ubiquity and importance of medical devices for patient safety and public health presented. The features of medical devices that must be accounted for when designing epidemiologic studies are discussed, and we compare and contrast them with the analogous features of drugs. Descriptive and...