Discussion general considerations in the comparison of AneuRx outcomes with literature controls

The studies noted in the above section on open surgical AAA repair involve general populations of AAA patients, and are therefore not directly comparable to the study population used in Medtronic's study, for two main reasons 1. The sites participating in the study were institutions that see a high volume of patients with AAA. 2. Also, the Medtronic study excluded the highest-risk patients. In particular, the AneuRx study excluded the following high-risk categories 51 American Society of...

Electromagnetic interference with medical devices

Medical device EMI is the disruption of the normal function of electrically powered medical devices by conducted or radiated electromagnetic energy or by electrostatic discharge (ESD). EMI can affect the safety or effectiveness of active, electrically powered medical devices in ways that can pose significant risks to patients and medical device users, and it has been reported to result in patient injury and death 1,2 . These events may occur in the hospital, the home, the workplace, the...

Devices used in corrective surgeries during adolescence

The period of adolescence makes up most of the second decade of life. Guidance issued by the CDRH, defining the pediatric age range up to 21 years, supports the consideration that issues of physical and hormonal growth and emotional behavioral development should be carefully addressed with device use in adolescent patients 63 . Human factors in device use should be considered as teenagers strive to become independent and take over their own medical care. One cannot always assume there will be...

FDA surveillance studies on breast implants

While there was a dearth of epidemiologic studies on breast implants, there was no lack of reports to the FDA's adverse event reporting systems on breast implants. The FDA receives reports of adverse events on all medical devices through its national reporting program. These adverse events are received from manufacturers, importers, user facilities, and voluntarily from concerned individuals. In order to review all reports on breast implants received by the FDA, three adverse event databases...

Insulin delivery devices Insulin delivery via pen devices

Technological advances in insulin delivery have resulted in devices that offer more convenience, more accurate dosing, and less pain from smaller-gauged needles. The manufacturers of these devices have made claims of better patient compliance, improved quality of life, and better social acceptability. Insulin pen devices, first introduced in 1985, combine the insulin container and the syringe in a single unit. The compact size allows insulin to be administered in a discrete manner. Smaller and...

Infections related to breast implants

Over an 8 month period in 1996, the FDA received two reports of deaths purportedly due to toxic shock syndrome in women after augmentation mammoplasty. There is some risk of infection associated with any surgery, but deaths due to cosmetic surgery are of particular concern because the surgery is elective and usually performed on an otherwise healthy individual. FDA undertook a study to characterize the infection reports related to breast implants. The FDA identified 1971 reports of infections...

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...

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...

References

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....

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...

Acupuncture needles

Ancient Japan And Medicine

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...

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

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...

Br J Radiol 2000 73 994-998

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...

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...

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...

Medical device epidemiology

Medical Equipment And Prosthesis Designs

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...