Process Improvement
Last revised on 12/02/03

Medical Device Adverse Event Reporting and Patient Safety

Invited lecture by Swayze and Rich

From FDA's Center for Devices and Radiological Health Consumer Protections

 

Introduction

The public expects, and the law requires, all medical devices to be safe, effective and manufactured in accordance with the good manufacturing practices. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.

Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act, which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 1299). These controls are the baseline requirements that apply to all medical devices; marketing clearance, proper labeling and monitoring device performance once it is on the market.

There are three steps to obtain marketing clearance of a medical device from CDRH.  The first step in the marketing process is to make absolutely sure that the product being proposed for marketing is a medical device, that is, it meets the definition of a medical device in section 201(h) of the FD&C Act. For example, the product may be a drug or biological product that is regulated by a component in the FDA other than the Center for Devices and Radiological Health (CDRH) and for which there are different provisions in the FD&C Act. If the product is a medical device and is also an electronic radiation emitting product, marketing clearance will have additional requirements.

The second step is to determine how FDA may classify a device, that is, which one of the three classes the device may fall into. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Unless exempt, FDA will classify all devices. Most importantly, the classification of the device will identify, unless exempt, the marketing process a manufacturer must complete in order to obtain FDA clearance/approval for marketing.
The third step is to select the appropriate marketing application. This includes the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's FDA's Investigational Device Exemption (IDE) regulation, in addition to marketing clearance.

Before marketing clearance is obtained the manufacturer must assure that the device is properly labeled in accordance with FDA's labeling regulations. Once clearance for marketing is obtained, the manufacturer must register their establishment and list the type of device they plan to market with the FDA. This registration and listing process is accomplished by the submission of specific FDA forms.

Once on the market, there are postmarket surveillance controls with which a manufacturer must comply. These requirements include the Quality Systems (QS) (also known as Good Manufacturing Practices, GMPs) and Medical Device Reporting (MDR) regulations. The QS regulation is a quality assurance requirement that covers the design, packaging, labeling and manufacturing of a medical device. The MDR regulation is an adverse event reporting program.

Session Objectives

  1. Discuss the impact of FDA's CDRH consumer protections on patient safety.
  2. Describe the Medical Device Reporting Regulation as a model for patient safety
  3. Identify criteria for FDA's CDRH medical device adverse event report review and evaluation. 
  4. Conduct an abbreviated medical device adverse event report review to identify a patient safety problem.
  5. Create a model for patient safety.

Medical Device Reporting Overview

Medical Device Reporting (MDR) is the mechanism for the United States Food and Drug Administration (FDA), to receive reports of adverse events involving medical devices from manufacturers, importers, user facilities, health care professionals, and consumers. FDA has been receiving voluntary adverse event reports involving medical devices from health care professionals and consumers since 1974, and mandatory reports from medical device manufacturers since 1984. The two programs were merged into MedWatch, FDA's adverse event reporting program for drugs, biologics, and medical devices in 1993.

What is a medical device? What is a medical device adverse event?

Simply defined, a medical device is an item used for diagnostic treatment, or prevention of disease, injury, or other condition that is not a drug, biologic, or food. A medical device adverse event is an event whereby a medical device has, or may have, caused or contributed to a death or serious injury.

Manufacturers and importers are required to report medical device adverse events involving deaths, serious injuries, and malfunctions to the FDA. User facilities (e.g. hospitals, nursing homes, diagnostic and therapeutic outpatient treatment facilities) are required to report suspected medical device related deaths to both the FDA and the manufacturer. User facilities report medical device related serious injuries directly to the manufacturer, and if the device manufacturer is unknown, to the FDA. Consumers and health professionals use the MedWatch program for voluntary reporting of adverse events involving deaths, injuries, or malfunctions with medical products. FDA's Center for Devices and Radiological Health (CDRH) receives approximately ninety-five percent of its adverse event reports from manufacturers, and five percent from health care professionals, consumers, and user facilities.

CDRH routinely receives adverse event reports involving patient deaths and serious injuries, and for product malfunctions involving medical devices used for patient monitoring, diagnostic testing, medical, surgical and therapeutic interventions, and telemedicine. Decreasing both the frequency of occurrence and the severity of adverse events associated with medical devices poses a major challenge for the Center.

FDA CDRH staff analyze medical device adverse event reports to determine if the use of a particular product is resulting in unexpected problems and to identify trends that can improve management and reduce use error. Significant adverse event reports, such as those involving fire, explosion, anaphylaxis, pediatric deaths, or multiple patient deaths or serious injuries, receive priority review. Well-known adverse events are reviewed in
the aggregate. Data related to the reported adverse event are reviewed to determine if further FDA action is warranted. Outcomes from FDA CDRH staff recommendations for action include: public health notifications, regulatory actions such as device recalls, published articles in peer-reviewed clinical journals, and education and outreach activities for health care professionals and consumers.

Medical device adverse event reports are evaluated individually, and in the aggregate, to identify actual and potential risks to patient safety. Review and evaluation of reported adverse events includes identification of approaches to mitigate risk and to promote patient safety. Comprehensive review and evaluation requires knowledge of FDA's Medical Device Reporting Regulation and familiarity with reporting policies, clinical expertise including experience, expertise, and knowledge of a device's intended use within various patient populations, and the ability to analyze, interpret, and synthesize adverse event data against the backdrop of patient safety implications. Review and evaluation of patient safety implications must take into account the myriad of reasons why adverse events occur; device specific problems such as manufacturing process and human factors design considerations, use error, and adverse outcomes inherent to a patient's underlying diagnosis. Evaluation requires a review of the circumstances related to a specific reported event, as well as, historical adverse event trends, and evaluation of the scientific and medical literature, including published failure mode and patient safety data. Analysis, interpretation, and synthesis of adverse events utilizing the aforementioned criteria facilitates a model for patient safety by identifying factors to mitigate risk and promote safe and effective medical device use.

Analysis and Interpretation of Medical Device Adverse Events

Analysis and interpretation of adverse events requires the ability to integrate knowledge of the medical device reporting regulation and reporting policies, clinical expertise and experience with medical devices in clinical settings, and the ability to evaluate complex data sets including historical adverse event reporting trends, and published reports of medical device adverse event experiences in the clinical, scientific, and regulatory literature. Adverse event reviews and evaluations include an assessment of risk versus benefit of a device, including actual versus potential device problems, and expected versus unanticipated device-related outcomes. Device problems that impact patient safety may be associated with poor device design, defects in device components, clear and concise device labeling and instructions for use, as well as, inadequate packaging of a device.

Use error also has implications for patient safety. Human factors including healthcare practitioner familiarity with device, (correct device assembly, connection and compatibility of device components), practitioner interpretation of device labeling and instructions for use, and the intended use of the device for appropriate patient populations must be evaluated. Environmental factors such as patient-staff ratios, urgent or emergent patient care scenarios, and a patient's underlying diagnosis, all have an impact on patient safety.

The Manufacturer's Role in Patient Safety

Manufacturers are required to report adverse events associated with deaths, serious injuries (adverse events requiring medical or surgical intervention), and device malfunctions. Submission of medical device reports by manufacturers was effective on December 13, 1984. The reporting requirements were subsequently revised in the Safe Medical Devices Act of 1990 and 1992 with an amendment of the regulation effective July 31, 1996. Manufacturers must report deaths and serious injuries within 30 days of becoming aware of an adverse event associated with their device. In addition, manufacturers are required to notify FDA of product recalls initiated as a result of product performance problems. Manufacturers are required to perform failure mode investigations and analyses of devices involved in adverse events. These investigations and analyses will vary in scope and complexity depending on the type of device and the device's intended use. Manufacturers may conduct an initial failure analysis of devices involved in an adverse event at a user facility, or may have the devices returned to their manufacturing facility for more complete failure analysis testing and evaluation. Results of failure mode investigations may result in submission of adverse event reports to FDA, implementation of manufacturing process or design changes, changes in labeling and instructions for use, or a firm-initiated recall of the device.

The User Facility's Role in Patient Safety

The Safe Medical Devices Act (SMDA), implemented in 1991, requires user facilities to report adverse events which reasonably suggest that a medical device has, or may have, caused or contributed to a death or serious injury. User facilities include hospitals, nursing homes, ambulatory surgical facilities, and outpatient diagnostic and treatment facilities. To comply with this requirement, user facilities need to educate and train health care professionals to recognize an adverse event that may be device related and to report it through their organization to the manufacturer or FDA.
The Food and Drug Modernization Act (FDAMA) in 1997 mandated that FDA move away from a universal reporting requirement for user facilities to that of a subset of user facilities that constitute an overall representative profile. FDA's Medical Product Surveillance Network (MedSun), consists of a sample of user facilities, which are specifically trained to recognize and report medical device adverse events. MedSun participants submit medical device adverse event reports associated with problems that have the potential for medical or surgical intervention, as well as for deaths and serious injuries. Currently, there are approximately 200 hospitals and nursing homes participating in MedSun.

Slides and Narrated Slides

  1. See accompanying slides
  2. Download narrated slides for:

Case Study #1
Electronic Fetal Monitors

Fetal deaths associated with electronic fetal monitors have been reported to the Food and Drug Administration (FDA). The electronic fetal monitor is a microprocessor based medical device that uses ultrasound transducers to measure and translate signals from the fetal heart. It is used primarily by nurses to monitor the heart rate of single or twin fetuses throughout labor and delivery; however, the monitor is limited in evaluating fetal heart rate (FHR) because of possible signal loss due to fetal movement, misreading due to maternal movement, artifact mistaken for normal variability of FHR, and possible recording of maternal heart rate (MHR) instead of FHR. The fetal deaths reported to FDA involved single and twin fetuses and have raised concern about the monitor and whether it detects and records the FHR as it should.

Fetal monitors provide both internal and external methods of monitoring single and twin fetuses. Transducers are positioned on the maternal abdomen and/or thigh and connected by cables to a monitor. Fetal heart information translated from the transducer is displayed on the monitor panel and can be recorded and printed on a strip or trace. Some monitors provide alarm surveillance for fetal heart rates that are outside of limits that have been set.

Reported adverse event:
A woman was about to deliver twins. Her nurse reported that an external and internal fetal monitor recorded two normal baseline heart rates. During a forceps delivery, an external fetal monitor was used to monitor both twins. The first twin had died before birth (in utero) 48 hours earlier. When a twin dies in utero, the monitor usually picks up the maternal heart rate (MHR). If the MHR and FHR coincide, the monitor is not able to differentiate between the two. In this case, the nurse assumed the monitor was recording the twins' heart rates; however, it was apparently monitoring the mother's and the second twin's heart rate. The second twin was delivered alive and without incidence. No technical failure of the monitor was identified following the event and information on the cause of fetal death was not reported.

Action taken by the FDA:

  1. Review and analysis of adverse events
    Adverse events reported to FDA's CDRH are consistent with those reported in the literature: false FHR that masked a fetus is distress, stillbirths that resulted during maternal and fetal monitoring, delivery of an infant in distress without previous signs of distress on the monitor, presentation of MHR as FHR, inaccurate interpretation and recording of labor progress.
  2. Review of literature

    A. Technical Evaluations

    1. The Medical Devices Directorate (Northern Ireland) published an evaluation on cardiotocographs (CTGs) (another name for electronic fetal monitors) manufactured by two different firms in 1991 and 1993. Evaluation results; no agreed upon performance standards for CTGs, FHR switching to MHR during gross fetal movement or when optimum Doppler signal not located, difficulty interpreting recordings, and differentiating between FHR of twins when their heart rates were similar.
    2. The Medical Devices Agency's March 1998 safety notice: Cardiotocograph (CTG) monitoring of foetus during labor. Models of CTG devices which do not include the facility of recording MHR have an increased potential for confusing MHR with that of the fetus.
    3. ECRI (a non-profit agency focused on healthcare technology and patient safety research) published a product comparison report on fetal monitors in February and May 1998. Problems reported; false FHR, masked fetal arrhythmias, presentation of MHR as FHR, and false FHR decelerations during uterine contraction.

    B. Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) educational program: Fetal Heart Rate Monitor Principles and Practice, which focuses on the application of essential heart essential heart monitoring knowledge and skills in antepartum nursing. AWHONN serves and represents more than 22,000 healthcare professionals in the U.S., Canada and abroad.

    C. American College of Obstetrics and Gynecology July 1995, technical bulletin guidelines for performing fetal heart rate monitoring entitled: Fetal Heart Rate Patterns: monitoring, interpretation, and management.

    D. Consultations

    1. International Federation of Gynecology and Obstetrics in 1995 established a committee on Intrapartum Surveillance, which supported availability of up-to-date equipment for the obstetric team to reach management decisions. However, the committee also acknowledged that excessive monitoring could interfere with maternal mobility, cause unnecessary concern, lead to inappropriate decisions and excessive interventions, and interfere with the whole birth experience.
    2. Discussions with the Chair of the National Institutes of Child Health and Human Development Workshop-Electronic Fetal Heart Rate Monitoring: Research Guidelines for Interpretation (1995). Workshop members agreed on definitions related to fetal monitors; however, they were not able to agree on management guidelines for fetal monitors.
    3. Discussions with industry: Manufacturer follow-up explained the reported events were caused by inexperienced users or devices not used as labeled. In some events user facilities quarantined or discarded the device, which prevented manufacturers from conducting device failure analysis.
    4. Published Article to alert users to fetal deaths. Swayze, S. C. (1998, January). Electronic Fetal Monitors: Are you monitoring mother or fetus? Nursing 98, 28,1.
    5. The CDRH Electronic Fetal Monitor Systematic Technology Assessment of Medical Products (STAMP) Committee convened to address the fetal deaths and injuries associated with electronic fetal monitors (EFMs). We reviewed adverse events, device labeling and the literature, and talked with users. During our discussions we recognized that we needed more information to better understand use of the device. Since nurses are the primary users of EFMs, we met with AWHONN to discuss our concerns and reviewed their educational and training materials, designed for labor and delivery nurses and includes information on clinical competencies, educational guides, and skills necessary for FHR monitoring. Although a section on instrumentation is included in the training materials, we offered recommendations on instrumentation and suggested that AWHONN include them in their educational and training materials to help practitioners use EFMs more safely and effectively. AWHONN published the recommendations in their July 2000 edition of the Beat Goes On, a quarterly newsletter sent to AWHONN's Principle and Practice Instructors.

The STAMP's recommendations to AWHONN:

  • Emphasize the importance of nurses learning how to operate monitors found in their own work setting.
  • Discuss adjusting monitor displays to minimize problems in viewing data.
  • Review how to verify the integrity of monitor cables.
  • Remind nurses that it is imperative to check both the patient and monitor when alarms sound.
  • Whenever a monitor doesn't work as expected, follow the adverse event reporting policy for your institution. You can also submit a voluntary report to FDA's Medwatch Program at 800-FDA-1088 or on the Internet at www.fda.gov/medwatch/report/hcp.htm.
  • Talk to representatives from fetal monitoring companies, and request that they provide user friendly laminated or pullout cards with a capsule version of the operating manual attached to the front of the monitor.

Summary of Findings

Opportunities for Use Error

  • Over-dependence on the monitor
  • Monitor substituted for direct care
  • Belief that an alarm will alert user to deteriorating patient condition

Device Limitations

  • Signal loss due to fetal movement
  • Misreading due to maternal movement
  • Recording MHR instead of FHR
  • Artifact mistaken for normal variability of FHR can conceal fetal status
  • Only one fetal heartbeat can be heard on the loudspeaker at any time

Conclusion

Nursing practice, as well as, literature on use of electronic fetal monitors emphasize, that monitoring should not replace a complete nursing assessment since the monitor may not detect and record FHR.



 

Case Study #2
Vascular Hemostasis Devices

Vascular Hemostasis Devices

Hemostasis devices are used percutaneously (applied through the skin) to seal off the femoral artery puncture site, which is accessed for diagnostic and interventional cardiac procedures, usually in cardiac catheterization laboratories. The devices provide an alternative to traditional manual compression by facilitating more rapid sealing of the arterial puncture site, thus allowing the patient to go home more quickly. The three types of hemostasis devices that were marketed and approved by the FDA at the time of the case study adverse event evaluation included: (1) Extravascular, a collagen plug placed at the femoral artery puncture site, (2) Intravascular, a collagen plug in combination with a biodegradable anchor placed inside the femoral artery, and (3) a surgical suture device, whereby arterial closure is accomplished by deployment of sutures around the arterial entry site.

Reported adverse event:
A 39 year old man underwent a diagnostic cardiac catheterization. During the procedure the cardiologist used multiple needle sticks to locate the femoral artery. It is believed that the backwall of the femoral artery was punctured. The patient became very restless during the procedure and additional sedation was needed to continue. After the procedure, a hemostasis device was used to control bleeding at the femoral puncture site. Continuous oozing was noted from the site, the patient remained restless, and within 15 minutes of the procedure his blood pressure dropped significantly. Medications and medical internventions did not improve the patient's condition. He continued to deteriorate, experienced cardiac arrest, and died. The patient's reported cause of death was exsanguination (a massive loss of blood) as a result of retroperitoneal bleeding (bleeding into the back side of the abdomen).

From 1996 to 2000, the FDA received more than 1000 serious injury and 26 death adverse event reports involving the use of the three types of vascular hemostasis devices referenced above. At the time of our analysis (January 2000), the most frequently reported problems associated with the use of hemostasis devices were hemorrhage (profuse bleeding from the femoral artery which may result in death by exsanguination), hematoma (bruising), and infection. These problems were more frequently reported with interventional cardiac catheterization procedures in females than males. The deaths and serious injuries reported to FDA associated with vascular hemostasis devices raised concerns about the role of the device-user interface and how it plays in adverse outcomes associated with hemostasis devices. At the time of the case study, there was scant published clinical or scientific literature on the use of vascular hemostasis devices.

Actions taken by FDA:

(1) The FDA convened a committee to evaluate the etiology of the reported complications associated with the use of these devices. Their deliberations, in an effort to reduce the number of complications related to hemostasis devices, led the FDA to issue a notification to users recommending that all manufacturer warnings and instructions regarding patient selection and device use be carefully followed. The following recommendations are excerpted from FDA's "Dear Colleague Letter" (Safety Alert) to health care practitioners:

  • Do not use vascular hemostasis devices to treat patients with suspected double wall punctures, as punctures of the posterior wall are not closed with these devices.
  • Carefully weigh the risk of bleeding at the puncture site against the benefits of using a vascular hemostasis device.
  • Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices.
  • Special attention should be paid to any post-procedure-management instructions or ambulation recommendations for the specific vascular hemostasis device used.

(2) Published articles authored by the adverse event reviewer on complications
associated with vascular hemostasis devices describing the implications for trauma nursing, in the peer-reviewed clinical journals, Nursing and the International Journal of Trauma Nursing in 1999 and 2000 respectively. The articles specifically caution nurses to observe patients receiving these devices for vital sign changes, signs and symptoms of blood loss, including the presence of a hematoma or ecchymosis at the arterial puncture site, or the loss of arterial perfusion distal to the puncture site.

(3) Poster Presentation at the 2001 FDA Science Forum. The purpose of this presentation was to describe a study, conducted as part of the ongoing adverse event evaluation, on the reported rates of serious injuries and deaths associated with hemostasis use by year of occurrence, type of injury (or death), and gender. The study used medical device adverse event reports involving vascular hemostasis devices received by FDA from 1996 to August 29, 2000 as numerator. The 1996 National Center for Health Statistics (NCHS) data on coronary angioplasty was used for denominator. Only adverse event reports of with hemorrhage, hematoma, or infection were included in the numerator.

Conclusions from the study indicate that serious injury rates associated with the use of vascular hemostasis devices in coronary angioplasty procedures are more than twice as great, and death rates are more than four times as great, in females than in males. The chart below depicts the rates of reported deaths and serious injuries associated with hemostasis device use by type of injury (or death) and gender from 1996-2000.





(4) Subsequent to these presentations, design of two epidemiologic research projects to obtain more accurate rates of serious injuries associated with vascular hemostasis device use and a comparison of serious injury rates associated with cardiac catheterization in patients with, and without, hemostasis device use have been undertaken in collaboration with the American College of Cardiology (ACC). Preliminary findings show that women are at a much higher risk than men for hemorrhagic events associated with the use of vascular hemostasis devices. Complete results are pending.

Conclusions

Patient safety data obtained from medical device adverse event reports have provided health care practitioners and researchers throughout the world with a better understanding of the occurrence of adverse events associated with the use of vascular hemostasis devices following cardiac catheterization. It is anticipated that the information obtained from further epidemiological research will assist health care practitioners to make better decisions regarding the use of these devices, as well as providing a basis for further research on the subject.

Field Report

1. Select a medical device problem of interest.

2. Review and analyze device adverse event data from the Internet Version of the FDA MAUDE adverse event database. Patient and problem codes are not available in this version of MAUDE.

3. Review device labeling, literature, and ascertain clinical significance of device problem. Most manufacturers have websites where device information can be accessed.

4. Discuss with manufacturer how they conduct a failure mode analysis of the device selected.

5. Identify patient safety implications:

A. Patient population
B. Device/user interface
C. User training
D. Environment in which event occurred

6. Communicate with users about patient and device problems.

7. Create a model of patient safety to help reduce adverse events associated with the medical device you selected.

8. Present model.

More

Amoore, J., Ingram, P. (2002, August). Quality improvement report: Learning from adverse incidents involving medical devices. British Medical Journal, 325, 272-275.

Baker, D. (2002, April). Successful performance improvement. AORN, 75 (4):825-827.

Benner, P. (2001, July). Creating a culture of safety and improvement: A key to reducing medical error. American Journal of Critical Care, 10 (4): 281-284.

Berman, S. (2000, July). The AMA clinical quality improvement forum on addressing patient safety. Joint Commission Journal on Quality Improvement, 26 (7): 428-433.

Beyea, S. (2003, January). Tracking medical devices to ensure patient safety. AORN, 77 (1): 192-194.

Beyea, S. (2002, June). Finding patient safety internet resources. AORN, 75 (6): 1171-1173.

Bogner, M.S. (1994). Human Error in Medicine. New Jersey: Erlbaum.

Boyer, M. (2001, June). Root cause analysis in perinatal care: Health care professionals creating safer health care systems. Journal of Perinatal and Neonatal Nursing, 15 (1): 40-54.

Ebright, P., Patterson, E., & Render, M. (2002, September). The "new look" approach to patient safety. Clinical Nurse Specialist, 16 (5): 247-253.

FDA Modernization Act of 1997, amended, Section 519 9b) of the Food, Drug, and Cosmetic Act 21 U.S.C. 360 I (b) (1997).

Ferguson, S. (2001, December). To err is human: strategies for ensuring patient safety and quality when caring for children. Journal of Pediatric Nursing, 16 (6): 438-440.

Gallauresi, B. (1999, January). Collagen hemostasis devices. Nursing 1999, 29:31.

Gallauresi B. (2000, April-June). Complications associated with vascular hemostasis devices. International Journal of Trauma Nursing, 6, (2): 64-65.

Killen, A., & Beyea, S. (2003, February). Learning from near misses in an effort to promote patient safety. AORN, 77 (2): 423-425.

Meaney, M. (2003, January-February). Case management and patient safety. Case Manager, 14 (1): 28-29.

Meurier, CE. (2000, July). Understanding the nature of errors in nursing: Using a model to analyze critical incident reports of errors which have resulted in an adverse or potentially adverse events. Journal of Advanced Nursing, 32 (1): 202-207.

Noble, A., & Brennan, T. (2001, Fall-Winter). Managing care in the new era of 'systems-think': The implications for managed care organizational liability and patient safety. Journal of Law, Medicine and Ethics, 29 (3-4): 290-304.

Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104, Stat. 4511 (1990).

Sainfort, F., Karsh, B.T., Booske, B.C., & Smith, M.J. (2001, September). Applying quality improvement principles to achieve healthy work organizations. Joint Commission Journal on Quality Improvement, 27 (9): 469-83.

Tavris, D., Gallauresi, B., & Rich, S. (2001, February). Risk of serious injury ordeath associated with hemostasis devices by gender. Poster presentation at the FDA Science Forum, Washington, DC.

Tavris, D,, Gallauresi, B., Rich, S., & Bell, C. Relative risks of reported serious injury and death associated with the use of hemostasis devices by gender. Pharmacoepidemiology and Drug Safety 2003, 12: 237-241.

U.S. Department of Health and Human Services. (1999). Complications related to the use of vascular hemostasis devices: FDA dear colleague letter. Rockville, MD: Feigal, D. 

Internet Websites

ADVAMED: Trade association representing medical device manufacturers
http://www.advamed.org/ 

Centers for Disease Control
http://www.cdc.gov 

CDRH website (premarket device clearance and postmarket medical device reporting requirements, medical device report submissions, safety alerts, notifications, and advisories, and Patient Safety Portal)
http://www.cdrh.fda.gov 

ECRI: A non-profit agency focused on healthcare technology and patient safety research http://www.ecri.org/ 

FDA http://www.fda.gov/ 

FDA Consumer Magazine
http://www.fda.gov/fdac 

FDA Device Advice (device classification and procedures)
http://www.fda.gov/cdrh/devadvice 

FDA Patient Safety News
http://www.fda.gov/psn 

Institute of Medicine Report
To ERR is Human: Building a Safer Health System (you can read on line free)
http://www.nap.edu/books/0309068371/html/ 

Mandatory and User Facility Device Experience (MAUDE) adverse event report data base
http://www.fda.gov/cdrh/maude.html 

MedSun
http://www.medsun.net/about.html 

MedWatch
http://www.fda.gov/medwatch

This page is part of the course on quality / process improvement.  For more information contact Farrokh Alemi, Ph.D.