Abstract and Introduction
Abstract
Although patient safety initiatives in the clinical environment have focused primarily on medication errors to date, medical devices also contribute significantly to patient injuries and deaths. This article addresses the Food and Drug Administration's (FDA) efforts to promote safe use of medical devices by nurses at the point of care. The nurses with whom we have discussed the effects of medical devices, and also those surveyed by the medical device industry and professional nursing associations, are concerned about the profound effects, both desired and undesired, that medical devices have on patient outcomes. We believe that professional nurses, individually and through their professional associations, can help address these concerns by becoming aware of how to share their observations with the FDA and by working with their professional associations to develop position statements that focus on achieving safe and desired patient outcomes. In this article we will identify factors contributing to adverse events related to medical devices, address the need for more medical device adverse-event reporting, describe position statements that have already been made by some professional associations, and share insights regarding future directions along with ideas for educating staff to use medical devices safely.
Introduction
A medical device is, simply defined, any item used to diagnose, treat, or prevent disease, injury, or any other condition that is not a drug, biologic, or food. The official United States (U.S.) definition of the term 'device' can be found in the Federal Food Drug & Cosmetic Act (1998) enforced by the U.S. Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services.
Medical devices range from items as simple as tongue depressors to more complex devices, such as ventilators. They represent some of the most innovative technologies developed in recent years. Yet regardless of how novel a device may be, the public expects, and the Food and Drug Administration requires that medical devices be safe, effective, and manufactured in accordance with current manufacturing practices.
Medical devices are subject to the general controls of the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010). All manufacturers must register their establishment, list any type of device they plan to market, and assure that their device is labeled in accordance with the FDA's labeling regulations, before marketing clearance is given. Despite premarket studies required of high risk devices, such as ventilators, safety concerns may arise with a device once it is on the market. Thus the FDA must rely on manufacturers and device users to recognize and report problems that may contribute to poor patient outcomes. Lower risk devices, such as infusion pumps and physiological monitors, require only documentation that they are as safe and effective as similar devices already on the market before receiving marketing clearance. However, once any device is marketed, it is subject to post-market surveillance controls through Medical Device Reporting (MDR) regulation.
…the public expects, and the Food and Drug Administration requires that all medical devices be safe, effective, and manufactured in accordance with current manufacturing standards. 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 (Code of Federal Regulations 21, 2010). The actual number of device-related adverse events that occur annually in facilities across the US is not known. What is known, however, is that in the fiscal year 2000 the FDA received 69,959 medical device adverse event reports; by 2009, the most current data calculated, the number had increased to 540,204 reports (FDA Manufacturer and User Device Experience Database [MAUDE], 2010b).
In medical device reports for which the reporter role was documented, nurses submitted 12,758, and risk managers submitted 26,512, of the 315,673 reports submitted. Nurses who work as risk managers are in a unique position to promote medical device safety. When nurses recognize a device problem, the FDA encourages them to use their facility's incident reporting system to alert appropriate staff regarding the problem or adverse event. Unfortunately for patients, not all device problems that occur are reported; yet unreported problems increase the potential for harm to patients and nurses alike.
…unreported problems increase the potential for harm to patients and nurses alike. Medical devices can cause, or contribute to commonly known adverse events, such as the frequently reported problems of 'arching' and 'burns' from defibrillator pads. The FDA requires documentation of these well-known events even though these events are included in the manufacturer's device labeling (Code of Federal Regulations 21, 2010).
Generally technological devices, such as specialty beds, infusion pumps, and monitoring devices improve patient outcomes. Although such devices usually have a positive effect on patient outcomes, problems with these devices have contributed to injuries and deaths. For example, patients have become entrapped in hospital bed siderails, have received too much or too little fluid and medications when intravenous infusion pumps did not deliver the appropriate dosage, and have been given unnecessary or inappropriate interventions due to erroneous data displayed on blood pressure monitoring screens.
If a device failure occurs, nurses should remove the device from service immediately, tag it with a label describing the problem, and report the incident to the appropriate department within their facility so it can be evaluated and returned to the manufacturer. Manufacturers have tests and methods that can reveal defects or flaws in their devices. Additionally, the FDA audits manufacturers' device production processes routinely and on an as-needed basis.
If a device failure occurs, nurses should remove the device from service immediately, tag it with a label describing the problem, and report the incident to the appropriate department within their facility so it can be evaluated and returned to the manufacturer. We (the authors of this article) are nurses within FDA's Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics. The focus of this office is to communicate and collaborate with healthcare facilities and professional organizations about the safe use of medical devices. Staff activities range from clarifying what a medical device is and alerting device users as to how human factors can lead to medical device-related adverse events, to conducting follow up with device manufacturers and clinical professional organizations to address reported problems. We meet with nurses, as well as risk managers and other healthcare professionals, on inpatient nursing units and during different shifts to share what the FDA knows about medical devices and to learn about devices that are of concern to providers at the point of care. We also serve as a resource for facilities when they have questions regarding specific device failures.
Our goal in this article is to describe the FDA's efforts to promote safe use of medical devices by nurses at the point of care, and highlight the role of professional nursing associations in promoting the safe use of medical devices by developing position statements that increase an understanding of the safe use of medical devices. In this article we will identify factors contributing to adverse events related to medical devices, address the need for more adverse-event reporting, describe some position statements already developed by professional associations, and share insights regarding future directions needed along with ideas for educating staff to use medical devices safely.