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.
Keywords: MedSun, point-of-care, medical devices, adverse events, human factors, recognize and report, position statements, patient safety
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. 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.
Factors Contributing to Adverse Events
As mentioned earlier, an adverse event is an event whereby a medical device has, or may have, caused or contributed to a death or serious injury (FDA Code of Federal Regulations 21, 2010). It often signals an actual or potential device problem and may occur for several reasons. Two reasons frequently reported to the FDA involve (a) device manufacturing problems and (b) device-human interactions (human factors) problems. Human factors problems, which may also be referred to as ‘ergonomics and human-factors engineering’ focus on the human-machine interaction (Bogner, 1994). Device and human factors problems reported to the FDA are summarized in Table 1.
The following incident illustrates how a device and/or human factor can lead to a patient problem. The FDA received an increased number of reports of over-infusion of medication when using the Alaris Signature Edition Gold Infusion Pump. The pump had a design defect called ‘key bounce’ (FDA, 2006). The keypad sometimes registered a number twice when pressed only once. For example, if the infusion rate was entered as 4 milliliters per hour, the intended rate, the key bounce might cause the number to register as 44. When not detected during programming verification, the key bounce events caused or contributed to serious patient harm and death in some cases. The device problem was the defective keypad, the human factor problem was the nurse using the defective keypad to enter data, and the patient problem was harm or death. After the FDA confirmed the key bounce problem, the FDA requested seizure of all infusion pumps at the manufacturing facility that were likely to have the key bounce problem. The manufacturer has subsequently incorporated new designs to eliminate this key bounce problem.
Other factors also contribute to adverse events. These factors may include environmental factors such as poor lighting in a patient room, excessive noise, and emergency situations. Additionally the American Nurses Association (ANA, 2006) and the National Association of Neonatal Nurses (NANN, 2008) have both developed statements linking human (staff) fatigue with adverse events. They have recommended risk-reduction strategies for employers and nurses at the point of care to help decrease fatigue and improve safety for patients and nurses.
It’s important to note that not all device events result in FDA regulatory action. Instead, some generate FDA Safety Notifications, Patient Safety News Broadcasts, publications in peer-reviewed clinical journals, or presentations at clinical practice organizations and conferences. Sometimes the events may be added to a trending algorithm to assess frequency in occurrence over time.
The Need for More Medical Device Adverse Event Reporting
In 1988 the FDA recognized the need for increased safety regarding nursing usage of medical devices. The FDA convened a three-day conference, Nursing and Technology: Moving into the 21st Century, to “foster collaboration between the private sector, nursing and government in the development of strategies to prevent the occurrence of iatrogenic incidents associated with medical devices” (Smith & Murray, 1989, p 1).
In the mid 1990s, the FDA realized it was not receiving sufficient data to understand root causes of medical-device problems occurring in healthcare facilities. The FDA decided to pilot a program to collect data on medical device problems in clinical settings that might warrant manufacturer or FDA action. The primary goal of the program was to create a network of health-related facilities representing all types of healthcare settings in the US that would provide the FDA with timely and high quality information about medical device use. Currently there are 350 such facilities nationwide that comprise the Medical Product Safety Network (MedSun). Risk managers are able to inform staff as to whether their facility is included in the MedSun network. MedSun, located in the Division of Patient Safety Partnerships within the Office of Surveillance and Biometrics, is CDRH’s newest medical device adverse event reporting program.
In our role as nurses in MedSun, we work collaboratively with the MedSun facilities to advocate for patient safety. We educate staff in MedSun facilities to recognize actual and potential device problems, remove malfunctioning devices, and report these problems to the FDA. Front line healthcare professionals report through their hospital’s incident reporting system. Then the MedSun facility liaison, generally the risk manager at a given facility, submits device-related reports of deaths, serious injuries, “close-calls” or “near-misses,” or problems representing a potential for harm to MedSun. Reports are submitted online through a secure, Internet-based data entry system. The FDA then follows up with the manufacturer to evaluate and address the reported problem(s). The FDA also alerts healthcare facilities to major actions by the FDA and manufacturers, presents medical device safety information at clinical and professional meetings, and publishes device safety tips addressing problems occurring in clinical use.
Reporters can choose whether they desire to provide their name or to remain anonymous. Nurses involved in medical device adverse events are encouraged to use the incident reporting system of their facility to alert appropriate staff of the device event. These staff can then alert the FDA to the problem. If your hospital is a part of MedSun, your MedSun liaison will forward the report to MedSun. If your facility is not part of MedSun, you can report a medical device adverse event online directly to the FDA through a voluntary program called MedWatch. Those who report these events receive an acknowledgement from the FDA directly, indicating that the report has been received. The reporter’s identity will not be shared with the manufacturer unless otherwise requested (Kessler, 1993). Reporters can choose whether they desire to provide their name or to remain anonymous.
Table 2 summarizes the literature describing nurses’ views and concerns regarding medical devices. What is surprising about the surveys listed in this table is the consistently small number of nurses who responded to the survey. Because of the small number of respondents it’s difficult to draw valid conclusions about problem devices. All of these devices mentioned in Table 2 are as worrisome today as they were when the earlier surveys were conducted, as evidenced by the increased number of reports of deaths and injuries involving many of these devices that the FDA continues to receive (FDA MAUDE, 2010b).
The FDA believes the surveys should continue and new methods developed to obtain medical device-use data from nurses working at the point of care. Identifying factors that contribute to device-related adverse events will help professional nursing associations (PNAs) develop position statements focusing on specific device problems and encourage device manufacturers to work with nursing professionals to prevent or minimize risks associated with device use.
Professional Nursing Organizations’ Statements to Promote Safe Use of Medical Devices
A position statement by a professional nursing association defines the policies, standards, and issues important to the nursing profession and serves to enhance nursing practice (ANA, 2009; Clifford, 2007; Rowell, 2003). We encourage all PNAs to work with the FDA to develop position statements that address key problems nurses in their associations encounter when using medical devices so as to enhance patient safety. This collaboration will enable professional nursing associations to have a positive impact on preventing or reducing adverse device events.
Nurses’ concerns have already provided an important stimulus for some professional nursing associations to develop position statements related to the safe use of medical devices. Nurses’ concerns have already provided an important stimulus for some professional nursing associations to develop position statements related to the safe use of medical devices. For example, the Association of Women’s Health Obstetrics and Neonatal Nurses (AWHONN) has developed statements on fetal heart monitoring (AWHONN, 2008), internal fetal spiral electrode placement (AWHONN, 2010), and the role of the nurse and catheter techniques used for analgesia and anesthesia (AWHONN, 2002/2007), in response to concerns expressed by members. After the AWHONN and the FDA discussed the increase in fetal deaths associated with electronic fetal monitors (EFMs), AWHONN published FDA’s recommendations for user education and training in The Beat Goes On, a quarterly newsletter for AWHONN’s Principle and Practice Instructors.
In the early 1990s the FDA (1992) issued a Safety Alert titled Needlestick and Other Risks from Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V.; and the FDA (1999) subsequently developed guidance for manufacturers to apply warning labels to medical devices containing natural rubber latex. These regulations have helped to facilitate safe care of patients and staff who are allergic to latex. The Emergency Nurses Association (ENA) has developed statements on latex allergy and percutaneous sharps and needlestick injury prevention (ENA, 1997/2005; 2003/2011).
The Association of Operating Room Nurses (AORN) has developed statements on the care of perioperative patients with implanted electronic devices and on fire prevention in the operating room (OR) (AORN, 2005). This latter statement encourages facilities to report device-related fires to the FDA, the Joint Commission, and ECRI (formerly known as the Emergency Care Research Institute). It also identifies factors that contributed to fires and includes recommendations to minimize risks. The FDA receives approximately 100 adverse event reports a year related to OR fires and is currently collaborating with AORN and other healthcare providers to address such fires.
Future Directions
Twenty-three years after the FDA convened Nursing and Technology: Moving into the 21st Century (described above), the FDA is still trying to find ways to prevent iatrogenic incidents, now called adverse events. The FDA is drawing upon the 1988 conference proceedings (Smith & Murray, 1989) to encourage nurses and professional nursing organizations to take a supportive role in addressing (a) The Impact of Device Technology in the 21st Century, (b) The Technological, Regulatory, and Legal Factors That Impinge on the Nursing Environment, (c) Key Issues in Device Use as They Relate to Nursing Practice Today, (d) The Development of Nursing Education Models Relevant to Today’s Device Technology, and (e) Nurses Concerns about Devices (See Table 2).
As the FDA continues to approve more novel and more complex medical device technology for use at the point of care, nurses will require a more in-depth knowledge base related to technology, greater understanding of the technology, and new skill sets to use technology. The Carnevali Nursing Education Model (Dressler, 1988) and the Abbey-Shepherd Device Education Model (Abbey & Shepherd, 1988) presented at the conference in 1988, provided strategies for incorporating device technology into nursing practice. We recommend that nurses and nursing professional associations adopt existing educational models and/or develop new models to teach safe practice in the use of medical devices. We also encourage the development of position statements addressing safe medical device use that provide guidelines for use of specific devices and classes of devices, thus equipping nurses to recognize and report device-related events as part of their professional responsibilities. Suggested topics for device education and training are summarized in Table 3.
Education of Staff for Using Medical Devices
Professional nurses in clinical practice are the principal users of medical devices at the point of care. Professional nurses in clinical practice are the principal users of medical devices at the point of care. They are confronted daily with devices used for patient monitoring, diagnostic testing, surgical and therapeutic interventions, and telemedicine. Over time, these devices have become increasingly complex and sophisticated, reshaping the delivery of healthcare both in the hospital and the home, and subsequently creating more challenges for nurses.
If a nurse is not knowledgeable in the use of a device, patients are at risk. Nurses can become knowledgeable by participating in educational programs to ensure safe operation of the medical devices they use. The literature suggests that medical device education for nurses focus on the following areas:
- knowledge of the intended use of the device
- manufacturer’s instructions for use, labeling, warnings, contraindications, and known complications
- outcomes of proper use of a device
- the agency’s clinical practice manual and nursing education department guidelines
- the importance of complying with expiration dates (given by manufacturers) that indicate the time period for optimal use or ‘shelf life’
- recognition that device sterility may be guaranteed only until the expiration date
- insight into differences in device use and design between similar devices
(Konecny, 2003; Dumais, 2003; Haghenbeck, 2005; McConnell, 1994, 1995a, 1995b)
The FDA is asking nurses and professional nursing associations to partner with their staff to educate nurses about the safe use of medical devices in patient care. As nurses move from one unit or hospital to another, or care for patients with differing conditions using the same devices, the potential for error increases. This occurs because devices may be similar in design, yet have different ‘bells and whistles.’ For example, two different versions of an infusion pump manufactured by the same firm may look similar, but operate differently, causing confusion. It is important that nurses understand how to operate each individual device they use.
In addition, nurses need to be familiar with their patient’s disease and/or pre-existing conditions, along with the effects of all concomitant devices, medications, and other treatments/procedures, to better understand device events that might occur. Additionally, the aforementioned factors should be included in a description of the device problem when reporting medical device-related adverse events.
Conclusion
Reporting device events to the FDA will help...identify the root cause of problems...and improve patient safety at the point of care. Medical device technology will continue to evolve and challenge nurses at the point of care. The FDA is asking nurses and professional nursing associations to partner with their staff to educate nurses about the safe use of medical devices in patient care. The FDA is very willing to share with professional organizations what is known about medical devices from the adverse-event reporting program. This information can guide organizations as they develop position statements designed to address medical device safety, and the importance of reporting device-related problems, so as to promote optimal patient outcomes. In the same manner we encourage all nurses and professional associations to share important medical device adverse events with the FDA. Reporting device events to the CDRH will help all of their staff work with manufacturers to identify the root cause of problems encountered and to improve patient safety at the point of care.
Acknowledgement
The authors wish to acknowledge the team of nurse reviewers and engineers in the MedSun program and the MedSun sites participating in the program
Author
Sonia C. Swayze, RN, MA
E-mail: sonia.swayze@fda.hhs.gov
Sonia Swayze is a Senior Project Manager for Communication and Outreach in the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), MedSun Patient Safety Staff Partnerships. An important part of her role is to communicate what the FDA knows about medical device use to healthcare professionals, organizations, and associations in an effort to promote safe use of medical devices. Prior to becoming a member of the Patient Safety Staff Partnerships, Sonia supervised a team of experts in the review and evaluation of medical device adverse event reports submitted by manufacturers, user facilities, and voluntary reporters.Her clinical practice background includes intensive care, home health, public health, ambulatory care, obstetrics and gynecology, neurology, and cardiovascular nursing along with healthcare research. Prior to joining FDA, Ms. Swayze coordinated clinical trials for the National Heart, Lung and Blood Nursing Department at the National Institutes of Health in Bethesda, Maryland. She has numerous publications and presentations in her areas of expertise. She received her diploma from Huron Road Hospital (Cleveland, OH), and her BA in Sociology and MA in Health Promotion Counseling from Trinity College (Washington, DC). Ms. Swayze is currently vice president of the Black Nurses Association of the Greater Washington, DC area.
Suzanne E. Rich, RN, MA, CT
E-mail: Suzanne.rich@fda.hhs.gov
Suzanne Rich is a Senior Project Manager in the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), MedSun Patient Safety Staff Partnerships. She coordinates reviews, evaluations, and follow-up activities. Suzanne provides healthcare professionals with education and outreach communication related to medical device adverse event reports submitted to the FDA from MedSun participating hospitals. Suzanne leads the KidNet subnetwork of MedSun, which focuses on device events occurring in neonatal and pediatric intensive care units. Prior to becoming a member of the Patient Safety Staff Partnerships she was responsible for supervising the review and evaluation of medical device adverse event reports submitted by manufacturers, user facilities, and voluntary reporters. Ms. Rich has previously worked in a variety of critical care settings. Certified in Thanatology she serves as an End-of-Life Nursing Education Core Curriculum Trainer and a bereavement volunteer in a local hospice. She has numerous publications and presentations in her areas of expertise. Suzanne received her AA in nursing from Montgomery College (Takoma Park, MD) and her BA in Psychology and MA in Thantology from Hood College, Frederick, MD).
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