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Approach to Improving Safety
- Communication Improvement 9
- Culture of Safety 2
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- Error Reporting and Analysis 19
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- Legal and Policy Approaches 3
- Logistical Approaches 4
- Quality Improvement Strategies 22
- Specialization of Care 3
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Safety Target
- Alert fatigue 1
- Device-related Complications 57
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- Discontinuities, Gaps, and Hand-Off Problems 3
- Identification Errors 2
- Medical Complications 11
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- Transfusion Complications 1
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Search results for "Hospitals"
- Hospitals
- Medical Device Design
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Journal Article > Commentary
Improving infusion pump safety through usability testing.
Miller KE, Arnold R, Capan M, et al. J Nurs Care Qual. 2017;32:141-149.
Usability testing is an important step toward safely integrating new technologies into medical practice. This commentary describes the testing processes used for an infusion pump integration initiative. The authors highlight the importance of proactively identifying and addressing potential failures when introducing new equipment.
Journal Article > Study
Determining current insulin pen use practices and errors in the inpatient setting.
Brown KE, Hertig JB. Jt Comm J Qual Patient Saf. 2016;42:568-582.
Medication errors related to insulin use are common. This survey study sought to characterize current insulin pen use and associated safety issues in the inpatient setting. Investigators found that insulin pens are widely utilized, but safety issues—such as using the same pen on multiple patients—persist. The authors suggest that further research is needed regarding how to mitigate risks associated with insulin pen use.
Newspaper/Magazine Article
More than half a million heart surgery patients at risk of a dangerous infection.
Sun LH. The Washington Post. October 13, 2016.
Medical devices can contribute to the spread of health care–associated infections. This news article discusses a government report that raises concerns that patients may have been exposed to a deadly bacterial infection related to an essential piece of equipment used in cardiac surgery worldwide. The resulting infection can be difficult to diagnosis as symptoms may remain dormant for months after the initial exposure.
Journal Article > Study
The frequency of intravenous medication administration errors related to smart infusion pumps: a multihospital observational study.
Schnock KO, Dykes PC, Albert J, et al. BMJ Qual Saf. 2017;26:131-140.
Medication errors associated with intravenous smart pumps are a safety concern. Because errors are not always reported, the magnitude of this problem has been unknown. In this study, direct observation of nurses using smart pumps revealed that 60% of medication infusions involved one or more errors, but actual harm to patients was rare. The most common errors involved incorrect infusion rates and workarounds like bypassing the smart pump. These results accentuate a need for improvements in smart pump design to enhance safety and usability. A previous WebM&M commentary describes consequences of an incorrect medication infusion.
Cases & Commentaries
Robotic Surgery: Risks vs. Rewards
- Spotlight Case
- CME/CEU
- Web M&M
Tara Kirkpatrick, MD, and Chad LaGrange, MD; February 2016
Despite mechanical problems with the robotic arms during a robotic-assisted prostatectomy, the surgeon continued using the technology and completed the operation. Following the procedure, the patient developed serious bleeding requiring multiple blood transfusions, several additional surgeries, and a prolonged hospital stay.
Book/Report
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.
Book/Report
Medical Device Use Error: Root Cause Analysis.
Wiklund M, Dwyer A, Davis E. Boca Raton, FL: CRC Press; 2015. ISBN: 9781498705790.
Applying human factors engineering to examine mistakes associated with medical device use can lead to valuable learning opportunities. This publication discusses equipment use errors and provides information about utilizing root cause analysis (RCA) to identify weaknesses in device design that enable those mistakes. The book includes examples of RCAs to illustrate how the method can uncover flaws that contribute to error in various situations.
Journal Article > Commentary
Making healthcare safer by understanding, designing and buying better IT.
Thimbleby H, Lewis A, Williams J. Clin Med. 2015;15:258-262.
Design weaknesses for medical devices can remain unrecognized due to insufficient reporting and the tendency to place blame on the user rather than question whether the equipment functioned appropriately. Discussing flaws in health IT design and how they can contribute to patient harm, this commentary advocates for enhanced reporting of device-related incidents to raise awareness about risks and enable learning from errors.
Cases & Commentaries
Departure From Central Line Ritual
- Web M&M
Dustin W. Ballard, MD, MBE; David R. Vinson, MD; and Dustin G. Mark, MD; May 2015
A man with a history of poorly controlled diabetes and pancreatic insufficiency was found unresponsive. Paramedics transported him to the emergency department, where a resident placed a right internal jugular line for access but was unable to confirm placement. The resident pulled the line, opened a second line insertion kit, started over, and confirmed placement with ultrasound. The patient went into cardiac arrest, and a chest radiograph noted a retained guidewire in the pulmonary artery.
Journal Article > Review
Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review.
Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Syst Rev. 2015;4:37.
As the use of medical devices and health care technologies expands, adverse events linked to their use have become a significant concern. This systematic review focused on incident reporting for adverse events related to devices and technologies. Most studies of incident reporting identified were not specific to technology. Investigators found that fear of blame, time constraints, and uncertainty about what to report all led to under-reporting, as prior studies across settings have suggested. The authors conclude that further study is needed to understand clinicians' reporting practices specific to devices in order to move toward effective surveillance for adverse events associated with devices and technologies. A previous AHRQ WebM&M commentary describes an adverse event related to medical device use.
Web Resource > Multi-use Website
Injection Safety.
World Health Organization.
Poor injection practices contribute to health care–associated infections. This Web site provides resources related to a global campaign to enhance the safe use of injections through training, communication, policy development, and syringe design.
Journal Article > Organizational Policy/Guidelines
Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.
Heinemann L, Fleming GA, Petrie JR, Holl RW, Bergenstal RM, Peters AL. Diabetes Care. 2015;38:716-722.
Insulin is a high-alert medication that can lead to harm if incorrectly administered. Insulin pump problems can be caused by human, mechanical, or drug stability failures. This policy statement describes ways to use adverse event data, manufacturer information, and technical specifications to enhance the safety of insulin therapy.
Press Release/Announcement
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
Mistakes due to small-bore Luer connector similarities can contribute to patient harm. This guidance provides ways for manufacturers, policy makers, and product designers to prevent misconnections, including recommendations regarding improvements for labeling, user testing, and risk assessment.
Journal Article > Study
Insights into the problem of alarm fatigue with physiologic monitor devices: a comprehensive observational study of consecutive intensive care unit patients.
- Classic
Drew BJ, Harris P, Zègre-Hemsey JK, et al. PLoS One. 2014;9:e110274.
Alarm fatigue, in which clinicians ignore safety alerts if they are too frequent or perceived to be clinically irrelevant, can lead to lack of awareness of an unsafe situation. This concern is particularly acute in intensive care units where patients are typically monitored with multiple devices, each with alarms. This retrospective review examined all alarm data regarding physiologic monitoring, including electrocardiogram, blood pressure, and oxygenation, from five intensive care units in a medical center. The vast majority of alarms were false-positives. Inappropriate alarm settings, electrode failure leading to poor signal quality, and alerts for non-actionable events were common causes for unnecessary alarms. The authors call for improving device design and monitor algorithms in order to reduce alarm fatigue. A previous AHRQ WebM&M perspective discussed the safety of medical devices.
Journal Article > Commentary
New enteral connectors: raising awareness.
Guenter P. Nutr Clin Pract. 2014;29:612-614.
Redesigning tubing connectors according to new ISO standards has the potential to reduce tubing misconnections. This commentary provides information about changes to enteral connectors to prepare clinicians to use the new devices in their organizations.
Journal Article > Study
The mixed blessings of smart infusion devices and health care IT.
Nemeth CP, Brown J, Crandall B, Fallon C. Mil Med. 2014;179(suppl 8):4-10.
This study provides a detailed description of the overlapping technological, organizational, and human factors associated with the use of smart pumps and includes insights into potential pitfalls that may pose patient safety threats. The authors make specific recommendations to improve the real-world use of smart pump technology.
Newspaper/Magazine Article
Multifaceted initiative to reduce "alarm fatigue" on cardiac unit reduces alarms and increases nurse and patient satisfaction.
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. June 18, 2014.
Clinical alarms have been described as a serious patient safety issue. This article relates how one hospital implemented a series of actions reduce nuisance alarms in a cardiac unit and reports a substantial decrease in audible alerts with no subsequent adverse effects. Interventions included expanding limits for triggering heart rate alarms and collaboration between two nurses to design customized alarm parameters for individual patients.
Journal Article > Study
Patient safety, error reduction, and pediatric nurses' perceptions of smart pump technology.
Mason JJ, Roberts-Turner R, Amendola V, Sill AM, Hinds PS. J Pediatr Nurs. 2014;29:143-151.
In this study, surveys found that pediatric nurses perceive that smart infusion pumps improve patient safety. Accompanying data captured by smart pumps supported that perception, documenting 65 instances in which those same nurses prevented medication errors by appropriately utilizing the devices.
Newspaper/Magazine Article
Using good design to eliminate medical errors.
Jaffe E. Fast Company. November 11, 2013.
This article reports on a British initiative that studied health care processes for the purpose of designing devices to prevent medical errors.
