Stephanne Hale on Patient Safety
Preventing Tubing and Luer Misconnections
Tubing misconnections of delivery systems in the health care setting can be an unintended consequence of the universal design of medical devices. Those consequences can have an adverse effect on patient safety, resulting in serious patient harm and even death. As a result, new delivery specific design standards have been introduced into the marketplace beginning late 2014. The new components will have an impact on the supply chain from clinicians who use them on a day-to-day basis, as well as caregivers who manage enteral devices in the home setting.
GEDSA is coordinating efforts to introduce new ENFit enteral feeding device connectors to health systems. This device will not be compatible with a Luer connection or any other small bore medical connectors, thus preventing misadministration of an enteral feeding or medication by the wrong route.
In February, the FDA released Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff, which provides recommendations to manufacturers, FDA reviewers, and other entities involved in manufacturing devices that contain small-bore connectors designed for enteral feeding, as well as those submitting or reviewing premarket notification submissions for these devices.
The Joint Commission recently introduced Sentinel Event Alert 53: Managing Risk During Transition to New ISO Tubing Connector Standards, which offers strategies to help prepare for the new standards.
A Novation Clinical Contract Resource — Improving Patient Safety: Preventing Tubing Misconnections — is available to members through Marketplace|Procure, and can assist members in understanding the rationale for the device changes as well as information on the proposed launch timeline for the new design.
Additional resources, including FAQs and transition checklists to help your team begin the transition, are also available on the GEDSA website.
In a recent Novation survey of hospital providers titled “Tubing Misconnections Standards,” about 88 percent of respondents indicated that they had a policy in place to report a tubing misconnection event involving the delivery of an incorrect substance or utilization of an incorrect delivery route to a patient. Tubing misconnections are a serious patient safety issue, one that can be fatal, and one that is believed to be seriously underreported. Also referred to as Luer misconnections, small bore misconnections, or wrong route errors, tubing misconnections occur as a result of connecting a medical device from one delivery system to another delivery system that serves a completely different function. Based upon root-cause analysis and industry review of reported misconnection events, the Luer appears to be a contributing factor in many instances as the Luer allows therapeutically dissimilar devices to be easily connected. Examples of reported adverse events involving the Luer include connection of a feeding tube to a tracheostomy tube; delivering milk into an infant’s lung and a peripheral intravenous (IV) route connected to an automatic blood pressure cuff; delivering air to the bloodstream. Both misconnection events resulted in the patient’s death.
In March 2013, the Centers for Medicare & Medicaid Services (CMS) issued an immediate communication to state and regional office training coordinators, survey and certification staff and staff managers regarding the issue. The memo provided information to surveyors on what to look for and questions to ask healthcare personnel during a misconnection investigation regarding variables contributing to the cause of the error. Additionally, questions regarding tubing misconnections and prevention steps are allowed during routine survey visits. In the event that the Luer or a similar connector is implicated in the cause of the adverse event, the surveyor should determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse events.
In addition to investigating possible causes of misconnections and prevention methods, the March memorandum communicated to surveyors, that they may encourage [health care] facilities to report misconnection issues to the Food and Drug Administration (FDA), even in the absence of an adverse event and reporting of such events should be in accordance with the procedures establishes by the facility. Research suggests that tubing misconnections and medical errors in general are believed to be seriously under reported and for various reasons including the perceived threat of sanctions, malpractice suits, stigma related to professional identity and reputation and fear. Learning from tubing misconnection errors can be productive and not necessarily punitive, therefore, despite actual or perceived seriousness of consequences, transparency in healthcare is vital to identifying recurring problems and creating a culture of patient safety and reporting of such events should be encouraged.
There is work currently underway by an international working group to address this patient safety issue from a policy perspective. In 2009, California Senate Bill 158 was passed, requiring state manufacturers to adopt a series of standards for preventing device misconnections. The initial bill, passed by the state legislature, required adoption and implementation of new device standards by manufacturers and hospitals by January 2013; that deadline has since been extended to January 1, 2016. Actual language from the bill mandates that “a health facility is prohibited from using an intravenous connection, epidural connection, or enteral feeding connection that would fit into a connection port other than they type it was intended for, unless an emergency or urgent situation exists and the prohibition impairs the ability to provide health care.”
The group that is developing the small bore misconnection standards consists of clinicians, manufacturers and regulators, including the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO) with the Association for the Advancement of Medical Instrumentation (AAMI), members of the medical device industry and Novation. Collectively, the group is developing the 80369 series which will require small bore connector designs involving the Luer to be specific to the applications they were intended for and not a universal fit.
In January 2011, AAMI adopted the standard ANSI/AAMI/ISO 80369-1:2010, which provides general requirements for small bore connectors for liquids and gases, with additional standards being developed for application-specific designs as follows:
- 80369-2 — Small bore connectors for liquids and gases in health care — connectors for breathing systems and driving gases
- 80369-3 — Small bore connectors for liquids and gases in health care — connectors for enteral applications
- 80369-4 — Small bore connectors for liquids and gases in health care — connectors for urethral applications
- 80369-5 — Small bore connectors for liquids and gases in health care — connectors for limb cuff inflation applications
- 80369-6 — Small bore connectors for liquids and gases in health care — connectors for neuraxial applications
- 80369-7 — Small bore connectors for liquids and gases in health care — connectors with 6% (Luer) taper for intravascular or hypodermic application
To address those anticipated concerns, education efforts are beginning to take place regarding tubing misconnections and the new standards. Recently, an informative panel discussion was held during the recent Health Care Supply Chain Conference (HSCA) in Washington, DC. The panel was comprised of subject matter experts from Novation, the Joint Commission, US Food and Drug Administration, Centers for Medicare and Medicaid Services, AAMI, Premier, Collaborent Health-Global Enteral Device Supplier Association (GEDSA) as well as the co-chairperson for the AAMI/ISO Technical Advisory Group (TAG) involved in the development of the ISO standards. The group discussed development of the standards, a tentative timeline for implementation and supply chain implications for healthcare providers. Awareness efforts are also being developed by a collaborative group that includes AAMI and other partners and will be led by the Joint Commission. The group is developing an awareness campaign addressing the need for change by developing tools and resources to disseminate timely and appropriate information. The group hopes to facilitate rapid adoption of the new global standards while minimizing disruption to the supply chain and clinical practice while maximizing patient safety.
Stephanne Hale, Sr. Clinical Manager, Sourcing Operations at Novation, provides clinical expertise and insight into the bid process for healthcare and supply chain quality and safety. She is responsible for developing educational resources and tools that address clinical efforts for the hospital members that Novation serves.
Prior to Novation, Hale was a Patient Care Manager for one the nation’s leading palliative care organizations where she had responsibility for the clinical program. Her clinical experience includes liver-kidney transplantation and traumatic neuro-rehabilitation primarily at Baylor University Medical Center, Dallas. Her background also includes experience in sales and marketing as a National Nurse Clinician for a major manufacturing and distribution company.
Hale holds a bachelor’s degree in nursing from Baylor University as well as both an MBA and MHA from Texas Woman’s University. She is currently pursuing a Ph.D. from TWU where her research efforts are dedicated to promoting health and improving lives with evidence-based practice interventions and evaluation.
Preventing the spread of Ebola virus disease
During an outbreak, the Ebola virus can spread quickly throughout an area such as a community or health care setting. Health care workers have been infected while caring for patients suspected to be infected with the virus or positively confirmed to have the disease and where proper protective equipment is not utilized and worn appropriately. It is paramount that personal protective equipment such as gloves, gowns and masks are worn and discarded properly, and that proper disinfecting, cleaning and disposal of instruments used in the care and treatment of patients is conducted. The Centers for Disease Control and World Health Organization have posted recommended isolation and infection control practices to help manage patients with known or suspected Ebola virus disease.
Prevention of Ebola virus disease in the health care setting requires vigilance on the behalf of caregivers. It is important for health care workers to be able to recognize signs and symptoms of the disease. If Ebola HF is suspected, the CDC recommends immediate practical viral hemorrhagic fever isolation precautions be implemented. A request should be made to provide a confirmatory diagnostic test, and health care workers should remember that body fluids are an extreme biohazard risk and should be handled under maximum biological containment conditions. Barrier protective techniques should also be implemented, including:
- wearing personal protective equipment including masks, gloves, gowns and goggles
- use of infection control measures
- isolating the suspected/confirmed Ebola case from contact with others
- avoiding contact with blood or body fluids/secretions of the suspected/confirmed case
Health care workers and caregivers should immediately report to their supervisor any potential exposure to blood, body fluid or secretions of a suspected/confirmed Ebola virus case. If a person dies who has been confirmed to have Ebola HF, the WHO advises that direct contact with the body must be avoided, and that the deceased be handled only by trained case management professionals.
Currently, there is no preventive vaccine or cure available for Ebola virus disease. Patients who test positive for the virus are treated by providing intensive supportive care and management of symptoms.
For more information, visit Novation’s Ebola Hemorrhagic Fever clinical contract resource guide on Marketplace|Procure or these government and industry resources:
- Centers for Disease Control and Prevention’s Ebola Hemorrhagic Fever Page
- World Health Organization’s Global Alert and Response for Ebola Virus Disease
- Open Letter to All U.S. Healthcare Professionals
- Ebola Virus Disease Screening Criteria
- Health Care Facility Preparedness Checklist for Ebola Virus Disease
- Detailed Hospital Checklist for Ebola Preparedness
PREVENTING VENTILATOR-ASSOCIATED COMPLICATIONS
Mechanical ventilation can be a necessary and lifesaving procedure for patients suffering from respiratory failure or other critical illnesses. However, patients that are mechanically ventilated have a higher probability of acquiring complications related to a ventilator, such as a ventilator-associated event or ventilator-associated pneumonia, commonly referred to as VAE and VAP.
According to the Centers for Disease Control and Prevention, more than 300,000 patients receive mechanical ventilation therapy each year in the U.S. While ventilation therapy can be a lifesaving procedure, it can also lead to complications. In fact, VAP is the second-most common hospital-acquired infection in the U.S., and it is a major cause of patient mortality and morbidity as well as a significant contributor to health care costs.
The CDC suggests some of the things doctors, nurses, and other health care providers are doing to prevent ventilator-associated pneumonia:
- Keep the head of the patient’s bed raised between 30 and 45 degrees unless other medical conditions do not allow this to occur.
- Check the patient’s ability to breathe on his or her own every day so that the patient can be taken off of the ventilator as soon as possible.
- Clean their hands with soap and water or an alcohol-based hand rub before and after touching the patient or the ventilator.
- Clean the inside of the patient’s mouth on a regular basis.
- Clean or replace equipment between use on different patients.
For more information, visit Novation’s VAE and VAP Clinical Resource Guide on Marketplace|Procure.
Preventing Health Care-Associated Infections: Hand Hygiene
Hand hygiene — hand-washing with soap and water or use of a waterless, alcohol-based hand rub — has been considered one of the most important measures to prevent the transmission of pathogens that cause health care-associated infections.
Health care-associated infections are a major cause of morbidity and mortality, and the cost to treat them is tremendous. In fact, research shows that there are approximately 2 million health care-associated infections annually, and in 2011, HAIs resulted in more than 80,000 deaths in the acute care setting (Centers for Disease Control and Prevention, 2014). Estimates show that the annual direct medical cost to treat HAIs is in excess of $40 billion (CDC, 2009).
Despite these alarming figures, evidence suggests that compliance by health care workers with recommended hand hygiene procedures has remained consistently below 50 percent.
Several guidelines offer support and tips for reducing infections through proper hand washing practices.
- A Guideline for Hand Hygiene in Health Care Settings was developed by the CDC's Healthcare Infection Control Practices Advisory Committee, and is part of an overall CDC strategy to reduce infections in health care settings to promote patient safety.
- How-to Guide: Improving Hand Hygiene, A Guide for Improving Practices among Health Care Workers was developed by the Institute for Healthcare Improvement. It discusses tips for minimizing transmission of health care-associated pathogens, which most often occur via the contaminated hands of health care workers.
- The WHO guidelines on Hand Hygiene in Health Care provide a comprehensive review of scientific data on hand hygiene rationale and practices in health care settings.
For more information, visit Novation’s hand hygiene clinical contract resource guide on Marketplace|Procure.