• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events

Complete Transcript

A Patient Safety Webcast Sponsored by FDA’s
MedSun KidNet Subnetwork
November 19, 2008

Co-Presented by FDA and Beaumont Hospitals Beverly Gallauresi, RN, MPH, FDA Tammy M. Muczinski, MS, RN, CPNP-PC, Beaumont Hospitals Alyson Phillips, BS, Beaumont Hospitals Suzanne Rich, RN, MA, CT, FDA

Objectives

  • List three factors that contribute to Luer lock misconnections
  • Identify four examples of Luer lock misconnections resulting in adverse events with patients
  • Discuss elements to include in an education program to recognize and report potential or dangerous Luer lock misconnections

Luer Misconnections: Overview

  • Luer connector misconnections are under-recognized but common and potentially dangerous events
  • Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians mistakenly connect the wrong devices and deliver substances through the wrong route
  • Prevention of these errors is dependent upon the clinician’s knowledge of the Luer connectors used and careful attention to all connections and tubing involved

Food and Drug Administration (FDA)

Promotes the safe and effective use of medical devices, drugs, biologics, foods, and cosmetics through consumer protection programs

  • Foods
  • Drugs
  • Biologics
  • Cosmetics
  • Devices

Center for Devices and Radiological Health (CDRH)

CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and radiological products

FDA and CDRH Medical Device Adverse Event Reporting

  • MedWatch
    • ‘Umbrella’ term for all FDA post-market product adverse event reporting
      • foods, drugs, biologics, cosmetics, devices
  • Medical Device Reporting
    • Center for Devices and Radiological Health (CDRH)

MedSun

  • CDRH’s newest adverse event reporting program is the Medical Product Safety Network (MedSun)
  • 350 site network across the United States
    • consists of large and small hospitals, including teaching institutions and community-based facilities, and nursing homes.
    • Within the MedSun network are subnetworks focusing on clinical specialty areas:
KidNet HeartNet LabNet
TissueNet HomeNet SightNet

MedSun

  • Dedicated to developing a relationship with the clinical community to
    • learn about
    • understand
    • solve

      problems with the use of medical devices.…
And – to feedback timely information to health professionals so they may improve patient safety.

MedSun and Beaumont Hospitals

  • Partnering together to better understand and develop solutions to Luer tubing and catheter misconnections to improve patient safety
    • Perform risk assessment on tubing and catheter connectors in PICU, identifying potential misconnections and assigning applicable severity.
    • Develop educational initiatives to increase awareness on misconnections.

Luer Connectors: History

  • Prior to the 1800s, medication was administered by mouth or inhalation, into the skin, or into an accessible body cavity
  • In 1800s new ways to deliver medications quickly through subcutaneous or IV routes using syringes, trocars, lancets, and cannulas
  • The Luer connector was developed in 1896 by a Parisian surgical instrument manufacturer, the H. Wulfing Luer Company

Luer Connectors: History

  • Luer connectors were designed to securely attach hypodermic needles to glass syringes using a push fitting that also allowed for easy separation when administration was complete.
  • Today, Luer connectors are used worldwide to connect a variety of vascular, enteral, respiratory, epidural, and intrathecal medical devices, components, and accessories.

Luer Connector: Definition

  • The International Organization for Standardization (ISO) describes the Luer connector as a “conical fitting with a 6% taper for syringes, needles, and certain other medical equipment.”

Luer Connectors

  • Luer connectors have a male and a female component that are joined to form a secure yet detachable leak-proof connection.
  • The connection is achieved by use of a push fitting (a Luer slip) or a screw-in threaded fitting (a Luer lock) that joins the male and the female tapered fittings.

The left hand side of the picture shows the clear plastic male end of an IV tubing Luer lock. On the right hand side of the picture is the white female IV catheter connector in to which the male connector fits. Pictures courtesy of Beaumont Hospitals.

Picture Courtesy of Beaumont Hospitals

Examples of Luer Connectors

Here are five pictures that show different brands of I V tubing Luer connectors. The upper and lower left-hand pictures, as well as the middle picture, show the male end of the I V tubing Luer connectors. The lower left hand picture also shows a green arrow pointing to the left and a red arrow pointing to the right of the Luer connector. These arrows indicate that the Luer lock can be loosened by twisting to the left and tightened by twisting to the right. The upper and lower right-hand pictures show the female aspect of an I V catheter Luer slip connector. Pictures courtesy of Beaumont Hospitals.

Picture Courtesy of Beaumont Hospitals

How Do Misconnections Occur?

The Luer connector design allows direct or functional connection between unrelated delivery systems (e.g., vascular, enteral, respiratory, epidural, and intrathecal medical devices, components, and accessories)

Multiple connections between medical devices and tubing are common in patient care

“In a coronary care unit there are as many as 40 connectors on the devices used with a single patient. — not surprising that misconnections are made”

European Committee for Standardization (CEN)

Factors in the Clinical Environment

  • Demographics (increased patient acuity)
  • Fatigue (staffing levels or well-worn equipment)
  • Environmental factors (noise, lighting, etc)
  • Innovation: new medical technologies (new procedures for device operation)

Case 1: Oxygen tubing to a Needleless IV port

  • A child's oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV tubing Y-site.   The connection was broken in seconds, but not before an air embolism caused the child's death.

Oxygen tubing to a needleless IV Port

There are 2 pictures. The picture on the left shows clear oxygen tubing disconnected from its fitting on the nebulizer tubing. The picture on the right shows the same oxygen tubing connected to the injection port of a needleless I V tubing Y-site.

Picture is printed with permission from The Institute for Safe Medication Practices. All rights reserved.

Case 2: Blood pressure tubing to IV catheter

  • A patient went to the ER because of nausea, vomiting, and rectal bleeding. An IV catheter was placed in anticipation of a computed tomography (CT) scan, but no IV fluids or medications had been started
  • The patient also had a noninvasive automatic BP cuff placed for continuous monitoring. The cuff tubing was disconnected when the patient went to the bathroom, and it was reconnected upon return
  • Patient’s spouse found the patient “blue from the neck up.” Despite resuscitation efforts, the patient died. The BP tubing had been connected to the IV catheter and had delivered about 15 ml of air. An autopsy confirmed a fatal air emboli

Blood Pressure tubing to IV catheter

Picture is printed with permission from The Institute for Safe Medication Practices. All rights reserved.

The left hand side of the picture shows the end of a noninvasive automatic blood pressure tubing line. On the right hand side of the picture there are 2 lines pictured. The upper right hand picture shows the end of the blood pressure cuff line that connects with the automatic blood pressure tubing line. The lower right hand picture shows the needleless I V tubing Y-connector port that is capable of connecting with the automatic blood pressure tubing line.

Picture is printed with permission from The Institute for Safe Medication Practices. All rights reserved.

Case 3: Feeding tube to suction catheter

Feeding tube to suction catheter

  • A neonatal night nurse connected a tube-feeding line to a suction-catheter saline installation port instead of to the 10-Fr. Argyle feeding tube.
  • She noted that both connectors looked the same and the room was dark. She also noted that the end cap of the tubing matched that of the in-line suction device (blue-blue).
  • Some of the tube feeding was instilled into the sheath surrounding the catheter.

Feeding tube to suction catheter

The lower left hand corner shows the capped distal end of a nasogastric feeding tube. The right hand side of the picture shows the end of a suction-catheter saline installation port (erroneously) connected to a nasogastric tube feeding line.

Picture Courtesy of Beaumont Hospitals

Color Coding – An Example

Supine lying female mannequin is orally intubated. The cuffed endotracheal tube extends from the mouth and connects to in-line suction tubing that is draped over the sternum and left arm. The in-line suction tubing is connected via a blue locking thumb port to suction tubing that is labeled with a red piece of tape and leads to wall suction. Also coming from the endotracheal tube and extending from the mouth over the neck and to the left of the mannequin is tubing that leads to a continuous subglottic suction port. The end of the port is yellow and it connects to suction tubing that is labeled with a green piece of tape that leads to wall suction.

Picture Courtesy of Beaumont Hospitals

Labeling Lines and Tubes – An Example

Round green sticker reading “Airway Only” is taped to the end of the white capped lavage port of the in-line suction device.

Picture Courtesy of Beaumont Hospitals

Case 4: Anti-embolism stocking pump to heparin lock

  • A patient was admitted for stroke had a pulsatile anti-embolism stocking (PAS) in place on the left lower extremity and none on right lower extremity due to an IV heparin lock in the right ankle.
  • The patient was alert and oriented but 15 minutes later the patient was found unresponsive and cyanotic. Despite aggressive resuscitation attempts, the patient died.
  • The PAS pump tubing was found connected to the IV heparin lock in the patient’s right ankle. The autopsy report indicated that death was due to a massive air embolus.

Anti-embolism stocking pump to heparin lock

There are two pictures that show the same photograph from different angles. On the left hand side of the picture is I V extension tubing with a needleless port that is used for heparin installation. On the right hand side of the picture there is a connection port and the air supply tubing for a pulsatile anti-embolism stocking device. The picture is meant to show how the two devices are unable to physically fit together.

Picture Courtesy of Beaumont Hospitals

The Beaumont Experience

Beaumont Healthcare Facilities

  • Three hospital campuses
  • Over 1,600 patient beds
  • Over 7 million Sq. Ft.
  • 22-Outpatient Facilities, Eye Institute, Renal Center, Imaging Center
  • Recipient of several patient safety & quality awards

Factors that Contribute to Misconnections

  • Disconnections, adapters, Luer fittings, look-alike connectors
  • Focus on equipment design and hospital administrative controls
    • Connector standards are essential
    • Device changes are the best way to prevent misconnections
    • Policy changes and training are needed
    • Pre-purchase acceptance and usability testing are necessary

The Beaumont Experience

  • In 2004, Beaumont created the Misconnections Task Force
    • Membership
      Multidisciplinary approach to address Luer misconnections
    • Mission
      Develop initiatives to prevent misconnections, ensuring a safe and an effective patient care environment

The Beaumont Experience (cont’d)

  • Endorsement
    • Medical and Safety Administration
  • Ad Hoc Groups
    • PICU Ad Hoc Group – Clinical & Human Factors Engineering and Nursing
      • The MedSun/Beaumont Project Phases I & II
    • Education Ad Hoc Group – Educators, Clinical & Human Factors Engineering, Nursing

The Beaumont Experience (cont’d)

A hospital wide memo was initiated providing the following recommendations to hospital staff on preventing potential misconnections:

  • All managers were asked to alert users to the risk of misconnections between different fluid delivery lines.
  • Users were asked to always trace the fluid and air delivery lines from their respective sources before making connections.
  • Users were asked, where possible, to position catheters, feeding tubes, IVs exiting from the patient on different sides of the patient’s body.

The Beaumont Experience – Phase I

  • Risk Assessment in Pediatric Intensive Care Unit (PICU)
    • Gathered all equipment from the PICU storage room, except for ventilator related equipment
    • 165 devices for PICU
  • Database development
    • Identification and classification
    • Photographing of all connecting ends
    • Connector definitions developed

Connector Definition Examples:

There are 3 pictures with examples of tubes that can accommodate Luer connectors. The picture on the far left shows the male fitting of an I V tubing Luer lock with a fixed threaded cuff. The middle picture shows the distal end of an enteral feeding tube with an orange conical male fitting with a 6% (Luer) taper. It is graduated 3 times. The right hand picture shows the white female end of a needleless central I V line adaptor. The blue diaphragm at the end of the tubing is closed.

Picture Courtesy of Beaumont Hospitals

The Beaumont Experience – Phase I

  • Developed severity scale, for potential misconnections
    1. No patient harm and no increased monitoring
    2. Minor injury with increased monitoring required
    3. Moderate injury with therapeutic or diagnostic intervention required
    4. Serious injury which could result in permanent harm
    5. Injury resulting in death

The Beaumont Experience – Phase I

  • Human factors protocols & usability simulations
    • The Beaumont Commercialization Center (BCC)
    • Checklists for equipment evaluations and incoming equipment inspections
  • Development of administrative controls

The Beaumont Experience – Phase I

Administrative Controls

  • General Awareness
    • Presentations & Meetings
    • Articles in Nursing and Pharmacy Magazines
    • PR materials for patients, visitors and caregivers
    • Corporate Policy, “Misconnections Prevention Policy”

Educational Posters

Two posters are shown. The left-hand poster is designed for patients and visitors and requests that these individuals “contact a staff member for assistance with connecting or disconnecting any tubing, wires, equipment or devices.” The poster pictures examples of the types of lines that can be disconnected/misconnected and includes: a Lopez valve, which is a 3-way stopcock for enteral feeding lines; I V extension tubing; the distal end of I V primary tubing; enteral tubing with the drip chamber, blue pull tab that controls the rate of flow and the conical male end. The right-hand poster is entitled “Check Before You Connect” and contains the same picture as the left hand poster but is designed for caregiving staff. Six “Nursing Interventions To Prevent Misconnections” are listed.

The Beaumont Experience Phase I Administrative Controls

  • Educational Initiatives
    • Education Ad Hoc Group to address Joint Commission Sentinel Event Alert
    • On-line training
    • Connector database
    • Computer admission assessment - denied
    • Interactive display - Simulation

Interactive Display

There are two pictures. The large picture in the center of the slide, shows a group of 8 clinicians gathered around a table. A 3-foot tall stuffed toy monkey is in the center of the table. The clinicians are touching and looking at the following lines that are sewn in to the monkey: external ventricular drain, endotracheal tube, in-line suction device, oral feeding tube, nasal cannula, tracheostomy with pilot balloon, chest tube, pericardial catheter, multi-lumen central line, epidural, peripheral arterial catheter, PEG tube, and bladder catheter. The smaller picture in the upper right hand corner shows a supine lying baby mannequin. The medical devices/lines that are pictured in the mannequin are the same as those sewn in to the stuffed toy monkey.

Mr. Monkey Construction

Sewn in:

  • External ventricular drain
  • Endotracheal tube
  • In-line suction device
  • Oral feeding tube
  • Nasal cannula
  • Tracheostomy with pilot balloon
  • Chest tube
  • Pericardial
  • catheter
  • Multi-lumen central line
  • Epidural
  • Peripheral arterial catheter
  • PEG tube
  • Bladder catheter

Mr. Monkey Construction

Box:

  • Epidural tubing
  • Pressure tubing
  • Oral syringes
  • Slip-tip luer syringes
  • Catheter tip syringe
  • Luer-lock syringes
  • Stop cock
  • Peripheral IV tubing
  • Extension tubing
  • Nasal prongs
  • Enteral feeding tubing
  • Urine drainage bag
  • Oxygen tubing

The Beaumont Experience – Phase II

  • Prevalence study
  • All inpatients, on one day we assessed for number and types of connectors.
  • 5 case studies for potential misconnections
  • Refer to Beaumont report to MedSun for findings

The Beaumont Experience – Phase II

  • Case studies for potential misconnections
    • Medical ICU
    • Surgical ICU
    • PICU
    • NICU
    • General Med-Surg

Conclusions

  • Although Luer connector misconnections are a well-known and well-documented issue and each misconnection event carries the potential for a lethal outcome, they continue to occur because Luer connectors are:
    • easily connected to compatible, but unrelated delivery systems
    • widely available
    • easy to use
    • inexpensive

Recommendations

  • Be aware that changes to policy and clinical practice may reduce, but may not prevent Luer misconnections.
  • Encourage manufacturers to develop non-compatible connectors for unrelated delivery systems.
  • Participate in your facility’s connector purchasing decisions.
  • Alert healthcare professionals, patients, and lay caregivers to the potential for Luer misconnections.

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

Internet Websites

Internet Websites (cont’d)

Bibliography

  • 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.

Bibliography

  • Ball C, Westhorpe R. Intravenous equipment—the ongoing development of the syringe. Anaesth Intensive Care. 2000;28(2):125
  • Beaumont Hospitals Royal Oak, Troy, & Grosse Pointe, MI. Phase II: A prevalence study to identify the type of connectors and misconnections between medical devices in a clinical setting. 2008 July
  • Center for Devices and Radiologic Health. (2006). The Food and Drug Administration. Retrieved from database MAUDE http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/search.cfm
  • Eakle M, Gallauresi B, Morrison A, Luer-lock misconnects can be deadly Nursing September 2005
  • ECRI. Preventing misconnections of lines and cables. Health Devices. 2006 March;35(3):81-95. http://www.ecri.org

Bibliography

  • Gallauresi, B.A, Eakle, M., & Morrison, A. (2007) Misconnections between medical devices with Luer connectors: under-recognized but potentially fatal events in clinical practice. Safe Practices in Patient Care. Vol. 3 No. 2 http://www.safe-practices.org/SafePractice8.pdf
  • Health and Environment Sector Committee. Luer connectors: a report to CEN CHeF from the CEN forum task group "Luer fittings" (PD CR 13825:2000). Brussels: European Committee for Standardization; 2000 June 15
  • ISMP. Blood pressure monitor tubing may connect to IV ports. Medication Safety Alert. 2003 June 12. Available from: http://www.ismp.org/newsletters/acutecare/articles/20030612.asp

Bibliography

Bibliography

  • Technical Committee ISO/TC 84. Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment—part 1: general requirements (ISO 594–1:1986). Switzerland: International Organization for Standardization; 1986
  • Technical Committee ISO/TC 84. Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment—part 2: lock fittings (ISO 594–2:1998). Switzerland: International Organization for Standardization; 1998
  • Technical Committee CEN/BT/TF 123 DRAFT “Small bore connectors for liquids and gases in healthcare applications;” (prEN 15546-1: 2006)
  • Webster C. Datascope Customer Letter. 2006 July

 Complete Transcript

Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events 

A MedSun Webcast sponsored by KidNet
November 19, 2008
1:00 – 2:00 p.m. ET

Moderator: Suzanne Rich

Coordinator: Welcome and thank you for standing by. At this time all participants are in a “listen only” mode. Today’s conference is being recorded. If you have any objections, you may disconnect at this time. During the question and answer session you may press “star one” to ask the question. At this time I’d like to turn the call over to Ms. Suzanne Rich. Thank you ma’am. Please begin.

Suzanne Rich: Hi, my name is Suzanne Rich and I want to welcome you to this one hour webcast on Luer misconnections, co-presented by FDA and Beaumont Hospital. I’m a Senior Project Manager with FDA’s MedSun Program and I’m also co-lead of the KidNet subnetwork, part of the larger MedSun network.

First of all, if you have any problems at all during this Webcast – accessing, slides or not being able to hear audio, please contact MedSun at 800-859-9821. Again that number is 800-859-9821.

Before we begin our program today I would like to give you some background about MedSun; for those on the call who may not know about this important patient safety initiative.

The Center for Devices and Radiological Health at FDA learns about problems with medical devices through a variety of mechanisms. One of these mechanisms is the Medical Product Safety Network or MedSun, which is a network of about 350 health care facilities across the US that share information with FDA about problems experienced with the use of medical devices in their clinical community.

MedSun uses an internet based system that is designed to be an easy and secure way to report adverse medical device events. Now within MedSun, we have some networks focusing on learning about medical device related adverse events in clinical specialty areas. KidNet focuses on recognizing and reporting adverse events involving devices used in the neonatal and pediatric patient care areas.

Following our KidNet Roundtable on May 15 of this year, Beaumont Hospitals, which is part of the MedSun and KidNet network, responded to a registration question soliciting input for future Roundtable topics. They suggested Luer Lock misconnections and offered to co-present with us. And that’s what brings us here today. This webcast is being offered to better understand and develop solutions to Luer tubing and catheter misconnections to improve patient safety.

Electronic certificates of participation are available to all registrants after this education program by going to the registration site and filling out a very brief evaluation. Additionally, one nursing contact hour through the California Board of Registered Nursing is available to those who work at participating MedSun sites.

Please note that during this webcast, in order to assist blind participants, the speakers will verbally note when the slides are being advanced. Again, if you have any questions about or are having difficulty with accessing the slides or hearing us, please call MedSun at 800-859-9821. Next slide.

Our objectives for today’s discussion are to list three factors that contribute to Luer lock misconnections, identify four examples of Luer lock misconnections resulting in adverse events with patients, discuss elements to include in an education program to recognize and report potential or dangerous Luer lock misconnections. And one that’s not listed there is to be able to share some of our experiences and questions with each other.

Now I would like to introduce our first speaker, Beverly Gallauresi, RN, MPH, who until just recently was a nurse analyst here at CDRH reviewing medical device adverse events reports involving a variety of cardiovascular and other clinical specialty area devices. She has just accepted a position in the Office of Women’s Health in the FDA’s Office of the Commissioner and has come back to join us for today’s webcast. Beverly? And next slide please.

Beverly Gallauresi: Thank you Suzanne. Good afternoon everyone. I want to give you a brief overview regarding Luer misconnections. Luer misconnections are under-recognized but common and potentially dangerous events. Luer connectors easily link many medical components, accessories, and delivery systems.

Clinicians mistakenly connect the wrong devices and can deliver substances through the wrong route. Prevention of these errors is dependent upon the clinician’s knowledge of the Luer connectors used and careful attention to all connections and tubings involved. Next slide please.

Here at the Food and Drug Administration we promote the safe and effective use of medical devices, drugs, biologics, foods, and cosmetics through a consumer protection program. Next slide please.

At the Center for Devices and Radiological Health, our mission is to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and all radiological products. Next slide please.

The FDA and CDRH medical device adverse event reporting consists of different types of programs. The first is MedWatch, which is utilized for all FDA postmarket product adverse event reporting. Through MedWatch you can report any adverse events with food, drugs, biologics, cosmetics, or of course medical devices. There is also the medical device reporting segment. Next slide please.

Suzanne has already given you a bit of background regarding the MedSun program. It is CDRH’s newest adverse event reporting program and as Suzanne stated, it consists of a network of 350 hospitals across the United States; and they do consist of both large and small hospitals including teaching institutions, community based facilities and nursing homes.

And as was also brought forward, MedSun itself consists of many other subnets -- KidNet, HeartNet, LabNet, SightNet, HomeNet, and TissueNet. Next slide please.

MedSun is dedicated to developing a relationship with the clinical communities to learn about, understand, and solve problems with the use of medical devices and to give timely feedback and information to help professionals so that patient safety can be improved. Next slide please.

MedSun has partnered with Beaumont to better understand and develop solutions to Luer catheter tubing misconnections so that patient safety can be improved. Beaumont performed risk assessments on tubing and catheter connectors in the PICU identifying potential misconnections and assigning applicable severity. Beaumont also developed an educational incentive to increase awareness on misconnections. Next slide please.

I’d now like to give you a little bit of history about Luer connectors and how they came about and how they have progressed over time. Prior to the 1800s, medications were administered by mouth or inhalation, into the skin or into an accessible body cavity. In the 1800s, new ways were developed to deliver medications quickly through subcutaneous or IV route, using syringes, trocars, lancets and cannulas.

The Luer connector was developed in 1896 by a Parisian surgical instrument manufacturer, the H. Wulfing Luer Company; therefore, that’s how we get the name Luer connector. Next slide please.

Luer connectors were designed to securely attach hypodermic needles to glass syringes using a push type fitting that also allowed for easy separation when administration was complete. Today’s Luer connectors are used worldwide to connect a variety of vascular, enteral, respiratory, epidural, and intrathecal medical devices components and accessories. Next slide please.

The International Organization for Standardization, or ISO, describes the Luer connector as a “conical fitting with a 6% taper for syringes, needles, and certain other medical equipment.” Next slide please.

Luer connectors have a male and female component that are joined to form a secure yet detachable leak-proof connection. The connection is achieved by using a push fitting, which is known as a Luer slip or a screw-in threaded fitting, a Luer lock, that joins the male and the female tapered fittings. Remember this is a general high level definition of Luer connectors. There are many different types of Luer connectors used in multiple applications. Next slide please.

These are just some examples of Luer connectors. And you can see that there certainly is a variety of them. And these photos are courtesy of Beaumont Hospital. Next slide please.

And now we get to the meat of this topic -- how the misconnections occur. The Luer connector design allows for direct functional connections between unrelated delivery systems that includes vascular, enteral, respiratory, epidural and intrathecal; medical devices, components and accessories.

Multiple connections between medical devices and tubing are common in patient care. In fact, it’s estimated that in the coronary care unit there can be as many as 40 connectors on the devices used with a single patient. So it’s certainly not surprising that misconnections occur. Next slide please.

Factors in the clinical environment which may cause or contribute to Luer tubing misconnections: demographics -- certainly now patients have an increased acuity level, fatigue -- staff members are asked to work longer hours, and the device equipment may be outdated. There are environmental factors: noise -- everyone certainly knows how noisy it can be in an ICU or a PICU unit -- lighting and other environmental factors.

Then on the other end of the spectrum there’s innovation. There’s so many new medical technologies, newer procedures, newer devices, and certainly more training that’s involved with these devices. The higher patient acuity is associated with a greater variety of treatment modalities and associated routes of therapies and administration. There are more connections and more connectors. There’s urgency of time constraints. There are medication variation complications, and there’s certainly no room for do-overs. Next slide please.

What I’m going to do now is present to you some cases - they’re actually based on adverse event reports that were submitted to the Food and Drug Administration. And I want to make it very clear that although there are photos that go with these pictures, the photos - some of which are courtesy of Beaumont Hospitals, do not indicate that these adverse event reports were in any way associated with Beaumont or submitted to the FDA from Beaumont.

The first case is oxygen tubing to a needle-less IV port. A child’s oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV Y-site. The connection was broken in seconds, but not before an air embolism caused the child’s death. Next slide please.

And as you can see, this is an example of the oxygen tubing to a needle-less IV port. In Figure 1 you see the tube delivering the oxygen fell off the nebulizer and then in Figure 2, the oxygen tube was inadvertently connected to the needleless port. Next slide.

The second case involved different tubing but the outcome was certainly the same, deadly. It was blood pressure tubing to an IV catheter. The patient was admitted to the ER because of nausea, vomiting and rectal bleeding. So it was certainly not in any way, case or form a life-threatening situation, but it certainly became that way.

An IV catheter was placed in the patient because they were going to be receiving a CT scan. Although it was just a heparin lock at that point, no IV fluids or meds had been started. The patient also had a non-invasive automatic blood pressure cuff placed for continuous monitoring because the patient was having rectal bleeding. The cuff tubing was disconnected when the patient went to the bathroom, and upon return, it was reconnected. The patient’s spouse then found the patient blue from the neck up. And although there were resuscitation efforts, the patient died. The BP tubing had been connected to the IV catheter and so in the next round of inflation, the automatic blood pressure cuff instilled air into the IV tubing. The autopsy confirms that there was a fatal air embolism. Next slide please.

And here you can see on this slide to the middle left side there is the gray automatic blood pressure tubing, and you can see that there is the IV catheter. And that was the error; because they were compatible. However, as an example of market driven change based on clinician suggestions, some manufacturers are now producing blood pressure tubing that is no longer compatible to IV tubing. Next slide.

In Case number 3, this is a feeding tube suction catheter. A neonatal night nurse connected a tube feeding line to the suction catheter saline installation port instead of to the 10 French argyle feeding tube. She noted that both connections looked the same and the room was dark. She also noted that the end cap of the tubing matched that of the in-line suction device, so it was a blue to blue connection.

Some of the tube feeding was instilled into the sheath around the catheter; however, the child did survive. There is tubing that is able to be used for IV solutions as well as enteral feeding solutions. In response to this, some manufacturers have developed specific enteral feeding tubes that are compatible with neonatal internal feeding tubes. Next slide please.

And this shows the example in this photo. If you can see toward the back left, it is a blue tube - the end of the tube. And then you can also see that each end cap is baby blue, which facilitated the incorrect connection. Next slide please.

So since we’re talking about color coding, here’s an example. Color coding can provide consistency, or can it be confusing? To avoid confusion between continuous suction of the endotracheal tube, the ICU departments of Beaumont decided to label the endotracheal suction with green tape. Green because oxygen is green, and other suction tubes red. Red because the top of the suction devices are also red.

Here the top of the endotracheal suction tube is yellow. There are issues to consider. Consistency in colors used to label lines from unit to unit and institution to institution; because certainly if a patient is transferred from one institution to another, how does one know if there’s consistency across all of the hospitals?

And even if the color scheme is committed to memory, equipment can always change. And it’s also been brought to light that some clinicians are after all color blind, and so then the whole color scheme just goes out the window. Next slide please.

Labeling lines and tubes. A possible solution is new labeling from companies that allows the end user to apply a sticker to tubing. The sticker in this slide says Airway Only and is green -- once again green indicates oxygen. Next slide please.

Case 4, our last case, is an anti-embolism stocking pump to heparin lock. These anti-embolism stockings are also known as pneumatic compression devices or sequential compression devices. A patient was admitted for a stroke

and had pulsatile anti-embolism stocking -- or PAS -- in place on the left lower extremity, but not on the right lower extremity, as that was the only area they were able to access an IV line. So they placed an IV heparin lock in the right ankle.

The patient was alert and oriented at this point, but 15 minutes later was found unresponsive and cyanotic. Despite aggressive resuscitation attempts, the patient died. It was noted that the PAS pump tubing was found connected to the IV heparin lock at the patient’s right ankle. Once again, the autopsy report indicated that the death was due to a massive air embolism. Next slide please.

This slide shows an anti-embolism stocking pump next to a heparin lock. But this is a Beaumont success story. Now Beaumont does not have PAS tubing that can connect to heparin locks. So the adverse event that I just told you about will not occur at any Beaumont hospitals because they have updated equipment, and so therefore this will not occur. Next slide please.

And now back to Suzanne so she can introduce the next speaker, who is a Beaumont employee. Thank you so much.

Suzanne Rich: Thanks, Bev. Alyson Phillips is our next speaker. She’s a clinical engineer with the Clinical Engineering and Technology and Management Department at Beaumont Hospitals in Royal Oak, Michigan. She’ll begin by giving us some background on Beaumont hospitals and their involvement in Luer connections, safety, and research initiatives. Alyson?

Alyson Phillips: Suzanne, I have been involved in the Beaumont Misconnections Taskforce as well as the MedSun Beaumont project phases, and I’m going to tell you about the Beaumont experience.

Beaumont is a teaching and research center with three large hospital campuses and 22 outpatient care buildings including an eye institute, renal center and imaging center. Beaumont has over 1500 patient beds spread over 7 million square feet. As one of the busiest hospital systems in the US, our dynamic environment provides a wealth of opportunities to study the needs of medical device users in controlled settings. Beaumont is a recipient of several patient safety and quality awards. Next slide please.

Factors that contribute to misconnections -- disconnections, adapters, Luer fittings, and look-alike connectors. To prevent misconnections, we can focus on equipment design and hospital administrative controls. Administrative controls are when the hospital purchasing department gets involved in decisions and hospital administrators and management make policies.

To prevent misconnections, connector standards are essential. Device changes are the best way to prevent misconnections. Policy changes and training are needed. Pre-purchase acceptance and usability testing are necessary. Some misconnections articles and alerts include the ECRI guidance article from March 2006 called Preventing Misconnections of Lines and Cables. There’s also the Sentinel Event Alert 2006 called Tubing Misconnections: A Persistent and Potentially Deadly Occurrence.

I’m going to review some statistics. The 1999 Institute of Medicine report stated that medical errors kill more people in hospitals yearly in the United States -- between 44,000 and 98,000 -- than those who die from AIDS, which is around 16,000, motor vehicle accidents around 43,000, or breast cancer 42,000.

Also, the total national cost for preventable adverse events ranges between $20 billion to $75 billion annually. And that is from the Institute of Medicine and the FDA. And lastly, over 290,000 medical device reports per year are received by the FDA. More than 1/3 of these reports involve use errors. And use errors are often linked to design flaws. Next slide please.

In 2004 Beaumont created the Misconnections Taskforce. The membership of the taskforce was based on a multi-disciplinary approach to address Luer misconnections. The mission of the taskforce is to develop initiatives to prevent misconnections, ensuring a safe and an effective patient care environment. Next slide please.

The taskforce is endorsed by the Medical and Safety administration at Beaumont. Ad hoc groups were developed. This includes the PICU ad hoc group, which has representatives from clinical and human factors engineering and nursing.

This group led to the MedSun Beaumont project Phases 1 and 2. Another ad hoc group is the education ad hoc group. This group includes educators, clinical and human factors engineering, and nursing. The Misconnections Taskforce deliverables were to develop educational tools and resources and also to create an educational presentation, including presenting at the MedSun Conference in March 2007. The MedSun Beaumont project Phase 1 was completed in April 2007, and project Phase 2 was completed in July of 2008. Next slide please.

A hospital wide memo was initiated providing the following recommendations to hospital staff on preventing potential misconnections. All managers were asked to alert users to the risk of misconnections between different fluid delivery lines. Users were asked to always trace the fluid and air delivery lines from their respective sources before making connections.

Users were asked, where possible, to position catheters, feeding tubes, IVs exiting from the patient, on different sides of the body. And I’m going to turn it back over to Suzanne.

Suzanne Rich: Thanks Alyson. Our final speaker is Tammy Muczinski, MS, RN, CPNP-PC, which means that she’s certified in pediatric and primary care as a nurse practitioner, and she’s currently a Clinical Informatics Specialist with Beaumont Hospitals in Royal Oak, Michigan.

Tammy will take us from Slide number 33 through the end of our presentation.

Tammy Muczinski: Hi, everyone. I’d like to say a special hello to our Canadian friends. I’d just like to say that I am engaged to a Canadian from Tofield, Alberta, so I’m glad to have you on our call.

At the time of the Phase 1 study, I was the Clinical Nurse Specialist for the pediatric intensive care unit, and I wanted to revert a little bit backwards to let you know who was on our hospital wide committee. Actually it was an institution wide committee. We had members of Purchasing, members from our public relations team, Nursing of course, Clinical Engineering, managers, and physician representation.

At the time, one of the things we didn’t know was - what are the potential problems. So I volunteered the PICU. We went shopping in the PICU storage room and we gathered one or several of every single piece of equipment that the PICU had. And as you can imagine, it’s a very expensive endeavor, but much supported by the management team of the PICU. All in all we collected 165 devices not including any ventilator related equipment.

From that, the Clinical Engineering department and some clinical engineering interns and I met on a weekly basis. We identified, photographed, and classified not only all of the products, but every single little connecting end of the product.

At first we tried to classify the device connectors or the devices by the substances they carried -- for example gas, fluids, et cetera, -- but it became apparent that we should classify the devices by the anatomical destination. Next slide please.

Here you can see some examples of connecting ends. Luers you’re all familiar with. The middle picture is a conical male. As you can see, the gradation in size is greater than 6% so we called that a cone, and then the end of the needle-less adapter, which has a diaphragm.

Some of the devices actually had up to eight connections in the PICU and up to 36 connections in one of the adult ICUs. And I’ll talk about that later. Next slide please.

During Phase 1 development, what we wanted to do was develop a severity scale of what would happen if two devices that were not meant to be connected were accidentally connected together. This was a score from one to five, one being no patient harm and no increased monitoring to five -- injury resulting in death. Next slide please.

We’re very fortunate in our institution to have the Clinical Engineering department, which actually has hired a human factors engineer. We also have a Beaumont Commercialization Center which partners with businesses in the community to look at medical device equipment. And they developed a checklist for equipment evaluations for incoming and also equipment that’s being used for trials here at Beaumont. And then we developed administrative controls which I’ll talk about later. Next slide please.

Our administrative controls - what we did is we got Purchasing involved. And then they got a checklist that they go through now, and our management team came up with a policy. Our goal was general awareness about the problem of misconnections, because I think everyone has heard of them but doesn’t know the severity of the problem.

We presented our findings at meetings, we did poster presentations, we published articles in both nursing and pharmacy magazines throughout the Beaumont institutions. PR helped us develop materials for patients, visitors, and caregivers. And as I said before, we developed a corporate misconnections prevention policy. Next slide please.

There you have a screen shot of the posters that were put together with PR. You can see the one on the left is real quick and easy to read, and that’s for patients and visitors. The poster on the right is for staff members. And basically what it says is we - taking the Joint Commission’s recommendations for preventing misconnections. We’ve placed it on the poster. And the one thing was always trace the line back from site of origin back to the machine. Next slide please.

I did want to say that one of the administrative controls we tried was to get a checkbox on a patient transfer sheet that says, “I am the nurse and I have traced all my lines back,” but we were shot down on that. We were also shot down on suggested changes to adverse event reporting. Some of you may call them incidents reports. We wanted to have a special checkbox on there to identify whether a misconnection had occurred or not, and were shot down in that endeavor as well.

As for our educational initiative -- we developed an educational ad hoc group from the big committee, and we focused on the Joint Commission Sentinel Event Alert. We did some online training, because that was the best way that we could reach our physicians. We established a connector database. We already talked about the computer admission assessment, and we - our biggest accomplishment was the development of an interactive simulation display. Next slide please.

Because many of us are very visual and psychomotor learners, we thought we could all learn by doing. Your institution can adapt something like this to whatever population you are serving. Our initial prototype was the baby mannequin in the upper right corner. We had to retire the baby mannequin because a lot of employees were too disturbed by seeing the baby with all these devices in them.

So we decided to use a stuffed monkey. And inside the monkey we have various pieces of equipment sewn in. You can achieve this by using a fishing line and upholstery needles to sew into the stuffed monkey. We wanted all the nursing staff to apply the worst case scenarios imaginable when doing these visual connections. Next slide please.

Here’s a list of the items sewn in to the monkey. Some of the items include: an oral feeling tube, an arterial line, a chest tube, a bladder catheter, et cetera. Next slide please.

From the picture of two slides before, you saw that the nurses were playing with a clear box. Inside the box are possible connectors, and here’s a list of the connectors that were in the box. We cut them down so that they could all fit in one easily transportable box. Next slide please.

So that concluded our Phase 1. We were approached to do a Phase 2 study also, and it was a prevalence study. We are about a 1000 bed hospital, and in March of 2008 we decided to visit every patient on every unit and count up their number of connectors.

We visited 782 patients that day. We didn’t assess labor and delivery, peri-op or operative areas. We identified 240 products for use in patient care areas for that day. The top five products found -- and I don’t think these will come as any surprise -- were primary IV tubing, angio IV catheters, six inch IV extension tubing, foley catheters, and secondary IV tubing. Next slide please.

During our prevalence study, we decided to pick five patients - five example patients, gather all their equipment up in a room and see what potential misconnections we could make for five patients. Our sample included a medical ICU patient, surgical ICU, pediatric ICU, neonatal and then general med-surg patient. And we tried to pick the patients who had the highest amount of products on them so they might have the most potential for misconnections.

Two clinical nurse specialists and a representative from a local university were there to look for potential misconnections. When we made the misconnections, we provided a severity score, and these results can be found in our paper, which is referenced in the bibliography.

In conclusion, although Luer connections are a well known and well documented issue, each misconnection event carries a potential for a lethal outcome. They continue to occur because Luer connections are easily connected to compatible but unrelated delivery devices. They’re used widely, they’re easy to use, and they’re inexpensive. And right now I’m going to turn it over to Suzanne.

Suzanna Rich: Okay…looking at the recommendations. And I think a lot of these are pretty much no-brainers based on what you’ve been hearing, but it’s useful to be reminded once again. We need to be aware that changes to policy and clinical practices may reduce but may not prevent Luer misconnections; that we need to encourage our manufacturers, if they ask us what do we want and what do we need, to develop non-compatible connectors for unrelated delivery systems. We need to participate in our facility’s connectors purchasing decisions, and we are also -- all of us: government, academia, professional practice organizations, as well as practitioners -- need to alert health care professionals, patients, and lay care givers to the potential for Luer misconnections.

Now I think we’re about ready to provide an opportunity for some questions and answers. We received several questions on our registration website and tried to address them in the presentation, but we invite you to call in any questions that you may have at this time and we’ll see if we can’t address them.

Please just use your first name for confidentiality purposes.

Coordinator: Yes. If you’d like to ask a question, please press star one. To withdraw the question you can press star two. Again, to ask a question press star one.

(Caller): Yes, can I have a written copy of the PowerPoint?

Suzanne Rich: It’s on the registration website and you’re welcome to download it. And if you’ve got any questions you can call us at MedSun at 800-859-9821.

Suzanne Rich: Do you have anything else to ask?

(Caller): That’s it. Thank you very much.

Suzanne Rich: Okay, thanks.

Coordinator: We have another caller. Your line is open.

(Caller): Yes, thank you. Can someone describe what is involved with a line reconciliation policy?

Suzanne Rich: Let’s see, Tammy?

Tammy Muzinski: Oh I’d be happy to take that. The policy that we wrote was a misconnection prevention policy so we kind of combined our administrative controls with our nursing controls. We combined our purchasing requirements in that Beaumont will not purchase non-intravenous equipment with connectors that can physically mate with Luer lock lines unless there is no other option, and all purchasing of equipment passed through our clinical and Biomedical Engineering department.

Before when we had issues where physicians or nurses would need products, they’d contact the vendor themselves. They would totally bypass our Clinical Engineering department. So now it has to go through Purchasing and they have that checklist they developed, which is some - what they call acceptance testing.

But for line reconciliation, for the clinical staff, they have to always trace the tube or catheter from the patient to the point of origin before connecting a new device or an infusion. And also on transfer of care, they - whenever possible, they have to route the IV line toward the head, the enteric lines towards the feet. And again whenever possible, some space considerations or issues may need to be taken into account.

They must inform non-clinical staff that whenever the patient gets up or they need to reconnect things, to go get a clinical person to put the catheters or the connectors back together, because one thing we focus on in talking about misconnections is the involvement of the medical professionals, but also, patients and visitors think they’re being super helpful -- and they try to put pieces of equipment together.

One of the other things we also said was to use oral syringes to deliver medication. But we quickly found out that the oral syringes that we carry here at our hospital don’t fit into our enteral feeding tubes. So we’re still working on trying to find a syringe that would actually fit into our feeding tubes. Our pharmacy does dispense oral medication syringes, but the nurses have to transfer the contents to an IV syringe. So that is what’s involved in a reconciliation policy.

(Caller): Thank you very much.

Tammy Muzinski: You’re welcome.

Suzanne Rich: Do we have anyone else on the line?

Coordinator: At this time we have no further questions.

Suzanne Rich: Okay. I wanted to go over a couple of questions received on the registration website that I thought our listeners might want to hear about. The first is how to involve front line staff in reporting. And the reason I wanted to make sure we got to this is we’ve got a wealth of information that’s available in terms of educational materials.

And if you go to www.FDA.gov\CDRH\MedSun -- that’s also on the bib and references -- you will note that under the educational material section there’s a Recognize, Remove, Report DVD that’s about 20 minutes long and is quite interesting and helps exemplify how important it is for us as caregivers on the front line to not only recognize and identify potential problems but also to report them.

There’s also some downloadable slides and scripts targeting general pediatric and In vitro diagnostic devices that have examples of reported events from those areas.

Also that website has the MedSun newsletter that’s updated monthly. And it also has sections that are broken out for each of the subnetworks, and we also have some medical device summaries of reported events that we’ve received through our MedSun reporting program.

Coordinator: I have someone on the line.

Suzanne Rich: Oh yes. Let’s go ahead and take that one.

Coordinator: Okay. Caller your line is open.

(Caller): Yes, I just was curious to learn what plans there might be for collaboration across hospitals and with FDA to look at standards, you know, rather than approaching manufacturers on a one-to-one kind of a basis to look at what standards - what efforts there might be in process to develop standards.

Suzanne Rich: Well we would welcome any collaborating. And I’m thrilled. What we like to do is we’d like to try to work as collaboratively as we can with our industry, academic and clinical partners to identify and work out some possible solution strategies to medical devices problems. What I would like you to do so that I can get back with you, is have you call the 1-800-859-9821 number so I can give you a call back and we can initiate dialogue.

Tammy Muzinski: This is Tammy. There are some international efforts to develop standards. AAMI -- or the Association for the Advancement of Medical Instruments -- is trying to develop systems to prevent cross-connections, and they’re developing international standards for small connections in six areas -- general, enteral, urinary applications, limb cuff, (no-axial), and Luer lock fitting. And I think that agency will develop some standards to go to device manufacturers.

Suzanne Rich: Thank you caller. Did we answer your question?

(Caller): Yes, that’s fine. Just as there’s an opportunity as we come up with some findings and recommendations that they can be input into the consensus both for FDA and for AAMI, which I was aware of.

Suzanne Rich: Right. That’s great.

(Caller): Thank you.

Suzanne Rich: I think the new business mode is for everyone to play together so to speak. And, yes absolutely. So we appreciate that. Is there anyone else on the line?

Coordinator: I show no further questions.

Suzanne Rich: Okay. I wanted to get to two questions that came to us via the registration website. One, I’m going to ask Tammy and then follow up with Bev. Tammy, there was a question about whether there are systems to prevent cross connections with Luer locks?

Tammy Muzinski: Some devices have hard stops in them where the (more solid ‘G’) and the shape of the connector can only be connected one way. Those aren't universal yet, obviously, but some companies are addressing that potential, and then all of the AAMI things, which I spoke about earlier.

Suzanne Rich: Okay, great. And there was one final question that I’d like to have Bev address, and that was where was a question that came in about what companies have introduced technology that avoids misconnections? And I’m going to have Bev just share some of her perspective from the FDA.

Beverly Gallauresi: Well I think that’s a great question; however, being the FDA, we cannot endorse or promote any specific product or device. However, there’s an article in your bib that I co-authored in the journal of Safe Practices in Patient Care entitled Misconnections between medical devices with Luer connectors: under-recognized but potentially fatal events in clinical practice and it does give a little insight, but the main thing that as clinicians you have to really press is the manufacturers and let them know that you do not want to purchase devices that can be connected or misconnected. And this is really a market driven issue at this point, and obviously because some of the manufacturers are changing their products to make them safer and to increase the patient safety.

So that’s the best information that I can give you from the FDA is to continue to push your hospital purchasing agent to do the right things so to speak. I’m sure that probably some of these newer devices may be more expensive, but in the long run it certainly would - if it saves a patient life or - and of course saves your hospital from being sued, then it’s much wiser to get something that’s a safer device.

Suzanne Rich: Okay, thanks Bev. Once again I’m going to just check with the operator to see if we have any other questions.

Coordinator: Not at this time.

Suzanne Rich: Okay. Well then what I’d like to do is - wait I’ve got one other question from someone here. We have some of our staff attending.

Diana: Hi, my name is Diana. And in the spirit of collaboration, what is the website for AAMI please? This’ll help all of us get on board.

Tammy Muzinski: It’s www.aami.org

Diana: Thanks very much. This’ll definitely help all of us to be able to collaborate together.

Suzanne Rich: Great. Well at this point I just want to remind everyone that the slides are posted on the registration Website. If you want to download them, that’s wonderful. If you are interested in joining MedSun or any of the subnetworks including KidNet or if you have any additional webcast related questions, please call us -- 800-859-9821.

And one other thing is that electronic certificates of participation are available to all registrants by filling out a brief evaluation on the registration site. Your feedback’s really important to us because it really helps us to improve our educational programs and outreach to device users.

Additionally, one nursing contact hour is available to those who work at participating MedSun sites. We thank you for your participation today. This ends our call.

Coordinator: Thank you. You may disconnect at this time.

END