MedSun's KidNet - A Model for Patient Safety
MedSun: Newsletter #59, April 2011

Suzanne Rich, RN, FCN, MA, CT
MedSun/OSB Division of Safety Partnerships

KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

The goals of KidNet are: (1) to improve the recognition, reporting, and understanding of device-related adverse events occurring with pediatric patients, especially those in NICUs or PICUs, and (2) to develop a clinical community to validate signals of actual or potential medical device problems affecting NICU or PICU patients. This concept is based on collaboration and communication between FDA, KidNet participants, and device manufacturers, in order to better understand device safety and to identify solution and prevention strategies to address identified problems.

Currently, 48 of the 350 MedSun nationwide network of hospitals are participating in KidNet. A little over a third of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. We launched KidNet in June 2007. Although the focus of KidNet is on device-related problems occurring in the NICU or PICU, reports of ‘near-miss’ or ‘close-call’ events, and events representing ‘a potential for harm’ involving pediatric patients that occur in other areas of the hospital are also welcome.

For calendar year 2010, MedSun, from the entire complement of participating hospitals, received a total of 556 reports from 100 hospitals involving pediatric patients (those with ages less than 21 years).

Of these, 108 are from sites participating in KidNet; reports were received from 32 of the 48 KidNet hospitals. This represents an increase in both the number of KidNet reports and the number of KidNet hospitals submitting reports; 62 reports were received from 21 of the 42 MedSun hospitals participating in KidNet during 2009. The data discussed in this article are derived from the 108 KidNet reports received in 2010.

This bar graph illustrates the number of KidNet reports received by quarter. These reports were submitted by KidNet participant sites over the 2010 calendar year. The 108 KidNet reports have been grouped by quarter (1st quarter, 2nd quarter, 3rd quarter, 4th quarter). The x-axis corresponds to quarter; the y-axis corresponds to the number of reports. Left to right description of image: of the 108 KidNet reports received in 2010, the light purple data point shows that 15 KidNet reports were received in the 1st quarter. The burgundy data point shows that 29 KidNet reports were received in the 2nd quarter. The yellow data point shows that 35 KidNet reports were received in the 3rd quarter. The tallest data point, depicted by a light blue bar shows that 29 KidNet reports were received in the 4th quarter.

As part of the larger MedSun network, KidNet emphasizes the importance of device users recognizing and reporting device related adverse events that occur in NICUs and PICUs. To this end, we provided learning opportunities for MedSun KidNet hospitals through on-site presentations for healthcare professionals working in NICUs and PICUs to raise their awareness of the need to identify and report device-related problems for those vulnerable patients. We plan to continue offering learning opportunities via webcast to those KidNet hospitals that weren’t able to participate in the on-site presentations during 2010.

All but three of the 2010 reported events from KidNet involve device-related problems described as minor harm, potential for patient harm, or close call events. Three reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury). There were no KidNet reported events in 2010 associated with a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2010. The 108 reports are categorized by event type, specifically by the categories of: device problems, serious injury, and death. Of the 108 reports, 105 reports were submitted as product problems, depicted by a light purple pie wedge. 3 reports were submitted as serious injury and 0 reports were submitted as death, which is depicted by burgundy and yellow pie wedges, respectively.

The three reports describing serious injury events (those requiring medical or surgical intervention taken to prevent permanent impairment or damage) involve a peripheral IV catheter, a peripherally inserted central venous catheter (PICC), and a neonatal electrocardiograph electrode. Both events with the catheters cite leaking at the catheter hub requiring catheter removal. The PICC catheter broke upon removal, necessitating surgical removal of a retained catheter fragment. The event involving the neonatal electrocardiograph involves a burn mark noted when the electrode was replaced.

The 108 KidNet reports reference 124 devices, of which there are 41 different types. The number of devices is greater than the number of reports as more than one device may be referenced in a report. The 41 reported device types have been grouped into 6 clinical medical specialty areas as defined below for the chart that follows.

(1) IV devices –
IV tubing, PICCs, infusion pumps, umbilical artery catheters, short term peripheral IV catheters, central venous catheters, implanted ports, thermal infusion fluid warmer, infusion line filter

(2) CV/Neurology devices -
EKG electrodes, cardiopulmonary bypass devices, thermal regulating systems, physiological monitor, blood pressure monitor transducer, central nervous system shunt, intracranial pressure monitor

(3) AN/Respiratory devices –
high frequency ventilators, tracheostomy tubes and cuffs, oximeters, respiratory humidifiers, ventilator tubing, nebulizer, tracheobronchial suction catheter, anesthesia gas machine, manual emergency resuscitator

(4) All other reported devices –
implantable staple, electrosurgical cutting and coagulation devices, bronchoscopes, arthroscopes, patient data software, flotation therapy mattress, blood lancet

(5) Neonatal/pediatric devices- infant heel warmers, neonatal transport incubators, liquid medication dispenser, circumcision clamp, infant radiant warmer

(6) GI/GU devices – dialyzers, gastrointestinal tubes, genitourinary catheter accessories, feeding tube

This bar graph illustrates the number of reported medical devices by type in 2010 KidNet reports. The 124 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to type of device; the y-axis corresponds to the number of reports in descending order. Left to right description of image: of the 124 devices reported in 2010, the tallest data point, depicted by a light purple bar, shows the number of reports that involve Intravenous (IV) devices. The burgundy data point shows the number of reports that involve Cardiovascular/Neurology devices. The yellow data point shows the number of reports that involve Anesthesiology/Respiratory devices. The light blue data point shows the number of reports that involve All Other device types. The dark purple data point shows the number of reports that involve Neonatal/Pediatric devices and the peach data point shows the number of reports that involve Gastroenterology/urology devices.

Reported patient demographics include patient age and gender. Patient gender was provided in 87 of the 108 KidNet reports. There are almost twice as many reports involving males as females.

This pie chart illustrates the number of 2010 KidNet reports that specify patient gender. The 87 reports are categorized by gender, specifically by male and female. Of the 87 reports, 56 reports involving male patients were submitted, which are depicted by a light purple pie wedge. 31 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

The patient ages provided in 85 of the 108 KidNet reports range from 1 day to 21 years with the majority involving patients 0-30 days old.

The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels online available at: http://www.fda.gov/cdrh/ode/guidance/1208.html.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2010 KidNet reports. The 85 reported patient ages have been grouped by pediatric subpopulations. The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of reported patient ages. Left to right description of image: of the 85 reported patient ages in 2010, the tallest data point, depicted in light purple shows that 43 reports involve newborn patients (0-30 days). The burgundy data point shows that 19 reports involve infant patients (30 days-2 years). The yellow data point shows that 6 reports involve child patients (2 years-12 years). The light blue data point shows that 17 reports involve adolescent patients (12-21 years)

Information on the device user was provided in 57 of the 108 KidNet reports with the nurse most frequently cited as the device user and family members least frequently noted as using the device in the report.

This pie chart illustrates the number of reports by device users - who was operating the device at the time of the event – in 2010 KidNet reports. 57 KidNet 2010 reports indicate the device user. The largest segment in light purple shows that nurses were operating the reported device at the time of the event. The burgundy segment shows that doctors were operating the reported device at the time of the event. The yellow data point shows the reports that identify other allied health providers as the user operating the reported device at the time of the event. The light blue data point indicates that a family member was using the device at the time of the event.

In the fall of 2010, KidNet sponsored a webcast on PICC and Umbilical Catheter Safety featuring educators from participating MedSun KidNet hospitals. The webcast discussed how to optimize patient safety when inserting and maintaining peripherally inserted central venous catheters (PICCs) and umbilical catheters in the neonatal patient. Examples of medical device adverse events with safety tips to manage and prevent problems associated with PICCs and umbilical catheters in the neonate were also presented.

Printable presentation slides and a video of the slide presentation are available for this webcast online at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm234684.htm.

Additional educational materials from prior MedSun KidNet programs are available online at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112724.htm.

Reporting medical device problems seen in the neonatal and pediatric clinical settings promotes patient safety. MedSun KidNet reports are associated with manufacturer actions taken to address device problems including leaking catheter luer hubs, smoking infant warmers, monitor screens spontaneously blanking, and patient burns associated with neonatal transilluminators used to locate veins for vascular access.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of KidNet or MedSun, or through your hospital’s reporting policy. If you are not affiliated with a MedSun hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related problems a model for patient safety.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun