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U.S. Department of Health and Human Services

MedSun: Newsletter #71, April 2012

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Newsletter #71, April 2012

Articles

FDA Continues to Study BPA

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FDA Consumer Update

Bisphenol A (BPA) is a chemical used in the production of plastics and resins, such as some water bottles and the coatings of some food cans. It is also used in some consumer goods, such as compact discs and thermal cash register tapes. BPA has generated controversy about its impact on human health and development. The Food and Drug Administration’s assessment is that the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe. FDA is continuing its research and monitoring of studies to address uncertainties raised about BPA.

Additional Information:

FDA Consumer Update. FDA Continues to Study BPA. March 30, 2012.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm297954.htm

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Acclarent Inspira AIR Balloon Dilation System - Class 1 Recall

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FDA MedWatch Safety Alert

Acclarent received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. In each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. The force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate.

Additional Information:

FDA MedWatch Safety Alert. Acclarent Inspira AIR Balloon Dilation System - Class 1 Recall. March 13, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm295875.htm

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Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs) - Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. The unit's self test may not detect the failure or impending failure of the component.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs) - Class I Recall. March 2, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm294538.htm

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Safety tips for intense pulsed light therapy

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FDA Medical Device Safety

Although IPL is safe and effective when clinicians follow the manufacturer's instructions for using and properly maintaining the equipment, complications have been reported when these measures weren't taken. One of the main factors contributing to these complications was the failure to adhere to the device’s operation and maintenance instructions.

Additional Information:

FDA Medical Device Safety. Safety Tips for Intense Pulsed Light Therapy. February 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm294084.htm

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MedSun's KidNet Update: Continuing as a Model for Patient Safety

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KidNet, launched in June 2007, 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, with an emphasis on 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. The goals are accomplished through collaboration and communication between FDA, KidNet participants, and device manufacturers.

Currently, 46 of the 350 MedSun nationwide network of hospitals are participating in KidNet. A little over one-third of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. The focus of KidNet is on medical device-related problems occurring in the NICU or PICU, which includes adverse events, ‘near-miss’ or ‘close-call’ events, and events representing ‘a potential for harm.’

From all hospitals participating in MedSun, we received a total of 634 reports involving pediatric patients (those with ages less than 21 years) in 2011. The number of reports received is up from a total of 556 pediatric reports in 2010.

Of these total 634 reports, 153 are from sites participating in KidNet; reports were received from 21 of the 46 KidNet hospitals in 2011. This represents an increase in the total number of KidNet reports received from 2010, which was 108. The data discussed in this article are derived from the 153 KidNet reports received in 2011.

 This bar graph illustrates the number of KidNet reports received by quarter.  These reports were submitted by KidNet participant sites over the 2011 calendar year.  The 153 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 153 KidNet reports received in 2011, the light purple data point shows that 44 KidNet reports were received in the 1st quarter.  The burgundy data point shows that 27 KidNet reports were received in the 2nd quarter.  The yellow data point shows that 36 KidNet reports were received in the 3rd quarter.  The tallest data point, depicted by a light blue bar shows that 46 KidNet reports were received in the 4th quarter.

We provided learning opportunities for MedSun KidNet hospitals through presentations via teleconferences and webcasts for healthcare professionals working in neonatal and pediatric patient care areas, focusing on the need to recognize and report device-related problems as part of their patient safety efforts. Additionally, in 2011, we increased the education and outreach to KidNet hospitals via telephone and e-mail. We believe this is a major factor in the increased number of reports received for 2011.

All but four of the 2011 reported events from KidNet involve device-related problems described as minor harm, potential for patient harm, or close call events. These types of reports demonstrate that our efforts to encourage the reporting of problems before a death or serious injury occurs have been successful. Three of the 153 reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury). One event in 2011 is associated with a patient death.

 This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2011.  The 153 reports are categorized by event type, specifically by the categories of:  potential for harm, serious injury, and death.  Of the 153 reports, 149 reports were submitted as potential for harm, depicted by a light purple pie wedge.  3 reports were submitted as serious injury and 1 report was submitted as death, which are 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 IV products; two involve peripherally inserted central venous catheters (PICCs), and one event involves an IV connector. One event with a PICC catheter describes a complication of cardiac tamponade seven days after catheter insertion with recovery of infant’s heart rate immediately after emergency pericardiocentesis. The second event involves shredding of the guidewire when the inner cannula (dilator) was being pulled out of the PICC micro-introducer during insertion procedure. The wire was located via x-ray and then successfully removed by a pediatric surgeon. The third event involves a leaking IV connector whereby the patient did not receive the appropriate amount of medications resulting in a drop of blood pressure and blood sugar. The leaking connector was replaced and the patient’s blood pressure and blood sugar returned to normal values. The sole death report involves a rupture of extracorporeal membrane oxygenation tubing which caused the pump to stop.

In spite of being placed on emergency ventilator settings while the tubing was being replaced, the patient arrested and the patient’s cardiac function did not return.

The 153 KidNet reports reference 157 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, short term peripheral IV catheters, central venous catheters, implanted ports, fluid transfer sets, saline vascular access flush, infusion line filter

(2) AN/Respiratory devices – ventilators/high frequency ventilators, tracheostomy tubes and cuffs, oximeters, blood gas analyzer, nitric oxide delivery apparatus, bronchial tube, ventilator tubing, tracheobronchial suction catheter

(3) General Hospital devices - hypodermic needle, piston syringes, electronic thermometers, medical device disinfectants, skin pressure protector, pediatric bed, neonatal incubator, neonatal transport incubator

(4) GI/GU devices - gastrointestinal tubes, enteral feeding pumps, GU injectable bulking agents, implanted hemodialysis catheter

(5) CV/Neurology devices - EKG electrodes, electroconductive media, cardiopulmonary bypass devices/accessories, physiological monitor, blood pressure monitor transducer, central nervous system shunt, implantable clip

(6) Operating Room devices - lacrimal stents and intubation sets, electrosurgical cutting and coagulation instruments, bone fixation screws, spinal interlaminal fixation appliance, hysteroscope

 This bar graph illustrates the number of reported medical devices by type in 2011 KidNet reports. The 157 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to device type; the y-axis corresponds to the number of reports.  Left to right description of image: of the 157 devices reported in 2011, the tallest data point, depicted by a light purple bar, shows that 86 reports involve Intravenous (IV) devices.  The burgundy data point shows that 33 reports involve Anesthesia/Respiratory (AN/Respiratory) devices.  The yellow data point shows that 11 reports involve General Hospital devices.  The light blue data point shows that 11 reports involve Gastroenterology/Urology (GI/GU) devices.  The dark purple data point shows that 10 reports involve Cardiovascular (CV)/Neurology devices.  The salmon data point shows that 6 reports involve Operating Room devices.

Reported patient demographics include patient age and gender. Patient gender was provided in 131 of the 153 KidNet reports. Reports involving males represent 58 percent of reported patient gender.

 This pie chart illustrates the number of 2011 KidNet reports that specify patient gender.  The 131 reports are categorized by gender, specifically by male and female.  Of the 131 reports, 76 reports involving male patients were submitted, which are depicted by a light purple pie wedge.  55 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082188.pdf.

Patient ages provided in 142 of the 153 KidNet reports range from 1 day to 21 years with the largest number of reports involving patients 30 days to 2 years old. This is a change from 2010 where the majority of KidNet reports are associated with patients 0-30 days old.

 This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2011 KidNet reports. The 142 reported patient ages have been grouped by pediatric subpopulations.  The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of patient ages reported.  Left to right description of image: of the 142 reported patient ages in 20``, the light purple data point shows that 35 reports involve newborn patients (0-30 days).  The tallest data point, depicted in burgundy, shows that 46 reports involve infant patients (30 days-2 years).  The yellow data point shows that 32 reports involve child patients (2 years-12 years).  The light blue data point shows that 29 reports involve adolescent patients (12-21 years).

Information on the device user in reported events was provided in 74 of the 153 KidNet reports with the nurse most frequently cited as the device user, consistent with reported events from 2010.

 This bar graph illustrates the number of reports by device users - who was operating the device at the time of the event – in 2011 KidNet reports. 74 reports indicate the device user.  The x-axis corresponds to specific device user; the y-axis corresponds to number of reports.  Left to right description of image: of the 74 reports indicating device user in 2011, the tallest data point, depicted by a light purple bar shows that 56 reports specify nurses were operating the reported device at the time of the event.  The burgundy data point shows that 8 reports show that Allied Health Providers were operating the reported device at the time of the event.  The yellow data point shows that 6 reports identify a doctor as the user operating the reported device at the time of the event.  The light blue data point shows that 2 reports state patients were operating the reported device at the time of the event.  The dark purple data point shows that 2 reports indicate that the user was unknown.

As part of MedSun’s education and outreach efforts, KidNet sponsored a webcast on Phototherapy and Cooling Device Safety in Neonatal Patients featuring educators from a participating MedSun KidNet hospital. The webcast discussed how to optimize safety considerations when using devices used for phototherapy and cooling therapy with case study examples of problems reported to MedSun.
Presentation slides with audio and a printable transcript of the program can be accessed at:
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm280655.htm

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

Recognizing and reporting medical device problems seen in neonatal and pediatric clinical settings promotes patient safety. In 2011 alone, MedSun KidNet reports contributed to four recalls and several manufacturer actions taken to address device problems that were reported.
The recalls involve:

(1) a temperature probe used in used in conjunction with a measuring/monitoring device to continuously measure or monitor a patient's core body temperature, recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105007

(2) an ambulatory infusion pump intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patient-controlled analgesia), recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?i d=100377

(3) an inline filter for the patient airway system of a respirator or an anesthesia machine for the measurement of end-tidal CO2 in infants and neonates, recall link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99419

(4) a drug delivery system used with ventilators to deliver a preset concentration of nitric oxide for inhalation for critically ill patients, recall link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104896

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/Safety/MedWatch/HowToReport/default.htm.

Together, we can continue to make recognition and reporting of actual and potential medical device-related problems a model for patient safety.

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Discussions with Healthcare Providers

Burn Wound Management: MedSun Small Sample Survey Summary

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Survey Topic: Burn Wound Management - Summary of Responses
Year Conducted: 2011
Commissioner's Fellowship Project

Background
Each year more than a million people in the US sustain burn injuries, with approximately 450,000 receiving medical treatment. In spite of progress in burn care leading to increased survivability numerous areas for improvement and innovation persist.

FDA would like to better understand the current state of burn wound management to identify unmet needs and evaluate obstacles that potentially hinder product development and the use of burn care products in the clinical setting. This survey effort addresses the use of current and new products, technologies and advancements in burn care and their effect on clinical outcomes. Information from the survey will help FDA incorporate evolving thinking about the practice of burn care to determine changing needs, use innovation, and identify the barriers and perceptions that hamper advancement in burn care for patients.

The survey respondents include eight surgeons who are Directors of Burn Units and a Registered Nurse who is a Nursing Director of a Burn Unit. Two of nine respondents practice in pediatric hospitals. Of the eight surgeons, six specialize in General Surgery and two in Plastic Surgery. The information that follows is a summary of responses.

Summary
The size of the burn centers in the survey ranges from 5 to over 40 beds with the majority of units having 15 beds or less. Most have the capacity for overflow, if needed. One burn center has a dedicated operating room and another has dedicated therapy rooms. Seven of nine burn centers are verified through the American Burn Association and one center is in the process of becoming verified.

Over the last three years, respondents report having an average census up to 10 patients per day with one larger center averaging up to 29 patients per day. Most have not seen an upward trend in census except for one respondent that attributes the increase to an extensive outreach campaign promoting their outpatient services.

Most of the burn centers are located in an urban setting and receive patients from a large geographic area. The total number of admissions for all of the burn centers ranges from 170 to 475 patients per year. A few respondents report they are seeing more male patients than females that are between the ages of 30 to 45 years old.

The average length of stay for four of eight centers ranges from 4 to 5 days, to 7 to 8 days. The remaining four centers report less than 1 day per percent burn of the patient’s total body surface area.

Some of the changes in demographics with adult patients over the past few years include a decrease in larger burns and a bigger trend toward earlier discharge and more outpatient treatment. This is due particularly to the use of dressings that are changed now every seven days instead of once or twice a day. Also, many respondents are seeing more elderly patients with chronic diseases and more significant burns from scalding, smoking, misuse of accelerants, and the use of oxygen in the home setting.

Respondents from pediatric burn centers have also seen a decrease in larger burns with admissions remaining fairly consistent for patients up to two years old with mostly scalding burns. However, one respondent reports seeing more patient admissions with mental illness, drug and alcohol-related problems, injuries due to other risky behaviors, and some airbag type injuries in teenagers.

All but one center participates in research that is clinical, translational or basic science. Some of the burn centers are currently involved in clinical research that is multi-center, industry-sponsored, investigator-initiated, and observational.

Home Health Services plays a role in the care and management plan for five burn centers and a very major role for one where most patients are discharged to home with an outpatient service that is very active. For the remaining respondents, home health plays a minimal role for several reasons such as limited knowledge of burn wound care by home health providers, many post operative patients are discharged to rehabilitation or skilled nursing facilities for dressing changes, patients with smaller burns provide care for themselves, and many patients return to the hospital for physical and occupational therapy in the outpatient department. Some respondents also say that involving home health services is often driven by the patient’s insurance.

According to one respondent, wound care is the most common reason for getting home health involvement. Other reasons for home health services include pain management, outpatient therapy, and when dealing with social issues, such as, pediatric patients who are hospitalized under suspicion of child abuse. One burn center program is developing a more integrated system with home health to manage burns so that more effective care can be provided in the home. This particular outreach program involves having outpatient nursing staff accompany home health staff on patient visits and home health staff visits to the outpatient center. The respondent for this burn center program believes that if this relationship is strengthened it may influence and decrease readmissions to the hospital.

All respondents believe that patient compliance is a factor in the outcome of the individual’s care and utilize several approaches to promote better outcomes particularly when a patient is non-compliant. For example in the pediatric setting, longer-wear dressings are often used if there’s a question of patient compliance in the home setting. Also, if one appointment is missed staff contacts the authorities to get the child because it’s seen as a child abuse situation. For other centers, adult patients will be kept in the hospital to prevent wound failure for several reasons. These reasons include: the risk of patients hurting themselves by not complying, the need to wait and see if the graft takes, if home health services for the area are not good, or if insurance is an issue. In some situations, non-compliant patients are often sent to skilled nursing facilities as a “bridge” to independent living.

Most respondents use several types of professional resources to guide their patient care. However, their primary resources are research-based and peer-reviewed literature. Several use guidelines from associations such as the American Burn Association (published in the Journal of Burn Care and Research), the Society of Critical Care and Medicine, the American College of Surgeons, and some also use guidelines from individual states. Additional resources include using a burn handbook, attending professional meetings, talking with colleagues, obtaining expert opinions, and following hospital policies and procedures.

All respondents have a “standard of care” or treatment modalities in place for burn wound management that includes early debridement, topical wound care, and rapid assessment and determination for early excision and grafting. All respondents use algorithms that are based on the degree and percentage of the burn and follow a pathway for regulating fluids, lab work, medications, and vitamins.

Respondents vary in their standard approach to treatment in several areas, such as, the use of enzymatic and non-enzymatic debriding agents, the amount of time before a patient is taken to the operating room for excision of large, third degree or deep second degree burns, and when selecting products for skin grafts. Of nine respondents, five use non-enzymatic debriding agents, one is decreasing use, two respondents who practice in pediatric settings never use them, and one didn’t specify using them or not. When respondents discuss taking patients to the operating room for initial excision and grafting of third or deep second degree wounds, the time frames range from within the first 24-48 hours to 5 days after admission to the burn unit. Regarding products for skin grafts, most use superficial silver dressings after wound debridement and ‘artificial skin substitutes’ on donor sites. Several mention not using cadaver skin for donor sites because of prior disappointment with size or thickness and difficulty with curling edges.

Most respondents report having a multi-disciplinary team in their center that conducts rounds at least once a week. All have at least one attending physician that is a general surgeon or plastic surgeon and also have team members who are nutritionists, physical therapists, respiratory therapists and nurses. Some teams also include pharmacists, anesthesiologists, surgical residents, advance practice nurses, and physician assistants. When discussing how burn centers function with regard to who performs procedures, all respondents state that the attending surgeons or Medical Director performs all major procedures and may have residents, burn fellows or members of their critical care team insert central and arterial lines and perform other bedside procedures.

In a discussion about staff and training, one respondent focuses on the need to integrate other hospital staff to the burn center’s processes and concepts involving early wound excision. In this particular center, any new product in the burn center is integrated with other services and new hospital staff receives wound care training as part of the individual’s competency training. Also according to procedure, if a patient’s wound is not excised within the burn center’s standard time frame, it’s communicated and included in the hospital’s peer review process and justification is needed as to why the excision didn’t occur.

Newly marketed products are incorporated in most respondents’ centers. However, there is some variation in the responses from those who are just learning about new products to others who say they try too many. All respondents have a hospital-based product evaluation committee or value analysis committee. Typically, these committees follow their institutionally established process or procedure to evaluate and approve the purchase and use of new products. Seven of eight respondents believe there are no barriers to bringing in a new product to the hospital if it appears better and promotes faster healing. One respondent does experience resistance from the hospital to try new things but also believes that new products should come with protocols, learning objectives for nurses, comparisons with historic data, etc. Examples of characteristics or criteria most use for evaluating new products are ease of use, lower cost and better value, less pain, and fewer future hospitalizations and surgeries for patients. To further reduce costs, one respondent reports keeping only enough stock on hand for two to three surgeries at a time and others mention they are often asked what older, similar products currently in stock will be removed and replaced with the newer ones. The cost of silver dressings remains an issue. One respondent states that before considering use of a newer silver dressing they make sure the product is cleared by the Food and Drug Administration and that efficacy data is readily available, mainly through peer review publications. Almost all respondents regard pain reduction as a priority and try to use longer-wear dressings and longer acting agents to minimize the number of dressing changes and subsequent trauma for the patient. Also, most respondents have a process in place at their center to trial new products for a period of time and then based on evaluations and other reviews are able to get it on the hospital’s official formulary.

The products and therapeutics used most frequently varies among burn centers. One respondent mentions occasionally using enzymatic debriding agents and frequently using hydromechanical debridement to excise eschar. The majority of respondents use silver impregnated dressings and mention they use many other products too. Some report using antibacterial/antifungal solutions and other types of topical wound dressings for acute partial thickness burn management and silicone sheets after healing for scar management. Also, many respondents mention using dermal regeneration templates as a means to facilitate definitive closure of full thickness burns.

Six of eight respondents believe they have the products at their centers to serve their clinical and patient needs but add that improvements are necessary. For example, there are always ongoing issues related to the basic science of would healing where improvements would help promote faster healing or help with a patient’s pain control. One respondent adds however, that the burn market is a small niche market, and it’s an investment and may be a capital gamble for a manufacturer to develop a ‘skin substitute’ indicated only for burns.

When considering burn care additions and innovations over the past 15 years, about half of the respondents think that ‘skin substitutes’ and longer lasting silver dressings have had an impact on patient care particularly with healing and less scarring. Other changes making a difference in patient care are advances in critical care management and pharmacology, enteral nutrition, topical hemostatics, and the use of cultured autologous epithelial sheets. Early excision and hydromechanical debridement also have had an impact along with better resuscitation guidelines; however, one respondent notes that problems still need to be addressed regarding over-resuscitation (i.e. excessive fluid administration during the initial 48 hours post-injury that can lead to multi-systemic organ dysfunction).

Respondents think there are several areas that pose the greatest need for innovation that can translate to improved patient outcomes. Several would like a user-friendly objective method to accurately diagnose the depth of a burn wound. Current laser Doppler flow instruments are cumbersome and expensive. One respondent suggests that a hand-held device would be better and easier to use. Other areas where innovation is needed is in the treatment of inhalation injuries, regenerative medicine, and with epithelial and full thickness skin replacements. Additionally, the treatment of scars particularly hypertrophic scars is an area where more research is needed to lead to better functional and cosmetic results for patients.

According to respondents, the gaps that exist in meeting patient needs are in the areas of psychological services and effective pain management. Many patients have post traumatic stress and adequate support and resources are needed for them particularly after discharge from the burn center. Also, providing sufficient pain control without causing other physiologic issues continues to be a challenge in burn management.

Most respondents feel there are no barriers that impact their ability to change patients’ care; however, some believe product expense remains an issue. One respondent believes that more recognition of burn centers by the government for their commitment to patient care is needed and adds that regionalization of burn care similar to what has been done with trauma care would be good. These approaches would bring this particular patient population together, promote better coordination and utilization of available burn beds, and expedite better product evaluation and development.

In addition to previous responses about therapeutics, diagnostics, interventions, etc., about where burn management may be lacking, respondents believe there are other needs as well. These include better modalities for permanent wound closure, better pain control and sedation protocols to minimize delirium in patients, better approaches to dealing with antibiotic resistance, improved products for neck wounds that prevent decubitus and allow for cervical spine imaging, and a need for research about the use of inhaled antibiotics for lung injuries. Also, one respondent believes that the use of telemedicine could have a huge impact in the burn community.



******

Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

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Ferromagnetic Detector Utility and Magnetic Resonance (MR) Safety: MedSun Small Sample Survey Summary

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Survey Topic: Ferromagnetic Detector Utility and Magnetic Resonance (MR) Safety - Summary of Responses
Year Conducted: 2011-2012

Background
The number of Magnetic Resonance Imaging (MRI) procedures is rising. At the same time, the sophistication of implanted and accessory medical devices used in the MR environment is increasing. While Magnetic Resonance Imaging (MRI) is a safe imaging procedure, there are contributing safety hazards inherent to the MR environment. Magnetic attractive forces to the strong MRI magnet can cause objects to become projectiles. Although rare, when these events occur, they often cause serious injury or death. Projectile events have been reported to FDA as well as identified in medical literature and in the media. Most projectile incidents may be attributed to site-access issues where staff brought in ferrous devices or products, or screening methods that did not reveal metal that was present on the patients, i.e. jewelry, belts, etc. All solutions to overcoming risky projectile events must be considered to ensure the safety of patients, accompanying family members, healthcare providers and other personnel who routinely enter the MR suite.

Actions to reduce this hazard include conventional patient screening practices, site-access restrictions and markings, and facility-wide education. Additional actions to reduce these events may include broader use of Ferromagnetic Detectors (FD) to identify ferromagnetic objects not discovered by conventional screening methods or to guard the scan room entryway. However, wide-spread adoption of FD has been controversial. Opponents claim that FD provide a false sense of security or could potentially replace thorough screening practices (ACR Guidance Document for Safe MR Practices: 2007). The risks and benefits of FD systems needs to be assessed to better gauge their utility.

Special Study Purpose
This Special Study is a survey effort to learn about user facilities’ MR safety practices, particularly why and how the facility employs FD - archway or hand-held - in their MRI department and the role of FDs in screening practices. Survey questions aim to gather information about the FD system and the providers’ experiences with them, their FD Quality Control practices, and to learn about any projectile events sites encountered while using FDs, or ones that were prevented. The information that follows is a summary of responses. Seven* structured telephone surveys were conducted with healthcare professionals from hospitals participating in the Medical Product Safety Network (MedSun). Survey respondents include: Medical Physicists, Chief Technologists, MRI Coordinators and Supervisors, Imaging Directors and Managers, Biomedical and Clinical Engineers.

Summary
All survey respondents are affiliated with the MRI department in their hospital. Six facilities also have outpatient centers that perform MRI procedures. The number of scanners each facility uses ranges from 2 to 13 magnets. There is a direct association between the number of magnets and the number of patients scanned per day, which can be anywhere from 13 to 125 patients. The respondents specify their magnet strengths are either 1.5 or 3.0 Tesla. Pole-style, archway and handheld FD systems are used by survey respondents. For the most part, archway and pole-style systems are primarily used to screen staff; whereas handheld detection is primarily used to screen patients in addition to other screening methods.

Below is the breakdown of FD systems used by all respondent facilities (n=7):
• Only handheld system (2)
• Archway system (1)
• Archway and Handheld systems (2)
• Pole-style, Archway and handheld systems (1)
• Neither+ (1)

Of the hospitals that employ archway or pole-style FDs, respondents indicate they rely on the vendor to install and set sensitivity, which is set high, as even eyeglass screws can set off alerts. One facility indicates MRI staff had a training session with the FD vendor and, at this site the Lead Technologist performs routine adjustments to their archway system. Other respondents indicate that, for the most part, no formal training is provided by the vendor and they do not adjust sensitivity. Two facilities chose to reduce the archway’s sensitivity because staff routinely pass by the FD (they do not enter through) with medical equipment containing metal, which frequently set off alerts. Archway and pole-style detectors always remain on as these provide auditory and visual alerts when ferrous objects are nearby. However, one facility elected to turn off the system’s auditory alerts and only relies on visual alerts because FD alerts are common. Existing suite architecture is a problem for respondents who purchased archway FDs. MR suite design contributes to false FD alerts, mainly due to metal door hinges and knobs that set them off. In fact, to solve this problem one facility attempted to redesign Zones^ 3 and 4 to decrease false positives.

Of the five sites that employ handhelds, three have no formal training on how to use them; one respondent indicates that new employee orientation includes detector training and another reports that their facility receives informal training from their local police department on how to ‘wand’ patients using a handheld detector. Respondents who use handheld detectors indicate they are off when not in use and that batteries are checked at least two times per day. Handheld detectors are used in interview rooms at Zone 2 or 3, mainly by the MR Technologists. One respondent indicates that handheld detectors can be invasive when used to screen a patient and that they are in the process of better understanding their sensitivity relative to the distance from a patient.

Respondents indicate that handheld systems are an adjunct to their patient screening practices. Typically, they are used as a secondary or tertiary method, after the screening questionnaire or after the FD has alerted staff to the presence of metal, i.e.: cell phones and pagers, lighters, shirt buttons, underwire bras, jewelry such as belly button rings, hair pins, glasses, metal on shoes, keys, paperclips, scissors, and pens. One facility requires that all employees screen themselves with handhelds and anyone else entering the area; this site also requires escorts depending on the hospital employee entering the MRI suite who may not have formal access or training. Three respondents indicate that staff, in addition to patients, must complete a screening questionnaire prior to entering the MR suite.

Most respondents still use paper-based questionnaire forms. Some sites use a combination of paper and electronic formats. For example, paper is used to gather information from patients initially; electronic methods are used for information storage and retrieval. Questionnaires are typically completed prior to scheduling and again prior to the scan. Respondents indicate that patients may be screened 3 times at the most: once by the physician when a scan is first ordered, then by phone, and a third time onsite. The individual that completes the questionnaire depends on inpatient versus outpatient status. For inpatients, it may be the ordering physician and the ‘competent’ patient; for outpatients, the scheduler completes the form preliminarily, followed by a more detailed questionnaire filled out by the MR Technologist when a patient arrives for the scan. If a patient is unable to answer questions, respondents say they use other sources, notably the referring physician or family members that may be able to answer questions to confirm whether a patient is a candidate for an MR scan. X-ray or CT may also be done to rule out presence of other devices or metal. Patients, family members, referring physicians, and hospital support staff may all play a role to assist in gathering patient information, but all respondents indicate it is the MR Technologist that reviews and verifies the information provided in the questionnaire. One respondent states that they have received negative feedback from referring physicians about the screening questionnaire forms because they are time consuming; however, they still require the physician to complete them. Another respondent indicates they do not allow the patient to fill out their form – it can only be completed by an MR Technologist. Five respondents indicate that all patients are gowned prior to an MRI scan. Two respondents add that finding gowns without metal snaps is challenging.

Staff MR Safety training is required, typically on an annual basis or may be included in general hospital orientation for all employees. Some respondents’ hospital policy requires specific MR Safety training for anyone who has access to the MRI suite in addition to imaging personnel, such as, specific nursing unit staff that take care of patients receiving MR procedures. Other respondents’ facilities require specific MR safety training for all staff with access to Zones 2 or 3. As a result of a recent projectile incident, one respondent has expanded their MR Safety Training beyond radiology to include critical care/ICU employees, respiratory therapy nurses, surgeons and surgical staff. Housekeeping staff also are included in annual MR Safety training, with the exception of one respondent who shared that they use a specialty MRI cleaning company due to housekeeping staff turnover. For the most part, respondents indicate that the MRI suite has site access controls to preserve patient and provider safety. Two facilities require a keycard or badge access to gain entry.

At some points in survey respondents’ careers, they indicate experiencing a projectile event with one of the following items: floor buffers, stethoscopes, tools, wheelchairs, oxygen tanks, or ventilators. One respondent indicates there have been many close calls but staff caught them in time. At one facility, there is an equipment check that occurs at Zone 2 as this is the transition zone where equipment on a patient is exchanged for MR Safe or MR Conditional equipment before entry to Zones 3 or 4. Other facilities have invested in MR Safe or MR Conditional equipment, i.e. wheelchairs, stretchers, IV pumps and poles, anesthesia machines, which remain in MR suite at all times. However, even MR Safe or MR Conditional equipment has set off the FD alerts - respondents note that some cart wheel bearings are problematic because they contain metal.

Equipment may also be marked with stickers to indicate MR Safe or MR Conditional. Facilities often will create a device listing referencing MR safety designations, notably for implants. Often times, this information is obtained from the device manufacturer, from product catalogues, or online. One facility requires that the Biomedical Engineer and Physicist also test for safety because there is concern that some devices may become magnetized over time, which impacts their safety status. One site purchased oxygen tanks and fire extinguishers that are safe for use in the MR environment for use hospital-wide, not just in or near the MR suite. Another facility maintains what they term to be an MRI safe housekeeping closet.

Overall, respondents indicate that FD systems – archway, pole-style and handheld – are effective in preventing harm, yet want to emphasize they are only as good as the people who use them and policies in place. Respondents express the need for more information about FD sensitivity limits. There is concern that FDs provide a false sense of security and concern that staff may become habituated to regular FD alerts.

Respondents feel that current guidelines are open for interpretation and, consequently, want better defined recommendations about how FDs should be set up in MR suites because, in their opinion, FDs are best utilized when they are installed as a part of the architectural plan rather than as add on equipment. One facility that only uses handhelds feels that by using a thorough questionnaire-based screening process combined with handheld detection gives the provider more control and is a cost-efficient practice. The majority of respondents indicate that archway and pole-style FDs are expensive but can be worth the cost when best utilized. Regardless of FD utilization, all responses represent the various safety measures employed by hospital facilities prior to an MR procedure.

*An eighth facility was contacted for this special study. They indicate they do not employ any FD (archway or hand-held) at this time. To come to this decision, they evaluated the use of FD and found they were not necessarily sensitive enough to detect all metal. Their concern is that they [FDs] would give staff a false sense of security and, instead of an FD, elected to rely on diligent screening processes on multiple levels.

+One facility is in the process of purchasing an archway or pole-style FD system in response to a costly projectile event. This respondent feels strongly that the high investment for an FD detector outweighs the associated costs after a projectile event. Costs incurred include MRI scanner repair, unquenching the magnet in addition to lost revenue when a scanner is down.

^Zones are described in ACR Guidance Document for Safe MR Practices: 2007.


******
Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

Additional Information:

Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for safe MR practices: 2007. AJR Am Roentgenol. 2007;188:1447-1474. Retrieved from:

http://www.acr.org/SecondaryMainMenuCategories/quality_safety/MRSafety/safe_mr07.aspx

Public Workshop: Magnetic Resonance Imaging Safety. October 25-26, 2011. FDA Workshops and Conferences.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm270720.htm

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period January 1 through January 31, 2012. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device 1:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02F1101570

Device 2:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02H1100392

Device 3:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02H1102877

Problem:
The ventilator circuits are coming in from the manufacturer with cracks in them, making them unusable. The company was made aware of this problem a month ago and circuits were replaced. We are experiencing this problem again. This defect makes it difficult to set up a ventilator urgently because the circuits will not pass the compliance and leak test on the ventilator. Twice the therapist had to manually ventilate two patients as he went through 5 to 6 circuits and could not get them to pass. Our current solution is to inspect the circuits when we have down time and try to do the circuit compliance then leave the vent in standby mode so it's ready when we need it for a patient. So far, three separate lot numbers are affected: 02F1101570, 02H1100392, and 02H1102877.

Device:
Type: Endotracheal Tube
Manufacturer: NeoTech Products, Inc
Brand: Neobar
Lot #: 21800

Lollipop Icon

Problem:
There have been 5 reported instances of grey NeoBar failure at this hospital in December 2011. All of these issues were with NeoBars from Lot#21800. On 4 separate occasions, the duoderm pad adhesion failed and the bar became disengaged from the adhesive tab. In other words, the adhesive tab adhered to the patient's face, but the grey plastic arm came loose from the adhesive connection, causing problems with the intubation. Four of the incidents occurred to the same patient.

There was no permanent harm to any of the patients, but one patient experienced the following due to the detachment of the neobar "bar": Pt. was coughing and gagging on secretions and ETT and neobar became loose. The RT in room with nurse retaped neobar, but patient was gasping and coughing due to low volumes on vent, so removed ETT and paged anesthesia to reintubate. NICU attending came over to assist, and intubated pt. with 4.0 ETT. Pt was bagged during entire event, no LOC, brady and desat initially, and recovered. The 2nd patient self extubated in one incident, but was discovered and was not harmed.

All NeoBars of that lot number were pulled from stock and replacements have already arrived from the NeoTech plant. According to anecdotal information on a list serve, at least 2 other facilities have reported the same issue. No other problems have been reported with the new lot of gray NeoBars, however, only one has been put to use so far.

It is recommended that this lot number be evaluated for a nationwide recall.
======================
Manufacturer response for NeoBar ETT (per site reporter)
======================
They replaced the stock of Lot number's affected with a new lot number.


Device:
Type: Gas Machine, Anesthesia
Manufacturer: GE Healthcare
Brand: Avance S/5

Problem:
The Biomedical Engineering technician discovered that the GE Anesthesia Machine Model: Avance S/5 with software version: 6.20 that was installed December 2010, has a problem with Pressure Ventilation Mode's not defaulting properly. The three modes affected are Pressure Support with Apnea backup mode (PSVPRO), Synchronized Intermittent Mandatory Ventilation (SIMV-PC), and Pressure Control Ventilation (PCV). When using these modes the Peak Inspiratory Pressure, max (Pinsp) does not default back to initial default settings when the case has ended. When selecting a "new case" on the machine the "Pinsp" defaults back to the last case setting and not the original default for this mode. The only way for the "Pinsp" to default back to the default setting is for the clinician to shut the machine completely off and reboot the machine. The Biomedical Engineering technician notified the GE Technical Support line and made them aware of the issue. GE Clinical Support instructed biomedical engineering to call in the GE technical support engineer to evaluate the problem. The problem was replicated by GE technical support but GE Healthcare does not have a fix for the problem at this time. Biomedical Engineering informed the head of anesthesia about the problem. This is one of sixty anesthesia machines at this facility.
======================
Manufacturer response for Gas Machine, Anesthesia, Avance S/5 (per site reporter)
======================
Biomedical Engineering notified the GE Technical Support line and made them aware of the issue. GE Clinical Support instructed Biomedical Engineering to call in the GE technical support engineer to evaluate the problem. The problem was replicated by GE technical support, but GE Healthcare does not have a fix for the problem at this time.


Device:
Type: Humidifier, Respiratory Gas
Manufacturer: Allied Healthcare Products
Brand: B&f Medical
Model#: 64377

Problem:
Patient was experiencing flash pulmonary edema and required high flow oxygen, with humidification. Nasal cannula with bubbler humidifier set up. Water was filled to less than the max-fill line. Patient was placed on 13L of O2. There was a small amount of saline noted in tubing initially but quickly resolved with O2 flow. Approximately 5 minutes later, the bedside sitter alerted nursing staff that patient was complaining of choking sensation and there appeared to be water in the tubing flowing into the patient's nasal cannula. RN quickly disconnected the tubing and bubbler and began to suction the patient. Patient did have O2 saturation decline into the 60s for a brief period of time. Fortunately, the patient's O2 sats came back up to the 90s within a few minutes and after the suctioning and Bi-pap being set up.


Device:
Type: Ventilator
Manufacturer: Maquet Critical Care, AB
Brand: Servo I


Problem:
Patient ventilator was found alarming, on arrival into patient's room, staff found vent screen reading Apnea alarm in red, with the Oxygen box, PEEP box, rate box tidal volume box missing. Patient taken off of the vent and hand bagged. Ventilator had no flow coming through the circuit although it was connected to oxygen and air. Changed vent out with same vent settings. Biomed investigated the event logs on the Servoi, downloading them to a service card. Biomed contacted manufacturer regarding the error code. Manufacturer stated that the PC 1771 Board needs to be replaced. Manufacturer rep came in and downloaded the logs and took the faulty board and sent to Maquet HQ's for further investigation.


CARDIOVASCULAR

Device:
Type: Catheter, Percutaneous
Manufacturer: Vascular Solutions
Brand: Guide Liner
Model#: 5571
Lot #: 553043

Problem:
During the procedure, the catheter would NOT pass through the guide catheter. Another guidewire was used. The patient suffered no adverse effects.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: Access Closure Inc.
Brand: Mynx Cadence
Lot #: F1125203
Cat #: MX5001

Problem:
The doctor was using the Mynx device to gain hemostasis of the femoral artery. When deploying the vascular plug, the device was missing its plug advancer. The piece that was missing was the white shaft that is used to hold the plug on an artery when the balloon and the device is removed. Manual compression was used for 20 minutes to obtain hemostasis. There was no change in the patient's outcome due to the device failure. We have other devices from the same lot, but none of the other devices used have had pieces missing.


Device:
Type: Filter, Intravascular, Cardiovascular
Manufacturer: Cook Medical
Brand: Celect
Model#: IGTCFS-65-FEM-CELECT-PERM
Lot #: E2819480

Problem:
Patient required placement of a vena cava filter due to deep venous thrombosis and recent major hemorrhage from a ruptured aneurysm. A 9 French sheath was placed and using ultrasound to determine placement, the filter was delivered without difficulty. However, when deployment was initiated, the initial feet deployment did not occur. Surgeon was able to capture the filter and remove under fluoro guidance. At the very end of the removal the sheath came off the filter and the filter came through the soft tissue and everted; however, there was no damage to the vein by ultrasound. Procedure was performed again using a Greenfield stainless steel filter.


Device 1:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Israel Ltd.
Brand: Horizon Cardiology Hemo
Other #: V 12.1 Hemo

Device 2:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Israel Ltd.
Brand: Horizon Cardiology Cvis
Other #: V. 12.2 Imaging

Problem:
The McKesson Hemodynamic application experienced issues that prevented the use of the systems. Main three labs inoperable necessitated diverting potential emergencies (ST segment elevation myocardial infarction - STEMI) to another facility thereby potentially delaying care. Fortunately, no patients had to be diverted during the 3 hours software was inoperable. This hospital is a Level 1 trauma and cardiac facility.
======================
Manufacturer response for Horizon Cardiology Hemo, Imaging App & Hemo App, Horizon Cardiology Hemo, Imaging App & Hemo App (per site reporter)
======================
McKesson performing root cause analysis of each Hemo station. Lab 1 had a corrupt user profile that prevented the normal account from logging in. Labs 2&3 had corrupt SQL instances on their local databases. Final determination of what caused both corruptions is not complete, but it was determined that the systems had been "hard booted" (pressing power button to restart) many times. This is a known way to cause SQL corruptions. Preventative measures are to configure one PC to be a hot spare. McKesson coming on site to physically rebuild to a baseline "pristine" build. This will remove any residual settings from the devices.

Device:
Type: Lead, Lv/cs
Manufacturer: St. Jude Medical
Brand: Quickflex µ
Model#: 1258T/86CM

Problem:
The patient had a Biventricular (BiV) ICD implanted. Upon ICD evaluation by the St. Jude Medical rep on the following day, the left ventricular (LV)/coronary sinus (CS) lead threshold had increased, requiring further investigation. Upon fluoroscopy, LV/CS lead was noted to have dislodged from the coronary sinus. The patient was scheduled for lead revision the next day. The patient was doing fine after the procedure.
======================
Manufacturer response for CS/LV lead, SJM Quickflec CS/LV lead (per site reporter)
======================
none at this time.


Device:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Dash 4000

Problem:
Patient's monitor did not alarm; however, it was noted that the patient had an erratic rhythm, which was obviously not this patient. This has happened multiple times with different patients on this date. Biomed advised and are working on the situation. Apparently this is a widespread issue with the Dash monitors with software version 5.4. Additional fact findings:
1-Rewind back to the original event of last summer. If you analyze the frequency of the QRS's on the graph paper you would come to the conclusion that it is not humanly possible, not even with a pediatric patient. This analysis was confirmed to be correct by GE.

2-The symptoms for these events are consistent with the original event. GE has acknowledged the two issues to be the same. However what appears to be different according to GE is the CPU board manufacturing and revision versions. The original issue was related to CPU boards manufactured between January 2003 and January 2007. These events (seven current ones) occurred with Dash monitors having CPU boards manufactured post January 2007.

3- Problem defined: According to GE this issue is definitely a Dash problem, hardware related. It is not physiological/patient issue. It is caused by high network traffic overheating a component (Ethernet chip) on the CPU board, which in turn causes the waveform to be condensed. The monitor does not alarm when this happens, since processing has already taken place. "Arrhythmia processing" would have seen the correct patient rhythm but somehow was displayed incorrectly by the Dash monitor.

4-One of the challenges relates to the newer CPU board type which do not accept original software version. The latest software version is not the same as older version causing potential for user interface errors.


Device:
Type: Tubing, Contrast Injection
Manufacturer: Medrad, Inc.
Brand: Avanta Fluid Management System
Model#: AVA 500 MPAT
Lot #: 113401

Problem:
Upon refilling the fluid management system with more contrast, the air vent port of the MPAT contrast tubing spike popped off when pulling the spike out of the existing empty bottle of contrast.


Device:
Type: Vascular Closure Device
Manufacturer: Cordis
Brand: Exoseal
Lot #: 15475795
Cat #: EX600

Problem:
According to the operative procedure notes, following injection of contrast into the right groin for possible closure device the arterial sheath was removed and closure device (Exoseal 6FR) was deployed. Seventeen seconds later, the closure device was noted to have failed. Arterial sheath pulled and manual pressure held for 20 seconds. Oozing noted after holding manual pressure; therefore, a Femstop device was applied to site with successful hemostasis. Femstop removed and Opsite dressing and sandbag applied.


GENERAL & PLASTIC SURGERY

Device:
Type: Active Electrode, Esu, W/suction
Manufacturer: Medtronic Advanced Energy LLC
Brand: Peak Plasmablade 3. 0s
Lot #: 47588
Cat #: PS210 - 030S
Other #: P/N LBL-00009 Rev A

Problem:
PlasmaBlade is used in implantation of AICD, revision, or extraction of same. It is knife, electrode (cuts & coagulates) and separate suction portal (which connects to wall suction), in one hand held device. In this case, the suction did not work during the procedure, in that it did not suction the smoke that is created when the PlasmaBlade is cutting. The operative field was obscured. It was changed out for a new unit. I was told by the doctor that this is the second occurrence of this same malfunction. It was not reported to me initially. Now that we have a 2nd malfunction of the same lot number, we have pulled the devices with that number off the shelf and will return the PlasmaBlades to the manufacturer. We submitted this unit to our BioMed Dept. for evaluation. They found that it did not work as intended.
======================
Manufacturer response for Active Electrode, ESU, w/Suction, Peak PlasmaBlade 3.0S (per site reporter)
======================
I have spoken with the local sales representative for Medtronic Surgical Technologies, who has taken over Peak Surgical in Palo Alto, CA. He is unaware of any issues with these PlasmaBlades. He will query other institutions that use this product, and get back to me. He believes it may be a matter of practitioner technique. Sales representative update: Meeting with sales representative yesterday. He has queried other institutions, and has not had any negative feedback. He believes that product difficulties are practitioner dependent, and will schedule an in-service for EP Lab staff. The Nurse Manager has agreed to the in-service.


Device 1:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Microtek Da Vinci
Model#: 400180 ver-10
Lot #: C11192

Device 2:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Microtek Da Vinci
Model#: 400180 ver-01
Lot #: c11192

Problem:
During surgery using the laparoscopic Da Vinci, the surgeon noticed arcing from the accessory tip cover that was covering the scissors. Upon closer inspection, small holes were discovered in the cover allowing current to escape. The surgeon voiced concern about an increased risk of an inadvertent burn to surrounding tissues. The same problem has been reported twice within the last week. No patient injury was sustained on either event. Additionally it was noted on both used tips that the ink that is used labeling is flaking off making it illegible.

Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: SS 3000

Problem:
During a transoral robotic-assisted surgical procedure, the robotic monopolar cautery was being used and suddenly a small flame appeared at the surgical site. MD immediately stopped surgery, PA withdrew instrument, and sterile saline was poured into the field extinguishing the flame. It appeared the disposable cautery spatula tip was what had caught on fire as it was burned and a piece fell off - it was removed from mouth. Moistened raytec were in place surrounding the mouth and retractors. Charge nurse and MDA (MD Anesthesiologist) notified. Mouth and throat were examined by surgeon and MDA. No apparent harm to patient. Cautery tip was removed and replaced with a new one. Patient was being ventilated with 100% oxygen prior to incident due to low Sp02 when N2O was used and after incident water was poured into the mouth and throat and a small cuff leak was noticed. Pt stable and case continued without incident after all parties concurred it was safe to continue. Family notified by MD after procedure.

Device:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc.
Brand: Vicryl
Model#: J232H
Lot #: DC2652
Cat #: J232H

Problem:
Thread frayed while suturing.
======================
Manufacturer response for Suture, Adsorbable, Vicryl (per site reporter)
======================
We sent pictures for their review. They will review and get back to us.


Device:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc.
Brand: Endoknot, Coated Vicryl
Model#: JK10G
Lot #: CBX763
Cat #: JK10G

Problem:
When the OR nurse opened a sealed(brand new)package of Endoknot suture size 0 Coated Vicryl she discovered pin hole/s in the foil packaging and discarded the product inside assuming since there was a hole the suture must not be sterile anymore. The nurse could not figure out how the hole/s were created hence, it was suggested to the staff that when they open the package to inspect for holes before handing the suture to the surgeon. There have been 5 packages discovered with holes. The manufacturer is aware and it was reported by the manufacturer that the hole was tested for leaks. This is their response: A dye penetration test was performed on the suspect areas, and there was no leakage of the dye through the voids, indicating that the barrier had not been compromised. The OR nurse did her own test on 4 different packages and 2 out 4 packages had leaked confirming that the foil packaging are not reliable for sterility especially if the pin holes are not discovered.


GENERAL HOSPITAL

Device 1:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Lot #: ST2114652
Other #: 22 G 1inch

Device 2:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Lot #: ST2094256
Other #: 22 G 1inch

Problem:
Plastic tips of several 22G catheter IVs are noted to be split when taken out of packaging or are splitting during insertion.

Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv

Problem:
Since our facility switched to the Smith Protectiv IV over 1 year ago, we have received over 100 event reports related to its use, such as kinking of the catheter, inability to advance the needle, puncture of the catheter by the needle when removing the cap, burrs noted on the needle, safety feature not engaging needle. The facility has assembled a team to determine root cause of the issues. The manufacturer is also retraining staff.
======================
Manufacturer response for IV Catheter, Protectiv (per site reporter)
======================
The manufacturer, Smith Medical, has re-trained staff on use of device.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Brand: Bd Insyte Autoguard
Lot #: 1286765
Cat #: 381423

Problem:
Nurse inserted IV catheter without difficulty, removed needle, and connected catheter to IV tubing. Nurse immediately noticed leaking of the IV fluid at the point where the catheter tip joined the blue Luer connector. The catheter was then removed and a new one inserted, which worked properly.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Model#: 3065
Lot #: ST2127875
Cat #: 3065
Other #: 18G x 1 1/4"

Problem:
An experienced Emergency Department nurse was performing a routine IV start when after the IV was cannulated, the nurse pulled the safe needle retractor out and the nurse got stuck by the exposed needle in the left index finger. The manufacturer was contacted and the device will be picked up by the manufacturer and inspected.


NEUROLOGY

Device:
Type: Chair, Rotary, Vestibular Balance Testing System
Manufacturer: Neuro Kinetics, Inc.
Brand: Neuro Kinetics Barany Chair System
Model#: RCS-365

Problem:
Description of Device:
A vestibular/balance testing rotational chair was purchased in 2007. After installation of the chair, in collaboration with the manufacturer, modifications were made to the software / hardware for an additional clinical testing protocol. The chair came programmed with several protocol options. Newer machines now include hardware that does require the modifications made at this facility as a standard option. Additionally, with manufacturer knowledge, a knee strap was developed which could be secured to the chair. The chair is standard with a four point chest restraint and foot guards. The four point restraint, knee strap and foot guards are utilized to secure a patient in the chair.

Event:
Patient in NeuroKinetics rotational chair for vestibular/balance testing. Staff had secured the four point chest restraint correctly. The knee strap and the foot retention systems were not utilized. During the test the patient slid down in the chair and attempted to remove the four point chest restraint. Patient was choked by the four point upper strap, lost consciousness and was projected to the floor by the spinning motion of the chair. Patient assessed and admitted to the hospital for multiple lacerations, back and rib fractures, pain.

The manufacturer was contacted regarding the event. Internal discussions ensued regarding need for enhanced safety features with auto-stop magnetic sensors if restraint/straps are not secured. The manufacturer is being contacted regarding participation in this type of modification. Manufacturer stated they filed report with FDA.

The manufacturer performed the routine maintenance check on the equipment three days after the event (pre-scheduled). System was in normal working order.


Device:
Type: Device, Neurovascular, Embolization
Manufacturer: Covidien
Brand: Pipeline

Problem:
The first patient died within 24 hours of Pipeline stenting of cerebral aneurysm. Patient had an unexpected and catastrophic intracerebral hemorrhage.

The second patient had cerebral infarcts, thrombosis of Pipeline stent, subarachnoid hemorrhage, neurosurgery and unexpected death after Pipeline stenting procedure.


RADIOLOGY

Device:
Type: System, Ultrasound, Pulse Volume Recorder
Manufacturer: Parks Medical Electronics
Brand: Flo-lab
Model#: 2100SX

Problem:
This was a near miss where the design of the connectors have the potential to cause serious harm to the patient. We had an actual misconnection approximately 1 year ago with this same machine. This was also reported to MedSun.

Patient was undergoing arterial duplex study and within a few minutes of the blood pressure cuff inflating, the patient went into cardiac arrest. Initially staff felt they may have connected the blood pressure cuff to the IV (which is possible) and gave the patient an air embolism. They felt this based on the fact that we did have the situation happen approximately 1 year ago and based on the sequence of events that took place. After a thorough review of the process, we have learned that the misconnection did not occur and rather the patient’s medical condition caused the cardiac arrest. This is a very serious design problem that is going to cause someone to be significantly harmed. For that reason (and we had 1 event and 1 near miss since we have had this machine), we are looking to see if a better product exists on the market to replace this current machine.


Device 1:
Type: X-ray System, Radiographic, Dr
Manufacturer: Philips Medical Systems
Brand: Digital Diagnost
Other #: S/W version 2.1.2 Workspot S/W version 22.6.6

Device 2:
Type: X-ray System, Radiographic, Dr
Manufacturer: Philips Medical Systems
Brand: Digital Diagnost
Other #: S/W version 2.1.2 Workspot S/W version 22.6.6

Problem:
Philips Digital Diagnost Auto-Stitching issues dating back to the date of install (Software version 2.1.2 and Workspot software version 22.6.6):

The hospital purchased and installed 2 Digital Diagnost (DR) X-ray machines from Philips Healthcare in 2011. They are both in the Orthopedic Clinic and at the time of purchase have auto-stitching software package with the version listed above.

During the clinical application training, and many more times up to the date of this report, the department noticed 2 issues. On numerous occasions we have approached Philips with these issues especially the auto-stitching problem:

1. Ghosting: During the acquisition of images for scoliosis patients, two X-rays are taken, one after the other on the same breath hold. The system is supposed to transfer the first image and erase the plate before the second image is acquired. Ghosting occurs when residual image data is not completely removed from the imaging plate before the second one is acquired, leaving part of the initially acquired information on the second image. This causes issues especially for the radiologists and clinicians.

2. Auto-Stitching: The software is supposed to automatically stitch both images to form a single image. The problem with this is that often, there is an overlap of the acquired images during the stitching process leading to distortion of the final image. This image, especially the improper alignment created by the software causes a serious patient safety issue.

We have contacted Philips on these issues and they are aware of the significant impact this can cause to patient safety. There have been communications between the Department of Radiology and Philips without any significant resolution.



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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problems With Chemotherapy Transfer Devices

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Chemotherapy transfer devices are intended to transport chemotherapy medication from storage containers to patient infusion routes. The National Institute for Occupational Health and Safety, under the Center for Disease Control and Prevention, defines a closed system drug transfer device as, "A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system." (NIOSH, 2004)

Over the past 2 years, MedSun has received 13 medical device reports associated with chemotherapy transfer devices manufactured by B Braun Medical, Carmel Pharma, Equashield Medical, and ICU Medical. The reports were submitted by 7 hospitals between March 2011 and March 2012.

The reported device problems were:
• 6 reports of leakage
• 5 reports of component separation
• 2 reports of failure to infuse

None of the reports involved a patient death. One report described a healthcare practitioner being exposed to chemotherapy after a medication leakage.

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 4 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 3 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with Chemotherapy Transfer Devices
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA During initiation of chemotherapy, while nurse hanging bag, the chemotherapy spilled on nurse. Phaseal infusion adapter dislodged from bag allowing the leakage (approximately 50 mls leaked from bag).
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA Patient discharged home with continuous infusion ambulatory pump with chemotherapy to infuse over 46 hours. Both pump and infusion bag secured in portable carry case at time of discharge by trained personnel. Patient called hospital infusion suite shortly after discharge to report fluid leak from carry case. Patient returned to infusion suite with pump and case. Case opened by nurse who found chemotherapy bag empty which was properly still secured in case. The Phaseal infusion adapter dislodged from infusion bag causing the leakage.
B. BRAUN MEDICAL, INC., Onguard Tevadaptor NA, 412111, M2105C11 The Tevadaptor Onguard vial adapter was found leaking. The chemo therapy drug etoposide is not a restricted drug for this adapter. We were aware of manufacturer's change in process as a result of leaking issues. The adapter was placed on vial for approximately 20 hours when the failure occurred. B. Braun recommends the adapter to be used within 72 hours time frame.

This is the third similar event with this type of device. All events have been reported to MedSun. No cracks were noted on the device or any other manufacturing problems. The vial size was 20 mm and the converter ring was not used. Only one vial of medication was pierced with the adapter.
EQUASHIELD MEDICAL LTD NA, NA, NA Infusion started but would not infuse until device removed from tubing.
EQUASHIELD MEDICAL LTD NA, NA, NA Equashield female and male luer parts were connected to the IV tubing, but chemotherapy drug would not infuse. Adjustments were made without success. The device was removed and infusion ran without further problems.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA The nurse was adding the final flush via a syringe into the safety port of the bag. The piercing pin ejected from the bag and spilled the residual gemcitabine hcl.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA The gemcitabine arrived to the unit and it was leaking into the transport bag. The staff was unable to determine the origin of the leak. The whole system was discarded.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA After change of shift, the on-coming nurse was assessing the chemo infusion (arsenic) when she noticed fluid dripping onto the IV pump and the floor from the infusion set.
CARMEL PHARMA AB., Connection Luer Lock NA, C35, NA A patient alerted the nurse a tubing disconnection. Tubing/infusion was disconnected. The IV flushed well and without resistance. It appeared either the injector or the connector were backed up.
ICU MEDICAL, INC, ChemoClave NA, CH-10, 2284824 Nurse was hanging chemotherapy infusion and a glued cap came off the connector device resulting in a large chemotherapy spill on the floor and IV pump. The pharmacist notified the device representative.
ICU MEDICAL, INC, Spiros NA, NA, NA Patient just finished receIVing her bleomycin IV push. Nurse went to disconnect the Spiros from the port of the IV tubing and the Spiros detached from the syringe instead. Approximately 1cc of fluid leaked out onto the chemotherapy spill pad.; patient just finished receIVing her bleomycin IV push. Nurse went to disconnect the Spiros from the port of the IV tubing and the Spiros detached from the syringe instead. Approximately 1cc of fluid leaked out onto the chemotherapy spill pad.
ICU MEDICAL, INC, Spiros NA, NA, NA Our outpatient clinic has had multiple problems regarding leaking with the spinning Spiros. They have dealt with multiple occasions where the Spiros began leaking from the female luer area. They have reported this to the manufacturer each time, but the manufacturer has done nothing to fix the problem. Their response is that it was a user error. Staff has witnessed that the pin where it fits into the clave will break and instead of locking, the Spiros will continue to spin. They have dealt with multiple leakage issues on staff and patients.
ICU MEDICAL, INC, Spiros NA, NA, NA The Spiros connecter piece that was on the syringe of daunorubicin leaked and spilled out.

Additional Information:

NIOSH Hazardous Drug Safety Working Group (September 2004). Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Retrieved from:
http://www.cdc.gov/niosh/docs/2004-165/2004-165d.html

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Updated April 1, 2012

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