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U.S. Department of Health and Human Services

MedSun: Newsletter #66, November 2011

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Newsletter #66, November 2011

Discussions with Healthcare Providers

Pediatric Hospital Cribs: MedSun Small Sample Survey Summary

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Survey Topic: Pediatric Hospital Cribs - Summary of Responses
Year Conducted: 2011



Background
Pediatric cribs in hospitals have a common design feature of side rails that drop down for providing care to pediatric patients. The Consumer Product Safety Commission (CPSC), which regulates consumer household products, is planning to issue a new standard that eliminates the feature of drop down side rails on cribs that are used in the home or a day care facility.

The purpose of this survey was to learn about clinicians' experiences with pediatric hospital cribs with drop down side rails to gain a better understanding of the clinical perspective and the importance of this feature to the provision of hospital-based care for pediatric patients. The survey was conducted with nine healthcare professionals from nine MedSun hospitals. The majority of the hospitals are stand-alone pediatric hospitals and the remaining are adult hospitals with pediatric care units. Survey respondents include nurse managers, nurse educators, risk managers, and biomedical engineers. The information that follows is a summary of responses.


Summary
All respondents have pediatric cribs in their hospitals with drop down side rails; none have cribs with fixed rails. All respondents believe that cribs with drop down side rails are important to patient care because it allows staff to reach patients quickly and easily. Drop down side rails allow staff to perform CPR and other life-saving procedures effectively, and to perform many other tasks effectively and efficiently such as drawing blood, inserting IVs, providing respiratory care, wound care, etc. in addition to daily care. All respondents comment on how difficult it would be for staff to provide care if the feature of drop down side rails were eliminated and believe it would present a patient safety issue.

Although crib models vary, most have cribs made by two or three manufacturers with a similar mechanism for raising or lowering side rails. A few of the models also have rails that raise and lower at both ends of the crib. Many cribs have a canopy or bubble top made of vinyl or hard plastic if there is a concern for patients who may try to climb out. All respondents have cribs that are made of steel and chrome; none are made of wood.

Responses vary somewhat about the age of patients usually placed in pediatric cribs. Most patients are under 3 years old. However in addition to age, the decision depends on other factors such as the patient’s size and weight, developmental age, therapy or care needs, and activity level at home.

In pediatric hospitals, cribs are in use in the intensive care unit, the operating room for patients who are sedated, and occasionally in the emergency department. Smaller infant cribs and isolettes are in the neonatal intensive care units. In adult hospitals, pediatric cribs are mostly in the general pediatric units, the pediatric intensive care units, some pediatric specialty units, but not in the post–anesthesia care unit or emergency department.

Respondents report no major safety problems with use of drop down side rails on pediatric cribs. However, the most common issue and concern is the lack of understanding of side rail operation and the need for reinforcing patient safety when the side rails are raised or lowered. There are many staff observations of parents forgetting to pull the rails all the way up before leaving the crib, not properly locking the rails into place, and then checking to make sure the latch mechanism is engaged. One respondent states the latch mechanism is not intuitive which is why parents frequently don’t understand how the rails work. An improvement that half the respondents think should be made is the placement of a label on the crib to illustrate how to properly operate the side rails with a reminder to check that the rails are locked before leaving the crib. Although all respondents’ hospitals provide continuous education for parents and closely monitor patient care, they report that it continues to be a challenge to reinforce proper use of side rails to prevent harm and maintain patient safety.

In terms of adverse events, one respondent recalls a past situation involving patient entrapment with a drop down side rail on a pediatric crib. In that event, the bumper pad did not fit properly on the rail and a child’s limb was caught, causing a fracture. As a result, bumper pads are no longer in use at this hospital and also all mattresses are consistently checked to ensure a tight fit against the rails with no gaps. Most respondents report not using bumper pads in their hospitals with the exception of two who use them for seizure precautions.

Other types of adverse events or where there is the potential for harm occurs occasionally according to a few respondents. They mention situations when an area on a patient’s body is hit with a rail coming down too fast and ice needs to be applied to the site. To mitigate this problem, one of the hospitals is implementing new protocols to educate parents and staff on operating the side rails. Two other respondents describe instances where parents have had their fingers pinched when operating the latches. There are no reports of events that involve patients playing with the latches or patient falls from cribs when the siderails drop unexpectedly.

In addition to providing training for parents, all respondents report they conduct training to educate new staff on the proper use of cribs and their components.

Almost all report that the average age of their pediatric cribs is between 10 and 15 years old. Some respondents have cribs that are 20 years old. The most common crib repair involves the wheels when the locking mechanism or brakes no longer work. Sometimes, the trigger assembly (the ends of the latching pins) breaks, brackets need replacements, or other hardware becomes loose and needs to be fixed. Occasionally, if the crib has a canopy or bubble top, the plastic cracks or it becomes opaque over time. The majority of respondents believe their cribs are sturdy and hold up very well for long periods of time. Typically, cribs are permanently removed from service when they can’t be repaired. Half of the respondents say preventive maintenance checks are conducted annually while others say preventive maintenance is done when a repair or safety inspection is necessary.

Some respondents have suggestions for future improvements. They include: adding emergency releases on side rails for faster access to patients, the ability to raise and lower the rail at the head of the crib (some models have this feature) particularly for procedures such as airway protection during intubation or C-spine immobilization, decreasing the distance to an inch between crib slats that allows for the size of tubing but will help prevent some patients from putting their arms or legs through the slats, and better mattress quality to reduce pressure ulcers. Also, another suggestion is having larger casters on wheels for easier movement over thresholds particularly for transporting patients in cribs on and off elevators or over carpeting. And, as previously mentioned, a well-designed, simple label or “cheat sheet” on the crib that parents can read and understand, made of a material that wouldn’t break down with cleaning, and that will also serve as a reminder to the user to check and make sure the rails are securely latched before leaving the side of the crib.

In the event of a hospital or unit evacuation, half of the respondents say they would use the cribs to remove patients if it is a horizontal evacuation and elevators are safe to use. For a vertical evacuation when only stairs are safe to use, some hospitals have what is known as an “apron” which enables a staff person to carry up to six babies at one time.

According to respondents, when a decision is made to change to a new pediatric crib several groups provide input. The nursing unit and management staff provide the clinical perspective on use. The facilities management and the biomedical engineering staff are involved because of their responsibility for maintenance. And, hospital groups such as a value analysis, new products, or standardization committee typically work with the purchasing department to evaluate the new cribs for quality and cost effectiveness. Some respondents say their hospitals are beginning to standardize the type of cribs they purchase to make replacements of components, including mattresses, easier and to maintain familiarity with the cribs for parents and staff.

As to whether pediatric hospital cribs are ever ordered for home care use after a patient is discharged, only one hospital respondent remembers a patient’s family requesting information on purchasing a bubble top crib. At the time, the patient’s physician and the hospital were not involved and it’s not clear if a crib was ever obtained from the manufacturer. Most respondents say that devices for the home may require a prescription and training from the vendor, and that insurance coverage would probably vary from state to state.

Overall, respondents provide many reasons for using drop down side rails on pediatric hospital cribs and explain why this feature is critical for providing safe care. They allow fast access to patients particularly in emergency or urgent situations. If the side rails are fixed, response time would be delayed because staff would have to reach over the rails to get to the patient. Also, a patient would need to be moved to an open surface to perform CPR and all other procedures would have to be performed on stretchers in procedure rooms such as starting IVs, drawing blood, suctioning, treatments, etc. Even basic diaper changes and bedside care would be difficult to do safely, effectively and efficiently. For staff and other caregivers including parents, the concern is also an ergonomic one. Constantly reaching over side rails to get a patient in and out of a crib that has fixed rails may lead to back issues and other injuries including the potential for harm or injury to the patients. The majority of respondents state they can’t imagine how care would be provided without drop down side rails because logistics and body mechanics would be problematic. They believe fixed side rails wouldn’t be safe for anyone.

******
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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Harmonizing Emerging Risk Documents: MedSun Small Sample Survey Summary

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Survey Topic: Harmonizing Emerging Risk Documents - Summary of Responses
Year Conducted: 2011



Background
FDA currently uses multiple communication vehicles with different formats to convey new and emerging risk information to the public about drugs, devices and biologics that are regulated by the FDA. These Web-based documents have the common goal of providing important safety information to healthcare professionals in a variety of settings, caregivers, patients, and consumers.

However, recent feedback from the general public indicates that having multiple FDA risk communication vehicles with each using different formats can be confusing. To address these concerns, a survey was conducted with nine healthcare professionals, most of whom are Risk Managers, from nine MedSun hospitals. The purpose of the survey was to obtain feedback on the format and design of two sample risk documents and to learn about their experiences with reviewing and sharing safety information within their hospitals.

The information that follows is a summary of responses. The two sample formats used during the survey interviews are referred to as “Example A” and “Example B.”

Summary
Overall, eight out of nine respondents prefer Example B over Example A. Respondents report that the information in both examples is clear and complete but Example B is more user friendly and appealing. This is due mostly to section headings that are phrased as questions. Also, several think Example B may be more effective at encouraging readers to seek more information and also view it as an educational resource. There are no major changes or suggestions for either example. However, respondents suggest some minor changes such as re-ordering section headings, including a statement that directs individuals to contact their physician if they have additional questions, and adding some information to the shaded box (or blue box) that appears at the beginning of the document.

Document Title and Audience
Respondents think the main message of both communications is the same and is evident in the title and summary in the blue shaded box. Most prefer the title format on Example B and think it is more impactful and direct. They also think it is more important to lead with the issue instead of indicating that it is an FDA communication since the information appears on the FDA Web site. The title of Example B attracts their attention right away than the title in Example A.

In terms of perceived audience, more than half of the respondents think that Example A is written more for healthcare professionals and Example B is written for the general public. The less formal language and question format in Example B seems friendlier and is written more for a broader audience. The other respondents think that both formats would be appropriate for all audiences including healthcare professionals, caregivers, and the public. One respondent suggests including the term, “caregivers” because of the increasing numbers of people who are not healthcare professionals but provide care to patients.

Blue (or shaded) Summary Box
When asked to respond to the information in the blue shaded box that appears in the beginning of the communication, all think it is very important. Most respondents think the information included in both boxes is attention-getting and easy to read. Healthcare professionals may not have time to read the entire document so the shaded box briefly summarizes the most important information. Many believe it allows them to easily determine if the message applies to them. Respondents also like that the particular audience for the communication is identified in both boxes.

The response varies on which example of the shaded box was better, however, a majority prefer the section headings that appear in a question format in Example B. Also, Example B provides more clarification and can help anticipate questions they may receive from patients. One hospital Risk Manager who prefers Example A thinks it is shorter and more succinct, and probably more appealing to healthcare professionals.

When commenting on whether reading either example of the shaded box would make them want to continue reading the entire document, one person would continue reading more regardless of which box she’s looking at particularly if the affected product is used in her facility. Another believes it’s dependent on who needs to be involved, what day it is, and how pertinent the information is at the time. Some others also think the boxes have enough information that they don’t need to read any further. Of those who will read further, they prefer Example B because Example A doesn’t hold their attention the same way.

There is also a comment on the placement of the heading, “Communication Type – Take Immediate Action.” Most respondents think that this information should be above the blue box, as in Example B, instead of inside of it. This allows the reader to prioritize the urgency of the message quickly. In addition, the phrase “Take Immediate Action” is viewed as significant and indicates a priority level that would provoke action. Another comment is that instead of “Communication Type,” use the word “Urgency” because “Communication Type” isn’t very descriptive.

Terminology for Communicating Levels of Alerts and Actions
In response to a question about terminology or a framework that FDA could use to help recipients prioritize safety information and respond accordingly, respondents suggest using larger fonts, bold type, or all uppercase letters for information requiring an urgent response. Another suggestion is to use different colors for different levels of urgency. However, if colors are used FDA would need to assure compliance with Section 508 of the Rehabilitation Act; 29 U.S.C. § 794d.

The terms, “High, Urgent, and Take Immediate Action” are suggestions from respondents to indicate high priority FDA messages. Words such as, “Moderate” and “Warning” could be terms for the next level. Using “Information Only,” “No Action Required,” General Information,” and “Low,” are suggestions for lower risk issues. One Risk Manager states that maybe a third or lowest level isn’t needed. Other respondents also agree that it may not be necessary to send out a message that says “For Information Only.”

Section Headings
All respondents prefer section headings worded as questions instead of statements as in Example A. Example A’s headings may be too clinical and boring. One person believes the questions in Example B make you think more and are less overwhelming than the section headings in A.

Upon review of the section headings, respondents suggest “Products Affected” appear as the 2nd or 3rd heading in the list. When facilities receive communications they want to know quickly what products are affected after they read about the problem. Also, they want to determine whether their facility has the affected products without having to read through the entire document. Additional comments involve the section heading entitled, “Reporting Problems to FDA.” Respondents believe it may be confusing to the public and suggest wording such as, “What Sort of problems is FDA interested in” or “What kinds of problems does FDA want to know about?”

Responses vary about the section entitled, “Review of Data” and whether it should appear in the body of the document or on a separate page with a link to it. Some think having the link to additional information saves time. Those who prefer the section left in the document say they probably won’t read it right away but would like it there so they could come back to it if needed. One respondent thinks the information is good so it should be left in the document. Another respondent likes having a link to the “Review of Data” but notes that it could be a problem for those in rural areas where internet access may be intermittent or for individuals who may use mobile communication devices such as a BlackBerry.

Additionally, some miscellaneous comments include: keeping the section entitled, “Contact Us” because it’s very helpful, keep messages clear, simple and at an appropriate reading level to reach all audiences, and include pictures of the affected products on all FDA communications, when possible.

In conclusion, there are many common themes in the respondents’ feedback about both examples but overall, the preference for design and format is Example B.


******
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 products. Additionally, FDA continues to receive adverse event reports from its Reporting Programs. 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 products 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 products, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.


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Radio Frequency Identification (RFID) and Real Time Locating Systems (RTLS): MedSun Small Sample Survey Summary

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Survey Topic: Radio Frequency Identification (RFID) and Real Time Locating Systems (RTLS) - Summary of Responses
Years Conducted: 2010 - 2011



Background
Hospitals, like their retail commercial and industrial counterparts, are deploying systems which employ RFID (Radio Frequency Identification) and RTLS (Real Time Locating Systems) technology for a wide variety of applications. Applications may be as diverse as access control, inventory control, theft management, real time tracking of the location of specific devices and even interrogation of RFID-based devices embedded in patients' implanted medical devices.

The FDA is studying the nature of RFID and RTLS systems and working with manufacturers to learn how these systems co-exist in the hospital environment with a variety of medical devices and systems. This survey effort was to learn how hospitals plan for and deploy these systems, where they are located, how they are used, and if there are any concerns or experiences with interaction between these systems and nearby medical devices.

The survey was conducted with nine healthcare professionals from nine MedSun facilities. Survey respondents work in various hospital departments such as Clinical Technology Services, Environmental Safety, Cardiac Services (for the cardiac catheterization and electrophysiology labs), Compliance, and IT Services and Information Systems. The information that follows is a summary of responses.


Summary
Eight of nine respondents currently have RFID or RTLS systems in their facility. One facility does not currently have a system but previously piloted a product that is no longer available. The respondents with RFID systems use several manufacturers and most have the RFID technology throughout the entire facility. Those that do not have it house-wide, have RFID systems in areas such as the Cardiac Catheterization and Electrophysiology labs, the Operating Room, Obstetrics, and Interventional Radiology.

In response to where RFID readers are installed, some have fixed RFID readers in their facilities while others do not. Those who have fixed readers have them installed on door frames, in hallways, patient rooms, and inside cabinets. Non-fixed readers are part of a wand system, are located in consoles, or are readers that plug into outlets. None of the respondents report having any signage that identifies where the readers are located.

Most report having RFID systems that are active-tag systems with some operating on the hospital’s 802.11 wireless system. However, other systems operate frequencies in the 433 MHz or 900 MHz frequency range. Also, the times for transmitting information from the readers range from every millisecond to once every 10 minutes.

Respondents are currently tracking multiple and varied devices in their facilities. They report utilizing RFID for portable assets and other expensive equipment that frequently moves around the facility. Infusion pumps, portable monitors, wheelchairs, beds, and ventilators are among those devices that are tracked the most. Telemetry boxes (Wireless Medical Telemetry System), pacemakers, bladder scanners, defibrillators, custom ultrasound, vital sign monitors, balloon pumps, CVVH machines, pulse oximeters, surgical sponges and towels, coronary stents, and electrophysiology catheter devices are mentioned as being tracked using RFID technology.

Prior to implementation, several respondents report working with vendors to monitor RFID interaction with other medical devices. During implementation, almost all respondents describe in detail the consideration given to where the RFID hardware is placed and its proximity to potentially sensitive medical devices and systems. Before installation, several hospitals tested for interference by taking RFID tags into certain areas. One respondent notes that an RFID tag was causing delays with ventilator alarms so in that particular facility tags are not placed on life support systems. Another respondent reports interference to an RFID sponge tracking system from devices such as an anesthesia machine, EKG monitor cables, surgeons’ headlamps, electrosurgical units, and video towers. Also at the room level, sensors in some equipment interfere with RFID tags resulting in interference with alarms. The remaining respondents, however, report no problems with medical devices in the vicinity of RFID readers.

Currently, most respondents are piloting or planning to deploy other RFID-based inventory control systems including those that scan supplies, for example, in supply closets on nursing units, or systems that track emergency department patient records. Several are also looking into refrigerator temperature trackers for alerts when a temperature falls out of a threshold.

The majority of respondents do not use RFID devices to track medications or other pharmacy products. However, one respondent’s hospital is currently looking into a program that tracks expiration dates of medications. Another hospital uses a bar coding program for medication administration.

When asked about the use of access control or “people finder” systems, several are currently looking into them to track both patients and employees. Some reasons include tracking patients who may be confused or have a brain injury and also for tracking patients in the Emergency Department to avoid delays with x-rays and lab testing. Two facilities are using RFID/RTLS technology to protect infants from abduction with a system that alarms when infants are taken outside of certain locations. In contrast, some respondents know that management and employee unions have concerns with implementing these types of systems. Additional comments relate to hospital cultures that are not ready to implement “tagging patients” at this time.

Almost all respondents report collaboration with multiple hospital departments during the decision-making process to purchase, implement and support RFID/RTLS equipment. These departments include information technology, biomedical engineering, nursing, purchasing, materials management, and finance. Information Technology usually takes the lead and is responsible for supporting RFID/RTLS equipment. A “lesson learned” from a respondent is to obtain more input from clinical staff before implementation. Another respondent, whose facility piloted an RFID system, plans to choose a larger manufacturer next time since their manufacturer stopped marketing RFID products.

Overall, responses indicate many advantages to RFID or RTLS systems in hospitals such as improved inventory control, which may decrease the time staff need to look for equipment, improved cost containment and cost savings, and some report improved patient care. Additionally, it is important to test RFID or RTLS systems for electromagnetic interference with devices in the individual hospital environment prior to purchase and implementation.


******
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 is 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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External Defibrillators: MedSun Small Sample Survey Summary

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Survey Topic: External Defibrillators - Summary of Responses
Year Conducted: 2010


Background
External defibrillators are critical life-saving devices that are used successfully hundreds of times each year to treat patients experiencing sudden cardiac arrest. The FDA recognizes the important life-saving benefits of external defibrillators and that users trust they will operate properly. It is unlikely that an external defibrillator will malfunction however, the FDA is aware of infrequent problems associated with external defibrillators that impact patient safety.

This survey was an effort to learn about experiences with external defibrillators and to gain a better understanding of the clinical perspectives of these devices and suggestions for improvement. The survey was conducted by phone with nine individual healthcare professionals from nine MedSun facilities. Survey respondents included clinicians from areas such as the emergency room, intensive care unit, and clinicians who are also members of the code or rapid response team. Respondents also included some biomedical engineers and emergency medical technicians (EMTs). The EMT respondents work with an ambulance service affiliated with a MedSun facility. The purpose of interviewing EMTs was to discuss their experiences specifically with the use of automatic external defibrillators (AEDs). The information that follows is a summary of responses.

Summary
The Philips HeartStart XL and MRx, Medtronic Lifepak Models 12, 15, and 20, and the Zoll M Series were cited as the primary brands of external defibrillators used by respondents. All respondents believe that the defibrillators they use will perform as expected when needed. Most said they are happy with their current external defibrillator model, and once hospital staff is properly trained and familiar with the devices, they also believe the devices are easy to use.

One clinician said they prefer their particular model of defibrillator for transport because it weighs less, which is especially important for transport by helicopter, and because the data on the screen remains stable during transport. However, another respondent said they avoid using this lighter weight defibrillator because it only runs on battery and if there is no electricity available during transport, treatment cannot be delivered. Other respondents did not say there is a particular brand they avoid using.

The function mode used most often on these devices by respondents is the manual mode. A few use a combination of manual and monitoring modes. The pacer and AED modes are rarely used. Usually, the mode selected depends on the patient’s condition.

Nearly all respondents report there are defibrillator design features that affect functionality. A primary issue is the large size of most defibrillators. Respondents think these devices tend to be too cumbersome in size and weight and would like to see them lighter and more portable. This is especially problematic when defibrillators are needed for transporting patients within and also outside of the hospital setting.

Those who use external defibrillators think having different cables for pads and paddles is confusing and would like to see that changed. Some cables are more user friendly than others because they are easier to plug-in and remove. Another user said he would like to see regulation for universal pads and paddles that all connect the same way. Another criticism of defibrillator design is the large pouches on each side of some units that make it difficult for users to reach the cables and cords quickly. Respondents also said they would like to know how to sterilize external paddles because in trauma cases there may be contact with blood and body fluids. One manufacturer does not recommend sterilization of paddles because it causes the material to degrade but do not offer users any alternative sterilization solutions.

Another suggestion involving a design change is to make defibrillators more modular so hospital staff can easily remove parts or accessories that aren’t needed at the time. Also, a better way to secure the defibrillator in an emergency vehicle is needed. Currently, some EMTs can only use a passenger seatbelt or a strap to hold the defibrillator in place in a vehicle. They would also like device handles that are more rigid to withstand stress, pull, and torque. Another design feature that would be particularly helpful to have when transporting patients is pulse oximetry. However, it was noted that some of these suggested changes may affect having a model that is lightweight.

Defibrillator accessories may include external pads, paddles, electrodes and batteries. Most users report that these accessories work well. Other users had suggestions for improvement. One said it would be nice if electrodes were double packaged by all manufacturers to prevent the conductive gel from drying out too quickly. One user would like longer and more durable wires, as well as longer lasting batteries. Several respondents would like power cords that are more secure because they can easily come loose during transport. Some users said cord dislodgment is a design problem they would like to see improved and suggest a lock or snap feature for the cord to prevent dislodgement. When discussing batteries, respondents report failures occur most often because the defibrillator was not plugged-in by staff when not in use.

Most respondents said they have not seen problems or adverse events with the use of external defibrillators. Any problems they do see are usually the result of use error or physical damage to the device from being dropped or bumped by other devices. In case of defibrillator failure, all respondents said their facilities have backup devices. The number of backup devices available in hospitals varied from hospital to hospital and by type of patient unit. One respondent said that on their ambulances there are no backup devices and if the defibrillator failed they would have to continue CPR with continuous assessment of the patient.

All said that their hospital clinical engineering departments have preventative maintenance schedules for external defibrillators. Maintenance includes following manufacturer guidelines and having clinical engineering inspect the devices on a quarterly or semi-annual basis. Also, all respondents said that defibrillators are checked by nursing staff at least every 12 to 24 hours to make sure they are working. Several clinical engineering departments report they change defibrillator batteries routinely every two years. One user said they would like better education from the manufacturer on the automatic “midnight check” performed by some devices. This task caused confusion at one hospital because staff thought they did not need to perform additional safety tests because of the device’s automatic self-test.

Training on the use of external defibrillators is mandatory in all of the facilities involved in the survey. Many require staff certification in ACLS or BLS every two years. Additional device training occurs at several facilities and includes mock codes, hospital skill days for staff, and other hands on approaches. Written materials, online training, power point presentations, and other texts are also part of the training courses. It was noted that transport nurses tend to be savviest with external defibrillators because they use many different models or brands and can switch use among various devices without difficulty.

Reviews of external defibrillator user manuals are mixed. One user said they don’t need to reference the manual. Some thought their manuals are small and easy to use while others said their manuals are too large and cumbersome. Some manuals are kept on the crash cart with the defibrillator. Most respondents say they don’t refer to the user’s manual and some haven’t seen the manual at all. One user reports that manuals are often too difficult and too technical to understand by most staff. Some don’t use the manual because they’ve developed their own checklists and “cheat” cards for staff who are less familiar with the devices and who are infrequent users.

When respondents need information about external defibrillators they go to several sources. Most cited the American Heart Association (AHA) as a primary source for defibrillator information. EMT trade magazines, conventions, in-service training, and word of mouth are also utilized as sources for information. A few respondents also said they contact the manufacturer’s representative and website when necessary. Several also cited FDA as being a valuable source of information to determine which manufacturers are having device issues.

When external defibrillators are recalled by the manufacturer most respondents said that if they have the device in their facility they take the manufacturer’s recommended action. Usually, these recalls are initially handled by the clinical engineering department, materials management, or both. These departments filter information to clinical managers, clinical educators, and charge nurses. Respondents noted that some vendors will come on site to take care of problems with their defibrillators. Recall information is also shared within the hospital by phone or email. Several utilize web-based recall systems such as RASMUS and ECRI. Several respondents report that it’s a challenge to keep up with recalls when they occur outside of the schedule for their preventative maintenance. Most respondents did say, however, that the rate of servicing for defibrillators compared to other devices was relatively low.

Respondents had several opinions about what they would do to make external defibrillators better. In general, they would prefer if the devices were more standard across manufacturers. One respondent would like external defibrillators to be less complicated and have less functions. They think it is critical that the basic functions are very straightforward. Other comments on improvement centered on device design and accessories including lighter weight, better durability, retractable cables, cord locking features, universal pads and paddles, and increased duration of conductivity of the electrode gel. Despite comments on how to improve external defibrillators, one respondent believes most of their problems revolve around uncharged batteries and human factor issues.

Overall, survey respondents believe that the external defibrillators in their facilities perform as expected when needed but would like to see improvements in design and functionality that assist them in performing successful defibrillation and resuscitation of cardiac arrest victims.

******
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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FDA Center for Biologics Evaluation and Research

The FDA is clarifying its October 21, 2011 communication to inform the public that inactivated influenza vaccines labeled for IM injection are intended for administration using a sterile needle and syringe. FDA has recently received questions regarding the use of jet injector devices to administer inactivated influenza vaccines. There is one inactivated influenza vaccine labeled for ID administration, this vaccine is supplied in its own pre-filled syringe. The live attenuated influenza vaccine is given through the nose as a spray; the sprayer is not a jet injector. Currently, there is only one vaccine, Measles, Mumps and Rubella (MMR), that is approved and specifically labeled for administration by jet injector. At this time, there are no inactivated influenza vaccines that are approved and specifically labeled by the FDA for administration by jet injector.

Additional Information:

FDA Communication on Use of Jet Injectors with Influenza Vaccines. FDA Center for Biologics Evaluation and Research. October 26, 2011.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm276773.htm

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Carefusion Initiates Class I Recall Of EnVe Ventilators

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Carefusion Press Release

The voluntary recall only affects EnVe ventilators manufactured between December 2010 and May 2011 and therefore, has no affect on the company's current product production or shipping processes. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. On September 12, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators.

Additional Information:

Carefusion Initiates Class I Recall Of EnVe Ventilators. Carefusion Press Release. October 20, 2011.
http://www.fda.gov/Safety/Recalls/ucm276704.htm

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Baby Products with SIDS Prevention Claims

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FDA Center for Devices and Radiological Health

The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS. Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include: baby monitors, mattresses, crib tents, pillows, crib bedding, including bumpers and blankets, and infant positioners. Because of these claims, these baby products are medical devices, subject to FDA regulation.

Additional Information:

Baby Products with SIDS Prevention Claims. FDA Center for Devices and Radiological Health. October 18, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SIDSPreventionClaims/default.htm

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CooperVision Avaira Toric Soft Contact Lenses: Class I Recall - Unintended Residue on Lenses

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FDA MedWatch Safety Alert

The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. Consumers should return their lenses to their eye care practitioner if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

Additional Information:

CooperVision Avaira Toric Soft Contact Lenses: Class I Recall- Unintended Residue on Lenses. FDA MedWatch Safety Alert. October 14, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm275876.htm

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Preventing Surgical Fires - Collaborating to Reduce Preventable Harm

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FDA Safe Use Initiative

Surgical fires are fires that occur in, on or around a patient who is undergoing a medical or surgical procedure. An estimated 550 to 650 surgical fires occur in the United States per year, some causing serious injury, disfigurement, and even death. Despite the fact that the root causes of surgical fires are well-understood, surgical fires still occur. Many healthcare organizations have developed tools, implemented strategies, and conducted education and outreach efforts to reduce the risk of fires. To supplement these efforts, FDA and its partners are launching the “Preventing Surgical Fires” initiative to: increase awareness of factors that contribute to surgical fires, disseminate surgical fire prevention tools, and promote the adoption of risk reduction practices throughout the healthcare community.

Additional Information:

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative. October 13, 2011.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

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H & P Industries Custom Dialysis Trays/Kits: Recall - Potential Microbial Contamination - Update

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FDA MedWatch Safety Alert

Additional Lee Medical International Inc., Custom Dialysis Trays/Kits have been recalled. Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

Additional Information:

FDA MedWatch Safety Alert. H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination. October 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm

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Program Encourages Reporting Accidents Waiting To Happen

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Anesthesiology News

A new system that encourages every clinician to report situations that put patients at risk appears to be succeeding. Within 24 months, the new program, based at Johns Hopkins Medicine, in Baltimore, distributed 27 so-called "Good Catch Awards" (Table) to clinicians who reported situations that resulted in changes that were potentially lifesaving, including a national recall of improperly labeled drugs that had caused look-alike medication errors.

Additional Information:

Program Encourages Reporting Accidents Waiting To Happen. Anesthesiology News. September 2011.
http://www.anesthesiologynews.com/ViewArticle.aspx?d=PRN&d_id=21&i=September+2011&i_id=760&a_id=18907

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HeartNet

Charge Circuit Timeout: A Sequence of Events Leading to Failure of an Implantable Cardioverter-Defibrillator to Deliver Therapy

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PubMed

The importance of reporting medical device problems to FDA and the manufacturer. The MedSun program is referenced in this article.

Additional Information:

Charge Circuit Timeout: A Sequence of Events Leading to Failure of an Implantable Cardioverter-Defibrillator to Deliver Therapy. PubMed. August 2011.
http://www.ncbi.nlm.nih.gov/pubmed?term=charge%20circuit%20timeout

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KidNet

Baby Products with SIDS Prevention Claims

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FDA Center for Devices and Radiological Health

Please see this month's article referenced in the General Articles section about baby products with unproven safety claims.

Additional Information:

Baby Products with SIDS Prevention Claims. FDA Center for Devices and Radiological Health. October 18, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SIDSPreventionClaims/default.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=66#7

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Office of Pediatric Therapeutics

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FDA Website

The Office of Pediatric Therapeutics (OPT) is mandated by Congress. Its primary mission is to assure access for children to innovative, safe and effective medical products. Historically, many medical products have not been tested for use in children, leading to an increase in adverse events and the use of ineffective products. Given its legislative mandate, OPT has developed four distinct yet interrelated programs to support FDA efforts to improve pediatric access.

Additional Information:

Office of Pediatric Therapeutics. FDA Website. October 21, 2011.
http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018186.htm

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SightNet

Decorative Contact Lenses: Is Your Vision Worth It?

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FDA Consumer Update

Tips from the FDA on how to safely buy decorative contact lenses.

Additional Information:

Decorative Contact Lenses: Is Your Vision Worth It? FDA Consumer Update. October 20, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm275069.htm?slb=declenses1

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Highlighted MedSun Reports

Highlighted Reports

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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 August 1 through August 31, 2011. 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.



CARDIOVASCULAR


Device:
Type: Sheath, Removal, Pacemaker Electrode
Manufacturer: Spectronectics
Brand: Sls Ii
Model#: 500-001
Lot #: C11D21B
Other #: P002566-03

Problem:
A lead extraction procedure was being performed to remove two pacemaker leads implanted 11 years ago. There was one right atrial and one right ventricular lead. The Spectronetics machine was turned on and calibrated appropriately. A 12 French SLS II laser sheath was connected to the machine and the calibration button was pushed with no response. It was repeated multiple times with no calibration done effectively. The Spectronetics rep was called and instructed us to wipe off the sensor with alcohol and dry. This was re-attempted with no success. They asked us to clear the sensor on the laser machine and use the control sheath which calibrated fine. The laser sheath would still not calibrate. The rep then informed us to use another 12 FR Laser sheath. We instituted a new 12 FR laser sheath that calibrated fine without difficulty.


Device:
Type: Zoll Pacemaker/defibrillator Pd 1400
Manufacturer: Zoll Medical Corporation
Brand: Zoll
Model#: PD 1400

Problem:
A patient presented to the Emergency Department (ED) undergoing CPR (cardiopulmonary resuscitation). Patient was in asystole for a few minutes then went into a ventricular tachycardia rhythm that could be defibrillated. The ED RN charged the defibrillator, with sync button on the first time and accidentally pushed the buttons on the paddles instead of the multifunction cable to discharge. It did not discharge for this known reason the first time. The RN turned off the machine (defibrillator) and recharged without the sync button, pushing the buttons on the multifunction cable to discharge and the discharge did not occur. The first RN enlisted the Charge RN to double check everything and the device would not discharge with the 3rd attempt either. A new device was then used and worked fine. Patient's condition was such that the short delay did not contribute to this patient's demise. It is known that the equipment is greater than 10 years old so is most likely getting to its end of use time. It is also known that in the heat of the moment, there could have been something performed incorrectly, although we will never know. The RNs involved are skilled and detailed. Report is being made in case others might have the same issue.


GENERAL & PLASTIC SURGERY


Device:
Type: Absorbable Hemostat
Manufacturer: Medafor, Inc.
Brand: Arista Ah Absorbable Hemostat
Lot #: W1601418, W1579122

Problem:
Physicians have reported that their patients developed small lymphocysts after Arista Absorbable Hemostat was used.


Device:
Type: Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer: CONMED CORPORATION
Lot #: 110114
Cat #: 138105

Problem:
The surgeon was using the needle tip with the electrosurgical handpiece during the procedure; Brand: ConMed., REF# 138105, Lot # 110114. The handpiece was plugged into the argon beam unit and the settings were for coagulation and cut, set to 40/40 and on blend. The needle tip was found to be melted after use by the surgeon. Biomed engineering was informed and came to inspect the needle tip and argon beam electrosurgical generator. Biomed evaluated the argon beam machine and found it to be in proper working function. Biomed determined that the current settings used for this handpiece needle tip exceeded recommended settings of 25 W. Settings as noted were 40/40. Communication to all Surgeons by the Surgical QA chair regarded the proper settings intended for the specific needle tip. There is no indication on the needle tip packaging to indicate the proper settings for the generator. Nor are there recommendations from ConMed as to specific settings for specific needle tips.

See device images:

Image of two ConMed Bovie Tips.  One is shown with a brownish melted needle tip; the other Bovie Tip is not melted.

 Second view of two ConMed Bovie Tips.  One is shown with a brownish melted needle tip; the other Bovie Tip is not melted.

Device:
Type: Needle, Suturing
Manufacturer: Arthrex Inc
Brand: Multifire Scorpion Needle
Model#: AR-13995N
Lot #: 409680A
Cat #: AR-1399SN

Problem:
Needle improperly tempered resulting in misfire of suture passing. All in lot were found to be abnormal. Surgeon has seen same problem at another surgicenter, suggesting widespread problem.


Device:
Type: Negative Pressure Wound Therapy System
Manufacturer: Kinetic Concepts, Inc.
Model#: 60090

Problem:
Wound vac pump running off battery power even with the power cord plugged in. Battery was not charging with the power cord plugged in.

See device images:


This image shows the power cord correctly plugged into the Wound VAC system.  The plug is correctly plugged in because there is a indicator light on, which shows that the Wound VAC system is operating on AC/DC power.

 This image is a close up, which shows the power cord correctly plugged into the Wound VAC system.  The plug is correctly plugged in because there is a indicator light on, which shows that the Wound VAC system is operating on AC/DC power.  The white arrow found on the power cord faces the indicator light.

This image is a close up of the power cord plugged into the Wound VAC system.  This time, the cord is not correctly plugged in because no indicator light is on.



Device:
Type: Sponge, Gauze
Manufacturer: Surgicount Medical
Brand: 18 X18 Master Tagged Lap Sponge
Lot #: 8009
Cat #: SM-1818-PS

Problem:
Circulating RN opened a package of lap sponges to give up to the scrub person and upon opening inner wrapper, noted several (more than 2) black specks on the laps. She did not pass the laps up to the sterile field, and removed them from the room.


Device:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate
Model#: PXW35
Lot #: H43V95
Cat #: PXW35

Problem:
Stapler 1 of 3 misfired during the same procedure.


Device 1:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate Plus Md
Model#: PMW35
Lot #: H4421K
Cat #: PMW35

Device 2:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate Plus Md
Model#: PMW35
Lot #: H43Y7Y
Cat #: PMW35

Problem:
Patient was having a non-emergent cesarean section and during closure the OB doctor was attempting to use the Proximate Plus MD skin stapler. Three staplers needed to be opened. The first 2 staplers would not release staples but the 3rd did. Per the OB Nurse and Nurse Manager, the patient experienced a prolonged time for the incision to be open. Other risks include: increased risk for breaking sterile field due to staff having to open numerous staplers before finding one that would work and increased risk for infection.

Manufacturer response for Stapler, Skin, Proximate Plus MD (per site reporter): Manufacturer is sending replacements at no charge and they are sending a "return shipper kit" to us so that we can ship back the defective staplers for QA.


OBSTETRICS/GYNECOLOGY


Device:
Type: Clamp, Circumcision
Manufacturer: Cardinal Health

Lollipop Icon


Problem:
This one-day-old healthy newborn male was to undergo a routine circumcision performed by an experienced obstetrician. During the placement of the bell and clamp, the physician was not satisfied with the components of the first circumcision tray components so requested another tray be opened. She interchanged the clamp while leaving the bell in place, and therefore did not check if the new components fit together properly. During her first cut the instrument slipped causing a degloving injury of the shaft of the penis.

The standard practice in this facility is the use of Gomco surgical instruments assembled in a tray (circumcision) that is returned and re-sterilized in the Central Processing Department on campus. The exception to this rule is the use of the plastic bell device used by the pediatric surgeons in the NICU and pediatrics. However, some disposable sets were left in OB to be used on a trial basis as instrument trays were always readily available for use. Despite these being identified as "disposable," the appearance of components of the kit looked very similar to the reusable ones that are in use on a routine basis. With careful inspection, it was questioned if these disposable items were returned to Central Processing as a result was inter-mixed with the Gomco product.

After careful inspection of the instruments, it was noted that the bells differed in length by approximately 3 mm. This could lead to a clamp that is not proper and safe for use in the procedure.

The disposable kits were taken off the shelf immediately. Those physicians credentialed in circumcision procedure were notified that the Gomco components are not interchangeable. The Plastic bell device will continue to be supported by the pediatric surgeons.





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Lollipop Icon

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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Updated November 1, 2011

Return to MedSun: Medical Product Safety Network

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