Pediatric Hospital Cribs: MedSun Small Sample Survey Summary
MedSun: Newsletter #66, November 2011

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.

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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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