Philadelphia Bed Rail Recall Lawyers: Suing Manufacturers For Injured Patients

The Dangers of Bed Rails

Before we can determine the best way to keep elderly patients safe in their nursing home beds, it is important that we understand what is putting them at risk of harm. Often, bed rails are used in nursing homes to keep patients safe. However, sometimes bed rails can have just the opposite effect. The FDA has reported that people can be suffocated or strangulated as a direct result of using bed rails. Bed rail accidents can cause serious injury or even death.

In order to prevent bed rail accidents, it is important to understand what these injuries are and how they occur. Typically, patient injuries occur when the patient falls into a gap created by the bed rails or has a body part that becomes trapped in a gap. The four most common types of entrapment occur when a person falls:

  1. Through the bars of an individual side rail;
  2. Through the space between two split side rails;
  3. Between the side rail and the mattress; or
  4. Between the headboard or footboard, side rail and the mattress.

Death may occur if the patient’s head or neck gets trapped in one of the ways described above. Fractures, cuts and other injuries can occur if a patient’s arm, hand, leg, foot or other body part gets caught in one of these ways.

Injuries can also occur if a patient attempts to climb over the bed rails to get out of bed. A patient who is confused, disoriented, or who is not receiving adequate attention from thenursing home staff might not be able to figure out how to lower the bed rails and may attempt to climb over the rails which can result in a fall. The injuries from these falls can be serious especially in an elderly patient who might break a hip or suffer from another serious injury.

Any patient can be at risk of entrapment. However, there are some patients who are considered high risk for entrapment and the potential complications that arise from entrapment. Patients with conditions that cause confusion, restlessness or a lack of muscle control are at greater risk than the rest of the population. Ironically, it is often those patients for whom bed rails seem most necessary.

Bed rails create many problems for patients that are avoidable. In order to avoid the problems associated with bed rails it is important that patients and their families speak with nursing home staff about their concerns and about possible alternatives to bed rails.

Despite the dangers of side rails, many nursing homes routinely continue to use them.In some nursing homes all of the beds have rails and there is no consideration for the individual needs of the patient. So, why do nursing homes insist on using bed rails?

There are potential benefits to using bed rails that are often cited by nursing homes. First, bed rails may make frail patients feel more secure. Bed rails give them something to hold on to when they are getting in and out of bed which might make them feel like they are less likely to fall and get hurt. Next, bed rails can help patients reposition themselves in their bed and be able to reach for the bed controls and their things on their bedside table. This might be important for the patient’s independence, comfort and safety. Some patients find that they are able to get in and out of bed without assistance and to reach things such as a cup of water, a book, or the light switch that they would otherwise need the assistance of a nurse to reach. They, therefore feel like they have more autonomy and dignity than they otherwise would have without the bedrails. Further, some nursing home staff believe that having bed rails on the bed makes it easier to transport patients who may need to be transported for medical tests or other reasons. The rails may prevent patients from falling out of bed and having to endure the pain and danger associated with a fall.

For more involved patients who may be a danger to themselves or others, nursing home staff may use bed rails as a form of restraint. The bedrails may prevent some people from getting out of bed at all. Some nursing home staff find this desirable for patients who are suffering from dementia who could potentially get lost and for patients with psychological disorders that make them potentially dangerous.

Some nursing home staff may argue that another benefit to bed side rails is that they make the nurse’s job easier. Nursing home staff view the bed rails in much the same way as a parent may view the safety bars on a crib. They allow staff to supervise patients a little less closely and to trust that they will safely remain where they had been left. Whether these arguments are applicable to the vast majority of patients is unknown. What is known is that many nursing home staff believe in the potential benefits of bed side rails and that some of them are making bed rails standard operating procedure for every patient.


For many people, it is hard to imagine how a person can be trapped by a bed side rail in such a way that it causes serious injury or death. Yet, the FDA reports that more than 700 people have been hurt or killed in this way since the 1985. So, it is important that people understand exactly how bed rail entrapment occurs.

To that end, the FDA has put pictures of typical entrapments on its website. The pictures illustrate the most common danger zones associated with bedrails including:

  • Zone 1: Entrapment within the rail: this occurs when a person’s head or other body part gets caught between the bars on the side rail.
  • Zone 2: Entrapment under the rail: people become entrapped under the rail when there is a space between the rail and the mattress. An elderly or disoriented person may get his or her head stuck in this space which can be fatal.
  • Zone 3: Entrapment between the rail and the mattress: this occurs when there is space between the mattress and the bed rail. So, when a person rolls over he or she does not fall out of bed but instead gets stuck in the space between the mattress and bed rail. An elderly, sick or hurt person may lack the strength to free himself and his cries for help may be muffled if his head is face down in the gap between the mattress and the bed rail.
  • Zone 4: Entrapment under the end of the rail: this occurs because of a design defect that has the bed side rail raised off of the mattress. Thus, it is easy to get caught in the space under the end of the rail.
  • Zone 5: Entrapment between split rails: sometimes the bed rails are not continuous on the same side of the bed. Instead, the rail has two or more distinct parts and there is a gap where they come together.
  • Zone 6: Entrapment between the rail and the headboard or footboard: There is often a significant gap between where the rail ends and where the headboard or footboard begins. This is another area where people often become trapped.
  • Zone 7: Entrapment between the mattress and the headboard or footboard: Mattresses that do not properly fit a given bed can create gaps where a person may become trapped resulting in injuries that are similar to those created by bed rails.

Zones 1 -4 account for most of the injuries and deaths from entrapment while zones 5-7 show possible other entrapment zones that may lead to injury.

In addition to the entrapment danger zones, it is important to think about the mattress and the bed. A mattress with a soft edge can lead to bed rail accidents as can a mattress that is too small and does not fit securely on the bed. Hospital beds, also known as bending and articulating beds can also create dangerous gaps when the bed is articulated and the rail remains straight.

In conclusion, there are many different ways in which a person may become entrapped in a bed with a side rail. It is important to review the FDA’s pictures of typical entrapments and the recommended ways to prevent such accidents so that you and your loved ones remain safe should you need to be in a facility that uses side bed rails.

Have you ever walked into a big mattress store and thought that all of your choices looked the same? While it can be difficult to differentiate between a Sealy and a Simmons bed, hospital and nursing home beds have some very definite characteristics.

Most hospital and nursing home beds have a frame, side rails and a mattress. The side rails are typically designed in one of three ways. They can be full rails which run the entire length of the bed, they can be half rails which extend for just a portion of the bed or they can be split rails which are two rails that are put next to each other on the same side of the bed. The mattresses can be conventional mattresses or air mattresses. They are meant to be used with different bed frames and side rails and it is not always safe to use them interchangeably. If the wrong type or size of mattress is used then gaps may occur between the mattress and the headboard, footboard or side rails. Hospitals and nursing homes also use mattress overlays for some patients. Patients who are essentially bedridden might need a mattress overlay to prevent bedsores. However, the overlay might change the fit of the mattress in the bed frame and with the bed rails resulting in dangerous gaps.

Often, the different components of the bed system are sold separately and, therefore, the pieces do not always fit together well. This leads to the dangerous gaps in the bed system in which people may become entrapped.

The FDA has reported that more than 400 people have been killed by becoming trapped in bed rails since 1985 and several hundred more have been injured. The deaths and injuries have prompted the FDA to issue voluntary guidelines and suggestions to keep nursing home and hospital patients safe while they are in beds with bed rails. Part of the FDA’s guidance has been to encourage health care teams to examine patient beds in order to determine if the pieces of the bed fit together correctly or whether there are any dangerous gaps which could lead to injuries and fatalities.

If you or a loved one is in a hospital or nursing home that uses bed side rails then be sure to do your own inspection as well and talk to your health care team about whether the side rails are necessary and safe because, after all, the goal is to leave the hospital or nursing home healthier than you were when you arrived.

A bed seems like a safe place to be. However, for an elderly person who is in a nursing home bed with side rails a bed can be a very dangerous place to be. Between 1985 and 2008, 772 cases of entrapment were reported to the FDA including 460 fatalities. Since 1995 the FDA has warned patients and healthcare providers about the danger of entrapment by side bed rails.

In 1995, the FDA issued a Safety Alert about the Entrapment Hazards with Hospital Bed Side Rails. The safety alert described the 102 incidents of injury and death that occurred because of side rails between 1990 and 1995. The descriptions included 4 different ways in which people could become trapped by the guard rails. As a result of the identified risk, the FDA recommended beds with side rails be carefully inspected when they are set up and monitored periodically to make sure that dangerous gaps between the rails and the mattress are not present. Further, the FDA suggested additional safety measures for patients who might be at high risk of entrapment.

The FDA’s Hospital Bed Safety Work Group was established in 1999 and consists of FDA representatives as well as representatives from the hospital bed industry, healthcare organizations, patient advocates and others. In June 2006, the FDA hospital bed safety work group published A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment. The Guide suggested the following seven steps to reduce the danger of entrapment:

  1. Assign responsibility;
  2. Determine high risk clinical units;
  3. Inventory bed systems;
  4. Evaluate bed systems for conformance to bed system entrapment dimensional guidance;
  5. Initiate corrective action;
  6. Guidance for purchasing beds; and
  7. Implement quality monitoring.

The FDA also published a document called, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment – Guidance for Industry and FDA Staff in 2006. Again, the risk of death and serious injury by entrapment is discussed at length and the agency issued voluntary guidance for the nursing home industry.

As recently as February 2008, the FDA put out a brochure about Bed Safety Rails. The brochure encourages health care teams to carefully assess each individual patient to determine if bed rails are appropriate. It goes on to describe the benefits and risks of bed safety rails and propose alternatives to their use.

Despite the danger and all of the FDA warnings, there have not been any recalls of bed rails by the FDA. All of the guidance provided by the FDA has been nonbinding on thenursing home industry. Nursing homes may continue to legally use these devices that have caused and continue to cause serious injury and death. The failure of the FDA to require an appropriate response to the bed rail danger may result in more injuries and deaths in the future.

Accidents resulting from the use of bed side rails are preventable. Side rails are not inherently dangerous nor have there been reports of manufacturing defects. Instead, the deaths and injuries that have resulted from side rails used in hospitals and nursing homes have occurred because of poorly designed side rails or improper installation.

Bed Rail Suppliers

Some entrapments and strangulations occur because of problems with the design of the bed rails. Some bed rails leave a dangerous gap in various places such as near the headboard, between the rails or between the rail and the mattress. These gaps are large enough that an adult human can get stuck but they are not large enough that the person can get back out without help. When it is the person’s head that is stuck and the person does not receive help in time, then strangulation might occur.

Some newer designs are being marketed as having a reduced gap between the rails and the mattress and headboard. However, these beds might still present a risk of strangulation particularly if they are sent to facilities without appropriate warnings and instructions or if they are being used as replacement parts with bed frames and mattresses with which they create a poor fit with resulting gaps.

Hospitals and Nursing Homes

In addition to the problems caused by the suppliers, problems also occur when a well designed and appropriately marketed bed gets to the hospital or nursing home. Sometimes the instructions that are sent with the bed are not read or are misunderstood by hospital or nursing home personnel and the bed is not safely put together.

Also, from time to time a piece of the bed system such as the mattress might need to be replaced. The replacement mattress might not have been made to fit the bed frame and side rails with which it is grouped. That creates dangerous gaps in the bed system and a risk of entrapment for patients.

Many nursing homes and hospitals are not aware of the FDA findings and suggestions regarding bed rails. They simply do not know that bed rails can be dangerous. Therefore, they give little thought to the set up, maintenance and oversight of the beds.

Whether it is the fault of the bed rail supplier or the facilities that use them, it is the patient and his or her family that suffers. Therefore, both the suppliers and the facilities should be aware of the FDA’s warnings and recommendations about bed rail entrapments and should take steps to protect the patients and residents who use the beds.

Victims of bed rail entrapments and their loved ones often wonder who is at fault for theentrapment accident. The consequences of bed rail entrapments can be extreme. Since 1995, several hundred people have died from bed rail entrapments and several hundred more have suffered significant injuries. With consequences that severe, it is natural that victims and their relatives want to hold the people who were responsible for the bed rail injury responsible.

Often, more than one person is responsible for the accident. If a person decides to file a lawsuit for the injuries or fatality caused by a bed rail entrapment then he or she will want to consider the following possible defendants:

  1. The bed rail manufacturer;
  2. The bed rail supplier;
  3. The hospital or nursing home facility;
  4. The ordering personnel and;
  5. The facility personnel.

It might be helpful to consider the following factors when trying to determine who was responsible for the bed rail accident. Did the bed rail manufacturer make a product where the bed rails and the bed formed an unsafe gap as a result of a design or manufacturing defect? Did the bed rail supplier fail to provide the facility with appropriate instructions or warnings? Did the hospital or nursing home facility fail to instruct their personnel on how to set up and monitor beds with side rails? Did they fail to have appropriate staff available to help patients in and out of bed or to check on patients periodically? Did the ordering personnel make sure that all components of the bed including the side rails, mattress and head and foot boards, work together as a cohesive unit? Did they research any warnings put out by the FDA or other agencies regarding the type and style of bed that they bought? Did the facility personnel use the directions provided to them when they set up the bed? Did they do their job, as instructed, in terms of helping the patient in and out of bed and regularly checking in on the patient to monitor safety?

Fatalities and injuries that are caused by bed rails are preventable. The Centers for Medicare and Medicaid Services include bed rail accidents as “never events” or things that should never happen to patients because they are completely preventable. Therefore, if you or your loved one has suffered from a bed rail entrapment it is important to determine who was at fault for the bed rail injury and to hold that person or persons responsible so that bed rail accidents do not happen again.

If you ignore a problem then it often does not go away. It seems that bed rail suppliers and hospital and nursing home facilities are doing business as if bed rails are no threat to patient safety despite FDA warnings and confirmed fatalities involving people becoming entrapped in bed rails. There are several reasons why bed rail accidentscontinue to be a problem and both suppliers and facilities have a role to play in the problem.

Suppliers who are responsible for selling and delivering the beds to hospitals and nursing homes can also be at fault. Sometimes, they are poorly trained by their companies and cannot provide necessary information to the facilities about how to assemble and properly use the bed systems. Some suppliers have little, if any, contact with the facility. The beds are ordered and delivered without any communication at all except about price and delivery terms. Further, the employees who are communicating with the facilities might not know of prior entrapment incidents regarding company bed rails or they might be aware of the information and fail to convey it to the facilities.

Hospital and nursing home facilities can be at fault in a few different ways as well. First, they may lack the knowledge necessary to keep patients safe in beds with side rails. They might not be aware that people can become trapped in bed rails and suffer serious injuries or die from strangulation. While the FDA has made many findings about the dangers of bed railsand suggestions for lessening the risk, none of the FDA guidance has been mandatory and some facilities remain unaware of both the danger and the suggestions.

Other facilities, especially those who have had patients suffer from bed rail entrapment, are well aware of the risks. Some even have policies that prohibit the use of bed rails in their facilities. However, those policies are not always communicated to the people who order, set up and monitor use of the beds. Therefore, beds with bed rails are inadvertently ordered and used. Other times, all of the employees have the necessary information and order the correct beds but the beds are delivered with bed rails and they are needed immediately.

The most important thing that can be done is for both suppliers and facilities to be well educated about the dangers of bed rail entrapments. Then, perhaps, they will take the necessary steps to ensure patient safety and to make sure that unnecessary bed rail injuriesdo not continue to happen on their watch.

In 2006, the FDA issued guidance for hospitals and nursing homes about how to make corrections to existing beds that might be in use at their facilities and that might not conform to the safety standards recommended for beds with side rails. These local corrections are relatively easy and inexpensive. However, they are not routinely implemented and when they are implemented they are not always implemented in a reliably safe way.

The FDA recommends that each facility begin by identifying employees who will be responsible for measuring beds in the facility and overseeing any necessary corrective action. It is important that this be an ongoing activity because as mattresses are worn down and pieces of each bed system are replaced, dangerous gaps can be created. It is suggested that the employees who are charged with this task begin with the divisions of the facility that might have patients who are at high risk for entrapment. They should then inventory all of the beds in the facility, beginning with the high risk divisions, for conformance to the FDA’s bed system entrapment dimensional guidance.

After the facility has been evaluated, all necessary corrective actions should be implemented. The exact corrective action depends on where on the bed system the problem is located. The FDA has identified 7 zones were entanglement is most likely to occur. If there is a problem with a large opening in the bed rail (zone 1) then the facility should contact the manufacturer and inquire about retrofits to correct the entrapment risk. If there is a problem with a gap between the mattress and the side rail (zones 2, 3, 4 and 7) then the facility should try and locate mattresses of appropriate size to close the gap and make the bed safe. Other fixes including mattress overlays or positioning poles should also be considered. Finally, removing the bed rails should be considered and carefully evaluated by the medical team. They may be able to think of alternatives to bed rails that will keep patients safe without the entrapment risk.

The majority of the time the corrections are add on or accessory pieces that can narrow the gaps created by the bed rails and thereby lower the risk of a person’s head, neck, chest or other body part becoming stuck. It is important that these add on pieces be carefully, thoroughly and routinely evaluated to make sure that they do not move or fall out. It is not enough that the corrective actions be taken. The corrections also need to be carefully monitored so that patients are safe from entrapment as well as other dangers.

Side bed rails are a well known hazard. Since the 1980s, the FDA has been informed aboutincidents of death and serious injury resulting from people becoming entrapped in bed rails. Since 1995, the FDA has been informing bed rail suppliers, hospitals and nursing homes about the potential dangers of side rails. The FDA has also issued guidance about how to lessen the risk of entrapment and protect patients.

There are two ways in which beds with side rails can be safer for patients. First, beds that are currently in use in hospitals and nursing homes can be fixed with simple, low cost accessories that are meant to reduce or eliminate the dangerous gaps created by the bed rails. In fact, the FDA’s hospital bed safety workgroup put out a A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment in June 2006. The comprehensive guide provides a lot of information about both how to assess beds for potential entrapment dangers and information about how to fix the problems that are found. Second, beds with side rails can be redesigned so as to completely eliminate the danger. In fact, some better designs already exist.

The Centers for Medicare and Medicaid have listed entrapment in bed rails as a “never event” meaning that bed rail accidents should never happen. They are completely preventable. So, why do they keep happening? Are over 700 injuries and fatalities too low a number to be concerned about? Certainly not, if you or your loved one is the victim. Are the costs of providing a safe bed higher than the benefits of preventing entrapment in bed rails? No, the FDA has provided facilities with information about low cost methods that can be used to significantly reduce the danger. Does retrofitting the beds create too great a burden for hospital and nursing home personnel? Again, the methods described by the FDA are simple and will not take a great amount of employee time nor effort.

It is clear that the danger created by side bed rails is well known. The United States government, the bed rail suppliers, the hospitals and the nursing homes are all well aware ofthe entrapment risk that is present when side bed rails are used, particularly with elderly patients. What is unclear is why people keep getting hurt and dying when the solution to the problem is simple and inexpensive.

Sometimes the very products that are meant to keep hospital patients and nursing home residents safe are the ones that cause injuries. The dangers associated with side bed rails are well documented as are the risks associated with Vail beds, tub grabs, raised toilet seats, wheelchair accessories, bed exit alarms and bed sore prevention products.

According to the FDA, Vail beds which were used in hospitals and nursing homes, presented an entrapment and strangulation risk. In 2005, the Vail Company stopped manufacturing the beds and all retrofitting materials. However, some facilities continue to use the beds and put patients at risk despite the FDA’s warnings.

Simple devices such as tub grabs and raised toilet seats can also result in harm to patients. Tub grabs are mounted to the sides of tub walls to assist people with safely getting in and out of the bathtub or shower. However, all too often these tub grabs are not properly mounted and they fall off when a person leans on them for assistance. The person then loses his or her balance and falls. Such falls can be very dangerous for elderly or frail patients. Raised toilet seats present a similar risk. If they are not securely and appropriately fastened then they increase a patient’s likelihood of injury from a fall.

Wheelchair accessories are also designed to make people safer and more comfortable. Whether it’s a tray that snaps on the wheelchair, a chair pad or something as simple as a rain covering, it is important to purchase accessories that are designed for the specific style or size of wheelchair that the patient is using. Otherwise, the accessories can get caught or fall off and cause a serious bed rail accident.

Other devices that are meant to protect elderly or sick people are also potentially dangerous. Take for example, a bed exit alarm. A bed exit alarm alerts hospital or nursing home staff when a person falls out of bed. However, by the time medical staff is alerted to the problem, the fall and any likely damage has already occurred. An over reliance on any product including a bed exit alarm and bed sore prevention products can be a problem. For example, it is not enough to simply reposition a patient and use some of the sheepskin bed sore prevention kits on the market.

A multifaceted approach must be taken so that the medical team is preemptive rather than reactionary and patients are able to stay safe with the very products that are designed to keep them safe.