FDA Bed Safety Guidance: Mitigating Risk

FDA bed safety guidance: Mitigating risk
Julie A. Braun, JD, LLM, interviews Larry Kessler, ScD, Director of Science and Engineering Laboratories, FDA Center for Devices and Radiological Health; and Mark Bruley, Vice-President for Accident and Forensic Investigation, ECRI

Beds are one of the few medical devices used by virtually every acute care patient and resident of a long-term care facility. A safe bed environment has long been the concern of nursing home residents and their families, healthcare practitioners, healthcare administrators, risk managers, clinical and facilities engineers, consumer advocacy groups, hospital bed and mattress manufacturers, and regulators, among others. A risk-management strategy to address entrapment risks involves developing and implementing an entrapment prevention protocol. The many components involved in creating such a protocol have been brought together in the Food and Drug Administration’s (FDA) Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment (Available at: www.fda.gov/cdrh/beds/guidance/1537.pdf) released March 10, 2006.

In 1999, the FDA, in partnership with the U.S. Department of Veterans Affairs (VA), Health Canada’s Medical Devices Bureau and representatives from national healthcare organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers, formed the Hospital Bed Safety Workgroup (HBSW) to examine real and potential causes of entrapment and make recommendations for design improvements in bed frames, bedrails, mattresses, and head/footboards. The guidance is the culmination of the HBSW’s seven-year effort to reduce potentially life-threatening entrapment.

The FDA received 691 entrapment reports over 21 years from January 1, 1985, to January 1, 2006, in which a person was caught, trapped, or entangled in the spaces in or about the bedrail, mattress, or bed frame. Most vulnerable are a person’s head, neck, and chest which, if entrapped, can cause strangulation and death. Elderly individuals in nursing homes and hospitals, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most at risk. Since 1985, 413 people have died, 120 were injured, and 158 experienced near-miss events without injury. The FDA shares that long-term care facilities report the majority of entrapments and the number of tragic adverse events likely is higher because many cases go unreported.

This nonbinding guidance, produced in collaboration with the HBSW, addresses the components to consider when developing a protocol and includes assessing a patient’s need for bedrails, caregiver ratios and training, equipment age and condition, and the variety of bed systems in the institution. Evaluating the dimensional limits of the gaps in hospital beds is another component of an overall assessment and mitigation strategy to reduce entrapment. Related methods for performing such evaluations are included in the guidance, along with references to relevant HBSW documents.

“This guidance assists individuals, families, nursing homes, hospitals, and other healthcare facilities in making informed decisions to ensure a safe bed environment,” says Larry Kessler, ScD, Director, Office of Science and Engineering Laboratories, FDA Center for Devices and Radiological Health. Kessler further reminds that “not all persons are at risk for an entrapment, and not all bed systems pose a risk of entrapment.” The new guidance, according to Kessler, “will help ensure that all new hospital beds are designed to reduce the potential for entrapment and that risks that may exist with current bed systems are identified and alleviated where possible and reasonable. The dimensional assessment may be incorporated as part of a manufacturer’s or facility’s comprehensive bed safety program.”

Nursing Homes/Long Term Care Management contributor Julie A. Braun, JD, LLM, chair of HBSW’s legal subcommittee, spoke with Larry Kessler, ScD, about the guidance. In a separate interview, Braun spoke to Mark Bruley, ECRI vice-president for Accident and Forensic Investigation on implementing bed safety protocols and testing.

In September 2002, Larry Kessler, ScD, was appointed Director of the Office of Science and Technology at the FDA’s Center for Devices and Radiological Health (CDRH). In this position, he directs the efforts of the laboratories of CDRH and the Standards Coordination Program. From 1995 to 2001, he served as Director of the Office of Surveillance and Biometrics, CDRH, and prior to that served as Chief, Applied Research Branch, National Cancer Institute.

Braun: Why did the FDA begin looking into bed entrapment?

Dr. Kessler: In 1995, we noticed a pattern of deaths and injuries in hospital beds. Further investigation into our adverse event reports suggested these were largely preventable deaths and injuries. Our August 23, 1995, safety alert (Available at: www.fda.gov/cdrh/bedrails.html) generated considerable interest from the healthcare community. In fact, reports of this type of injury increased following the alert. That suggested we had tapped into an important health issue.

Braun: Why did the FDA choose to undertake a voluntary consortium for the development of the Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment?

Dr. Kessler: We held a meeting with many stakeholders at the U.S. Department of Health and Human Services. When we heard from industry, patient care advocates, healthcare providers, and experts who investigate this type of accident and injury, we realized the problem was multidimensional. It became apparent that a single regulatory solution by the FDA would not be effective in addressing the many facets of entrapment. A voluntary consortium seemed appropriate for the complexity of this problem.

Braun: The HBSW identified seven entrapment zones. The FDA press release identifies seven zones. The guidance describes the same seven zones, yet offers dimensional limits for only four zones. Why?

Dr. Kessler: There are two reasons. First, while we have some reports of entrapments in at least two of these zones, the details about how entrapments occur in all three zones are not definitive. It would be imprudent for us to make wholesale recommendations where data do not clearly define the danger. We hope this guidance will call attention to the entire bed environment, and that might garner more information. We also have not been able to develop consensus recommendations from the HBSW on the other zones as yet. Simply stated, the FDA and the HBSW have concentrated their efforts where the problems are more defined and prevalent.

Braun: Healthcare providers are more receptive to the type of assessment suggested in the FDA guidance today than a decade ago when publication of the Institute of Medicine’s To Err Is Human: Building a Safer Health System created an immediate sensation and launched a spate of governmental and private projects to study the cause and reporting of medical errors and the means of preventing them. What changed?

Dr. Kessler: I don’t know whether they are more or less receptive. I would say generally that the report you mention and the work done by the FDA, the VA, and others have shifted the issues of patient safety a bit so that they are more in the forefront and that to some degree, we are moving away from a “blame culture” with regard to medical errors. I also believe that awareness about patient safety has been raised, and healthcare providers are looking at their practices more critically with patient safety in mind.

Braun: Place the guidance in a “real-world” policy and operational context.

Dr. Kessler: We believe that hospitals, long-term care institutions, and state healthcare officials will begin to take a more comprehensive look at the bed environment and work toward improvements. Because of the large number of beds currently on the floors of healthcare institutions, this process will take a while before the changes sweep through the healthcare environment.

Braun: Some states, such as New York, have adopted special requirements for the design of hospital beds with more stringent dimensional limits than used in the FDA guidance and include some beds the FDA excludes from the scope of its guidance. Will the FDA’s guidance influence or encourage state legislatures to demand adherence to its content that is voluntary and nonbinding in nature?

Dr. Kessler: We believe we have set a standard that will become used in practice every day. In addition to this guidance, the HBSW has worked with the International Electrotechnical Commission (IEC, www.iec.ch), which is also promulgating a new standard that will largely parallel our guidance, and this will further set the standards for bed safety for the general population. One key component of the HBSW recommendations includes Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings (Available at: www.ute.kendal.org/learning/documents/clinicalguidance_siderails.pdf), which provides information about patient assessments as part of a bed safety risk assessment. New York’s requirements were put into place to address the needs of developmentally disabled populations. This is another example of the complexity of entrapment issues.

Braun: If a nursing home assesses a hospital bed system and finds the bedrails incompatible with FDA recommendations, what do staff do?

Dr. Kessler: They should call the bed manufacturer and discuss the availability of mitigation options. They can also consult the material issued by the HBSW for additional suggestions.

Braun: Who bears the outlay of cash to conform hospital bed environments to the new FDA recommendations?

Dr. Kessler: For the most part, it will be the healthcare institution. However, we have worked with the providers and industry to create a gradual process and not one that will cause an instant economic upheaval. Achieving a higher level of safety almost always costs resources. We have tried to act with sensitivity to this reality by involving all stakeholders in the planning.

Braun: Who will train staff to undertake the contemplated bed assessment, and how will staff find the time to participate?

Dr. Kessler: Education and training are always an ongoing and dynamic part of any organization and, with the increased awareness about patient safety, bed safety is an appropriate issue to be included in ongoing education and training programs. Using the HBSW’s recommendations, facilities are encouraged to use a risk-based approach to assess their residents and patients to evaluate beds currently in use and to use the FDA dimensional limits as a guide in purchasing new beds. Clinical assessment and bed assessment information is available with the HBSW kit from National Safety Technologies (NST, www.nst-usa.com), on the FDA’s hospital bed Web site (www.fda.gov/cdrh/beds), and on the Web sites of many HBSW members conducting training workshops to help educate administrators and staff responsible for entrapment risk assessments.

Braun: Who is working with or within nursing homes that has expressed an interest in beginning its culture change journey with an assessment of its bed systems?

Dr. Kessler: As mentioned earlier, there has been an increased awareness of patient safety by leaders within the healthcare industry. Much of the focus now is shifting to quality systems for both the delivery of quality care and patient safety. Many institutions now employ a risk manager as a key member of their staff who is responsible for quality programs. A bed safety program could be one component of a risk-based quality system process.

Braun: Can we expect additional resources from the HBSW in the near future?

Dr. Kessler: Yes. HBSW plans to continue its work now that the FDA’s guidance is available. Specifically, HBSW will launch an outreach effort to raise awareness about entrapments and help facilities understand how to assess their beds for entrapment risk. HBSW is finalizing a corrective action document to provide recommendations to facilities to help them make simple modifications to their existing beds to reduce the risk of entrapment. HBSW will work with a vendor, NST, which will make available a bed safety entrapment kit and maintain a toll-free telephone number, (800) 678-7072, to assist facilities in assessing their beds. HBSW will establish an advisory committee to oversee and assist the kit vendor in providing customer service and technical support to facilities using the entrapment kit.

Braun: The FDA guidance offers a road map for assessing hospital bed systems. How will we know whether following the blueprint translates into an improvement in care over the short- and long-terms?

Kessler: The FDA will continue to monitor its adverse event database in combination with other sources of information. We will be working with the FDA’s Medical Product Safety Network (MedSun, www.medsun.net)to evaluate the impact of the guidance on its 350 participating facilities. We also will consider available information from other HBSW members. Finally, the vendor of the HBSW bed assessment kit, NST, will be getting feedback on its efforts, and we believe that will tell us even more.

Mark Bruley is a biomedical engineer and vice-president for Accident and Forensic Investigation at Philadelphia-based ECRI, an independent, nonprofit health services research agency that focuses on healthcare technology evaluation, technology assessment, and accident investigation. His involvement with the HBSW was critical in creating the recommendations concerning hospital bed dimensional criteria submitted for consideration as an FDA guidance document. HBSW members, including Bruley and his colleagues at ECRI, developed procedures for measuring and assessing gaps in bed systems in accordance with these criteria. Healthcare personnel, through participation in HBSW testing, validated the test methods and measurement tool in three rounds of testing. The FDA considered HBSW recommendations when preparing its guidance.

Bruley, along with other HBSW members, also was instrumental in developing a bed system measurement kit containing special testing tools and risk-assessment documents. The testing kit is now available through National Safety Technologies (NST, www.nst-usa.com). A “cone and cylinder tool” measures problem areas (or entrapment zones) to determine the extent, if any, of a potential risk.

Braun: The FDA guidance uses the term “hospital bed system.” What does it mean?

Bruley: The term encompasses the bed frame and its components, including the mattress, bed siderails, head- and footboards, and any accessories added to the bed. Bed rails (also called siderails, guardrails, and cotsides, among other terms) may be an integral part of the bed frame, or they may be removable and at times used either as a restraint, a reminder, or an assistive device. Bedrails may be full-length or shorter half-length rails and may be fixed or adjustable in height. Some rails move as the head or foot sections of the bed are raised or lowered, while others are fixed. Assessing entrapment risks considers that each of the three major components of a bed system (frame, rails, mattress) may be made by different manufacturers, each with different manufacturing specifications on product dimensions.

Braun: Does the FDA guidance cover all types of hospital beds? What about special-care beds and mattresses?

Bruley: The guidance lists products for which some, or all, of the dimensional criteria are not recommended including, but not limited to, air-fluidized beds, bariatric beds, range-of-motion tables, bathing units, and mechanical lifting devices. Several bed types have partial exclusion from the scope of the guidance, such as kinetic treatment tables and labor/delivery beds. Exclusions also apply to certain types of pressure-reduction therapy mattresses and overlays. The guidance notes that the exempted products are not free from risk of entrapment. Therefore, users should identify and address areas of potential entrapment for each resident through a comprehensive bed safety program.

Braun: Are all nursing home residents at risk for entrapment?

Bruley: No, and it’s important to note that not all hospital beds, whether newer or older, pose a risk of entrapment. Nursing homes should determine the level of entrapment risk and then take steps to mitigate any identified risk.

When evaluating the safe use of a hospital bed, component, or accessory, caregivers should be aware that the risk for entrapment may increase if the system is used for purposes or in a care setting not intended by the manufacturer. This evaluation can be done as part of a comprehensive plan that involves a clinical assessment of a patient’s need for bedrails. The HBSW Clinical Guidance for Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings provides assessment guidance, (Available at: www.ute.kendal.org/learning/documents/clinicalguidance_siderails.pdf.)

Braun: What role does the FDA guidance play in a nursing home’s bed safety program?

Bruley: Evaluating the dimensional limits of the gaps in hospital beds represents one component of an overall assessment and mitigation strategy to reduce entrapment, which also involves a multifaceted approach that includes, among other options, bed design, a comprehensive plan for resident and bed assessment, resident monitoring, and meeting the needs of vulnerable residents. Therefore, a comprehensive bed safety program likely will incorporate FDA guidance and input from manufacturers, as well as facility staff.

Braun: The FDA states that recommendations in its guidance may be useful to evaluate and reduce the entrapment risk of hospital beds already in use-beds that are also known as legacy beds. What burden does testing legacy beds place on healthcare facilities?

Bruley: The guidance states that healthcare facilities may use its recommendations to assess legacy beds. This is a valid suggestion considering that hundreds of thousands of legacy beds are in use-each with a life span of 15 to 20 years. Not including endorsements for testing legacy bed systems would be akin to saying that electrical safety inspections are indicated for only new electromedical healthcare equipment-an obviously flawed perspective. Recommendations to only address new beds miss the critical point that new bed systems quickly become legacy bed systems if the mattress is changed (a common occurrence) or if it is equipped with different rails (a less common occurrence).

A risk-benefit analysis should be conducted by facilities to ensure that any steps taken to mitigate the risk of entrapment do not create different, unintended risks or reduce the clinical benefits available to residents using legacy beds. Such steps may include, among other possibilities, checking with bed system manufacturers to identify compatible mattresses, rails, and accessories. Likewise, nursing homes may contact their equipment suppliers for entrapment mitigating solutions. Manufacturers should follow the appropriate FDA regulations regarding risk assessment, design controls, and documentation when developing mitigation components, attachments, and other accessories for legacy hospital beds.

Braun: Does movement of the hospital bed deck influence the assessment contemplated by the FDA guidance?

Bruley: Movement of the bed deck, known as articulation, introduces complex geometries that make applying the dimensional criteria to reduce entrapment difficult. Presently, the dimensional recommendations apply to hospital beds in the flat deck position and rails in the fully raised position, except where noted in the guidance. Of course, resident care and treatment also occurs while the bed is articulated and some articulated positions may pose a risk of entrapment. Thus, the FDA plans to gather data and consider other approaches for assessing gaps in articulated beds.

Braun: What key body parts are at risk for life-threatening entrapment?

Bruley: Three key body parts at risk are the head, neck, and chest. International anthropometric data references were used to determine the relative sizes of these body parts for the population at greatest risk for entrapment and to provide a guide for the dimensional limits that would reduce entrapment risk. For instance, the FDA guidance suggests that the space between the mattress and rail be no more than 4+” so a resident’s head cannot fit there after considering that a mattress would be compressed by a resident’s weight.

Braun: Identify and describe the potential zones of entrapment.

Bruley: The FDA guidance describes seven zones in a hospital bed system that present a potential risk for entrapment. Entrapment may occur in flat or articulated bed positions, with the rails fully raised or in intermediate positions. The zones of entrapment include:

Of these seven zones, the FDA recommends testing for dimensional limits in only Zones 1 through 4 at this time because the majority of the entrapments reported to the FDA have occurred in these zones.

Braun: What are the critical entrapment test zones?

Bruley: There are four tests designed to measure gaps in the bed system where a resident could become trapped. Each test measures a different area, or zone, where entrapment can occur (figures 1-4).

Each test requires use of simple tools, including a cone, a cylinder, and a spring scale (figure 5). The cone and cylinder is a combination tool that can be easily taken apart so the cone and cylinder can be used separately. Tests 1, 2, and 3 only use the cone. Test 4 uses the combined assembled tool.

The diameter of the large end of the cone represents the width of a small adult head (120 mm, or approximately 4-+”). The cylinder diameter represents the size of a small adult neck (60 mm, or approximately 2-⅜”). The cone and cylinder together weigh 15 lbs, the combined weight of an adult head (12 lbs) and neck (3 lbs). The cylinder defines contact angles in which the neck could become wedged (60¦ or narrower). The spring scale is used by the tester to pull with a force of 12 lbs on the cone when testing Zones 1 and 2.

Figure 5.

Braun: Is there any risk of injury to the resident or staff during the measurement process?

Bruley: The nursing home resident should not be in the bed during the measurement process.

The measurement test tools are heavy and, thus, are equipped with a safety strap that is attached to the bedrail and adjusted in length to protect staff from injury if the tool falls through a gap during testing. Not using the safety strap may increase the risk of staff injury and may expose the facility to a workers’ compensation claim. To avoid unnecessary bending or back strain, it is recommended to position the bed at a comfortable working height and lock the bed wheels.

Braun: Is there a possibility of cross-contamination as staff go from bed to bed during the assessment and measurement process?

Bruley: It is recommended that the tools be disinfected each time a different bed is measured to avoid cross-contamination. Follow the supplier’s disinfection recommendation.

Braun: How should test results be documented?

Bruley: Use any method that satisfies facility policy and methods of record keeping. For example, the nursing home may use customized data sheets or a generic form such as a table or spreadsheet to record a result of either “pass,” “not applicable,” or “not tested.” The HBSW supplies sample data sheets that the nursing home may use or modify according to needs. (To request a sample, e-mail braun@newnorth.net, with “HBSW Sample Data Sheet” indicated in the subject line.)

Braun: How are measurement test results interpreted? What happens if coworkers get different results from the same test?

Bruley: Different testers might get different test results for the same bed system. This usually is related to “close call” judgments sometimes made when evaluating whether a zone under test with the tools passes or fails. Or, the same tester may get a different result when he or she repeats a test. This may happen because (1) different people may handle the tools slightly differently; (2) an error or oversight may affect test result; (3) when a test is a very close call, some testers may be biased toward passing, and others toward failing; and (4) a long time has elapsed between tests (mattresses vary in softness and can compress over time; rails or rail supports may loosen or bend over time).

The design of the test tools and methods of application have tried to minimize varying results.

Braun: What should the nursing home do if a bed system fails one of the tests?

Bruley: The facility should strongly consider mitigation of entrapment risks for bed systems that fail any of the four tests, including bed systems that receive borderline passes. Mitigation may include, but is not limited to, resident assessment, as some residents are at lower risk for entrapment than others. The HBSW has produced A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment, which is included as part of the bed test kit and will be posted on the FDA Hospital Bed Safety Web site (www.fda.gov/cdrh/beds).

Braun: Is reassessment of hospital bed systems important? Please share an example of when such action is necessary.

Bruley: Yes. The FDA guidance appropriately recommends that a bed safety program include plans for the reassessment of hospital bed systems. After the initial assessment of the different bed systems, reassessment may be appropriate when, for example, (1) there is reason to believe that some components are worn (e.g., rails wobble, rails are damaged, or mattresses are softer) and could cause increased spaces within the bed system; (2) when accessories (e.g., mattress overlays or positioning poles) are added or removed; or (3) when bed system components are changed or replaced (e.g., new bed rails or mattresses).

Julie A. Braun, JD, LLM, is a Chicago-based attorney and writer who chairs the legal subcommittee of the FDA’s Hospital Bed Safety Workgroup. For further information, call (715) 649-3244. To send your comments to the editors, e-mail braun0506@nursinghomesmagazine.com.
Reporting an Entrapment Adverse Event

The FDA examines adverse event data on hospital bed entrapments. Complete and descriptive reports of each entrapment or near-entrapment event help the agency monitor the safety of hospital beds. When reporting an entrapment adverse event, manufacturers and users often leave out details that can help to identify the factors or conditions that led to the entrapment. Consequently, these incomplete reports only indicate to the FDA that an adverse event took place. To improve the quality of entrapment adverse event reports, it is important and helpful to include the following information:

  • the exact location or zone of entrapment (Tip: Use the zones described in the FDA guidance document to help describe entrapment events.)
  • the body part that was entrapped and, if possible, the size of the entrapped body part (e.g., head breadth, neck diameter, or chest depth)
  • the position of the rails (e.g., fully raised, intermediate, or lowered)
  • the type of siderail (e.g., full-length, +-length, +-length, +-length, or split rails), along with the number of rails raised at the time of the adverse event
  • the articulation of the bed deck (i.e., which sections of the deck were raised, and the approximate degree of elevation for each deck section)
  • the mattress type and height, as well as the height of the rail from the top of the mattress
  • information on the size of the gap that contributed to the entrapment

For more information on reporting adverse events, visit www.fda.gov/cdrh/mdr.

Topics: Articles , Regulatory Compliance , Risk Management