Design versus patient safety

Today more than ever you and the designers that you hire should understand the “safety” issues healthcare is facing and the rules facilities are required to comply with. A patient safety rule could mean preventing a fall or an infection. Design does not always create an environment that meets the regulatory requirements of those on the front line of safe healthcare delivery; i.e., nurse, therapist, doctor, and caregiver.

Further is how “human factors” play a role in design and patient safety. Awareness of these factors plays an increasing role where all sides need to work together in building design, device design, and patient safety.

Safety Regulations

Safety regulations are coming fast and furious at those who deliver our healthcare. In August 2007, CMS combined tags F323 and F324 under one tag F323, §483.25(h) Accidents. The goal is a hazard free environment with the proper use of assistive devices to help prevent accidents.

Our focus is on falls because of their prevalence, as well as the upcoming affect of CMS Hospital-Acquired Conditions (HAC) and the “Safety of Seniors Act of 2007” signed into law April 2008. You could say falls are in focus.

Falls are often multifaceted and misunderstood. Until recently there has not been a need to necessarily understand falls or create an environment to reduce the risks. As a designer or a facility administrator, you will need to be part of the prevention process when it comes to healthcare design. You, your staff, and patients should be part of this process. All will play an important role in moving design safety forward.

A fall without an injury is still a fall. One part of fall prevention is preventing falls that can be prevented while the other is reducing injuries from the falls that can’t be prevented. This is another area where design and safety awareness plays an important role. In a hospital or Long Term Care setting design modifications may need to meet specific requirements for accident avoidance.

Here are examples of design features that may help providers comply with regulations that previously didn’t exist or maybe didn’t have much compliance focus:

• Padded slip-resistant floors.
• Round cornered furniture with environment friendly pathways to high traffic areas like the bathroom.
• Furniture that is too high or too low, such as beds.
• Inadequate lighting or intense lighting that creates glare.

One of the lagging areas for human factors is medical device design and an area that is often misunderstood because many are not clear what the definition of a medical device is. This matters because the FDA regulates medical devices. Medical devices range from a tongue depressor, chair, or a pacemaker. It is important to know the difference for various reasons. Firstly, patient safety as well as risk management. Often regulations from the FDA are overlooked whereas ones from CMS are not.

An example of designs crossing over into the medical device realm is those of beds. Who would think that a bed you buy at your local mattress store could be a medical device just like a hospital bed in the hospital? It’s not called a hospital bed, it doesn’t look like one, and you won’t see it in the hospital yet it may be a medical device. Sometimes manufacturers don’t know the difference, aren’t aware of the regulations that may apply to them, or don’t care. New regulations and risk management issues means understanding these areas.

Recently, I got some firsthand experience with medical devices when I fractured my foot. Each device I was using created some issue when I used them for any length of time. This meant I needed multiple devices to avoid secondary issues from using any one device over a three month period. The lack of human factors in the design of the devices started to create secondary issues that could be prevented with a better understanding of human factors in their design.

Creating devices or buildings using human factors will help reduce safety risks caused by the lack of human factors in design. Value must be put on improved designs, reduction of injuries, and long-term healthcare cost savings. Often this type of innovation costs more upfront but has a large return on investment (ROI). Government is not just looking at cutting costs they are looking at “value-driven healthcare” which may not mean a reduction in upfront cost but a ROI which saves in future costs; i.e., fall prevention and injury reduction down the road. Quality devices can have an immediate ROI.

One of the best reports I have read about human factors comes from the Consumer Product Safety Commission (CPSC) called “Older Consumer Safety.” This report details:

• Older adult sensory systems
• Muscle strength
• Motor coordination
• Age-related decline
• Flexible thinking in unfamiliar situations

This is not a complete list but you get an idea of the many areas that need to be considered. Designs that are geared toward the aging or disabled population must understand human factors relating to this group. In a hospital or long-term care setting you also have other factors like IV’s or temporary drug effects that create complications you may not have in other settings.

Going Forward

Due to the unprecedented situation we are facing with falls, you will begin to find government working toward the same goal of prevention and working together like never before. It’s no longer an option.

New regulations and focus are going to change the landscape in ways many providers don’t realize yet. Product and building design and how they relate to regulations will matter more than ever. This is not just a human factor issue—it is also a risk management issue for those that are unaware. Companies that started out as nonmedical companies may now be crossing over into medical devices. Designers and facilities need to be aware of areas crossing over into a new realm while working together to create solutions.

Patrece Banks is CEO of Invisible CareGiver Innovations, LLC, a product development company specializing in mobility products to enhance activities of daily living, based in Bellevue, Wash. Banks is also a participant in the FDA Hospital Bed Safety Workgroup, WA Patient Safety Coalition, Stop Falls Network of California, and the Puget Sound Fall Prevention Collaboration. For further information call (425) 283-4321, e-mail Patrece@invisiblecaregiver.com or visit www.invisiblecaregiver.com.

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