Risk Management

What is risk management........

Example: You have a Fall Prevention program and have a home safety expert do Home Safety Assessments. You should know:

Leading causes of fall deaths or injury causes.
Do you use or recommend non-medical products for medical conditions.
Use or recommend the use of medical devices or assistive technology outside of their intended use.
Know the risks of devices used i.e. does the benefit out weight the risks.
Current knowledge of safety regulations and guidelines.

In today's environment it is important to look at the clinical setting and outpatient home setting.

Often devices used in fall prevention are not intended for fall prevention and not intended to be used by those with medical conditions (not medical devices).

Fall prevention programs continue to use many products because they are inexpensive. Not because they understand the risks and benefits or because they provide the needed support for changing user needs.

Do you know if the device you recommend is a medical device or an assistive technology device? If, not it may be a good idea to know.

If a person has a medical condition the device used should be a medical device and used according to it's intended use. Knowing this is risk management!

Are your patient safety programs up to date with current safety regulations or guidelines?

Example: An overlooked area is bed safety although the FDA published guidelines from the FDA Hospital Bed Safety Workgroup in March 2006 to reduce the risk of entrapment.

We are working to make products more transparent not only for risk management but for safety in general. The device comparison below will help you see how old designs have risks that are often undisclosed due to not knowing the intended use or the use limitations.

is the only device we know of that mentions fall prevention as an intended use.

We know most falls happen getting into or out of bed. We know falls from beds are the second leading cause of fall deaths. Take the quiz are learn more.

Take the Quiz: National Safety Council Fall Prevention Quiz link

	Bed Rails, Bed Assists Bed Bars, Transfer Bars
Multiple Attachment Options	Under Mattress Attachment
Does not promote bed sores Attaches to the floor, wall or bed frame Does not use the bed surface for support	Support structure increases pressure points. Contributes to bed sores. Can damage your bed system Fall prevention not an intended use

Tip Over Hazard Reduction	Tip Over Hazards
Multi-Attachment Option (floor, wall or bed frame) designed to virtually eliminate risk	Counter weight recommended by some manufacturers

Entrapment Reduction	Entrapment Hazards
Attaches to the head of the bed No vertical rails along side of bed Exclusive features: Swing out - no lifting required Easy lift off Virtually entrapment free. Important to understand how a person is at risk and understand bed fall causes.	Multiple entrapment risks: head, arm, body May increase injury risk if you roll off the bed Does not comply with FDA entrapment guidelines Special note: Many assume bed rails (bed assists) will stop a person from rolling out of bed. The above shows how it can also entrap them and create more risks.

Push-Pull (Lateral) Support	Push-Pull (Lateral) Support often not an intended use
Designed for vertical and lateral movement Floor/wall attachment for full weight support	Sit or Stand balance only Vertical load bearing only Something that slides under the mattress can slide slide out just as easily. Unstable by design.

Hospital Bed System Dimensional & Assessment Guidance to Reduce Entrapment
Clinical Guidance For the Assessment & Implementation of Bed Rails
Make Sure the Medical Device You Choose Is Designed for You
What is a Medical Device
Bed Rail Safety Risks
Spine Universe Mattress Ergonomics link
National Sleep Foundation Institute of Medicine Sleep Disorders link

Updated June 30, 2008