The most important element for a successful fall reduction program to minimize accidental patient falls and associated injuries is to identify one or more Fall Prevention Champions – A Fall Prevention Champion is a staff caregiver who is committed to reducing falls and realizes it is the staff, not any particular device that is key to reducing falls. Without Fall Prevention Champions to serve as a strong advocate, it is unlikely that any intervention device will be successful in helping to reduce falls in the long run.

Patients who should not stand, transfer or ambulate without assistance, such as hospital patients or frail elderly residents who cannot remember to call for help when getting up. The key risk assessment factor is whether the patient has fallen previously. Initially applying Fall Prevention Solution to patients with a history of recent falls is an excellent way to introduce Fall Prevention Solution to your facility.

Yes. Fall Prevention Solution is one of the “new generation” of wireless patient monitoring devices, and the first that has ever been proven in clinical trials to help reduce falls in the high-risk elderly. After several thousand patient-days of use, we know of no fall-related injury while wearing Fall Prevention Solution. References:

• Report of a Randomized, Controlled Clinical Trial to Assess Reduction in Falls and Related Injuries Using the Fall Prevention Solution Position Monitor. GD Clifton et al. (Submitted for publication) 50% reduction in falls, 82% reduction in injuries, 0 injuries while wearing Fall Prevention Solution, p ≤ 0.01, 43 SNF patients, 4,222 patient days.
• Evaluation of a Non-Intrusive Monitor to Reduce Falls in Nursing Home Patients, K.E. Kelly et al, J Am Med Dir Assoc 2002;3:377-382. 91% reduction in falls, 0 injuries, p=0.02, 47 SNF patients, 1,069 patient days.

The transmitter patch works by sending a battery-operated signal, much like a garage door opener, to the receiver alarm in the patient’s room when the patient tries to get up without assistance. The transmitter patch only alarms when the patient’s upper leg is approaching a weight-bearing angle at. When the patient sits down again, the alarm will shut off. The alarm is to both remind the patient not to get up unassisted and also alert the caregiver that the patient may be in need of help in time to intervene before a fall.

No. The alarm sounds when the patient’s leg is approaching a weight-bearing angle. The elderly typically rise slowly to a standing position so the alarm sounds before they are standing and in time for staff intervention before they become ambulatory.

The alarm can sound in several places. First the receiver alarm box emits a loud 94 decibel alarm in the patient’s room, reminding the patient to sit down. In addition, if the receiver alarm is attached to your nurse call system, it will simultaneously send a page, flash a light over the patient’s door, or otherwise activate the nurse call system as it is programmed.

Fall Prevention Solution activates when the patient’s leg becomes weight-bearing, at an angle that allows staff to be alerted that the patient is trying to get up unassisted without generating false alarms. The alarm stops sounding when the patient’s leg becomes horizontal again by sitting down.

This is where integration with the nurse call system is important. If a patient falls to the floor, the alarm in the room will stop sounding but the nurse call system is still flashing an alarm that requires a staff member to respond and investigate. Because of the lack of false alarms, staff tend to “come running” when they hear a Fall Prevention Solution alarm tied to the nurse call system and respond quickly because they know it is a true emergency. However, significant reductions in falls can be expected even if there is no nurse call system used with Fall Prevention Solution. The clinical trials of Fall Prevention Solution were not integrated to a NCS and still achieved significant reductions in falls and related injuries.

Yes. Both the device and falls reporting software work with your existing nurse call system. If the bed or call system has a non-standard receptacle, a custom cord may be ordered.

Yes. It is waterproof and shockproof.

No. However, it is recommended that the transmitter patch be removed for MRI studies.

The range is from 50-75 feet, depending on the construction characteristics of the surrounding structure. Each receiver alarm is dedicated to one patient, and the receiver alarm travels with the patient. Only one Fall Prevention Solution receiver is needed to monitor high-risk patient activity in the bed, bathroom, wheelchair, shower, and throughout the facility.

Yes. Once the unit has been initially charged for 24 hours, the alarm receivers can accompany patients when they leave their room for 5-7 hours on battery power. Detach the receiver alarm box from the power supply cord and reattach it to the back of the patient’s wheelchair with the use of the optional nylon/velcro sling. The receiver will start to chirp (see Function Test info on page 7) when its battery starts to run down and needs to be recharged.

Yes, but the patient would have to stand up to do so as the alarm receiver is recommended to be located on the wall out of reach of the bed. When properly attached to the back of a wheelchair, the deactivation button cannot be reached. Family members will receive instruction not to deactivate the alarm unless they are assisting their loved one to stand.

Fall Prevention Solution works quite well for geropsych patients. The receiver alarm can placed outside the door or at a nearby nursing station to keep the power cord out of the patient’s room. Very short power cords can be provided if required.

In addition to intentional deactivation by the patient, there are two scenarios that will defeat Fall Prevention Solution:

• By sliding out of a wheelchair or shower chair; or
• Rolling out of a bed without ever attempting to stand.

No. The device has not caused any pressure sores in several thousand days of patient wear and use Even a much earlier prototype version that was much thicker than the current patch caused no pressure problems.

Award winning MedicalHome® software is the newest enhancement to Fall Prevention Solution and provides integration with software that allows real-time reporting of falls documentation from admission through discharge. Quality Improvement reporting is facilitated, leaving your staff more time to spend with patients and less time filling out fall risk assessments and incident reports. Aggregate fall metrics can be calculated to meets oversight requirements. Contact your account executive for further information.

Access is provided the Internet using Bluetooth technology via analog phone line to standard ports HTTP (port 80) and HTTPS (port 443) at 209.249.145.183 & 209.249.145.184. For software technical support, call 847-420-7916.

First, the data captured is minimal and includes only the bare minimum data set needed to identify a patient and does not include medical record identifiers, social security numbers, patient address, or phone number. Even if that data is desired to be included, transmission via hard phone line to the secure MedicalHome® server is as secure as a FAX. Second, Oracle® security is used for authentication. Based on your authentication information you are placed within your environment which has no access to patient data outside your environment.

The FDA has approved direct application of the adhesive for 29 days. Skin tolerance to the adhesive on the transmitter patch by elderly patients was specifically studied in Phase I of the NIH-NIA-funded research project, the results of which are available on the FallSaver.net website. Response to the adhesive foam used in the patch was assessed after 7, 14 and 21 days. The results of the Phase I study were summarized as follows:

"The patch was well tolerated. No subjects were discontinued from the study due to medical problems associated with the adhesive or patch. Itching was the most common complaint and was reported by 4/40 (10.0%) subjects on 13 different days out of 1,923 (6.7% of days). 2/40 subjects (5.0%) complained of pain on one day each and 1/40 subjects (2.5%) complained of redness on one day. 3/40 subjects (7.5%) developed bulla formation under the patch. The duration of patch adherences to each of these individuals was 15, 21, and 25 days. In all three cases the patch was removed and a new one replaced at a different site. The lesions healed without incident. Interestingly, none of these subjects had subjective symptoms. None of the subject experienced a reoccurrence of the skin problem. 3/40 subjects (7.5%) were noted to have erythema that was associated with itching on 6 occasions."

Yes. The transmitter patch is both latex-free and mercury-free.

About two years from receipt. To preserve battery life, the patch should not be activated until you are ready to apply it to the patient. The longer an activated patch is kept horizontal, the longer it will last.

The transmitter patches are disposable with no special handling. They can also be returned to the manufacturer for parts recovery and credit towards future patch purchases. Patches removed from contagion/isolation rooms should be disposed of with other infectious waste. See more details on the FallSaver website.

In addition to sending an alarm when a patient attempts to get up unassisted, Fall Prevention Solution can also assess patient fall risk by being applied upon admission and using Fall Prevention Solution to monitor patient fall risk activity. At the end of a week, caregivers know who is likely to call for assistance and who will need Fall Prevention Solution. For additional details, see How to Use Fall Prevention Solution to assess a patient’s fall risk.

The receiver will chirp if a sitting patient (such as in a wheelchair) goes out of the 100-foot range of the receiver.

Yes. The current 2008 goals and related requirements for falls have not changed from 2007: Goal 9: Reduce the risk of patient harm resulting from falls, and Goal 9B: Implement a fall reduction program including an evaluation of the effectiveness of the program. These goals apply to hospitals (including critical access), assisted living, disease-specific care, home care, and long-term care. Fall Prevention Solution helps achieve Goal 9, and integration with the automated documentation and reporting software helps achieve Goal 9B.

Because of the significant cost savings to Medicare, we expect that Fall Prevention Solution will be eventually approved for reimbursement by Medicare. One independent technical assessment of Fall Prevention Solution has been completed.

We expect so. Two insurance companies have indicated their willingness to reduce liability insurance premiums if Fall Prevention Solution continues to be shown to be effective in reducing falls.

The FDA considered Fall Prevention Solution a Non-Significant Risk (NSR) device for clinical investigations. Fall Prevention Solution would now be considered an FDA "Class I exempt" device, or more correctly, a communications device.

In the USA.

A retired Sacramento heart surgeon, Dr. Paul Kelly, invented Fall Prevention Solution after noting the number of falls that were occurring in hospitals. Dr. Kelly also invented the CellSaver^®, the autologous blood centrifuge which is commonly used during surgical procedures to reduce the use of donated blood and reduce the transmission of blood-borne diseases.

No. The frequency is currently 433 MHz, which has been specifically selected not to interfere with any other wireless or hard-line devices in the healthcare setting.