Redsense is Ready to Make a DifferenceEasyLink Access #: 504
By Jane Hurst, RN, CLNC
In a world full of alarms and monitors, finally there is a FDA approved device to help detect the worrisome, potentially life threatening complication of dialysis, Venous Needle Dislodgement (VND) at home.
For those patients who choose the flexibility and freedom of home dialysis, the Redsense alarm is a welcome piece of mind. Few, if any, other serious complications of dialysis cause more concern than the unpredictable nature of a VND. It’s known that it can occur without warning even under the best situations. Patients are educated on precautions that can be used to reduce the likelihood of having one, but the fact remains, it can’t be accurately predicted.
Now that Redsense is available for home use, dialysis patients now have an additional layer of security to help ease their minds.
The Initiative
In April, the FDA instituted sweeping new changes in how all home medical devices are approved, as well as upping the expectations of how patients and their caregivers are educated regarding home procedures and treatments. All of these changes are in an effort to make home care practices and devices safer. The new initiative includes:
* Establishing guidelines for manufactures of home use devices
* Partnerships with home health accrediting bodies to support safe use
* Labeling made clear for the patient and caregiver
* Enhancement of post-market oversight
* Increasing public awareness and education
In May, Redsense Medical received FDA Clearance for their Redsense safety device to be used in home/self use during home hemodialysis. Redsense is one of the first; if not the first medical device companies to pass the FDA’s new stricter requirements for home use medical devices.
The Home Care Choice
Currently, 7.6 million individuals in the United States currently receive home healthcare[1], and the FDA recognizes that this number is going to skyrocket in the future. As our population ages, we are going to see home care utilized more and more. Patients with chronic illnesses are living longer and healthier thanks to changes in treatments and medical advances. Home care can produce significant benefits to patients, in terms of both quality of life and cost of care[2]. Not all patients are willing and able to use home care, but many other patients who meet the criteria are enjoying independence, as well as enhanced health.
Some of the FDA’s concerns in home care revolve around the use of medical devices by patients and caregivers who don’t have any medical background, and the home environment being so different from the usual controlled-clinical site. Equipment used in the clinical site isn’t exposed to all of the things that make a house a home, so modifications to the equipment may be necessary. Interference from home electronics such as televisions, microwaves, computers, videogames, and even telephones could cause equipment to malfunction. Pets and pet hair, as well as children in the home can also produce unique challenges. Devices that are compact and self contained work better in the home environment. It is also advantageous if devices are simple to use and sealed tightly so the risk of pet hair, liquid spills, or tiny curious hands don’t have an effect of the devices’ operability.
Venous Needle Dislodgement
In older literature, VND was considered a rare and potentially fatal complication of dialysis. It was considered so rare that there wasn’t a lot written about VND. It has always been a well recognized fact that if the venous needle dislodges, the patient can suffer serious effects, if not death. Newer U.S. statistics that are available paint a very different picture of how often VND occurs, and they are startling. They indicate that:
* More than 200 needles dislodge everyday[3]
* More than 2 patients have a VND with a serious outcome everyday[4]
* More than 2 patients die every week due to VND[5]
Beginning in the 1980’s, all dialysis machines were required to have internal pressure alarms that would sound in response to a drop in the pressure in the venous needle. These internal alarms were notoriously unreliable, even though they continued to be the accepted method for blood loss detection until the availability of the Redsense alarm.
Why This is Good News
For the first time, home dialysis patients have a cost-effective, easy to use device that is specific for blood loss. This means that the Redsense alarm doesn't false alarm with perspiration or water. It means that nocturnal dialysis patients can sleep easier knowing that just in case their needle would partially/completely dislodge, Redsense will awaken if blood is detected. The efforts of Redsense Medical to make dialysis treatments safer for the patient, and increase awareness of avoidable venous needle dislodgements have come together and are now in the hands of the patients who need it.
About the Author
Jane Hurst has worked in a variety of specialty areas in her 30 year career as a Registered Nurse. In 1992, Jane opened her own medical-legal consulting business. As a successful businesswoman, Jane has found a way to utilize her medical background and knowledge to work with attorneys, insurance companies, governmental agencies, and private corporations. Jane has a special interest in hemodialysis, having worked as a dialysis nurse.
[1] National Association for Home Care & Hospice (NAHC), "Basic Statistics about Home Care," 2008. Available online at:
http://nahc.org/facts/[2] FDA Homepage, Medical Device Home Use Initiative White Paper, available at:
http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf[3] Health and safety survey. To improve patient safety in end stage renal disease; Report of findings from the ESRD patient survey: March 2007 – 5% of the patients have experienced a VND during a quarter – 1/(3 month * 4,33 weeks * 3 times a week/5%)=1/774= 0,129%
http://www.kidneypatientsafety.org/uploadedFiles/HSSProfessionalSurveyReport_FNL_3-21-07.pdf[4] Patients Safety Advisory; Veteran Health Administration Warning System; Published by VA Central Office; October 21, 2008
http://www4.va.gov/ncps/alerts/BleedingEpisodesDuringDialysisAD09-02.pdf[5] Sandroni S, Sherockman T, Hayes-Leight K; Catastrophic Hemorrhage from venous needle dislodgement during Hemodialysis: Continued risk of avoidable death and progress towards a solution: J Am Soc Nephrol 19:2008, PUB354
http://www.kidneytimes.com/article.php?id=20100618124437
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