mdi ConsultantsReport on FDA’s Initiative
Report on FDA’s Initiative towards Safety of Patients Using Medical Devices at Home
In US, the use of medical devices at home has increased tremendously in recent years. Nowadays, medical devices have become more compact and portable which has made it possible to use them at home to treat and monitor chronic conditions outside the hospital. Using medical devices at home has its benefits. It reduces cost of inpatient care and also improves quality of life of the patient.
But using the medical device at home has its own risks. “Using complex medical devices at home carries unique challenges.” Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, said in a statement. “Care givers may lack sufficient training, products instruction may be inadequate or overly technical and the home environment itself may pose environmental or safety hazards that can affect the product functioning.” Most of the home medical care is given by lay caregivers who are not well trained for the use of the device. The labeling of the device should contain basic instructions for use, maintenance and cleaning in lay terms.
From 1997 to 2009, FDA has received more than 19000 reports of adversely safety events, Agency said. Pet hair, presence of children and Electromagnetic Interference from computers, videogames and home appliances has caused interferences in the working of devices used in the home which has also caused death of the patients. Even environmental hazards like noise levels and sanitation issues are of concern. There are many examples of adverse events that have been reported. A patient on peritoneal dialysis contracted peritonitis when the cat fur got into patients dialysis tubing and entered her peritoneum. The patient was subsequently treated and later she had recovered. In another case, a pediatric patient was receiving ventilator therapy at home, and the ventilator tubing became disconnected. The ventilator’s alarm couldn’t be heard by the patient’s mother as she was fallen asleep and also due to the noise level of television. The patient had died.
As FDA’s motto is patient’s safety, FDA has taken following steps to increase the safety of patients using complex medical devices at home:
FDA will develop a guidance document for manufactures of medical devices for home use. In order for approval of these devices to be used at home, the manufacturer may have to include testing of usability of devices by lay caregivers in non-clinical settings. Proper labeling of medical device will be a must as per this guidance. If FDA clears the device as ‘substantial equivalent with limitations,’ the label of the device should clearly state that the device has not been cleared for home use. Guidance document will also recommend the manufacturer to have post market surveillance to keep a check on any adverse events that may occur due to use of medical device in the home.
FDA is planning to create an online labeling repository for already approved or cleared devices where care recipients and caregivers will have easy access to information about correct use of the devices. For this, FDA has announced a 10 month pilot program where in manufacturers can voluntarily submit the labels of already cleared or approved devices electronically to FDA. Kinetic Concept Inc (KCI) is the first manufacturer who has committed to FDA on June 5 2010 to provide labeling for its devices which are cleared by FDA for home use as an initiative to the pilot program.
Some patients receive care from home health practitioners. To ensure that these practitioners are well trained for using the medical device, FDA has partnered with two major accrediting bodies for home health agencies, the Community Health Accreditation Program (CHAP) and the Joint Commission to support safe use.
FDA is promoting high-quality adverse event reporting of home use medical device by strengthening its Medical Product Surveillance Network (MedSun). Agency has completed a HomeNet Survey to collect information about safety issues and difficulties in using home hemodialysis. FDA is also planning to do a similar survey on the use of negative pressure wound therapy. If FDA, through surveillance, finds that certain devices being used in the home are not intended to be used outside of a health care facility then FDA may require premarket submission for these devices and device may be required to contain on its label that the device is not intended for home use.
Further, FDA has launched a new website Home Use Devices to increase public awareness for using home medical devices and educating them. This website will make public aware about any safety issue that has arise due to post market surveillance. FDA has already developed three informational brochures about home healthcare and in future it is planning to include series of educational videos for health care professionals and caregivers for the correct use of a device in home environment on the new Home Use Devices website.
Conclusion: Use of Medical devices in the home will continue to increase. Their use in the home has improved patient’s quality of life and also helped in saving healthcare costs. But using them at home with lack of usability and environmental hazards can lead to safety risks and can even cause death of patient. Hence FDA has taken this initiative for safety of patients using medical devices in the home through the Medical Device Home Use Initiative.