FDA Launches Initiative to Provide Oversight to Home Use Medical Devices

The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.


The FDA hopes that The Home Use Initiative will help address the potential challenges, by providing greater protection and awareness for patients who are being cared for in the home.


A home use device is a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care provider in order to be used safely and effectively.

“Medical device home use is becoming an increasingly important public health issue,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

The U.S. population is aging, and more people are living longer with chronic diseases that require home care, he said, adding that “more patients of all ages are being discharged from the hospital to continue their care at home.”

Changes in health care have moved care from the hospital environment to the home environment. In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.

The portable nature of modern medical devices enables wide spread use in the homes of patients. Devices commonly seen in homes today include including infusion pumps, ventilators, wound-care therapies, dialysis equipment, and intravenous therapy devices.

Using complex medical devices at home carries unique challenges. Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning. Environmental considerations and potential safety hazards providers and patients should be alert to when using – or considering using – a medical device in the home setting include;


· Geographic Location


· Age and Structure of a Home


· In-Home Environmental Hazards


· Pets
· Unsanitary Conditions
· Children at Play
· Plumbing
· Temperature Extremes
· Dust
· Fire Hazards
· Tripping Hazards
· Poor Lighting
· Background Noise

The agency has already received reports adverse events linked to medical devices in the home. “And due to widespread underreporting, it is likely just the tip of the iceberg,” Shuren said. For example, a dialysis machine became blocked by cat dander and would not function, he said. In another case, a ventilator whose alarm could not be heard in the home caused the ventilator to fail, resulting in injury and death.

To deal with these problems the agency plans to develop recommendations for approval of these devices, including testing with home caregivers and patients, enhance the FDA’s authority to require that certain devices are labeled as cleared for home use and develop post-market procedures to track and address adverse events in the home.

The FDA is already citing manufacturers on potential trouble from at-home devices. On Monday, the agency sent letters to makers of negative-pressure wound therapy devices indicating they will need to start testing their devices specifically for home use and labeling them accordingly or stating the device is not for home use, Shuren said.

“By providing greater assurance of the safety and safe use of medical devices in the home, FDA hopes to support the tremendous promise of home healthcare to provide patients with more comfort, convenience and independence in their medical care,” he said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products.


The new home use guidance document is being developed to;


  • Make recommendations for actions manufacturers should take to support premarket approval or clearance of these devices, including device testing with at-home caregivers and patients in a non-clinical setting


  • Define circumstances under which the FDA may exercise its authority to require that certain devices cleared for marketing carry a statement in the labeling that the device has not been cleared for use in the home



  • Recommend post market surveillance to identify and address adverse events that may occur in the home.


In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.


The Home Use Initiative also contains measures for enhanced post market surveillance through HomeNet, a subnetwork of the FDA’s Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.


Compiling Adverse Event data is not a new tool utilized by FDA. Adverse Event reporting is a current requirement under Title 21 for all non-home use devices, and drug therapies. This data is used not only to provide oversight on a case by case basis, but is also used to provide a mechanism for understanding issues experienced by the market place in general, and to identify meaningful trends.


The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.


For additional information about the Medical Device Home Use Initiative, visit these resources:

Media Inquiries: Karen Riley, 301-796-4674; [email protected]

Consumer Inquiries: 888-INFO-FDA

FDA Initiative: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf

Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209138.htm


Medical Device Home Use Initiative – White Paper: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf

Public Workshop Notice: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm205804.htm

Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home – December 9, 2009: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm205691.htm

Improving Patient Safety by Reporting Problems with Medical Devices – Home Version: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm205434.htm

Brochure – Home Healthcare Medical Devices: A Checklist: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070217.htm

Home Healthcare Medical Devices: Blood Glucose Meters – Getting the Most Out of Your Meter: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070212.htm

Brochure – Home Healthcare Medical Devices: Infusion Therapy – Getting the Most Out of Your Pump: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070208.htm

Home Health Quality Initiatives (Centers for Medicare & Medicaid Services): http://www.cms.hhs.gov/HomeHealthQualityInits/

Telehealth (Health Resources and Services Administration): http://www.hrsa.gov/telehealth/

Patient Safety (Department of Veterans Affairs): http://www.patientsafety.gov/patients.html

Assistive Technology (Administration on Aging): http://www.aoa.gov/AoAroot/Press_Room/Products_Materials/fact/pdf/Assistive_Technology.pdf

A Patient Safety Threat – Syringe Reuse (Centers for Disease Control and Prevention): http://www.cdc.gov/ncidod/dhqp/PS_SyringeReuseFS.html

Patient Safety Resource Center (Healthcare Technology Foundation): http://www.acce-htf.org/patient.asp

American Association for Homecare: http://www.aahomecare.org/

American Telemedicine Association: http://www.americantelemed.org/i4a/pages/index.cfm?pageid=1

National Association for Home Care & Hospice: http://www.nahc.org/

National Family Caregivers Association: http://www.nfcacares.org/caregiving_resources/

Joint Commission – National Patient Safety Goals: http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals/

Assistive Technology Devices: http://resna.org/resnaresources/resources-%E2%80%93-at-devices

Joint Commission Resources – Home Care: http://www.jcrinc.com/Joint-Commission-Requirements/Home-Care/

National Patient Safety Foundation: http://www.npsf.org/paf/





Gina Guido-Redden
Chief Technical Officer
Coda Corp USA
(p) 716.751.6150 (f) 716.751.6193
[email protected]



“Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives.”

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