November Monthly Topic:

Medical Devices for Home Use: 
Regulatory Issues and Recent Developments

Medical devices designed for use by patients outside of the healthcare environment, referred to as home use devices, represent the fastest growing segment of the U.S. medical device industry.  Indeed, the market for such devices is expected to double in as little as four years.  The breadth of devices now being used in the home is large and includes basic equipment, such as canes and wheelchairs to more sophisticated devices designed to assist healthcare providers and patients in monitoring medical conditions such as glucose monitors.  Many of these devices will offer the potential to improve the quality and efficiency of patient care.  This rapidly growing segment of the medical device industry raises new concerns, particularly relating to safety of these devices as use by patients outside of the healthcare environment and has lead the U.S. Food and Drug Administration (“FDA” or “the agency”) to begin to reassess regulatory oversight of these products.(1)  

Specifically, the agency hopes to establish improved and more consistent review criteria for remote monitoring devices, but has not articulated exactly what those criteria might be.  Nevertheless, in the next six months FDA plans to invite manufacturers to participate in a new online labeling repository for home use devices.  This voluntary database will give consumers access to current instructions for use for specific medical device models.  The agency hopes the repository will mitigate the potential hazards associated with use of older devices that were not originally intended for home use by patients, and for which current users may not have adequate instructions for use.  FDA is also preparing to launch a sub-network of its newly established adverse event reporting web site, MedSun.(2)  This sub-network, called HomeNet, will provide information collected from home health agencies regarding adverse events related to devices used in the home. 

FDA is not the only one interested in the influx of medical devices into the home.  Congress is working to improve access to remote monitoring technology through the Remote Monitoring Access Act of 2007.  The bill addresses the lack of reimbursement for remote monitoring to facilitate broader adoption of these technologies.(3)  The original bill was considered cost prohibitive.  However, a scaled down version of the Act has been introduced by AdvaMed in hopes that the new version can be incorporated into Congress’s broader Medicare package.  This package is scheduled to come up for a vote before the end of the year.

One example of a recently cleared home use device is the Electronic Medication Management Assistant (“EMMA™”) by INRange Systems, Inc.  EMMA™ is the first commercially available in-home medication management device that can select and deliver individual doses of prescription medications.  The device functions as a web-based pharmacy, allowing pharmacists, physicians, and other licensed practitioners to remotely schedule and alter a patient’s individual medications.(4)  The company successfully petitioned FDA to downclassify the device into class II per section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (“the Act”).  FDA has published a new rule in the Federal Register officially classifying remote medication management systems such as EMMA™ into device class II (special controls) and thus regulated via the 510(k) premarket notification pathway.(5)  The agency has also released a guidance document, Class II Special Controls Guidance Document:  Remote Medicine Management System, which outlines FDA’s expectations for remote medication management system submissions.(6)

With more and more devices moving into the home environment, stakeholders are stressing the obligation of device manufacturers to ensure that home use products are designed and marketed for such purpose.  These products should be specifically designed for patient use, making human factors engineering an important consideration.  The goal of human factors engineering is to ensure that manufacturers consider patient limitations with regard to home use devices so as to reduce the overall risk of unanticipated user error.  Device firms that intend to redesign institutional products for home use should remove all functionality that is unnecessary in a home environment and add new features to appropriately ensure patient safety such as patient alarms or monitors that ensure adherence to a prescribed protocol.  Specifically, in its review of marketing applications, FDA is increasingly focused on the incorporation of human factors in the design and development of medical devices intended for use by a patient outside the healthcare environment.  Where such factors have not been considered in the design of a device, the agency may request user studies to demonstrate that the device can be safety and appropriately used by the intended user and in the intended use environment. 

FDA has issued several guidance documents over the recent years on this topic to assist manufacturers in this area.  The agency published Do It By Design—An Introduction to Human Factors in Medical Devices in1996 in an effort to introduce the importance of human factors engineering to the device industry.(7)   Other human factors guidance documents available to assist manufacturers at various stages of the product clearance or approval process, include:

• Medical Device Use Safety:  Incorporating Human Factors Engineering into Risk Management (July 18, 2000)(8) 
• Human Factors Points to Consider for IDE Devices (January 17, 1997)(9)
• Human Factors Principles for Medical Device Labeling (September 1, 1993)(10)