September 10, 2013
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
Comments of nonprofit patient, consumer, and public health organizations
on Proposed Order
Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”
[Docket No. FDA-2013-N-0568]
As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
FDA is reclassifying this device in response to an October 22, 2012 petition. The petitioner cites its own history of use of stair-climbing wheelchairs, preclinical testing, and the development of consensus standards as reasons to down-classify the device into Class II. We are very concerned about the use of consensus standards such as the American National Standards Institute (ANSI) and International Standards Organizations (ISO). These are voluntary standards and do not have the force of law, and are therefore not adequate to safeguard patients.
In 1979, the Physical Medicine Device Classification Panel recommended that stair-climbing wheelchairs be considered high risk (Class III) because the design was experimental and data to support its safe and effective use was not available. Although the FDA’s current assessment is that “there is now adequate information sufficient to establish special controls” to provide reasonable assurance of safety and effectiveness, the FDA did not provide details about the “adequate information.” In addition, the safety of stair-climbing wheelchairs that are currently on the market is not the only concern. The down-classification of these devices means that companies manufacturing new models of stair-climbing wheelchairs in the future would not be required to prove that their products are safe or effective. The companies would only need to prove that their products are substantially equivalent to other wheelchairs on the market. As the Institute of Medicine report on the 510(k) process for Class II devices pointed out, that is not sufficient to ensure that the products are safe or effective.
The FDA notes that the stair-climbing wheelchair has risks to health that include the possibility that it could tip over and “may result in injury to the user” or could entrap the user. The FDA also points out that there is a risk of burns caused by batteries overheating, electrical failure, or the ignition of flammable materials. Any of these risks are especially serious because these are very vulnerable patients who are likely to lack the mobility to get out of the wheelchair without assistance. Batteries overheating have been a problem in the past, and it was the reason for a Class 2 recall in 2010. Falls and fractures are also a risk of this device, and FDA notes that the wheelchair is heavy and “can result in serious injury including fracture” to the individual or the caregiver.
According to the Manufacturer and User Facility Device Experience (MAUDE) database, 55 adverse events have been associated with stair-climbing wheelchairs (Product Code IMK). As is well known, the MAUDE database is a voluntary system for physicians, and as such it greatly underreports incidents. Some of the injuries reported to MAUDE include:
A man “sustained fractures to his right side tibia and fibula when his foot slipped off the foot plate and he caught it and his leg under the device while driving out a doorway into his back yard.”
- A person “sustained fractures to both femurs, requiring hospitalization and surgery.”
- A “user appears to have sustained a broken left leg, broken nose, and was transported to hospital by ambulance.”
- “The user sustained an injury to her elbow which required surgery.”
It is very important to note that fractures can be extremely debilitating and even life-threatening to elderly patients.
Although the FDA has listed special controls (performance tests) that manufacturers of stair-climbing wheelchairs would have to meet for the device to be cleared under the 510(k) pathway, these tests are not nearly as rigorous as pre-market approval (PMA) reviews. In addition, the 510(k) pathway does not include inspections to ensure quality control. In light of the serious injuries users of this device have sustained, as well as the possibility of greater disability or death, and the fact that the patients involved are among our nation’s most vulnerable men, women, and children, stair-climbing wheelchairs should remain a class III device and require a PMA.
Stair-climbing wheelchairs can provide better mobility to patients than standard wheelchairs but FDA needs to assure that the stair-climbing wheelchairs are as safe as possible. To do so requires them to be correctly categorized as the high risk devices that they are (class III) and be reviewed through the more rigorous PMA process.
American Medical Student Association
Annie Appleseed Project
Connecticut Center for Patient Safety
National Consumers League
National Research Center for Women & Families
The National Consumer Voice for Quality-Long Term Care
Center for Science and Democracy, Union of Concerned Scientists
 Food and Drug Administration Medical & Radiation Emitting Device Recalls (June 5, 2010). Class 2 Recall of the iBOT 40000 Mobility System Battery pack. Recall number Z-17755-2010.
 Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database (report received 11/25/2009). Catalog Number IT004709.
 Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database (report received 10/7/2009). Catalog Number IT004051.
 Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database (report received 11/26/2008). Catalog Number IT004061.
 Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database (report received 10/9/2007). Catalog Number IT004021.