If something goes wrong with recycled mobility equipment, could you be liable?

Felipe was buckled into his wheelchair as his parents carried him up three flights of stairs to their apartment. His mom went first, walking backward and holding on to the push-handles. Felipe’s dad was below, lifting his son and his new wheelchair by the footrests. The push-handles failed, causing the entire family to tumble down the stairs.

Felipe died a few days later of his injuries. While I don’t know all the details, this story is based on an actual case that happened in New Jersey this year. I am not an attorney, have no access to court records, and have not spoken to or been in contact with anyone directly involved in this case. This story is being told today as fiction, to alert providers and manufacturers to a potential area of concern.

The chair involved in this tragic accident was not really new, just new to Felipe. It was dispensed through New Jersey Medicaid’s new mandatory equipment recycling program. The chair had been cleaned up and given to Felipe by a private company contracted to run the equipment recycling program. A physical therapist (PT) contracted by the recycler had certified the chair safe to use.

The Food and Drug Administration (FDA) had not been informed that a new user was now in the chair, and had no record of its collection from the previous owner or its refurbishing (as is required by law). The manufacturer had requested that the chair be returned to them for inspection and refurbishment, but the recycler claimed they could do just as good of a job. No professional trained the family on how to safely use the chair, and the paper trail does not show who adjusted the chair to fit Felipe—or who made sure the cushion or other components were appropriate. Who made sure the bolts were tightened with the correct force? Who certified the welds? If this had been a power chair, who would ensure the batteries were safe and stable? What makes this case even more complicated is that when the chair was inspected after the accident, the push-handles appeared to be intact.

Could Felipe’s death have been prevented? Did the family know that the push-handles were not a safe place to support the weight of the chair and Felipe? Would the manufacturer have been able to detect a problem that could have prevented a weld failure (if in fact, that was found to be the cause)? Was this accident a product failure, a failure to educate, and/or a failure of the present recycling program?

New Jersey Medicaid now requires that all manufacturers participate in their equipment recycling program. If a manufacturer does not participate, they can be banned from receiving funding to provide equipment from New Jersey Medicaid. Two wheelchair manufacturers reportedly requested an official document stating that they would not be liable for events like the one that happened to Felipe. New Jersey Medicaid originally refused but has since offered to produce such a document, but do they have the legal ability to do this?

Can the manufacturer, on authority from a State Medicaid, be relieved of their accountability to the FDA? For now, New Jersey Medicaid has “blacklisted” the “uncooperative” manufacturers and refuses to allow Medicaid funds to be used to purchase their products. One company has since reversed its decision, perhaps because it resulted in such a huge loss of sales. One company continues to hold out for assurances that they can be responsible for refurbishing their own equipment, or at least be involved in some way to assure patient safety.

What would happen if all the facts in this case were just as I have told them? I bet the company that made Felipe’s wheelchair wishes they had asked for a letter stating that they were not liable. But who would be authorized to produce such a letter? Chances are that the manufacturer, the company that provided the recycled chair, as well as the PT that certified the chair as usable would all be sued and possibly held liable.

How should providers and manufacturers protect themselves? Get involved. Don’t just sit back and assume it is someone else’s problem. Industry groups are fighting on all fronts including reimbursement, credentialing, and coding. This just adds one more issue.

Medicaid and Medicare are looking for ways to save precious resource dollars. For years, Europe has used such programs. Equipment sold in Europe must be certified to last through at least two cycles of use. Many school systems and Easter Seal Programs have loan closets and recycle equipment. In Rhode Island, the NEAT Market has shown that recycling and sharing is a viable option for people with disabilities. What makes these programs work so well? What should you do if asked to participate in the recycling process?

The most important piece of a successful program may be the consultation from an occupational therapist (OT) and/or PT as well as a RESNA (Rehabilitation Engineering & Assistive Technology Society of North America) certified vendor (ATS or ATP). A rehabilitation professional needs to identify what piece of equipment the client needs. If an appropriate recycled unit can be located, a rehab professional needs to fit and adjust the unit, as well as instruct the user.

But is a PT or OT qualified to inspect welds, test transportation tie-downs, or determine that a cushion has retained its pressure-relieving qualities? Who is qualified to be certain that the electronics in the control box of a power chair are in perfect shape?

The manufacturer needs to be involved. They will ensure that only appropriate parts are used for refurbishment. The manufacturer is aware of proper torque for bolts, brake adjustments, and other features. In most cases, however, the manufacturer warranty extends only to the original user.

Users must be made aware that the chair has no manufacturer’s warranty, and know who they can contact for questions or problems. The manufacturer needs to maintain an audit trail of the users of their products by serial number in case of a product recall or notification. A user’s guide is also important because it contains safety instructions and warnings. This must be provided with the chair.

What about modifications made to transport options (parts that could save someone in a crash)? The manufacturer should be involved in ensuring proper installation and providing adequate instructions for tie-down and occupant safety.

Worth It?
As professionals, we need to examine whether a recycling program gives users adequate consumer protection, as well as providing equipment that meets medical needs. Understand the responsibility you are taking in participating in this supply chain. You may be taking on more responsibility (and liability) than you expected. The bottom line is that safety trumps everything. Until all the kinks are worked out, we should be involved but also cautious.

Ginny Paleg, MS, PT, is a pediatric physical therapist for the Montgomery County Public School Infant and Toddler Program in Maryland. She can be reached via e-mail: ginny@paleg.com.