Vol. 15 •Issue 23 • Page 5
Just Say No to Any Outside Medical Equipment
John, a therapist, works for a major teaching hospital as a supervisor in the PICU. As such, from time to time, he deals with some novel issues. One day he received a call from a PICU therapist who told him a patient was being transferred as a direct admit from home, and the physician had requested the patient be allowed to use his home ventilator in the PICU. The patient, Freddy, is a 15-year-old honor student and a paraplegic who has adapted well to life on a ventilator.
John inspected the home ventilator and found it to be the exact model the facility uses for its long-term-care patients, so he took one of the hospital units to Freddy’s room, only to be met by the physician who said: “I want this patient on the ventilator he is going to go home on.” John patiently explained the units were functionally the same, but the doctor refused.
“I want Freddy on the ventilator he will use at home so he’ll be comfortable with it. That’s what is important!” said the doctor.
John, being a smart therapist, called risk managers who advised: “Have the parents sign a liability waiver releasing us from liability for using their ventilator.” John promptly had the form signed and duly filed it away.
Problem solved, right?
Not exactly. In fact, the problem is not only not solved, it has just donned a Romulan cloaking device. John and his hospital could well have a surprise coming. What a person does not know, can indeed hurt him.
Freddy’s family did not have money to rent a ventilator from a DME company, and instead they used ventilator provided “as is” by a charitable organization. The family never had the unit checked to see whether it had been retrofitted as required by the manufacturer (it hadn’t) or whether it had the most current software and hardware installed (it didn’t). Instead they simply placed it on Freddy, and it appeared to work. That was good enough for the family. At this point, we now have a non-maintained, non-retrofitted unit in a small PICU room housing Freddy, its door dutifully closed to assure his rest.
On Day Three of his PICU stay, Freddy was set to go home. At that juncture, a patient in the next room required a portable chest X-ray. As the portable radiograph machine powered up, it caused a power surge hardly noticeable to anyone in the ICU. It was forceful enough, however, to cause Freddy’s ventilator to quit working. The alarm sounded as it was supposed to, but the noise of the radiographic technicians and equipment combined with the closed ICU door drowned it out for nearly four minutes until Freddy was in bradycardia. A nurse rushed in about that point and recognized Freddy was in serious trouble. She assumed the ventilator was still working. After a minute passed, with continued bradycardia, she finally heard the ventilator alarm (which had been set to low volume), removed the ventilator and bagged Freddy. Unfortunately, Freddy was brain injured.
An investigation opened, and the ventilator was quickly identified as the culprit. John, of course, quickly confirmed there was a release in his files. He filed his report, vowed never to accept another home ventilator and forgot about the legal aspects of the case.
Then a summons and complaint appear and John is named as a defendant because he is alleged to have supplied a faulty piece of equipment and because he negligently operated the equipment. John takes his “release” to the hospital attorney who slowly shakes his head.
“Not worth the paper it is written on,” he tells the therapist. “Parents can waive their own interest in liability proceedings because they have that ability. But a parent can’t waive a child’s right to sue. The parent does not have that legal power. When Freddy was injured and became incapacitated, a guardian was appointed. The guardian is bringing this suit on Freddy’s behalf, not on behalf of the parents.”
“That’s not fair,” John exclaimed “the only reason I agreed to let that ventilator in the hospital was because of the parents’ signed release.”
John has been the victim of a risk manager playing lawyer. A lawyer would, no doubt, have refused to permit the hospital to assume any liability for personal life support equipment brought in from outside the hospital. A lawyer would have been aware of the parents’ inability to release their child’s damage claim (which varies from state to state).
While the same rule does not apply to adults (who can release their liability in the event of equipment malfunction), a smart lawyer would know that if the equipment fails, liability may be premised on the actions of staff, not on the equipment. To put it another way, liability may ensue not because the ventilator failed, but because the staff did not discover the failure or act in a timely manner.
Equipment from outside sources creates a multitude of problems, none of them easily solved from a liability perspective. A piece of equipment from outside the hospital may have been maintained or not. Even if biomedical personnel evaluate and approve the equipment, that does not mean the equipment will remain in working order. Biomedical personnel frequently have no way of knowing what version of software or firmware is on board a particular ventilator absent specialized testing equipment.
The best advice, then, is simply not to accept equipment from outside sources. If forced into such a situation, there is a potentially safe way to accept it.
Where the patient has obtained equipment from a reputable home care dealer, the hospital can admit the equipment to the hospital subject to what is called an “indemnification and hold harmless” agreement.
Indemnification simply means that in the event of a problem with the equipment, the supplier will pay any court judgment ordered. “Hold Harmless” has a number of meanings, but generally it is inserted into an agreement to require the home care company to take over the defense of any lawsuit filed.
In this way the home care company becomes responsible should anything go wrong with the equipment.
Of course, these agreements must always be tied to a valid insurance policy, and the agreement between the hospital and home care company must provide for the naming of the hospital as an additional insured.
Otherwise the home care company may enter into such an agreement but never buy insurance to protect the hospital’s interests. When a lawsuit is filed, a home care company can file for bankruptcy, leaving the hospital to defend the suit itself.
If all this sounds like a twisted mess of forms and agreements, it is. If the hospital general counsel has not signed off on the arrangement, then the manager who agrees to any equipment sharing may be placing his hospital’s very existence at risk.
Allowing a patient to bring in privately owned equipment is never a good idea. The patient may not be properly caring for the equipment, and the hospital might well accept the equipment only to find itself facing a lawsuit of gargantuan proportions.
As Barbara Bush advised, “just say no.” This is especially applicable for anyone who wants to bring privately owned equipment into a hospital.
A.L. DeWitt is affiliated with the law firm of Bartimus, Freckleton, Robertson and Obetz, Jefferson City, Mo., and can be reached at firstname.lastname@example.org. His website is www.aldewitt.com. This column provides an overview of legal issues and is not a substitute for the advice of qualified legal counsel.