Legal Review and Commentary
Machine tips over while patient is asleep
Newly replaced knee is injured
News: A woman in therapy following knee replacement surgery was using a continuous passive motion machine to aid in strengthening her knee without her muscles being used. She fell asleep while using the machine, and it subsequently tipped over and twisted her knee. The woman sued the manufacturer of the machine and the hospital where she was undergoing therapy. A defense verdict was returned for the machine's manufacturer, but a jury awarded $206,000 in damages against the nurses.
Background: A 45-year-old woman underwent knee replacement surgery. Her post-surgery physical therapy at the hospital included the use of a continuous passive motion machine, designed to aid her recovery by gently bending and straightening her knee. Her doctors decided on the machine because attempts at joint motion in most patients following knee replacement surgery cause pain. The pain accordingly causes patients to not move their knee, which in turn allows the tissue around the joint to become stiff and scar tissue to form, resulting in a joint with a limited range of motion. The continuous passive motion machine moves the patient's joint without the patient's muscles being used, and it is often used for at least four hours during the day as well as all through the night.
While the patient was using the machine, she fell asleep. The machine subsequently tipped over, manipulated her knee joint at an odd angle, and damaged her knee replacement, which necessitated a second replacement procedure. The mishap also caused the woman to develop burning pain, stiffness, swelling, and discoloration in her joint.
The patient sued the hospital and the manufacturer of the machine. She claimed that the hospital's nurses had failed to properly set up the machine, which led to the tip-over, and that the machine should have had an automatic shut-off. The nurses claimed they used the machine as the physician had been and that the mishap was not why the woman required a second knee replacement.
A jury found that the machine manufacturer was not liable but that the hospital had acted negligently in setting up the machine and supervising the woman. The woman was awarded $206,000 in damages.
What this means to you: "When patients are in a hospital setting undergoing treatment, no matter what that treatment is or whether the patient is an inpatient or an outpatient, the key responsibility of the hospital staff is one of supervised safety," says Lynn Rosenblatt, CRRN, LHRM, risk manager at HealthSouth Sea Pines Rehabilitation Hospital in Melbourne, FL. "The amount of supervision required is, of course, based on an accurate assessment of the patient, the nature of the treatment provided, and the conditions under which the treatment is provided."
Rosenblatt emphasizes the supervision required in a case such as this one. Given that joint replacement surgery is extremely painful, particularly in the first few days immediately following the procedure, many surgeons use patient control analgesic (PCA) pumps to allow the patient to adjust a continuous flow of an appropriate narcotic medication over the course of the first 24 hours postoperatively. This practice, together with post-residual anesthesia, can alter the patient's consciousness to the extent that she could drift in and out of a fairly deep drug-induced sleep. And even without the PCA pump, the patient is likely to take narcotic medications by mouth every three to four hours following a joint replacement surgery.
As the patient progresses toward post-surgical recovery and more strenuous rehabilitation and therapeutic modalities, narcotic pain medications generally are given orally at frequent intervals. Depending on the individual's pain tolerance and past medication usage, oral pain control can have varying effects upon patients. Accordingly, Rosenblatt cautions that any patient in this situation would be deemed unsafe for the use of a mechanized piece of equipment without some sort of staff oversight. "Nevertheless, because a CPM machine is generally ordered for extended periods over the course of the patient's day or even at night, it would be impractical to assume that continuous supervision could occur," she says.
Rosenblatt suggests that the more realistic alternative is to prevent such a mishap in the first place. The CPM unit is a heavy, bulky contraption that sits on the bed with an elevated leg rest that moves the patient's leg back and forth in a flexion and extension motion. It is electrically powered and usually not battery-operated. Ideally, the unit should be set up so that the bed rail on the side of the affected limb is in an "up" position. Also, in case the unit does tip over, the unit should not be so close to the side of the mattress that the incline is severe. And there should be enough slack in the electric cord so that there is no drag on the machine while it rests on the bed. These provisions offer some degree of safety that the unit will not fall off of the bed or fall over to distort the position of the limb. And in conjunction with the alarms that are equipped on many mechanical devices, preventing an accident from happening in the first place is an attainable goal.
But Rosenblatt emphasizes that it is not sufficient for the nurses to merely set up the machine correctly without informing the patient about operating the machine. The patient should be fully instructed in the use of the equipment, its safety features, how to observe the equipment for safe and stable positioning, and how to quickly stop the operation and extract the limb safely. And if there is any reason to believe that the patient is sedated to a degree that he or she would not become aware or awaken should a problem with the machine occur, then the patient should not be left unattended.
"This accident speaks volumes to protocols that include assessment documentation of patients at the start of, conclusion of, and during the periods that equipment is utilized," says Rosenblatt. Flowcharts, for example, are an excellent way to maintain a running record of the treatment interval and to document the patient's tolerance to the process itself, and they are useful in establishing defenses in the case of a lawsuit. "Certainly a documented time line would have affirmed the assessment and oversight that would substantiate a reasonable and prudent standard of care," says Rosenblatt.
Reference
- United States District Court, Southern District at Huntington, WV. Case No. 3:03-2450.
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