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    Legally Speaking: Careful with that equipment

     

    LEGALLY SPEAKING

    Careful with that equipment!

    JOAN SOSIN, RN, JD

    The author is a nurse and attorney who has represented nurses, physicians, and hospitals in medical malpractice cases. She currently lectures and writes on health and medical-legal issues.

    Knowing how to inspect and properly use equipment can significantly reduce both the risk of patient injury and your own legal liability.

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    Equipment-related injuries and deaths are a reality the medical community is working to eliminate. Yet all too often these adverse events stem from human error—not product failure—and can be averted.

    Take, for instance, the case in which gas—rather than a continuous flow of fluid—was inadvertently pumped into the uterus of a patient undergoing diagnostic hysteroscopy. Because the nurses had no experience with the hysteroscope and pump apparatus, they used the wrong hook-up, an error that proved to be fatal. The 45-year-old patient died from a massive air embolism when the gas entered her bloodstream.1

    In cases like this, not only can the nurse face liability, but the nurse manager can place herself in legal jeopardy, as well. Supervisors can be held accountable for inadequate supervision and negligence in making an assignment clearly beyond the abilities of their subordinates.

    From high tech to low, danger exists

    Any piece of medical equipment—from monitors to beds—can cause patient harm if caregivers are not familiar with its proper use or diligent about using it properly. Consider the case of the 15-month-old who was rushed to the hospital after receiving CPR at home. The baby was admitted and placed on an apnea monitor, but the nurses on the unit never activated the alarm. So when he stopped breathing, no alarm sounded; resuscitation was delayed, contributing to his death several days later. The nurses faced liability for failing to activate the alarm as ordered and operating the monitor incorrectly.2

    A nurse who placed a patient with a spinal cord injury on a rotation bed without checking the position of an "essential bolt" faced similar charges. Without the bolt in place, the patient fell off the bed, striking the midportion of his back as the bed rotated. In a subsequent lawsuit, the patient claimed that the fall resulted in an increase in pain and spasms.3

    Injury can also occur when equipment is used for something other than its intended purpose. In one such case, an ICU nurse who was unable to find Posey restraints on her unit improvised and applied 4 x 9-inch padding covered with gauze to the wrists of a confused patient, then tied the gauze to the bed. The patient developed left wrist drop as a result.4

    Heading off potential problems

    Keeping risk to a minimum when working with medical equipment requires that you start off on the right foot. Visually inspect all equipment for defects, including the packaging. Failure to do so could spell legal trouble if a patient is injured by equipment that you knew was defective—or should have known, had you done a reasonable inspection.

    A broken seal on a package of IV tubing, for example, indicates not only that a product is unsterile but also that pieces or parts may be damaged or missing. Checking expiration dates and maintenance schedules on supplies and equipment can also alert you to potential problems. Look, too, for obvious defects, such as a frayed cord, missing knob, or broken switch.

    If you do find a flaw, affix an "out of order" sticker to the device and, if it's portable, remove it from the patient care area. If an equipment-related injury occurs, notify your supervisor after attending to the patient. And save even damaged throwaway equipment for possible testing or as evidence if legal action ensues. Consult your policy manual and your supervisor for additional reporting requirements.

    Another key to safety is learning how to use new equipment. Carefully read manufacturers' instructions and facility guidelines, and attend inservices and other programs related to medical devices whenever the opportunity arises. You should not try to operate a medical device or use a piece of equipment until you have received adequate training. Be diligent, too, about using the equipment or device in the way you were taught during that inservice or via an operator's manual. And of course, do not use equipment for something other than its intended purpose.

    Watch for equipment alerts

    Be on the lookout for reports of equipment misuse or malfunction in nursing publications, on Web sites, and in communications from your employer. The Joint Commission on Accreditation of Healthcare Organizations Web site (www.jcaho.org ), for example, periodically issues Sentinel Event Alerts on the causes of medical errors.

    One such alert was issued in response to a series of reports of deaths and near-fatal drug overdoses relating to the use of infusion pumps.5 In one case, a 66-year-old woman underwent repair of an abdominal aortic aneurysm, then died of an overdose of IV nitroprusside sodium (Nipride). Before transferring the patient out of the recovery room, the nurse had disconnected the infusion pump from the IV line, expecting it to be connected to a different infusion pump as soon as the patient arrived on the unit.

    But the nurse failed to manually engage the roller clamp on the IV line prior to disconnecting the pump—a vital step unless the pump has a set-based anti-free-flow mechanism. The pump in this case didn't have such a mechanism, and the rest of the medication in the bag rapidly emptied into the patient's vein.

    What makes stories like this one even more frightening is how difficult it can be to visually distinguish between infusion pumps that have anti-free-flow mechanisms and those that don't. The Institute for Safe Medication Practices (ISMP) in Huntingdon Valley, Pa., estimates that about a third of the more than 600,000 IV pumps used in hospitals nationwide are capable of free flow.6 In light of the risk to patients, the U.S. Pharmacopeia (USP) recommends that all pumps with the potential for unprotected free flow be identified and phased out of service.

    Not reporting only adds to the problem

    Under the Safe Medical Devices Act of 1990, all "device user facilities"—hospitals, ambulatory surgical facilities, nursing homes, outpatient treatment facilities, and outpatient diagnostic facilities (but not physicians' offices)—are required to report device-related deaths and serious injuries to the FDA and to the manufacturer within 10 business days of an incident. Failure to do so puts other patients at risk. It can also result in civil penalties for those who are responsible for reporting such device-related deaths or injuries at their facility and who fail to do so.

    Unfortunately, though, deaths and injuries associated with medical devices are still significantly underreported. As a result, the FDA is testing a new sentinel-type program, called the Medical Product Surveillance Network (MeDSuN), in approximately 200 facilities. The program, which is intended to eventually replace the FDA's current universal mandatory reporting system, involves training healthcare providers at key facilities to recognize and report events that could be device related. Unlike the current system, though, reporting would not be required for the vast majority of facilities nationwide. Rather, it would be required of a representative sample of facilities throughout the country.

    But mandatory reporting is only part of the effort to curb equipment-related injuries and deaths. There are also voluntary reporting programs for individual providers. Healthcare professionals can, for instance, submit a report to ECRI, a nonprofit health services research agency. ECRI investigates incidents involving medical devices and publishes information to help healthcare professionals avoid medical device injury and manage devices properly. ECRI's Problem Reporting Form is available online at www.ecri.org/documents/Prob_Reporting/problemReportForm.asp , and can be submitted electronically or printed out and faxed or mailed.

    There is, of course, voluntary reporting through the FDA's MedWatch program, as well. Healthcare professionals—and consumers, for that matter—can file a voluntary report about an adverse event involving a piece of medical equipment, a drug, or a dietary supplement. (See the "Reporting an event to MedWatch" box.) The incident doesn't have to involve a death or actual injury to warrant reporting. Reporting near misses can provide valuable information about the function or design of a device. The FDA uses this information when it issues product safety alerts and recalls, calls for the withdrawal of devices, or requires labeling changes.

    Systems like MedWatch and the new MeDSuN take time before they can create a meaningful change at the bedside. Your actions, however—from the inspection of equipment to the proper use of it—can have an immediate impact on patient safety. The question is: Are you doing all that you can to make things safer for your patients?

    REFERENCES

    1. Chin v. St. Barnabas Medical Center, 734 A.2d 778 (1999).

    2. Dent v. Memorial Hospital of Adel, 509 S.E. 2d 908 (1998).

    3. University Community Hospital v. Martin, 328 So. 2d 858 (1976).

    4. Schwabach v. Beth Israel Medical Center, 72 A.D. 2d 308 (1980).

    5. Joint Commission on Accreditation of Healthcare Organizations. "Infusion pumps: Preventing future adverse events." Sentinel Event Alert. 2000. www.jcaho.org/edu_pub/sealert/sea15.html (28 Nov. 2001).

    6. Institute for Safe Medication Practices. "IV pump set free-flow: When is enough enough?" ISMP Medication Safety Alert. 1998. www.ismp.org/msaarticles/free-flow.html (28 Nov. 2001).


    Reporting an event to MedWatch

    Through the FDA's MedWatch program, healthcare professionals—and consumers—can file a voluntary report about an adverse event involving a piece of medical equipment, a drug, or a dietary supplement. To do so, simply:

    1. call (800) FDA-1088,

    2. download Form 3500 from www.fda.gov/medwatch/safety/3500.pdf and follow directions to submit by mail or fax, or

    3. complete Form 3500 online at www.accessdata.fda.gov/scripts/medwatch .

    If you wish to file an anonymous report online, simply enter "xxx" in the name field. If you submit a report by fax or mail, you can omit information that identifies who you are.

     

    Emil Vernarec, ed. Joan Sosin. Legally Speaking: Careful with that equipment. RN 2002;2:59.

    Published in RN Magazine.