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Malpractice Issues in Radiology |
1
Department of Radiology, Massachusetts General Hospital and Harvard University
School of Medicine, 32 Fruit St., Boston, MA 02114.
2
Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point
Rd., Skokie, IL 60076, and Rush Medical College, Chicago, IL 60612.
Received March 21, 2001;
accepted after revision March 21, 2001.
Case summaries are based on actual events and lawsuits, although certain
facts have been omitted or modified by the authors. All opinions expressed
herein are those of the authors and do not necessarily reflect those of the
American Journal of Roentgenology or the American Roentgen Ray
Society.
The Case
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The arteriogram was performed using a pigtail catheter and involved a total of two power injections of contrast media. Between these injections, the catheter was double-flushed with normal saline solution, per institutional protocol. With the images showing no evidence of acute aortic injury, the interventional radiologist decided to terminate the study.
As the radiologist began removing the catheter, the patient suddenly became obtunded and hemiplegic. Worried that an acute thrombotic—embolic event was occurring, the radiologist removed the pigtail catheter and replaced it with a sheath. During the exchange, the radiologist noted that the distal portion of the catheter was missing, presumably having detached while in the patient's vasculature.
Now concerned that a foreign body was in the patient's vascular system, the radiologist immediately commenced a fluoroscopic search for the lost catheter tip, starting with the patient's head and neck region. In the intracranial portion of the left internal carotid artery distribution, the radiologist identified what appeared to be the radiopaque catheter tip.
After instructing the radiology technologist to call the trauma surgeon and an interventional neuroradiologist to the radiology procedure suite, the interventional radiologist performed an emergency cerebral arteriogram, starting with the left common carotid artery. The arteriogram revealed an abrupt occlusion of the middle cerebral artery at its origin, interpreted by the radiologist as representing a probable thrombus in the location of the lost catheter tip. Over the next 2 hr and with the assistance of the interventional neuroradiologist, intraarterial thrombolysis and foreign body retrieval, using a small loop snare, were attempted. Eventually, the clot was lysed and the catheter tip recovered.
Although the patient survived the procedure, he suffered an infarct in the distribution of the middle cerebral artery. Following a 10-day hospital stay, the patient was discharged to a rehabilitation facility. He was left with permanent and severe neurologic deficits.
An internal hospital investigation initiated immediately after the incident revealed that the interventional radiology section of the radiology department, faced with considerable financial pressure, routinely reprocessed and reused catheters and guidewires, even though the Food and Drug Administration—approved labeling of these devices indicated that they were intended for single use. This reprocessing, conducted within hospital facilities, achieved considerable monetary savings in the purchase, inventory, and disposal of these devices and substantially contributed to the hospital's ability to continue to offer a full range of interventional radiology services. The policy had been adopted by members of the interventional radiology section, with approval from the department chairman and hospital management. The investigation determined that the catheter used in the patient's arteriogram had been designed for single use but had been reprocessed. Although the catheter tip had indeed broken off, no evidence was found that the interventional radiologist had deviated from the standard of care in his conduct of the procedure.
After the investigation, and despite spirited debate among members of the department of radiology and hospital management about the safety and advisability of maintaining a reprocessing and reuse policy, the policy was left intact.
Eleven months after the incident, the interventional radiologist and the hospital were sued for medical malpractice by the patient and his family. The lawsuit alleged that the defendants were grossly negligent in reprocessing and reusing a device that had been intended only for single use and that the radiologist was negligent in the manner in which he had handled the catheter and in not appreciating in a timely fashion that the tip had broken off. The lawsuit sought $500,000 in compensatory and $1 million in punitive damages. A separate product liability lawsuit was also filed against the manufacturer of the catheter.
The radiologist and the hospital immediately informed their professional liability carriers of the legal action. These carriers in turn appointed legal counsel for the respective defendants, who, together with the attorney for the manufacturer of the catheter, undertook a thorough investigation of the incident, including reviews by experts in both interventional radiology and medical device reprocessing and reuse.
The expert in interventional radiology first evaluated the standard of care provided to the patient and could find no evidence of negligence in the actual performance of the arteriogram. She noted that catheter fracture was rare, that the interventionalist's initial concern for a thrombotic—embolic event had been valid, and that the short delay before the catheter failure was recognized was of little importance. Furthermore, she concluded, the actions taken by the interventional radiologist and the interventional neuroradiologist after localization of the catheter tip were well within the standard of care and, in fact, likely prevented further patient injury.
The conclusion of the expert in the reprocessing of single-use devices regarding the defendant-radiologist's reprocessing practices was not as supportive, however. The expert discovered that the reprocessing began shortly after each case was concluded, when the radiology technologist assigned to the procedure room visually inspected all catheters and wires that remained on the procedure tray. Any device that appeared damaged was discarded, with the remaining devices sent for reprocessing at a hospital-run facility.
At the reprocessing facility, catheters and wires were flushed, soaked in a disinfecting solution, and then rinsed with warm water. The products were once again visually inspected for defects, and those found to be intact were sent for sterilization. After a final visual inspection under sterile conditions, they were repackaged and returned to the interventional radiology section.
Both defense experts agreed that hospital-based reprocessing of single-use medical devices was not unusual. However, they also agreed that certain practices of the defendants raised concerns about the safety of the reprocessed products. In the defendants' system, catheters and guidewires were not individually identified or tracked; therefore, it was impossible to know how many times a particular device was reprocessed or whether a problem with it had been encountered. Furthermore, no testing was performed to ensure that the reprocessed products were functionally equivalent in integrity and performance to a new product.
On the basis of their findings, the defense team decided to subject the failed catheter to extensive evaluation at an independent testing facility. The tests revealed that the reprocessed catheter was considerably less flexible and more brittle than the original product, particularly at the curved portion of the catheter in which the fracture had occurred. The testing facility was unable to say, however, whether these altered properties were the sole cause of the failure, because occasionally new catheters showed a similar weakness in the same location.
After the investigation was completed, the attorneys for the defendants voiced concern about the legal exposure of their clients, given the obvious catheter failure and its catastrophic consequences, and recommended that a settlement be negotiated. After protracted negotiations, the plaintiff agreed to drop all legal actions in consideration of a payment of $250,000 from the radiologist's insurance company, $750,000 from the hospital, and $500,000 from the device manufacturer.
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The reprocessing and reuse of single-use products theoretically pose the risk of increased patient injury. Faulty resterilization may allow the transmission of infectious disease between patients, whereas the reprocessing process itself may alter a device's mechanical properties and thus risk product failure [1, 2]. Although there are anecdotal reports of patient injuries resulting from reprocessed single-use devices, some of which are receiving considerable national attention in the printed news media [3], the number of documented cases of patient injuries as a result of reprocessing is, in fact, quite low [4].
The practice of reprocessing raises a variety of regulatory and legal issues. The FDA has the authority under the Food, Drug, and Cosmetic Act (1938) and related legislation to regulate the reprocessing and reuse of single-use devices [5], although historically, the FDA has not applied the full weight of its regulatory power to physicians, hospitals, or other entities engaged in such reprocessing. To understand the FDA regulation of single-use device reprocessors, it is necessary to look at the agency's treatment of entities that manufacture new single-use medical devices, referred to as original equipment manufacturers. Before such entities can commercially distribute a new or significantly modified medical device, they must obtain FDA marketing approval either by establishing that the product is "substantially equivalent" to an existing legally-marketed product or by showing reasonable safety and effectiveness in the case of a genuine new device [6]. Production and distribution of the device itself are subject to a variety of manufacturing regulations designed to ensure that the product is fabricated under prescribed conditions and correctly labeled.
The FDA's traditional regulation of the reprocessing and reuse of single-use devices, as articulated in a 1987 policy document [7] and reinforced as recently as 1997 [8], placed responsibility for the safety and effectiveness of reprocessed products on those performing the reprocessing. Under this policy, neither hospitals that reprocessed devices in their own facilities nor third-party reprocessors were required to obtain FDA marketing approval for reprocessed products, despite the possibility that reprocessing might alter a single-use product to the extent that it effectively creates a new product. Furthermore, the FDA selectively enforced its manufacturing regulations only on third-party reprocessors, leaving hospitals essentially unregulated.
As public concern regarding iatrogenic medical injuries grew in the late 1990s, the FDA reexamined its stance on the reprocessing of single-use medical devices. The result was a revised policy, "Enforcement Priorities for Single-use Devices Reprocessed by Third Parties and Hospitals," issued in August 2000 [9]. Under this policy, all reprocessors of single-use devices became subject to the same marketing and manufacturing regulations that applied to original equipment manufacturers. Hospitals were to be given a full year from effective date of the new policy to comply with these regulations. Marketing approval regulations for both hospitals and third-party reprocessors were to be phased in over an 18-month period, depending on whether the medical devices were categorized as class III (high risk), class II (intermediate risk), or class I (low risk). The goal of the revised policy is to create an environment in which original equipment manufacturers, hospitals, and third-party reprocessors are all subject to the same marketing and manufacturing regulations.
After full implementation of the revised policies, expected to occur in early 2002, hospitals that reprocess single-use devices will be subject to a variety of governmental provisions designed to ensure that the reprocessing process and the reprocessed products themselves are safe and effective for their intended use. Failure to abide by these requirements could result in the FDA's instituting administrative sanctions against the noncompliant institution.
More importantly and more relevant to the case described in this article, violations of FDA regulations can subject the hospital or healthcare provider using nonconforming products to personal injury lawsuits under state laws [10]. The doctrine of "negligence per se" has been previously discussed [11]. This theory allows persons protected by government regulations to pursue legal actions against parties whose violation of these regulations causes them injury [12]. Negligence in these lawsuits is established by showing violation of an applicable regulation. Because patients almost certainly qualify as persons protected by the FDA's revised policy, there is little doubt that any entity or physician who violates these regulations could be subject to malpractice litigation.
Even in instances in which the FDA's revised regulations are not yet fully implemented, these regulations may still have an impact on legal liability. All physicians engaged in medical practice are subject to malpractice litigation for violations of the standard of medical care that cause injury to patients. The standard of care that is allegedly violated by a defendant physician is derived from a variety of sources. Although this standard is often established by physicians testifying as experts, the existence of government regulations may also define a standard of care. In the setting of the reprocessing and reuse of single-use medical devices, the FDA's revised regulations, whether they are technically in force, may well have the effect of establishing a standard to which physicians and other health care professionals may be held [13].
Under certain circumstances, the law allows injured patients to reach beyond the persons who are directly responsible for their injuries by allowing patients to sue those who control the actions of such persons who would then be vicariously liable [14]. Under this legal theory, patients injured by the actions of technologists or other hospital staff who, for example, have been ordered to reprocess single-use devices, can pursue legal actions against the physicians or supervisors who ordered the reprocessing and reuse [13].
Another legal doctrine on which a patient injured by a reprocessed single-use device may base a malpractice lawsuit is that of informed consent. It is well accepted that a physician must inform patients of risks and benefits of a procedure or service, including any alternatives that may exist. Failure to do so may hold a physician liable if patient injury occurs [15]. From a legal standpoint, informed consent required in the reprocessing and reuse of medical devices is conceptually similar to informed consent required in the setting of non-FDA-approved use of medical devices, a topic previously discussed [16]. Here, the non—FDA-approved use is the reprocessing and reusing of devices bearing FDA-approved labeling that unequivocally states that the product is for single-use only.
Most courts that have addressed this issue do not require physicians to inform a patient that a device is being used for a non—FDA-approved indication, reasoning that regulatory status is nongermane to patient risk [17]. However, this rationale may not hold if an off-label use could be seen as increasing patient risk, such as may be the case with reprocessing and reusing a product labeled for single-use only. Accordingly, if an injured patient could convince a court that a radiologist's actions in reprocessing a single-use product increased the patient's risk, there is the possibility that the radiologist involved in the reprocessing would be held legally liable for injuries that occurred as a result of not informing the patient of the reuse. One legal commentator maintains that any radiologist who, for cost-saving measures, engages in reprocessing and reuse is under an ethical obligation to inform patients of that practice, a position that could also influence the courts [18].
In addition to legal action based on negligence or informed consent, radiologists engaged in the reprocessing and reuse of a single-use medical device may also face actions alleging violation of product liability laws that are designed to protect consumers from dangerous products. Many jurisdictions have adopted a strict liability doctrine for such actions, under which an entity or individual manufacturing a product is liable for any injuries resulting from that product's use, regardless of whether negligence has demonstrably occurred. Typically, these actions simply require that the injured party show that the product is defective and unreasonably dangerous, that the defendant is in the business of selling the product, and that the product reached the user in the same condition as when it was sold [19].
The courts have yet to address the application of strict liability of medical device reprocessing, although courts have held reconditioners of other types of equipment accountable under the doctrine of strict liability. A hint as to how the courts might deal with the reconditioning of medical devices can be gleaned from a New Jersey Superior Court decision that dealt with a company that reconditioned football helmets. The court stated [20]:
The risk of harm from defective repair services is great.... Customers rely on the expertise of the providers of services as much as they rely on the expertise of the providers of products... Imposing strict liability would induce providers of services to invest in safety, leading to greater protection for their customers.... [Providers of services] are experts in the condition of athletic equipment; [it was] contemplated that they would use that expertise while inspecting the entirety of the helmet to determine the propriety of its continued usefulness. Indeed, the facts indicate that it was a basic procedure of the reconditioners to [reject] any helmets which appeared to be unsafe because of damage.... [The user] did not request a mere mechanical servicing of the helmet; it asked for the exercise of expertise dealing with the overall safety of the helmet.... Like the manufacturer, the reconditioners represented the goods as being safe to use.... The policy underlying strict liability, stated quite simply, is to provide that the cost of injury is borne not by the injured or damaged person who is unable to protect himself or herself, but by those who create the opportunity for a defective product to be used. Certainly, in light of this, it makes no sense to apply strict liability to a manufacturer who presents goods for use along with a representation of their safety, and not to impose similar responsibility on a reconditioner who retenders goods for use along with a representation of their safety.
Even if a court were to rule that the duties of reprocessors are the same as those of manufacturers, an injured patient, to prevail under grounds of strict liability, must still establish that the involved radiologist is in the business of selling the reprocessed product. Traditionally, the courts have been reluctant to find that physicians engaged in the ordinary practice of medicine meet this test. Nevertheless, when medical institutions engage in in-house reprocessing and when physicians are intimately involved, it is quite possible that a physician could be found to constitute a seller to justify imposition of the strict liability doctrine [13].
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Although there is at present no federal or state law or regulation that specifically prohibits the reprocessing and reuse of single-use devices, nonetheless, physicians and medical institutions that indulge in such practices may find themselves subjected to malpractice litigation and liability for any injury sustained by the patient. Risk management in radiology can lessen the likelihood of incurring such litigation and maximize the chances for a successful defense if a lawsuit is filed, while enhancing the quality of patient care. The following risk management pointers will help radiologists who are faced with potential liability from the reuse of medical devices meet all of these objectives:
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301-394 (1938)
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  L. A. Shratter, J. J. Smith, and L. Berlin Reprocessed Single-Use Devices and the FDA: Additional Information for Radiologists Am. J. Roentgenol., June 1, 2002; 178(6): 1570 - 1571. [Full Text] [PDF]
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