The Ethics of Explanted Orthopaedic Hardware Return to Requesting Patients

As a 25-year veteran orthopaedic trauma specialist, I have had the opportunity to remove and return hardware to patients upon their request on many hundreds of occasions. It is often with great anticipation that patients or their family members receive the gift, sterilized and packaged as an acknowledgment from their surgeon and hospital team for a journey well-traveled. I have listened to patients describe the hardware as providing closure for their traumatic experience, or proof of conclusion for a hard road traveled, or as a trophy signifying victory, or a token which yields pride, which they share with children and other loved ones. I have witnessed the gleeful results of patients who made jewelry, artwork, lampstands, and tools. Often it is the spouse or child or friend of the patients desiring the opportunity to turn the explant into a reward for their significant other. One can understand my shock and dismay when informed of a recent policy mandate from the hospital; “no hardware will be returned to patients going forward.” I felt pain in my soul and disappointment to my core. This mandate was a shot through the sacred bond between physician and patient.

Orthopaedic hardware is explanted from patients for a variety of reasons. There is a medical consensus that orthopaedic hardware should be explanted from patients in instances of nonunion, infection, soft-tissue compromise, or hardware failure.^1,2 It is also well-established that pediatric patients' orthopaedic hardware should be explanted posthealing to circumvent future complications associated with hardware degeneration and pediatric skeleton development.^1,3 Conversely, explantation of orthopaedic hardware is often elective and occurs after fracture healing. Reasons for the elective explantation of orthopaedic hardware include surgeon recommendation, fear of potential long-term effects associated with implant retention, reports of localized pain, decreased function, and cosmesis.^1,2 Although the elective explantation of orthopaedic hardware is an incredibly common orthopaedic procedure, the literature to support these elective procedures as an effective means to improve patient health is not well supported and as such, the elective explantation of orthopaedic hardware remains a contentious topic.^1–3

Currently, no universal standard governing the handling of hardware postexplantation exists and hardware handling protocols thus vary across health care institutions and are ill-defined.³ In a 2016 article published in the Orthopaedic Journal at Harvard Medical School, Walley et al³ delineate several paths that orthopaedic hardware may be funneled into postexplantation: hardware may be sent to pathology and subsequently recycled, reused by under-resourced countries, collected as a memento by the physician, returned to the patient, or disposed off. According to the Orthopedic Journal at Harvard Medical School and the Association of Perioperative Registered Nurses (AORN), one of these options is becoming increasingly common: a growing number of health care organizations are returning explanted orthopaedic hardware to requesting patients.^3,4 However, many health care organizations still do not offer patients the option to retain their explanted orthopaedic hardware. In the absence of standardized policies concerning the handling of explanted orthopaedic hardware, an opportunity exists to develop a standardized policy that prioritizes patient wishes—offering to return explanted orthopaedic hardware to requesting patients.

ETHICS

To our knowledge, there is no literature that explores the ethics of offering explanted orthopaedic hardware to requesting patients. However, some literature does exist that explores the ethics of medical implant ownership. This literature helps to lay the moral infrastructure that supports the development of patient-centered orthopaedic explant return protocols. We argue that patients have the right to expect that what happens to their explanted orthopaedic hardware is up to them, and that it is an ethical imperative of health care organizations to honor that right, based on their respect for patient autonomy.

For the following reasons, we recommend that health care organizations provide patients with the option to keep their orthopaedic hardware postexplantation: (1) health care organizations are morally obligated to respect patient autonomy, (2) respecting patients' bodily integrity requires considering their implanted and explanted hardware as their own, (3) honoring patient choice may positively affect patient outcomes, and (4) patients ultimately bear financial responsibility for their implants.

Respect for Patient Autonomy and Patient Interest in Autonomy Over Their Bodies

Historically, the physician–patient dynamic was one in which the physician assumed a paternalistic role and acted as the primary medical decision maker. Over the last 50 years, the dynamic of this relationship has shifted to empower patient autonomy and encourage the active involvement of patients in decisions concerning their medical care.^5,6 This shift was signaled in the work of medical ethicists such as Tom Beauchamp and James Childress who articulated the 4 widely accepted tenets of biomedical ethics (respect for autonomy, non-maleficence, beneficence, and justice). As these 4 principles underpinning the ethics of medicine are now largely accepted by the health care community, it has become the moral obligation of physicians, and the larger health care organizations of which they are a part, to uphold these tenets.

We argue that patient autonomy—the ability for patients to make decisions regarding their medical care—includes autonomy over the extensions of one's body (which we define as harvested specimens, explanted medical implants or hardware, or entities that were once physically attached to an individual, but are no longer a part of their anatomy). Whether intrinsic to a patient's body or incorporated into a patient's body, these have come to be considered by a patient as their own—a part of themselves. This claim is supported by the fact that when endowed with the opportunity to choose what happens with extensions of their body, patients have elected to exercise this right. Conversely, when patients were excluded in participating in decisions concerning extensions of their body, they expressed dissatisfaction. For health care institutions to truly demonstrate a respect for patient autonomy, a respect for patient autonomy over their bodily extensions must be observed as well. We will reinforce this position using 3 examples from the existing literature: 2 court cases, a survey referenced by Kirkpatrick et al, and anecdotal reports of patient dissatisfaction in response to amended hardware return protocols. All of this will contribute to the moral argument necessitating that health care organizations provide patients with the option to retain their explanted orthopaedic hardware.

First, in their 1995 article, “But Doctor, It's My Hip!: The Fate of Failed Medical Devices” authors Fielder and Black cite 2 legal cases to help argue their belief that patients should have control over decisions related to their bodies, including their bodily extensions. These 2 cases do not explicitly concern the handling of explanted medical devices but shed light on the ethics that should be considered when creating protocols related to the handling of explanted hardware. The first case Fielder and Black reference is Brotherton versus Cleveland in which a family sues the county coroner for the removal of the decedent's corneas without their consent.⁷ The courts ruled in favor of the family and suggested that property rights extend to deceased bodies. The second case cited by Fielder and Black—Moore v. Regents of the University of California—concerns a cancer patient undergoing treatment at UCLA whose cells were eventually used to develop a cell-line without his consent.⁷ The patient sued on the grounds that parts of his body—which, he argued, is his property—were stolen from him for the purpose of scientific research. Although the courts did not rule in Moore's favor, Moore v. Regents in conjunction with Brotherton v. Cleveland, demonstrate the significance that patients—and their families—place on maintaining control over extensions of their bodies. The involved parties felt compelled to take legal action because they so strongly felt that the health care community violated their right to exercise autonomy over extensions of their bodies. It is fair to assume that an emotional and psychological connection exists between a patient and their explanted orthopaedic hardware—an entity that was once a part of their anatomy. Because of this intimate connection, for health care organizations to truly demonstrate a respect for patient autonomy, they must allow patients to make decisions regarding their bodily extensions as well.

Second, patients' desire to exercise autonomy over their bodily extensions is demonstrated in an article by Kirkpatrick, et al, in which the legality, ethics, and logistics associated with the reuse of explanted cardiac devices in low-income and middle-income countries is discussed. In this article, Kirkpatrick et al cite a survey in which 62% of patients responded that they would be interested in signing advanced directives dictating the fate of their cardiac implants after their deaths.^8,9 The results of the survey demonstrate that a significant proportion of patients viewed their cardiac implants as their own and preferred to actively participate in decision-making processes related to determining the postmortem fate of their bodily extensions. It is not unreasonable to infer from the results of this survey that a significant proportion of patients would also prefer to determine the fate of their explanted orthopaedic hardware by having the option to retain their explanted hardware.

Third, a 2012 AORN resource provides anecdotal evidence that patient satisfaction is negatively affected by compromising patient autonomy over their bodily extensions. AORN references one health care organization that previously returned orthopaedic explants to requesting patients, but had since transitioned to not providing this option. In response to the policy change, AORN reports that patients expressed dissatisfaction. The patients requested the organization return to their previous practice of providing patients with the option to retain their explanted orthopaedic hardware.¹⁰ The dissatisfaction voiced by the patients in response to the amended hardware return policy reaffirms the importance that patients place on maintaining autonomy over extensions of their bodies—in this case, their orthopaedic explants. The decreased patient satisfaction in response to the amended explanted hardware protocol is justified because of the health care organization's violation of its moral obligation to respect patient autonomy—specifically, respect for patient autonomy over their bodily extensions. This underscores the moral duty of health care organizations to devise patient-centered hardware return protocols that respect patient autonomy.

The responsibility of health care organizations to respect patient autonomy is further heightened by evidence that suggests that patient-perceived autonomy in health care may actually result in improved patient-reported outcomes. In a 2010 article published by Lee and Lin, a strong positive link between patients who perceived greater “autonomy support” in the context of their “autonomy preferences” (meaning those who prefer to more actively participate in decisions related to their health care have the ability to do so) and patient-reported outcomes (satisfaction, trust, and mental health-related quality of life)¹¹ was discovered. This suggests offering patients the option to keep their explanted orthopaedic hardware empowers patient “autonomy support” which in turn may yield positive patient-reported outcomes. Health care providers should adopt policies and engage in behaviors that optimize patient-reported outcomes. Thus, health care providers should offer patients the option to keep their explanted orthopaedic hardware because this not only respects patient autonomy, but, as suggested by the Lee and Lin study, may also optimize patient-reported outcomes.

PATIENTS AS PAYERS

In addition to the aforementioned ethical arguments in favor of patient-centered hardware return policies, the patient should also be provided with the option to retain the hardware as they bear the ultimate financial responsibility for their hardware. In fact, most implants are financed by the patient via a contract with a third party. Thus, because the patient is ultimately responsible for financing the cost of the implant, the patient has the strongest claim to the implant and should be the arbiter who determines the fate of the medical device regardless of whether it is implanted or explanted.⁷ The AORN acknowledges that in many health care communities, the orthopaedic hardware is paid for by the patient as an element of the surgery and therefore legally belongs to the patient.^4,10 We echo these sentiments and believe that it is most ethical for patients—as those who are financially responsible for the hardware—to have the option to keep their explanted orthopaedic hardware.

OTHER CONSIDERATIONS

Although we contend that health care organizations should respect patient autonomy and offer patients the option to keep their explanted orthopaedic hardware, ethical considerations that may override this obligation exist. There are currently 2 scenarios in which health care organizations are precluded from returning explanted hardware to patients: (1) if the hardware is regulated by the US Food and Drug Administration (FDA) or (2) if the hardware is defective, in which case it is must be reported and returned to the manufacturer.^4,10 These mandates for return of explanted hardware are ethically grounded in our obligations to protect patients from harm and to promote their well-being by engaging in rigorous programs of research, development, and safety. When respect for patient autonomy is in tension with our duties to protect others and promote their good, it is reasonable to weigh the latter over the former in cases such as this. This is commonly accepted in cases where infection control practices restrict individual liberties to protect the community (eg, quarantine of multi-drug resistant TB patients). Patient confidentiality, based on respect for patient autonomy, may also be overridden if maintaining confidentiality will very likely result in grievous harm to others. In mandating return of explanted hardware in the above-noted cases, we are limiting patient autonomy to fulfill our obligations to other patients and the community. Significantly, the resulting improvement in our devices and increases of our knowledge will further enhance future patient choices in orthopaedic care. Patient autonomy, although limited by mandated return, will ultimately be expanded by rigorous programs of research, development, and safety. This does not preclude routinely offering to return explanted hardware to patients in all other cases.

It may be argued that routinely offering to return explanted hardware will be costly, and that programs to return this hardware will add to the costs borne by others in the health care organization. Sanitizing and other safety measures required to return the hardware to the public create additional costs. It would be unfair to shift these costs to others who do not benefit from the return of the hardware, and routine disposal is more cost-effective, some may argue. However, routine disposal also is costly, and the costs thereof would not be incurred in a routine return program. Furthermore, not all patients will exercise the option for return, and the costs for these cases will simply be those of routine disposal. If there is some additional cost incurred by return of the explanted hardware, cost-sharing with those patients who choose this option could be an option. The charges for return should not be a barrier to exercising this choice, however, because that would erode patient autonomy. If there are additional costs created by the option for return, they may well be justified by the higher levels of patient satisfaction and better outcomes for patients produced by routinely offering to return their explanted hardware.

CONCLUSIONS

Ultimately, we suggest hardware explantation protocols be universally amended to offer patients their explanted orthopaedic hardware. It is the moral obligation of health care organizations to provide patients with this option as this option respects patient autonomy, may positively contribute to patient-reported outcomes, and respects the patient as the bearer of financial responsibility for the hardware.