Legal/Regulatory Issues Cited
Revenues are down and the budget is tight. This is a common refrain among today’s healthcare managers. One possible solution: start reusing electrophysiology catheters labeled “for single-use only.” Since the catheters cost upwards of $400 apiece, the financial savings could be substantial. The more uses, the more potential savings. Expand the campaign to include breathing circuits, mechanical staplers, and laparoscopic retractors–and the economic rewards multiply.
But what about risks? They reuse of single-use medical devices raises a myriad of technical, legal, ethical, regulatory, and risk management issues. ECRI’s review and analysis of the published clinical studies concluded that there is no clear evidence that reuse of single-use medical devices is either safe or unsafe for patients.1 These unknowns mandate a cautious approach.
Physicians, healthcare organizations, device manufacturers, reprocessing companies, regulators, and patients all have a stake in the reuse debate. Device manufacturers and, more recently, third-party reprocessing companies have been subject to U.S. Food and Drug Administration (FDA) enforcement efforts. Physicians have not. Yet physicians are vulnerable to malpractice suits and may find it burdensome to defend the practice of reuse, which is an off-label use. Hospitals, too, risk liability threats and must grapple with a host of issues ranging from employee safety to protocol development to ethical issues.
The Regulatory Climate
FDA’s guidance, last revised on September 24, 1987, states:
…the institution or practitioner who reuses a disposable medical device should be able to demonstrate: (1) that the device can be adequately cleaned and sterilized, (2) that the physical characteristics or quality of the device will not be adversely affected, and 93) that the device remains safe and effective for its intended use. Moreover, since disposable devices are not intended by the manufacturer or distributor for reuse, any institution or practitioner who resterilizes and/or reuses a disposable medical device must bear full responsibility for safety and effectiveness.2
Although FDA’s guideline places the full responsibility for safe and effective reuse on the organization that reprocesses the device, the agency has never directed its efforts at physicians or healthcare organizations. Its current actions are focused on the manufacturers of single-use devices and reprocessing companies that provide services for healthcare organizations.
The Health Care Financing Administration (HCFA), the agency responsible for Medicare reimbursement, issued regulations covering reuse of hemodialyzer filters,3 which state that all patients in the facility “[must be] fully informed regarding the facility’s reuse of dialysis supplies, including hemodialyzers. If printed material such as brochures are utilized to describe a facility and its services, they must contain a statement with respect to reuse.”4 In addition, all medical records must contain documentation of whether the patient has been treated with a reprocessed hemodialyzer.5 Facilities are also required to ensure that “patients [are] informed of the policies and procedures” with respect to reuse.6
In a lawsuit alleging that a patient was injured by a reused device, a number of issues may be raised, such as:
- Was the decision to reuse the device reasonable?
- Was there a policy and procedure on reuse, and, if so, was it adequate?
- Did the facility adequately clean, sterilize, and prepare the suspect device?
- Were personnel adequately trained?
- Should the physician, hospital staff, or others have noticed a device defect?
- Was the healthcare facility’s selection of a reprocessing company reasonable?
- Was the patient adequately informed of the risks of the procedure?
- What is the evidentiary value of the devices’ labeling stating “for single use only?”
- Did the device manufacturer have an obligation to provide warnings or instructions?
Physician exposure to liability for reuse of single-use devices would most likely rest on theories of malpractice, vicarious liability, or failure to obtain informed consent. A malpractice suit might allege that, by permitting reuse, the physician violated reasonable standards of medical practice. This would likely involve an analysis of the weight that would be given to a departure from the device’s labeling stating “single-use only.”
Although, to date, there are no reported court decisions on reuse of single-use devices, there are several decisions that involve manufacturer recommendations and “off-label” use of drugs and devices. Reuse of a device labeled for single-use is an example of using a device in a manner that does not appear in the device’s FDA-approved labeling and is to approved by the FDA, a practice commonly referred to as “off-label,” “unapproved,” “unlabeled,” or “extra-label” use.
Off-label use is not new or unusual. Physicians frequently prescribe drugs for off-label indications or use devices in an off-label manner. It may even be so widely accepted that it is the treatment of choice. There is nothing in FDA regulations that limits a physician’s freedom to do this. Indeed, FDA has recognized that off-label uses of approved products may be appropriate, rational, and accepted medical practice that can lead to important advancements in medical therapy.7
Physicians may, as a part of the practice of medicine, lawfully prescribe a different dosage or otherwise vary the conditions of use from those appearing on a drug package insert without informing or seeking approval from the FDA.8 The same can be done for medical devices.
The absence of FDA restrictions, however, does not mean that there is a total absence of any legal restraints on physicians. The specter of malpractice liability is one. The device’s labeling, the manufacturer’s recommendations, and the FDA status of the device are likely to have an impact on the outcome of a malpractice case alleging improper reuse of a single-use device. In effect, the provider will need to demonstrate why the off-label use was reasonable.
Law and medical ethics require that patients be fully informed of the risks and benefits of medical procedures. Generally speaking, the physician, not the hospital, is responsible for obtaining the informed consent of the patient. The duty to obtain informed consent requires that the physician inform the patient of the nature of the proposed treatment and discloses material risks that would influence the patient’s decision whether or not to proceed.
There are no legal cases on the need for informed consent to reuse of single-use devices. The need to disclose will depend upon the specific device and whether reuse is part of a research study. For dialyzers, it is clear that there needs to be disclosure on reuse practices to comply with HCFA regulations.9 If reuse is undertaken as research rather than as routine diagnosis or therapy, then patients should be informed about the innovative nature of reuse, including the attendant harms and benefits, and obtain the patient’s explicit consent prior to any reuse.10 Even if the risks are minimal, obtaining informed consent to reuse is an important safeguard consistent with the current concepts of research.11
Clinical trails of reuse ought to be performed in accordance with applicable state and federal legislation and regulations that require informed consent from the participant.
Tell Patient of Reuse?
For nonresearch purposes, the legal requirement to disclose reuse may be identified by analyzing case law on the scope of disclosure necessary for valid informed consent. The question becomes whether a patient has a right to receive information about reuse. This right would depend on whether the jurisdiction has adopted a patient-based or physician-based standard for the scope of disclosure. The operative factor in the patient-based standard for disclosure is materiality of risk.12 A risk is “material” if a “reasonable” person in the patient’s condition would consider it significant in deciding whether or not to have the procedure performed. Materiality is a function not only of the severity of the possible harm, but also of the likelihood that the risk will occur. Regardless of the severity of a potential injury, courts have held that if the probability of a risk occurring is so small as to be practically nonexistent, then it is not a material risk.
Under the patient-based informed consent standard, patients should have the right to choose between a reused device or a single-use device if each in fact presents a significantly different material risk to the patient. It would seem that the materiality of the risks would depend of the scientific evidence as well as the quality of the facility’s sterilization and decontamination practices.
The physician-based standard for disclosure is based on a professional negligence theory and is cast in terms of the physician’s duty owed to the patient as measured by the standard of care in communicating information about a proposed treatment. That standard of care is based on the disclosure that physicians customarily provide to patients. For the vast majority of reused devices, it is unlikely that the medical community has adopted a standard of disclosure on reuse.
In addition to proving materiality, a plaintiff alleging a failure to obtain informed consent must prove that had the proper disclosures been made, he or she would not have undergone the procedure using the reused single-use device, or he or she would have undergone the procedure using a new single-use device, and would not have suffered the injury at issue.
Thus, the need to disclose reuse would depend on the specific device, the known scientific evidence, and whether reuse would pose a greater risk than the alternatives–that is, initial use of a single-use device or use of a reusable device. It would also depend on whether the physician or healthcare organization follows reuse protocols that ensure that there is no significant increase in risk to the patient. If this is the case, the physician or healthcare organization is unlikely to be liable for failure to disclose that a single-use device was reused. This assumes that the facility would not reuse a device in a situation where there were materially increased risks associated with the reuse.
For information on Special Report on Reuse of Single-Use Medical Devices: Making Informed Decisions, contact ECRI at 5200 Butler Pike, Plymouth Meeting, PA 19462, (610)825-6000.
Ronni Solomon is Vice President of Legal Affairs and Director of Risk Management Services at ECRI, a nonprofit health services research agency in Plymouth Meeting, PA. The agency focuses on risk management and technology assessment for the medical and healthcare communities. Ms. Solomon chaired ECRI’s reuse task force, which led to the issuance of ECRI’s Special Report, Reuse of Single-Use Medical Devices: Making Informed Decisions. Ms. Solomon has lectured and published extensively in the U.S. and abroad on areas of healthcare law, risk management, and technology.
- ECRI. Special Report on Reuse of Single-Use Medical Devices: Making Informed Decisions. Plymouth Meeting, PA 19462, USA.
- United States Department of Health and Human Services, U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health. Devices: reuse of medical disposable devices. In: U.S. Food and Drug Administration. Compliance policy guide 7124.16 § 300.500. Rockville (MD): FDA; reissued Sept. 24, 1987.
- 42 CFR §405.2150.
- 42 CFR §405.2138(a)(4).
- 42 CFR §405.2139.
- 42 CFR §405.2136(b).
- Schultz WB. Testimony before United States Senate, Committee on Labor and Human Resources, 1996 Feb.
- Kahan JS, Martin CJ. Extra-label uses of approved drugs. Pharm Exec 1992 Apr.
- See the discussion at notes 28 to 32 of this chapter.
- Priester R, Caplan A. Legal and ethical issues in the practice of reuse. Perspect Healthc Risk Manage 1991;11(4):31-37.
- See the discussion in: Lafferty R, Giboffsky A. Regulatory and legal issues in the reprocessing and reuse of hemodialyzers. J Leg Med 1988;9(2):279-311.