As healthcare budgets shrink dramatically, being creative in the medical field while preserving the optimal quality of care has become an overwhelming challenge for providers. During the past decade, the idea of reusing single-use devices (SUDs) gained prominence as the healthcare industry sought innovative ways to balance increasing consumer demand for services with more expensive technological advances. This article examines the clinical, ethical, and economic costs of reusing SUDs.
BACKGROUND
The practice of sterilization was developed for hospitals more than 100 years ago, and, in the US, the majority of medical devices designed and sold in the interim have been reusable. The production and development of plastic-based medical devices occurred during the 1960s. This drastic change within the medical supply industry represented manufacturers' response to demands for more convenient, efficient, and simple-to-use products. Staff welcomed the convenience of single-use, throwaway products because, at that time, their benefits outweighed their disadvantages. Using a new product for each procedure eliminated concern about its age, overuse, breakage, or malfunction.
Today, healthcare facilities are in the midst of another period of change. The fiscal crisis in healthcare has led to a reassessment of all areas of health delivery. The high expense of some SUDs has prompted the management of healthcare facilities to reevaluate their belief that these devices cannot be reprocessed for use on other patients. If this practice results in cost savings, many healthcare providers hold that the limited reuse of some instrumentation and materials is acceptable with appropriate approval, research, written procedures, quality control, and evaluation.
THE FDA's STANCE
On August 14, 2000, the FDA issued the “Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals” guidance document. This report detailed hospitals' and third-party reprocessors' responsibilities. Manufacturers engaged in reprocessing devices labeled for single use under the Federal Food, Drug, and Cosmetic Act, as amended by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and the Food and Drug Modernization Act of 1997.
One of the FDA's main objectives was to address the issue of public safety while providing regulatory requirements for original equipment manufacturers, third parties, and hospitals in order to minimize the risks associated with reprocessing SUDs. Importantly, these priorities do not apply to permanently implantable pacemakers, “opened-but-unused” SUDs, healthcare facilities that are not hospitals, and hemodialyzers. Although the FDA limited its regulations to third-party reprocessors and hospitals, the administration stated that it would review other agencies that perform reprocessing in the future. Basic terminology related to sterilization and reuse appears in Table 1.
COST ANALYSISOverview
Many individuals lose sight of the total cost of an item. Is cost strictly limited to dollars and cents? In the following sections, this article provides discussion points about the clinical, ethical, and economic costs of reuse.
Clinical Costs
At issue when considering whether to reuse a reprocessed SUD is whether (1) it is of the same clinical caliber as before it was used, (2) it will function as intended, and (3) it has experienced no degradation that will compromise patient safety (Figure 1). The vendor or company selling the product has the responsibility to educate you about the item. Information should include whether the product is single-use, reusable, or possessed of parts with both attributes (reposable). If you do not understand the “use” design of the item, you will be unable to determine whether the material will perform its intended purpose. If the manufacturer states that the device is reusable, you need to know whether the item was tested in its approval process for multiple uses and, if so, for how many uses (Figure 2). Can the SUD's performance be guaranteed with repeated reprocessing? The performance of the product, after all, was one rationale you used when selecting the item.
The clinical cost of reusing SUDs relates to the ease with which policies can be formulated concerning the disinfection, decontamination, cleaning, preparation, and sterilization/resterilization processes (Figure 3). Can your staff safely ready the product for resterilization without compromising patient care? For example, can the item be cleaned properly (Figure 4)? Is it reasonable to expose your staff to the unnecessary splattering, spilling, and aerosolization of infectious waste fluids? Do you have enough staff to guarantee that the reprocessing of an item is accomplished without question?
There is always the potential for spreading disease between patients and/or clinicians, although this principle is not understood and probably would not be accepted by the public. Medical regulatory and accrediting agencies are concerned about protecting patient safety and providing a successful surgical outcome. You need to compare the risks associated with reprocessing an SUD versus using it as labeled. The liability for reusing SUDs extends to all your employees, so a risk management program should embrace and address the practice of reusing SUDs.
Ethical Costs
Do your patients have the right to informed consent regarding the reuse of SUDs during their surgeries, and should they be permitted to choose whether a reprocessed SUD be used during their treatment? Do they have the right to understand that items designated for single use are being used repeatedly? Your risk manager must consider whether your facility's informed consent form must be revised to include a statement that the organization reuses materials that were designated for single use. Will your staff be able to identify whether a given SUD has been reprocessed two or 10 times? In the case of a liability claim, you will need to demonstrate control and documentation of each reprocessing of the SUD.
For many years, we have debated the question of which patients receive the first versus subsequent use of a surgical item. This argument gave rise to a new array of sterilizers. Now, reusing SUDs raises old questions.
Economic Costs
Is your decision to reuse SUDs based on purely economic reasons, and have you examined the total cost of reusing an item? You must analyze the cost-benefit ratio of reusing SUDs to determine whether the practice is worth the work it entails. You will need to evaluate the costs associated with labor, reuse protocols (eg, the process of resterilizing wraps, filters, indicators, tape, testing mediums, cleaning solutions; and maintenance of the equipment), documentation, possible replacement of the device, and potential litigation. You may or may not be able to decrease costs by standardizing your equipment, policies, and processes.
Another point to consider is whether your facility has the appropriate number and types of trays and individually wrapped instruments. Does your case schedule permit flexibility for the turnover of cases? Additionally, you must ensure that your facility complies with the accreditation requirements of providing written guidelines for the selection, storage, handling, use, and disposition of SUDs.
Finally, it is necessary to consider how your facility will treat staff members' infections and complications caused by their contact with pathogens. Can your organization function if employees call out sick because of exposure issues?CONCLUSION
This article does not provide specific conclusions on the subject of reusing SUDs. The decision of whether or not to reuse SUDs rests with each facility's physicians and administration. It is therefore important to recognize both the motivation behind your choice and all its potential consequences. Before making a decision, explore all the associated costs of reusing SUDs. Review the standards and practices recommended by the Association of Operating Room Nurses and Association for the Advancement of Medical Instrumentation. Gather information on each SUD you are considering reusing, and determine the total cost of every device. Consult legal and risk-management resources. Most importantly, put patient care first.
