Cost Containment: Single-Use Vs. Third-Party Reprocessing Issues for Review and Consideration

As seen in all facets of the health care industry, close attention must be paid to the supply costs of performing procedures. As a result of recent regulatory enhancements, reprocessing EP catheters is one effective strategy being more widely utilized by labs across the country to keep procedure costs in check. Many EP labs have historically engaged in reprocessing of EP catheters internally by utilizing their hospital s sterile processing department; validated and proper catheter reuse is supported by the North American Society for Pacing and Electrophysiology (NASPE) - Heart Rhythm Society.¹ Reprocessing electrophysiology catheters can reduce by half or more the total costs of the catheters used during an EPS.² Internal reprocessing of electrophysiology catheters by hospitals had a well documented safety record with no evident adverse outcomes as compared to baseline safety data of new devices.³ As a result of heightened FDA requirements, reprocessed devices are more highly regulated than almost any other medical device used on a patient. Couple this with the robust scientific validations used to assure quality and the tremendous cost avoidance potential for even a modest lab, and you ll see that reprocessing is earning the respect of even the toughest critics. With the passage and enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the reprocessing of devices labeled as single-use (SUDs) is now codified and supported in federal law for the first time. Getting to this point has not been easy for the industry; efforts by some of the original manufacturers to suppress the practice actually led to its advancement. Much of the successful history of reprocessing, along with the subsequent FDA regulatory hearings, evaluations, and townhall-style meetings occurring in 2000, are chronicled in the NASPE Policy Statement entitled Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations A Report of the NASPE Task Force on Reprocessing of Electrophysiology Catheters. The FDA began its process in 1999, with the end result being a document issued on August 2, 2000, entitled Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. In this document, the FDA defined a reprocessor as a hospital, original equipment manufacturer (OEM), or third-party company that reprocessed SUDs. It spelled out clear requirements and timelines for compliance that hospitals with internal reprocessing programs and other reprocessors had to comply with in order to meet the new guideline. Concurrent with the FDA s process in 1999/2000 and in response from the same pressure from OEMs, Congress instructed the General Accounting Office (GAO) to investigate reprocessing. On June 20, 2000, just two months prior to the release of the FDA s guidance document, the GAO released its report entitled Single-Use Medical Devices: Little Available Evidence of Harm from Reuse but Oversight Warranted. This confirming conclusion was drawn after searching through CDC databases, consulting with physicians, surgeons, nurses and other health professionals, speaking with professional associations, and evaluating the FDA s MAUDE database, among other things. It also stated, however, that additional regulatory oversight was needed. As we ve stated, FDA soon responded to GAO s suggestion. In the aftermath of these events, EP labs are basically left with three choices: 1) go through an onerous process of registering with the FDA and complying with the other elements of the guideline, such as filing 510(k) applications with the agency, meeting the requirements of the Good Manufacturing Practices act, and infrastructure development; 2) outsource reprocessing to a FDA registered and compliant third-party reprocessor; or 3) buy all catheters from the original manufacturer for single patient use at a significant cost. Given the infrastructure to comply with the FDA s Quality System Regulation and the costs and time required to complete the testing and data gathering for 510(k) applications for each catheter type and manufacturer, to the best of our knowledge, no EP lab has chosen to continue reprocessing catheters themselves. Even with the FDA s guidance, GAO s report, and the MDUFMA law, a hospital s decision to reprocess can be a complex issue. Chief among these concerns are clinical acceptance of the reprocessed product by the physician staff as it relates to patient safety, financial considerations affecting the total cost of the procedure, and ultimately, the profitability and operability of the lab. Clinical acceptability is, by far, the most important success factor for a reprocessing program. Ultimately, both physicians and the clinical support team must believe that the use of reprocessed catheters in no way negatively impacts patient care. If a catheter fails or for some reason is inferior to a newly purchased device, it may take longer to position, which could impact outcomes. Likewise, if additional catheters are needed, the result could mean an increase in time and expense of the procedure, thereby limiting lab productivity. To achieve the goal of having a successful reprocessing program, it must be supported by solid science, and the practitioner must be knowledgeable and confident with the science behind reprocessing. Third-party reprocessors are required to use scientific methodologies and data to support the three fundamental safety requirements of reprocessing a SUD: 1) it must be clean: all visible debris must be removed from the device along with non-visible debris such as proteins; 2) it must function as intended: the functionality of the cleaned device must be verified and matched to original specifications; and 3) it must be sterile: the device must be sterilized without harm to the integrity of the material from which it is made and also still function as intended. These are the key elements that must be addressed before we consider the economic impact of reprocessing. The premise behind reprocessing is that each device, besides being both clean and sterile according to industry standards and guidelines, functions according to the original equipment manufacturers specifications for performance in such categories as structural integrity, electrical impedance, and desired performance characteristics related to navigating the device into its correct anatomical positions and having it stay there for the desired length of time during the procedure, as the device was designed to do. The FDA has developed a guidance document for manufacturers that clearly spells out all the functional criteria, design elements, and safety requirements for EP catheters. This document is referred to as the Massy Document. Whereas OEMs test a specified number of devices in a lot to determine all these characteristics, reprocessors functionally test each and every device prior to sterilization, thereby providing a one-to-one ratio of testing and inspection, as opposed to a one-to-many as done by many of the OEMs. This rigorous testing certainly adds additional costs to reprocessing, which may not have been previously incurred by institutions that merely cleaned and sterilized their catheters, but it provides more internal controls, validating the safety and efficacy of the procedure. We must, however, remember that reprocessing returns a device to its original state of functionality. It does not add functionality, so a hospital must still consider all the desirable characteristics it wants in a device and build this into their acquisition plan for OEM devices. This is a fundamental point that must be reinforced in setting appropriate expectations with staff if a reprocessing program is to be successful. Physician and allied-health support for reprocessing is an absolute key. These stakeholders must play an active role in any evaluation or decision-making process that could effect the care delivery equation. Reprocessing should not be measured merely by its contribution to cost reduction; rather, costs should play a secondary role to quality and outcomes. As scientists, physicians rely on facts; the safety and science of reprocessing EP catheters is well documented in many articles and is thoroughly reviewed by NASPE upon development of its Position Statement supporting the practice. With the passage of MUDFMA, third-party reprocessors must now include pre-production validation data as part of their comprehensive 510(k) or PMR submissions documenting not only their ability to clean, functionally test, and sterilize the device, but also data supporting their cycle count claims. The MUDFMA legislation raised the quality assurance bar even higher on corroborating what many EP labs have successfully experienced for many years that reprocessed EP catheters can deliver outcomes commensurate to newly purchased devices, but at a significantly lower cost impact to the organization and patient. The years of positive anecdotal evidence and the newly minted technical requirements add legitimacy and credibility to the reprocessing practice. No SUD will be approved by the FDA as reprocessable without all the accompanying scientific data validating the proposed processes which are reprocessor-specific. Involving physicians in an understanding of the regulatory processes and scientific data behind reprocessing, along with some hands-on testing of reprocessed devices versus first-time-use OEM devices, will help build acceptance, and many times preference, of the practice. After the scientific elements, the financial considerations in evaluating a potential reprocessing program are fairly straightforward. A hospital must determine its original acquisition cost for the new product and factor in the average number of reprocessing cycles that can be safely performed per catheter (acquisition costs may increase when going from single use to multi use), which can be obtained from the reprocessor based on their 510(k) submission and actual experience. Most third-party reprocessors have approval to reprocess diagnostic catheters from three to six times. Inquire with the third-party reprocessor about what their typical success rates are with reprocessing. Although this is in some cases far less than what many hospitals were able to achieve when performing reprocessing internally, it yields a significant margin of safety and assurance that the catheter will also function according to the OEM specifications while delivering a strong financial value. The cost of reprocessing per catheter will vary between third-party reprocessors based on whether or not you are accessing price through a group purchasing organization arrangement or through a self-negotiated agreement, whereby bids are solicited from the available pool of candidates. When assessing potential savings through reprocessing, a lab must consider that it can only reprocess what it successfully collects. In addition, merely comparing reprocessing charges by vendor as opposed to conducting a comprehensive financial pro forma that includes your mix between diagnostic and therapeutic catheters and the numbers used per procedure, yield rates, and turnaround time by your reprocessor will have no reflection on your future results should you fail to adequately collect devices for reprocessing. Ultimately this is not only a financial and quality-based decision, but one where there must be a working relationship between the reprocessor and the healthcare organization from a cultural fit perspective. Currently, no third-party reprocessor reprocesses ablation catheters, as these are categorized as Class III by the FDA and require additional and very costly validation via a Premarket Report (PMR) submission, a requirement created through the newly enacted MDFUMA legislation. Furthermore, with the depth and breadth of diagnostic catheters on the market, there are limitations to the numbers and types of even diagnostic catheters a reprocessor is cleared to reprocess. The FDA has made it fairly clear that bundling, the practice of combining multiple manufacturers devices under one 510(k) clearance, may not be acceptable, so the number of cleared 510(k)s a third party holds is a good indicator of the depth of a portfolio of products they can cover. It is also prudent to confirm the list of device model numbers actually tested by the third party as part of its 510(k) investigation process, as not all reprocessors are equivalent on even this level. Diagnosis and treatment methodologies are constantly changing and improving. Working with a third party who is able to reprocess the catheters and is current with the latest technologies only increases your lab s opportunities. Having a resource to reprocess new technologies is imperative in keeping the lab s performance optimal and in continuing the ability to utilize newer methodologies. It is important to work with a reprocessor that has the financial resources and technical savvy to invest in working towards adding additional technologies that they can reprocess to their portfolio of products. Additionally, it is all of our responsibilities to lobby the OEMs not to redesign their products to limit their reprocessability, but rather to work with FDA-approved reprocessors in examining opportunities for collaboration that will bring value to all parties. Procedure costs must be reduced if healthcare facilities are to continue to meet patient demand and remain financially viable. Furthermore, without a strategy to control costs, we lack the ability to reinvest in our infrastructure, which requires constant updating and the introduction of new technologies to continuously strive to improve patient outcomes. The final component of a successful reprocessing program is to successfully implement the program and make it operational. The program must bring together all stakeholders to understand the purpose and processes and have consistent access to data with which to understand the ongoing success, challenges and benefits of the program. Education is also key to a successful program. The third-party reprocessor must have clinical resources in the field to work with your physicians and clinical support teams, training them on the subtleties of reprocessing and the myriad of scientific supporting data, answering technical queries, and providing logistic support. Although minimal, reprocessing does require additional time to prep used catheters for collection. However, minimal preparation steps such as wiping the catheters down with water or other non-electrolyte-containing solutions and loosely coiling them greatly enhances the yield received back as successfully reprocessed product. Most third parties provide collection systems which can vary in size and function, but are also easily customizable to fit current work flow and logistical patterns.

Conclusion

SUD reprocessing is being adopted as a useful cost containment tool by a growing number of medical facilities each year. After carefully evaluating all of the options available, hospitals and labs should evaluate if reprocessing single-use devices is right for their facility. OEMs continue to insist that devices labeled as single-use only, such as EP catheters, cannot be reprocessed. However, the term single-use is designated by the OEMs, not the FDA. The FDA clearly states that some single use devices can be reprocessed safely. It can be argued whether single-use devices are really designed to be single-use or if they are simply labeled that way to limit liability and assure a protracted revenue stream. If a hospital or lab decides to implement a reprocessing program, it will take dedicated research and planning to develop the safest and most effective reprocessing program that can consistently meet strict requirements for quality control. There are many issues that need to be weighed. These include pricing considerations, which catheters a reprocessor can or cannot reprocess, items that will not be able to be reprocessed in the near future (CARTO, ablation catheters, ESI balloon, etc.), turnaround time, success rate of reprocessing, and the extra time spent on handling these catheters post procedure. Once such a program is in place, medical facilities will be able to measure how reprocessing can reduce supply-chain costs and unnecessary waste without compromising patient care.