A: Stryker is a global leader in medical technology that offers a unique range of solutions across medical specialties. The acquisition of Ascent helps Stryker address the healthcare cost containment and environmental sustainability objectives of its customers in a meaningful way. Moreover, the acquisition of Ascent has propelled reprocessing/remanufacturing into the medical mainstream and has put a stamp of legitimacy on the third party reprocessing industry. Stryker envisions itself as a partner: helping hospitals meet their fiscal and environmental needs.
A: Most major hospitals are reprocessing/remanufacturing single use medical devices (SUDs), and the majority of these use Stryker Sustainability Solutions for their reprocessing/
remanufacturing activities. Stryker Sustainability Solutions’ 1,900 customers include most of the U.S. News & World Report “Honor Roll” hospitals. Many smaller hospitals rely on the supply cost benefits of reprocessing/remanufacturing to sustain operations and to improve overall quality of care by freeing supply costs to cover investments in technology and staff. Stryker Sustainability Solutions has agreements with all leading national group purchasing organizations as well as numerous nationally recognized hospital integrated delivery networks.
A: As required by the FDA, Stryker Sustainability Solutions must demonstrate that a reprocessed/remanufactured medical device is substantially equivalent to the original equipment manufacturer (OEM) device prior to marketing the device. FDA determines that the device is substantially equivalent from the evidence submitted by Stryker Sustainability Solutions in a 510(k) application. Additionally, Stryker Sustainability Solutions’ reprocessed/remanufactured devices go through a careful inspection process in which every single device is tested for functionality and is visually inspected to ensure process performance.
To illustrate, the 2008 GAO report noted that participants in FDA’s Medical Product Safety Network (MedSun) were aware “that reprocessing establishments are more stringently
regulated by FDA than are the manufacturers of the original devices, and this provided them a sense of confidence in the reprocessing process.” In fact, the GAO report noted that
some MedSun participants stated “that there were actually fewer performance problems with reprocessed SUDs than with new SUDs.”
A: This depends on the size of the hospital or the hospital network. We work with hospitals that save more than $1 million annually through reprocessing/remanufacturing. Smaller community hospitals report saving more than $250,000 annually. Every hospital can significantly cut supply costs as a percentage of overall hospital costs and redirect these funds toward hiring more nurses or investing in new technologies.
A: No. In fact, supply cost savings is only the most immediate effect that hospitals can register when entering into a reprocessing/remanufacturing program with Stryker Sustainability Solutions. By freeing resources from supply costs saved by using reprocessable/remanufacturable devices, hospitals have the ability to redirect these funds to initiatives that impact patient care directly, such as hiring more nurses, investing in new technology, or simply helping to keep the hospital afloat in difficult economic times. The impact on the environment in terms of reduced waste is also significant. According to an article published in the February 2011 issue of Archives of Surgery, healthcare facilitiesare the second leading contributors of waste in the U.S., producing more than 4 billion pounds of waste annually. Instead of adding medical devices to the landfills, hospitals that use Stryker Sustainability Solutions’ reprocessing/remanufacturing programs put these devices to use again—and devices that cannot be reprocessed/remanufactured are disassembled into their component parts and recycled.
A: We do not operate under license from the OEM. FDA considers the reprocessor/remanufacturer of a medical device as the “manufacturer.” All medical devices reprocessed/remanufactured by Stryker Sustainability Solutions are under warranty. Inspection routines by FDA are equally stringent for Stryker Sustainability Solutions and the original manufacturers of SUDs. These inspections ensure that our processes, as well as the devices we market are equivalent to those of the OEMs.
A: This varies a lot. Among hospitals that gain exceptional benefits from reprocessing/remanufacturing, this percentage can be as high as 100% for certain device lines. However, since devices can only be reprocessed/remanufactured a limited number of times, a typical hospital will continue to purchase OEM devices, while also using reprocessed/remanufactured devices. An optimal purchasing policy involves first using reprocessed/remanufactured devices, then, when the supply of these devices runs out, purchasing original devices. This strategy ensures optimal supply cost savings and minimizes environmental impact.
A: The most common devices reprocessed/remanufactured are in:
A: The level of savings from using reprocessed/ remanufactured devices varies by device type but is typically around 40-50%. While this reduction in supply costs is attractive, many clinicians view this level of savings as a substantial boost to the capacity of the hospital to retain or even enhance the quality of care in tough economic times. Hospitals can divert these savings to investments in technology, hiring more staff, educational programs and the like.
A: We believe many physicians are eager to use Stryker Sustainability Solutions devices because they are concerned with medical waste and because they understand the overall cost advantages of selecting reprocessed/remanufactured devices. From a safety, quality and regulatory perspective, devices are substantially equivalent so there is little reason for the physician to make discrete choices between them. As far as we know, physicians do not, as a group, make a selection between original and Stryker Sustainability Solutions devices based on situational or patient-related circumstances.
A: In our experience, physicians using reprocessed/remanufactured devices are generally excited about the quality and safety of our devices. Many physicians make sure to use Stryker Sustainability Solutions devices before they use original devices, simply because they know Stryker reprocessed/remanufactured devices are substantially equivalent to original devices. This practice leads to an overall purchasing policy that diverts resources to other meaningful, quality-improvement initiatives.
A: Just as with other materials and services that are equivalent (such as which physician performs a surgery or which brand of towel to use), there is no need to ask patients whether they are willing to have a reprocessed/remanufactured device used for their procedure. Stryker reprocessed/remanufactured devices are substantially equivalent to original devices, they are warranted by Stryker, and their performance is similar to that of original devices.
A: Before we can reprocess/remanufacture a medical device, we follow a thorough procedure of evaluating and documenting the reprocessing/remanufacturing process, materials, testing and inspection. The 510(k) process involves documenting what we intend to do, how it is done, and how the safety and quality of the reprocessed/remanufactured device becomes substantially equivalent to the safety and quality of an original device. So essentially, a premarket notification—a 510(k)—is a marketing application submitted to FDA demonstrating that the medical device we wish to market is as safe and effective as the original device that was or is currently being marketed in the U.S.
A: It depends. With some device types, each hospital gets its own devices back; with other devices, there is no distinction made between hospitals that send in the devices. Historically, this has been non-problematic since all devices undergo the same inspection and testing before being admitted back onto the floor, the lab or the operating room.
A: This depends on the procedure and the company supporting the case. If the original manufacturer is a partner of thehospital, support should stay consistent based on current levels. Also, Stryker Sustainability Solutions has a team of representatives in your area who are responsible for hospital management of a program. Stryker Sustainability Solutions does not support each surgical case for reprocessed/remanufactured devices. To ensure satisfaction with our reprocessing/remanufacturing programs, we do provide a clinical team for education of staff, device evaluations, account management, and routine service.
A: Yes, we do. Each hospital we service is visited regularly by Service Representatives and Account Managers who collect devices and assist surgeons, physicians, nurses, and other staff with understanding reprocessing/remanufacturing, and with using our devices. While the fundamental clinical support functions of our service representatives mirror those of OEM representatives, our representatives also serve as instructional staff to educate physicians and hospital staff members about reprocessing/remanufacturing as a sustainability initiative.
Our field representatives serve three functions simultaneously: 1) they function as your medical device sustainability facilitators by walking the halls of the hospital collecting used medical devices and ensuring that these important assets are not thrown away; 2) they function as sustainability educators by helping materials management and nursing staff understand the value of medical device sustainability programs through in-servicing and regular results updates; and 3) they function as sustainability consultants by working with materials managers and clinical directors to increase usage of reprocessed/remanufactured devices and to enhance the impact of these key sustainability programs at the hospital and hospital unit levels.
A: Yes; however, this number is very low, since most hospitals rely on savings from reprocessing/remanufacturing to sustain operations and to reduce expenses. Our experience has been that when hospitals have discontinued these programs, it was the result of either a random product failure and unfounded suspicion among physicians that the failure was characteristic of reprocessed/remanufactured devices (this relationship does not exist), or to lack of commitment among staff and resultant assessment that maintaining the program would not be worth the effort.
A: Out-of-box device failures occur occasionally for all medical devices, original or reprocessed/remanufactured. However, reprocessed/remanufactured devices are individually inspected and tested, so we believe many physicians have very strong confidence in the performance of our devices.
As reported by the Association of Medical Device Reprocessors (AMDR), FDA’s adverse event database contains over 6,500 reports of patient deaths associated with original (not including reprocessed/remanufactured) devices since 2004. According to the same FDA database, zero deaths have occurred as a result of the use of reprocessed/remanufactured devices. FDA’s database of medical device adverse events is available via the internet at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
In a letter from FDA to Congressmen Tom Davis and Henry Waxman, dated January 23, 2006, FDA indicated that a total of 65,325 reports have been filed since October 2003 for the malfunction or injury associated with the first use of devices labeled for “single use.” The same search produced 176 cases of apparent malfunction or injury associated with reprocessed/remanufactured devices. Upon further analysis of the latter reports, FDA determined that these adverse events were not related to the reprocessing/remanufacturing of the “single use” device (SUD).
A: We have never been found liable in connection with our reprocessing of medical devices. Should a problem occur, Stryker Sustainability Solutions warrants the devices we remanufacture and reprocess.
A: The number of times that a medical device can be reprocessed/remanufactured depends entirely on the type and model of the device. In determining how many times the device can be reprocessed/remanufactured, Stryker Sustainability Solutions uses a conservative estimation to select specific usage limits which is part of the 510(k) notification that is ultimately reviewed and cleared by FDA. Stryker Sustainability Solutions tracks each device to determine how many times it has been reprocessed/remanufactured. When devices have reached their maximum number of cycles, they are broken down to their individual parts and materials are recycled appropriately.
Stryker Sustainability Solutions employs a meticulous tracking system that makes it possible for us to determine not only how many times a device has been reprocessed/remanufactured, but also identify the specific component parts: each component of a device is individually marked and tracked.
A: Our process does not discriminate between lightly used and heavily used devices. The reprocessing/remanufacturing process includes multiple points of inspection to determine suitability for reprocessing/remanufacturing. Before our devices are released, they are subject to a multiple point inspection and testing process (including functional testing) that determines overall usability and thus negates the need to discriminate in the acceptance of used devices.
A: All devices with an expiration date have been put through aging and shipping validations. All samples go through distribution testing, then they are visually inspected before being put into the accelerated aging chamber. The accelerated aging chamber ages the materials and devices for one to three years depending on the device. After aging, samples are visually inspected and then function tested using our in-process procedures. Devices only receive the expiration date after the age testing has been completed. We use max cycle devices for the aging validations to represent a worst-case scenario in terms of device functionality, material integrity, etc. The expiration date begins from the date of sterilization. The accelerated aging studies are then followed up with real time aging studies.
A: Yes, we do. Some devices consist of many different components, and they may have defective parts that do not warrant the entire device being thrown away. We remanufacture these devices through a meticulous process of disassembly, repair, component replacement, re-assembly and testing. The remanufacturing process is quite complex, both from a technical and from an operational standpoint. Following remanufacturing, these devices go through several steps of testing, including function-testing, so that we can ensure that the finished device is substantially equivalent to the original device.
A: Stryker Sustainability Solutions’ supply chain solutions easily integrate with our customers’ ordering and inventory systems. With routine collections, orders are generated based on surgical volume to ensure replacement at current inventory par levels. Stryker Sustainability Solutions representatives work closely with OR buyers and Purchasing staff to ensure a seamless process is functional prior to product return. For additional support, Stryker Sustainability Solutions has a web-based customer system, Electronic Partner Account Manager (ePAM), for visibility and tracking of current orders at Stryker Sustainability Solutions with expected delivery dates on product return to the hospital.
A: Warranties vary based on their terms and on applicable law, and we cannot comment on your rights under any OEM warranty. However, from a technical and engineering perspective, nothing in the reprocessing/remanufacturing of a device alters the device in a way that would make it respond differently to the capital equipment. Since our devices are substantially equivalent to OEM devices, the added risk is simply non-existent. If it can be demonstrated that a capital equipment failure is attributable to a reprocessed/remanufactured device directly, Stryker Sustainability Solutions will reimburse the hospital for repair costs.