Reprocessing Single-Use Devices:
Choosing a Third-Party Reprocessor for a Given Single-Use Device
By Richard Radford
How will your hospital respond to the sweeping changes the FDA has mandated for the reprocessing of single patient use devices? The two seemingly opposite mandates of cutting costs and preserving the quality of patient care appear to hang in the balance when making this choice. Single-patient use devices (SUDs) have provided convenience, apparent cost savings, and an assurance that infection control standards would be maintained for over 30 years. But now, at a time when vital services are being challenged with budget concerns, new thinking is required.
The FDA has been looking at the SUD issue for several years. Hospitals, device manufacturers, and the FDA have been in serious debate attempting to find the "middle ground" that would reconcile the opportunity for cost savings and the safe reuse of SUDs. The most obvious opportunity for cost savings was found to be devices that were categorized as "critical devices" because they came into contact with blood, were invasive, or both. Diagnostic cardiac catheters, forceps, orthopedic burrs, and others were the likely candidates. These devices were very expensive and could offer hospitals thousands of dollars each year in savings. However, a question remained regarding the safety of this practice.
Independent studies, FDA reviews, and the history of third-party reprocessors over the years have demonstrated the risks of reprocessing many of these devices is equivalent to a device's first use when reprocessed under highly-controlled processes. In fact, the FDA inspected Third Party Reprocessors (TPR) and applied the same level of audit processes they utilize for the original manufacturer (OGM). The FDA found that all of the TPRs could improve their documentation and other issues of quality control. But this is a young industry, with standards of practice that could only be improved by this process. And the TPR industry responded with quality improvements in much the same manner that all medical device manufacturers respond when they are bringing new products to market. The good news in the development of this new reprocessing industry is the FDA has not been able to detect any significant patient risk issues during the emergence of the third-party reprocessing industry.
But, as this new industry has been forming, it has become clear that patient safety cannot be jeopardized with a "two-tier" system of quality regulation. That is to say, reprocessors are in effect offering back a device that has been re-manufactured for the next single-patient use. If patient safety is to be assured, the same quality processes needs to be maintained by both the reprocessor and the OEM. Given this logic, the FDA has established the position that a reprocessor is a manufacturer (remanufacturer) for the next patient use, and therefore must comply with all of the requirements of the OEM. This standard becomes effective January 1, 2001.
What does this mean for your hospital? A great deal if you intend to reprocess SUDs. Hospitals are considered manufacturer's under these new standards and must register with the FDA as such. This also means they must establish and maintain the same processes of quality that other manufacturers do. The standards required by the FDA are known as QSRs (quality systems regulations). The QSRs are similar but not the same as those typically found in healthcare i.e., JCAHO. They are tailored to produce "objects/devices" in a uniform and repeatable manner. Is this what healthcare is about? Is this a core competency your hospital requires to achieve its mission? These are questions each institution must face as it deals with the operational issues related to reprocessing under the new FDA guidelines.
Finding the Right Provider
If your choice is to focus on healthcare and not manufacturing, then utilizing third-party reprocessors to achieve the significant cost savings through SUD re-use is a good approach. A good deal has appeared in the popular press and various journals, which offer guidance on how to best select a vendor. Noticeably missing, however, from many of the vendor selection guidelines is the development of a long-term plan for reprocessing SUDs in your hospital. This planning is critical because the landscape of potential products has changed significantly beyond the initial few device options offered by most TPRs. The total number of devices that offer savings opportunities now exceeds 500 products and is growing. And the breadth of the reprocessing technologies, basic science, engineering, and manufacturing processes required are beyond the current capabilities of any single reprocessor.
Given this, the recommendations found in industry journals to select a "full-service provider" become problematic because there are none available. Given the growing volume of product types, which are labeled as single patient use, and the fact that no current reprocessors have the manufacturing depth that spans this gamut of devices, what policies can a hospital develop to resolve this issue?
It's important to remember that the Centers for Disease Control and Prevention (CDC) has designated three device classifications for various levels of reprocessing intensity:
- Critical devices (contact with blood) require sterilization
- Semi-Critical devices (contact with mucous membranes) requires high-level disinfection
- Non-Critical devices (Contact with skin or less) requires low-level disinfection/cleaning
The science, technology and manufacturing expertise for reprocessing each of these product types are different and the CDC classification may be the appropriate construct to begin a vendor selection process. If hospitals were to develop a multiple vendor approach based on the CDC reprocessing types, a more powerful selection criteria set could be developed to address the specifics of any given SUD to be reused.
However, this approach is contrary to the notion of minimizing and consolidating vendors. In this case, choosing multiple vendors reflects the immensity of product opportunity for the reprocessing of SUDs. No purchasing agent expects to buy EP catheters, diagnostic forceps, sequential compression devices, oxymeter probes, anesthesia circuits, resuscitation bags, cooling blankets, and ventilator circuits from the same vendor. These products represent a wide spectrum of product types falling into several reprocessing technique categories. No single manufacturer produces all of these products and it is unreasonable to expect a single TPR to have developed the deep science and reprocessing techniques necessary to offer a complete reprocessing product line. Establishing specific reprocessing vendor type criteria will assist in focusing the selection process and assure the best reprocessing techniques are applied to the specific SUD in question.
Over the past two years a great deal of information regarding the reprocessing of critical devices and the TPR's who perform this service has prevailed. The sterilization technique used by these companies is EO, which is regarded as an industry standard. These devices experience the same sterilization process the OEM uses prior to the first patient use. This industry is well understood and the quality practices in place give the clinician a significant level of assurance their patients will be safe from an infection control standpoint. The issues outstanding in critical device vendor selection relate to the cleaning, performance testing, records management, and level of service when preparing the device for reuse. Critical devices, however, represent a minor segment of the large array of SUDs, that a hospital can benefit from by reprocessing. The largest segment of waste stream reduction and cost savings will be derived from the reprocessing of semi-critical and non-critical devices.
Using Right Sterilization Technology
Semi-critical and non-critical devices do not do well when subjected to steam or EO. Many of these devices are manufactured utilizing various plastic compounds, and the physical conditions of sterile reprocessing techniques degrade plastic materials and alter their physical performance, limiting the life cycle capabilities of the device. With these changes in the device, both clinical and economic benefits are jeopardized. The optimum reprocessing technique for reprocessing semi-critical devices must be determined on a device-specific basis, given the large variation in the materials used and the construction and the manufacturing processes used. For these reasons, a set of device-specific questions should be posed to assist in selection of a TPR for the semi-critical/non-critical devices.
The historical methodologies used to high-level-disinfect (HLD), semi-critical and non-critical devices include a number of approved liquid or cold disinfectant solutions (glutaraldehyde, phenolics, alcohol, etc.) and pasteurization. Both the CDC and the FDA recognize these technologies as safe and appropriate for this classification of devices. Over kill with sterilization for these devices adds no known benefit to infection control, adds to the cost and "turn time" of the reprocessing cycle, and stresses the devices, reducing their useful life. Each of the HLD technologies has benefits and disadvantages on a device specific basis. In general, it is not a one-size-fits-all solution. Basic scientific research on chemical and physical changes to the plastic and the device's clinical performance is required. A TPR needs to have the capability to develop this data to ensure clinical safety and device performance after each use of the reprocessed device.
When beginning to reprocess single-use devices, recognize that the science of reprocessing is young and each hospital needs to understand the capabilities of their reprocessing partner to gain the savings.
Selecting a TPR vendor based on their specific reprocessing technologies and individual products reprocessed is the safest approach at this stage of the development of the reprocessing industry. Assuming any TPR to be a full-service reprocessor may limit the savings opportunity to the technical growth and capacity of a single company. Begin with an understanding of the vast differences in the reprocessing technologies and cost savings opportunities between Critical and Semi-Critical devices. Then develop your selection criteria based on the best fit for your hospital's long-term commitment to cost savings and reduction of medical waste.
Richard Radford is the President of ClearMedical in Bellevue, Wash.
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