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By Richard Radford
How will your hospital respond to the sweeping changes the FDA has mandatedfor the reprocessing of single patient use devices? The two seemingly oppositemandates of cutting costs and preserving the quality of patient care appear tohang in the balance when making this choice. Single-patient use devices (SUDs)have provided convenience, apparent cost savings, and an assurance thatinfection control standards would be maintained for over 30 years. But now, at atime when vital services are being challenged with budget concerns, new thinkingis 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 findthe "middle ground" that would reconcile the opportunity for costsavings and the safe reuse of SUDs. The most obvious opportunity for costsavings was found to be devices that were categorized as "criticaldevices" because they came into contact with blood, were invasive, or both.Diagnostic cardiac catheters, forceps, orthopedic burrs, and others were thelikely candidates. These devices were very expensive and could offer hospitalsthousands of dollars each year in savings. However, a question remainedregarding the safety of this practice.
Independent studies, FDA reviews, and the history of third-party reprocessorsover the years have demonstrated the risks of reprocessing many of these devicesis equivalent to a device's first use when reprocessed under highly-controlledprocesses. In fact, the FDA inspected Third Party Reprocessors (TPR) and appliedthe 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 otherissues of quality control. But this is a young industry, with standards ofpractice that could only be improved by this process. And the TPR industryresponded with quality improvements in much the same manner that all medicaldevice manufacturers respond when they are bringing new products to market. Thegood news in the development of this new reprocessing industry is the FDA hasnot been able to detect any significant patient risk issues during the emergenceof the third-party reprocessing industry.
But, as this new industry has been forming, it has become clear that patientsafety cannot be jeopardized with a "two-tier" system of qualityregulation. That is to say, reprocessors are in effect offering back a devicethat has been re-manufactured for the next single-patient use. If patient safetyis to be assured, the same quality processes needs to be maintained by both thereprocessor and the OEM. Given this logic, the FDA has established the positionthat a reprocessor is a manufacturer (remanufacturer) for the next patient use,and therefore must comply with all of the requirements of the OEM. This standardbecomes effective January 1, 2001.
What does this mean for your hospital? A great deal if you intend toreprocess SUDs. Hospitals are considered manufacturer's under these newstandards and must register with the FDA as such. This also means they mustestablish and maintain the same processes of quality that other manufacturersdo. The standards required by the FDA are known as QSRs (quality systemsregulations). The QSRs are similar but not the same as those typically found inhealthcare i.e., JCAHO. They are tailored to produce"objects/devices" in a uniform and repeatable manner. Is this whathealthcare is about? Is this a core competency your hospital requires to achieveits mission? These are questions each institution must face as it deals with theoperational issues related to reprocessing under the new FDA guidelines.
If your choice is to focus on healthcare and not manufacturing, thenutilizing third-party reprocessors to achieve the significant cost savingsthrough SUD re-use is a good approach. A good deal has appeared in the popularpress and various journals, which offer guidance on how to best select a vendor.Noticeably missing, however, from many of the vendor selection guidelines is thedevelopment of a long-term plan for reprocessing SUDs in your hospital. Thisplanning is critical because the landscape of potential products has changedsignificantly beyond the initial few device options offered by most TPRs. Thetotal number of devices that offer savings opportunities now exceeds 500products and is growing. And the breadth of the reprocessing technologies, basicscience, engineering, and manufacturing processes required are beyond thecurrent capabilities of any single reprocessor.
Given this, the recommendations found in industry journals to select a"full-service provider" become problematic because there are noneavailable. Given the growing volume of product types, which are labeled assingle patient use, and the fact that no current reprocessors have themanufacturing depth that spans this gamut of devices, what policies can ahospital develop to resolve this issue?
It's important to remember that the Centers for Disease Control andPrevention (CDC) has designated three device classifications for various levelsof reprocessing intensity:
The science, technology and manufacturing expertise for reprocessing each ofthese product types are different and the CDC classification may be theappropriate construct to begin a vendor selection process. If hospitals were todevelop a multiple vendor approach based on the CDC reprocessing types, a morepowerful selection criteria set could be developed to address the specifics ofany given SUD to be reused.
However, this approach is contrary to the notion of minimizing andconsolidating vendors. In this case, choosing multiple vendors reflects theimmensity of product opportunity for the reprocessing of SUDs. No purchasingagent expects to buy EP catheters, diagnostic forceps, sequential compressiondevices, oxymeter probes, anesthesia circuits, resuscitation bags, coolingblankets, and ventilator circuits from the same vendor. These products representa wide spectrum of product types falling into several reprocessing techniquecategories. No single manufacturer produces all of these products and it isunreasonable to expect a single TPR to have developed the deep science andreprocessing techniques necessary to offer a complete reprocessing product line.Establishing specific reprocessing vendor type criteria will assist in focusingthe selection process and assure the best reprocessing techniques are applied tothe specific SUD in question.
Over the past two years a great deal of information regarding thereprocessing of critical devices and the TPR's who perform this service hasprevailed. The sterilization technique used by these companies is EO, which isregarded as an industry standard. These devices experience the samesterilization process the OEM uses prior to the first patient use. This industryis well understood and the quality practices in place give the clinician asignificant level of assurance their patients will be safe from an infectioncontrol standpoint. The issues outstanding in critical device vendor selectionrelate to the cleaning, performance testing, records management, and level ofservice when preparing the device for reuse. Critical devices, however,represent a minor segment of the large array of SUDs, that a hospital canbenefit from by reprocessing. The largest segment of waste stream reduction andcost savings will be derived from the reprocessing of semi-critical andnon-critical devices.
Semi-critical and non-critical devices do not do well when subjected to steamor EO. Many of these devices are manufactured utilizing various plasticcompounds, and the physical conditions of sterile reprocessing techniquesdegrade plastic materials and alter their physical performance, limiting thelife cycle capabilities of the device. With these changes in the device, bothclinical and economic benefits are jeopardized. The optimum reprocessingtechnique for reprocessing semi-critical devices must be determined on adevice-specific basis, given the large variation in the materials used and theconstruction and the manufacturing processes used. For these reasons, a set ofdevice-specific questions should be posed to assist in selection of a TPR forthe 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 orcold disinfectant solutions (glutaraldehyde, phenolics, alcohol, etc.) andpasteurization. Both the CDC and the FDA recognize these technologies as safeand appropriate for this classification of devices. Over kill with sterilizationfor these devices adds no known benefit to infection control, adds to the costand "turn time" of the reprocessing cycle, and stresses the devices,reducing their useful life. Each of the HLD technologies has benefits anddisadvantages on a device specific basis. In general, it is not aone-size-fits-all solution. Basic scientific research on chemical and physicalchanges to the plastic and the device's clinical performance is required. A TPRneeds to have the capability to develop this data to ensure clinical safety anddevice performance after each use of the reprocessed device.
When beginning to reprocess single-use devices, recognize that the science ofreprocessing is young and each hospital needs to understand the capabilities oftheir reprocessing partner to gain the savings.
Selecting a TPR vendor based on their specific reprocessing technologies andindividual products reprocessed is the safest approach at this stage of thedevelopment of the reprocessing industry. Assuming any TPR to be a full-servicereprocessor may limit the savings opportunity to the technical growth andcapacity of a single company. Begin with an understanding of the vastdifferences in the reprocessing technologies and cost savings opportunitiesbetween Critical and Semi-Critical devices. Then develop your selection criteriabased on the best fit for your hospital's long-term commitment to cost savingsand reduction of medical waste.
Richard Radford is the President of ClearMedical in Bellevue, Wash.
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