 Reuse of hemodializers has become the standard of practice in the majority of clinical centers and for the majority of patients on hemodialysis in the United States. Whether one agrees or disagrees with the practice of reuse, all agree that patient safety and well-being are the prime concerns of everyone involved in dialysis. Patient care must not be compromised by reuse or any other procedure used in the clinical setting. Reuse of a hemodializer is defined for our discussion as the use of a hemodializer more than once on the same patient. The reprocessing of dializers has been practiced almost from the very beginning of dialysis and its frequency has varied over time. A recent Centers for Disease Control report showed that approximately 70% of all hemodialysis patients are treated with reprocessed dialysis. All experience and research indicate that the use of appropriate reprocessing procedures results in reprocessed dializers that are safe and effective. To assure patient safety and effective treatment, the medical profession, government agencies, manufacturers and patient organizations recognize the need to establish guidelines that would provide the essential elements of an acceptable practice for reprocessing hemodializers. A consortium of these interested parties came together under the auspices of the Association for the Advancement of Medical Instrumentation, AIME, and in 1986 published the document Recommended Practice, Reuse of Hemodializers. Later that same year, the Healthcare Financing Administration, HICFA, was required by Congress to establish regulations for the reprocessing of hemodializers for those facilities that elect to reuse such devices. As part of the regulations for reuse, HICFA incorporated by reference the guidelines developed by AIME into the Medicare conditions for coverage for dialysis facilities. HICFA will evaluate the facility's reprocessing procedures as part of their health and safety surveys. This videotape is not intended to be a complete compendium of instructions to fulfill all of the mandates in HICFA regulations. Neither is it intended to encourage or discourage dialyzer reuse. Rather, it has been prepared to assist facilities which reuse dialyzers to become aware of their responsibilities under the HICFA regulations. In addition to meeting federal regulatory requirements, an effective dialysis program, whether it includes reuse or not, requires communication and cooperation between all members of the dialysis team with as much involvement of the patient as possible. Each member of the dialysis team should be familiar with the HICFA regulations and the AIME recommended practice. As with the entire dialysis program, the medical director and the facility's governing body have the ultimate responsibility for the development, implementation, and monitoring of the facility's reprocessing policies and procedures. These reprocessing procedures should follow a logical sequence of steps. Before we start talking about all the specific details of reprocessing and training and techniques, we need to really understand two terms that are critical. One is master record file and the other one is process validation. The master record file should be a compendium of all specifications, policies, training materials, manuals, methodologies, and procedures. The file should also contain samples of forms and labels used in the facility. The master file either contains all of these records or indicates where they are kept. We talked about that there can be separate logs in terms of our quality assurance procedures, our health and personal safety records, our occurrence reports in terms of anything that is out of the ordinary on our unit or in the reprocessing procedure. All these records and logs... These files often refer to as operational logs and any other files which the facility may establish may be kept separate from the master record file. It is important that these files be kept current since they provide an ongoing record of the facility's reprocessing operations. As with all dialysis records, analysis of these records can identify problems which could, if not corrected, result in patient injury or ineffective treatment. Now let's talk about the second term, process validation. Let me read to you from the A&E document in terms of what the term process validation means. Validation is defined in the A&E document as the establishment of document and evidence providing a high degree of assurance that a given process will consistently yield a product meeting predetermined specifications and quality characteristics. In other words, it's a process of documenting that a particular reprocessing procedure works in our facility. Before establishing a reuse program, the medical director should initially establish criteria for the performance of the reprocessed dialyzer. Then a written procedure should be developed for each step of the reprocessing program. If followed conscientiously, these procedures will assure that the performance of the reprocessed dialyzer will not deviate from the pre-established criteria. These procedures should be noted in the master file and should be audited periodically. The procedures should be carefully reconsidered after any significant change in the reprocessing steps to assure that the pre-established criteria continue to be met. Finally, quality assurance checks of staff performance should be done periodically to determine that these written procedures are being followed. All of these procedures are included in what we have described as validation. Now let's examine each step of the reprocessing procedure in detail. Many facilities subject new dialyzers to the entire reprocessing protocol prior to their first use. This provides a standardization of procedures for all dialyzers used in the facility and establishes a baseline value of performance for that dialyzer. The dialyzer must be labeled with the patient's name and or identification number. This should be done prior to its first use. After the patient has completed dialysis, the used dialyzer is ready for the first step in the reprocessing procedure, rinsing and cleaning. Initiation of the rinsing and cleaning process should begin as soon as possible after the termination of the dialysis procedure. Each facility should establish time limits and develop written procedures that avoid delays and assure that the dialyzer will always be handled and transported in a clean and sanitary manner. It is very important that water used in all reprocessing steps meet the requirements of the Amy recommended practice for the reuse of HEMO dialyzers. The water should have a bacterial colony count of less than 200 per milliliter and or a bacterial endotoxin concentration of less than one nanogram per milliliter as measured by the Limulus Amoebocyte Lysate LAL assay. In addition to water, there are a variety of chemicals and procedures that can be used to effectively rinse and clean the dialyzer. The safety and effectiveness of the solutions used for rinsing and cleaning and the amount of flushing necessary to reduce the concentration of these solutions to safe residual levels should be established during development of the facility's initial reprocessing procedures. Both the dialysate and blood compartments of the dialyzer should be flushed with a rinsing or cleaning solution until the affluent is clear. A pinkish or brown tint is not acceptable. The facility's acceptance criteria for a properly rinsed and clean dialyzer should be established and noted in the master record file. After the rinsing and cleaning step, each dialyzer must be subjected to appropriate performance tests. To check the performance of the dialyzer after each use, Amy suggests that a test for clearance should be performed. For hollow fiber dialyzers, total cell volume is one test that can be used as an indirect measurement. Total cell volume, also known as fiber bundle volume or total blood volume, has been shown in published scientific articles to correlate closely with clearance. However, it is also important to monitor the clinical and laboratory status of patients during the long-term course of their treatment. Failure of dialysis therapy to provide adequate clearance should be recognized as a complication which can occur even though the performance test of reprocessed dialyzers may be satisfactory. Inadequate clearance can also occur with new dialyzers and may not be related to reprocessing. It is important, therefore, that the cause of inadequate patient dialysis be determined. Although the Amy document does not call for a leak test on each dialyzer, the Centers for Disease Control and the Food and Drug Administration recommend that this test be performed on each dialyzer to assure integrity of the dialyzer membrane. Automatic reprocessing machines perform this test as part of their normal operation. Once the dialyzer has passed the required performance tests, both the blood and dialysate compartments must be subjected to at least high level disinfection. The facility must assure that the germicides that are being used have been shown to be effective against a wide spectrum of microorganisms, including the highly resistant water-adapted forms. For germicides labeled for a dialyzer reuse, manufacturer's instruction should be followed. This data is supplied by the manufacturer of the germicide on the product label or the package insert accompanying the product. These values have been validated by the manufacturer and do not require revalidation if instructions are followed. When formaldehyde is the germicidal agent, the concentration in the blood and dialysate compartment should be 4% with a minimum contact time of 24 hours at a temperature of at least 20 degrees centigrade. Lower concentrations or shorter contact times are appropriate if equivalent results have been demonstrated under other conditions. Rationale or data supporting formaldehyde concentrations other than 4% must be documented in the master record file. To prevent any risk due to combined actions of different germicides during storage, a single dialyzer must not be exposed to more than one germicide. This is not intended to apply to the use of cleaning chemicals which may be employed to rinse and or clean the dialyzer after patient use. If the facility changes germicides, dialyzers which were exposed to the original germicide must be discarded. The facility's procedures must be updated to reflect use of the new germicide. As with rinsing and cleaning, the quality of the water used to prepare the germicide from concentrate is critical. The water quality should be tested frequently and should conform to any recommended practice for re-use of hemodializers. When filling the dialyzer with germicide, an adequate volume of germicide should be purged through the dialyzer to ensure that the germicide will not be diluted by any residual rinsing solution. The final concentration of germicide in the effluent should be within 10 percent of the prescribed concentration. In manual systems, each prepared batch of germicide should be tested prior to its use to verify proper concentration of the germicide. When the germicide is diluted with automated equipment, the germicide concentration in the dialyzer after it has been filled should be tested regularly. All germicides can be tinted to indicate its presence in the dialyzer. The facility should have a method to verify the presence of germicide in each dialyzer, and procedures should be developed to assure that each dialyzer is properly filled with germicide. If the dye method is not used, follow the instructions that accompany the germicide. If the instructions do not require testing each dialyzer, an appropriate test for the presence of germicide must be performed each day on a random sample of reprocessed dialyzers, according to a written procedure established by the facility. Verification of the presence of germicide must be documented whether the dye method is used or not. Written procedures should be developed to provide assurance that the appropriate concentration of germicide is present in each dialyzer. The outside of the ports should also be disinfected. The ports of dialyzers may be capped with new or disinfected caps. If dialyzer blood port caps are reused, they may be disinfected with either the chemical germicide that is used for disinfecting the dialyzer, or any other chemical germicide approved by the EPA as a sterilant sporicide. If the manufacturer of the germicide or reprocessing equipment makes specific recommendations regarding port-captis infection, these instructions should be followed. The use of germicides could pose an environmental hazard to staff and patients. In order to minimize exposure to those who may be involved in reprocessing, HICFA has adopted limits set by the Occupational Safety and Health Administration for a number of ingredients contained in the formulations of chemical germicides used in dialysis facilities. HICFA surveyors may look to see if the facility has taken steps, including providing adequate ventilation and air sampling, to assure that these limits have not been exceeded. In addition, appropriate precautions such as gloves, masks, eye protection, respirators, and protective clothing may be required to minimize staff exposure to hazardous chemicals. After the disinfectant is added, the dialyzer must be thoroughly inspected before it is placed in storage. Some aspects of the inspection include assurance that the dialyzer casing is free of blood or other foreign material. There are no leaks or cracks in the dialyzer casing or the dialysate or blood ports. There are no more than a few dark clotted fibers evident. The headers are free of all but small peripheral clots. Blood and dialysate ports are capped without evidence of leakage. And the label is properly filled out and legible. Reprocess dialysers which have failed any of the acceptance tests or the criteria established for passing inspection can be reprocessed again if written procedures permit. Reprocessed dialysers must be labeled as rejected and quarantined until they are further processed. Dialysers which continue to fail the acceptance tests must be discarded. Reprocess dialysers which have passed all acceptance criteria must be stored for at least the length of time required for the particular germicide. The storage area for reprocessed devices must be separate from storage areas for new devices, rejected devices, and devices awaiting processing unless the condition of the devices is clearly evident. Following storage and before use by the patient, another series of inspections and checks is necessary. These include at least the following. Assurance that the label of the device is intact, affixed to the device, legible, and contains the information required by the facility. Assurance that there is no structural damage or tampering with the device. Assurance that the dialyzer ports have been properly capped and there is no leakage from them or other portions of the dialyzer. Assurance that the storage time and conditions were appropriate for the germicide used. And assurance that the cosmetic appearance of the dialyzer is acceptable. Results should be recorded in the reprocessing records. This inspection report should be signed by the person performing the inspection. To ensure that each patient receives his or her own reprocessed dialyzer, two persons should check the first and last names and any other identifying information contained on the device prior to initiating dialysis. Do you want to check your dialysis? If possible, one of these persons should be the patient. Are you allergic to babies of any kind? No. Any shortness of breath? No. Thank you. This step should be recorded with the signature or other identification of the person or persons performing the verification. Prior to patient use, the dialyzer should be rinsed and primed according to the germicide manufacturer's suggested procedure. If no instructions are provided by the manufacturer, the facility's written procedures must be followed. These procedures have been designed to produce a reduction in the concentration of germicide to an acceptable level and to result in a physiological solution in the blood and dialysate compartments. The level of residual germicide should be measured by a test of appropriate sensitivity to assure the germicide level is below the maximum allowable concentration. If the germicide is formaldehyde, Amy recommends that the residual concentration should be no greater than five parts per million. Some states have set lower limits. Although clinic test is useful for determining the presence of formaldehyde at some concentrations, it must not be used for determining concentrations in the range of one to five parts per million. Also remember, the dye method is used to determine the presence of germicide in the dialyzer. The absence of dye should not be considered an indicator of the absence of germicide. The completion of the test for residuals should be recorded in the appropriate log or patient flow sheet. If the test indicate that the concentration of the germicide has not been reduced to the required level, a repeat of the rinsing procedure and a retest for germicide are necessary. After all reprocessing steps are successfully completed, the dialyzer may be used. It is important that the clinical course of the patient be observed and recorded during each dialysis to identify any possible complications. Any unexplained increase in temperature or chills occurring during treatment should be reported to the physician. Either of these symptoms could result from endotoxin contamination of water used in reprocessing or in preparation of dialysis as well as other possible causes. Other unexplained symptoms at the onset of dialysis such as pain in the blood access arm, flushing, hypotension, nausea or a strange taste may be an indication of a reaction to residual germicide. In this case, extracorporeal circulation should be terminated immediately and the blood should not be returned to the patient until the situation has been evaluated. Any significant events must be recorded on a special incident report which should include the results of any investigation or remedial actions taken. A pattern of new dialyzer failure should be reported to the manufacturer. Similarly, an unexpected pattern of failures of reprocessed devices or other unusual patient symptoms should result in an investigation of the reprocessing procedures. Results of such investigations and if appropriate corrective actions taken should be recorded. With the completion of the dialysis treatment another reprocessing cycle can begin. As with all of your dialysis procedures, HECFA surveyors will also look at your reprocessing practices. They will not only check files to be sure that they are complete but they will be particularly interested in determining if documentation exists that indicates the staff is properly following the procedures described in the file. Being aware of what the surveyors will look for during their visits can help the facility's personnel assure that the files are complete and are in compliance with the regulations. To run an effective reprocessing program it is essential the personnel possess adequate training and experience to understand and perform the procedures outlined by the individual dialysis facility. The facility may employ persons to perform the reprocessing procedures who have no medical background as long as they are fully trained in the essentials of their job by the medical director or his or her designee. Repair of automated equipment however is usually done by the facility's technicians specially trained in the maintenance and repair of that equipment or by a manufacturer's representative. Manufacturer's recommendations for periodic preventive maintenance must be followed as well. The medical director should establish a written training curriculum. It should encompass the full spectrum of the reuse process and safety considerations which are discussed in HICFA regulations and the AEMI recommended practice. Instructions applied by the manufacturer of automatic equipment and germicides should also be included in the curriculum. Each person performing reprocessing procedures must have successfully completed the facility's training course relevant to their task and have demonstrated competence in the area covered by the training. Documentation of the successful completion of the training should be recorded in the employee's personnel file along with the trainee's verification of having received the instruction. Realizing the personnel performance lies at the heart of good reprocessing. The HICFA surveyor may observe the performance of the persons carrying out their tasks to see if they are properly performed. Therefore, it is important that all staff be adequately trained. The welfare of the patient is the primary goal of any dialysis program whether it uses only new devices or reprocesses them. The patient's treatment should not be compromised by the procedures used. The decision to reprocess hemodializers should be made by physician knowledgeable about reprocessing and its medical implications. When patients have special medical conditions such as aids or hepatitis written procedures should stipulate whether and how reprocessing will be done. HICFA also requires that the patient be fully informed regarding the facility's reuse of dialysis supplies. However, in most states the decision on whether to require specific informed consent with respect to reprocessing is up to the medical director in the individual facility. If used, a copy of the consent form should be in the master record file and a signed copy should be placed in the patient's medical file. Patient cooperation in the facility's reuse program is best achieved through an open, honest, non-coercive and trusting physician-patient staff relationship, where the patient feels that his or her participation in the reuse program is in his or her best interest. Physicians and the clinical staff should be sensitive to the patient's physical and psychological dependency on the life-supporting treatment that they provide. The physician and patient may wish to discuss their joint responsibility to maintain the efficiency of the end-stage renal disease program while assuring quality of care. HICFA surveyors may be talking to your patients to determine how the facility informs patients about reuse and whether or not they are comfortable with the information they have received. The recommendations we have presented describe some of the elements of good practice for the reprocessing of hemodializers. But the real foundation of a successful program is made up of people. If the processes described in the Amy document are carried out by trained conscientious people, reuse will be done in a quality manner just like the rest of dialysis. If you do it right, it works. If you do not do it right, it doesn't work. To assure that one does it right, a few basic messages from this program should be remembered. First, water should meet the requirements of the Amy recommended practice. Never expose the dialyzer to untreated tap water. Second, be certain the performance of the reprocessed hemodializer is maintained for each use. Third, be certain that the proper germicide concentration is maintained within the dialyzer for the specified length of time and be sure the germicide has been reduced to required levels. Finally, always follow your facility's written procedures for reprocessing. Reuse can be safe and effective. However, it is up to the entire dialysis team to assure that the facility's standards are being met. It's common sense and knowledge, not mandatory regulation that should dictate good processes and adequate controls in your facility. Providing your patients with a reprocessed hemodializer which maintains its performance characteristics, aesthetic appearance and safety should be your goal.