 Hi, Jim. How are you doing, Mrs. Hubbard? They told me last week that today was your birthday. So I decided to buy you something to brighten up your day. Thank you. That was really very thoughtful. That'll certainly brighten up the unit today. How are you? Did you have a good weekend? I'm doing fine. Saw a basketball game this weekend and really excited me. I'm ready to get started. Okay. Now that you're the first one here, why don't we go ahead and get your weight, get your vital signs, get you started maybe a little bit early. Hi, Jim. How's school going? Oh, I got finals next week. Talking major headaches. Who courses are you taking? Physics, math, biology. I don't know where I'm going to get the time to study. You got plenty of time here to study. I know. I need to start bringing my books in. Okay, Jim. I'll run and I'll be right here if you need me. What's wrong? My arm is burning. We're going to take care of you. Did you check for formaldehyde? No. Let's get these lines disconnected. Don't start anyone else. Any time, any place, a scene like this can happen. No one wanted this to happen. It was just a collection of events that could have had tragic consequences. The cause was human error. Just as machines malfunction, people can malfunction too. You, me, anyone. But mistakes can be prevented. Injury avoided. And most of all, patient well-being assured. Accident prevention or avoiding human error is a continual process. It never ends. Events compound themselves. Errors are caused to happen. They don't just happen. Hemo-dialysis is a very complex therapy, no matter how routine it seems to us. Complex but routine tasks are a breeding ground for human error. As members of the health care team, we must be aware that these incidents can and do happen, and that they may be reportable to the Food and Drug Administration. Here at FDA, we receive a wide range of incident reports involving medical device safety. Some of these reports come into us from healthcare professionals like yourself through our voluntary reporting programs, such as the Practitioner Reporting System. Other reports come in from device manufacturers through our Medical Device Reporting Program, or MDR. In this reporting program, manufacturers are required to report to FDA any death, serious injury, or malfunction involving their device. Now, what we see in these reports is beyond just problems with medical devices themselves. Many problems can be traced to user or procedural errors that often seem preventable. Take the last two years of MDR reporting, for example. Of the 81 reports we analyzed that involved hemodialysis delivery systems, 28 of these incidents were determined to be device-related. 39 were attributed to user or procedural error, and nine were a combination of device and user or procedural error. These 81 reports also included eight deaths and 36 serious injuries. The FDA certainly can't regulate user or procedural problems, the human factor. Our role as defined by the Food, Drug, and Cosmetic Act is to assure the safety and efficacy of the device. So it's going to take a combined effort on the part of the dialysis community, physicians, nurses, technicians, professional organizations, dialysis product manufacturers, and state and federal agencies to determine the cause of these human factor problems and to prevent their recurrence. As renal physicians, we're concerned about these reports of human error and device malfunctioning, and we bear a great measure of responsibility for the safety of our patients. It is our role to provide supervision and guidance for our staff, and most importantly, to be alert and attentive to the needs of our patients. The renal physicians association considers the issue of human error in hemodialysis to be a matter of the highest priority for the organization. The development and implementation of protocols covering all aspects of the delivery of patient care services is extremely important, as is the development of appropriate audits and oversight to assure compliance. Training with continued retraining and reinforcement is critical. We encourage you to look at your own practices and to educate yourself and your staff. We in nephrology nursing recognize the great responsibility placed upon us to assure the safety of hemodialysis, and we're certainly concerned about the matter of human error and how it can be prevented. As in any area of medicine, education plays a major role in assuring patient safety, and many educational programs and materials on hemodialysis are available to you. For example, the major thrust of the American Nephrology Nurses Association is education. AN&A produces journals, seminars, and standards of care for nursing practice. Also, dialysis facilities offer their own orientation and training programs and in-service seminars. But ultimately, it is the responsibility of each of us as individuals to educate ourselves, and this must be a lifelong learning process. For example, if we really are concerned about human error during hemodialysis, we need to become aware of what each of us can do to reduce or eliminate these problems, and that's what the rest of this program is all about. First, we must read and follow manufacturer's recommendations and other important literature. Second, we must use a pre-dialysis checklist, and we must check the dialysate before beginning treatment. And finally, we must perform preventive maintenance on a routine scheduled basis. The last thing you want to hear is advice about reading the literature, labels, manuals, and periodicals associated with hemodialysis. How can anyone ever find the time to read all this material? And how important is it? Everything is important, but some materials must have a higher priority. Patient safety is of prime importance. You must know and understand the scientific principles underlying hemodialysis, and the unique features of the equipment you are currently using, and how they employ these principles. Following the manufacturer's procedures and unit protocol is imperative. Systems change, and all of us must continue to be familiar with the equipment we're working with. A pre-dialysis checklist, for example, is a reminder that keeps all of us from taking a shortcut that can lead to trouble. Completing a pre-dialysis checklist will ensure that the system is functioning properly prior to the start of a treatment. The initial check is to verify the removal of disinfectant from the dialysis delivery lines. The next item in a pre-dialysis checklist is verifying monitor performance. While the human body is remarkably sensitive, we should never rely on the patient's condition to let us know that the machine is not working properly. For example, the temperature monitor must be checked before beginning dialysis. The dialysate must be at normal body temperature. Cool dialysate is not always harmful, just uncomfortable for the patient. However, dialysate over 42 degrees centigrade will cause destruction of the red blood cells. The patient will become symptomatic almost immediately from a lack of oxygen. Test the temperature alarm by making sure the overheated dialysate bypasses the dialyzer. Some machines will also bypass in low temperature. Also verify both audible and visual alarms. The dialysate bypass function is a very important safety feature on the machine. The dialysate flow should bypass the dialyzer and go directly to the drain to protect the patient from overheated dialysate or an unsafe dialysate mixture. To test for bypass, make sure that the flow actually bypasses the dialyzer. The limits on the transmembrane pressure or negative dialysate pressure monitor must be set on those machines that require manual setting once the TMP has been calculated and set. To test the TMP or negative dialysate pressure alarm, set your limits, violate them, and then verify both an audible and visual alarm. It is possible for the patient to experience significant blood loss during treatment, so the limits for arterial and venous pressure should be set as soon as dialysis is started. Be sure that there is no fluid in the monitor lines or the monitors will be disabled. The alarms should alert you immediately if an obstruction or separation in the blood circuit develops. To test the pressure alarms, override the monitor needle with the limit indicator. Verify both audible and visual alarms. Also verify that the blood pump stops. The air detector is designed to prevent the patient from being infused with air during dialysis. To test the air detector, place the device in the armed mode and verify its performance. Note that the venous line is clamped, the blood pump is stopped, and that the audible and visual alarms are working. Make sure that the air detector is armed before initiating dialysis. Then adjust sensitivity. The blood leak detector is a sensor that detects red cells in dialysate outflow if a membrane leak occurs. Test the blood leak detector by turning the knob to the test position. You should get audible and visual alarms. Then adjust sensitivity. Another critical safety feature on the dialysis machine is the conductivity monitor. To prevent electrolyte imbalance or hemolysis, it's imperative to know that the dialysate composition is correct and that the conductivity monitor alarm is functioning. The dialysate should be independently checked with a conductivity meter, which is calibrated against a standard reference solution. You should know the correct conductivity meter reading for the concentrate being used. For bicarbonate dialysate, an independent pH check must also be done to assure proper electrolyte balance. Once you know that the dialysate is correct, check both the high and low conductivity alarms. Verify the bypass function as well as the audible and visual alarm. Visual inspection of the blood circuit assures sterility and integrity of the lines. Air should not be present. Check the dialyser and the patient's chart to verify that it is the correct dialyser for the patient. Again, check the patient's chart to assure that the concentrate formula is that prescribed for the patient and that there is enough concentrate to complete the entire treatment. Dialysate concentrate is available in numerous formulations and in a variety of sizes and shapes of containers. It is extremely important to double-check all concentrate containers to ensure that the correct formulation has been chosen and that the proper dilution is made each time. Read, verify, and re-read labels. Treat concentrate as you would a drug. Before mixing dialysate solutions, be sure you are using treated water, not tap water. The water should meet the minimum national standard for water quality for hemodialysis systems. Errors can also occur when transferring concentrate from one container to another. Be sure to label all containers properly. Additives must be carefully measured and well-mixed into the concentrate before initiating dialysis. Containers must be clearly marked to show additives. When the composition of the dialysate has been altered, conductivity must be re-verified. Bicarbonate concentrates and solutions require special attention. Assure adequate dissolution and mixing of powdered bicarbonate before combining with acid concentrate. Bicarbonate concentrate, once in solution, should not be stored because of deterioration and possible bacterial contamination. Criss-crossing of lines in bicarbonate treatments is a common error, as is the use of the bicarbonate line for acetate dialysis. Make sure that the lines are properly marked and placed in the correct concentrate containers or in the correct rinse ports. Do not start a treatment without enough concentrate to complete the run. The conductivity alarm should not be used as an empty jug indicator. Interruption of a treatment to replenish the concentrate means added exposure to potential errors. These events by themselves do not usually cause serious problems. However, if they occur when the conductivity meter has been miscalibrated or the conductivity alarm limits indiscriminately altered, the outcome for the patient may be serious injury or death. Any calibration or servicing is a maintenance function and should not be conducted while patients are being dialyzed. Regularly planned periodic equipment maintenance is a preventive measure which ensures against much costlier occurrences, such as patient injury or machine downtime. An important practice in equipment maintenance is to read and follow the manufacturer's recommended maintenance procedures and to keep the maintenance procedures manual in a convenient, readily accessible location for easy reference. It's imperative to keep a record of maintenance performed, together with a schedule indicating what the next maintenance to be performed will consist of and when it will be performed. There are some maintenance procedures which must be followed on a yearly basis. Others may be required on a monthly, weekly or even a per-treatment basis. For instance, most manufacturers recommend that the equipment be cleaned properly after every treatment. Sanitization or disinfection of the machine is usually performed between treatments or at least on a daily basis. Make sure that the machine is labeled or tagged if left unattended during disinfection to avoid mix-ups. Always test the dialysate lines after rinsing to detect the presence of any residual disinfecting agent. Use an appropriate residual test kit. All manufacturers recommend that some functions on the equipment be checked or calibrated periodically. Control and monitoring systems which may require periodic test and calibration include blood pump, infusion pump, dialysate flow, dialysate temperature control, dialysate conductivity monitor, blood leak detector, air detector and line clamp. And finally, the blood, dialysate and transmembrane or negative pressure monitors. Replace filters according to the schedule recommended by the equipment manufacturer using only the replacement filters specified. Check the system for fluid or salt deposits which may indicate fluid leakage. If the manufacturer's maintenance procedures require entering the electrical compartment of the machine, always be sure the plug is disconnected first. Certain components of the system can only be calibrated by a trained service technician. Never attempt to repair or adjust any part of your equipment you have not been trained in maintaining or which is specifically warned against in the manufacturer's instructions or labeling. As we said at the beginning of this program, hemodialysis is a complex procedure. The role that you and the entire hemodialysis team play in assuring the safety of your patients is a critical one. None of us wants to experience a situation like the one we saw earlier with Jim. Fortunately, his crisis was resolved. But perhaps with a little more attention to the areas we've just discussed, it could have been avoided altogether. Give it some thought.