By Kelly M. Pyrek
Chris Lavanchy, engineering director of the Health Devices Group at ECRI Institute, has extensive experience working with sterile processing departments and provides his insights regarding the imperatives of proper medical device reprocessing.
Q: How significant would you say device-related infections and adverse events are these days, and what is contributing to these so-called “never events”? What are some ways to combat them?
A: Device-related infections are a continuing concern and every year we hear of a few incidents where a large group of patients may have been exposed to improperly reprocessed instruments. Probably the most notable examples are the reports we hear related to flexible endoscopes – these often become headlines. I believe several things contribute to these events. First, flexible endoscopes are complex, delicate devices that cannot be reprocessed as readily as many conventional instruments, and as a result the reprocessing steps also tend to be more manually-intensive, complex, and consequently more error prone. Endoscope reprocessing typically takes place adjacent to the care areas and not in the central sterile department where processes are generally more carefully monitored and managed. Also, because flexible endoscopes are expensive, most hospitals run with a lean inventory, so when demand for the endoscopes is high, technicians handling the reprocessing are sometimes subjected to pressure from clinicians to do the reprocessing more quickly. This can lead to shortcutting procedures. We recommend several ways to help combat problems with improperly reprocessed flexible endoscopes. For example have the reprocessing technicians managed by the central sterile department and require well documented reprocessing procedures for each specific endoscope model. Periodic reassessment of technician competence combined with annual review of procedures can also be helpful. When changes to reprocessing protocols are made they should be reviewed by leadership in the central sterile department and reviewed with technicians. Finally, hospitals using older reprocessing machines should consider the purchase of newer systems that can eliminate all or some of the manual cleaning needed.
Q: Medical devices and instruments are evolving so quickly, and so the demand for knowing how to reprocess these devices is escalating as well – what suggestions do you have for keeping pace with these developments?
A: This is an ongoing challenge. The designs of instruments have become increasingly more complex and more challenging to reprocess. One way to manage the concern better is to require that any instrument being purchased not be accepted unless the vendor provides specific, adequately detailed reprocessing instructions. Central sterile department leadership should ideally be to weigh in on selection of new instruments or at least be able to review the equipment documentation before they are used. It is not unusual to hear from central sterile departments that the first time they became aware that an instrument had been purchased was when it appeared in their department for reprocessing. This was at one time common, but should never be allowed to occur today.
Q: What are clinicians and manufacturers’ shared roles when it comes to reducing the potential for device-related problems that can jeopardize patient outcomes?
A: One of the best strategies to overcome some of the device-related problems we’ve been discussing is for hospitals to encourage collaboration between purchasing and central sterile department leadership when discussing the purchase of new instruments from manufacturers. Too often little thought is given to the reprocessing stage of the instrument use cycle when equipment is being acquired. By involving central sterile departments in the process, manufacturers will perhaps more quickly see that ease of reprocessing is an important customer selection factor and give more attention to providing information about reprocessing when marketing their products.
Q: What are some of the common problems posed by endoscopes?
A: In the reprocessing arena, endoscopes are problematic. One of the things we have seen over the years is that it is critical to ensure that sterile processing personnel have the appropriate instructions for cleaning that specific endoscope. Endoscopes vary tremendously in their design and it is especially important if you are using an automated endoscope reprocessor, to have the appropriate adapters for that endoscope. One of the key messages for technicians is that they need device-specific reprocessing instructions. Reprocessing protocols should be documented somewhere and they should be something that is accessible to the person performing the reprocessing tasks.
Q: What are some of the specific problems you are seeing?
A: With regard to endoscope reprocessing, we continue to hear about horrible situations where many patients may have been affected by improper reprocessing. It's such a recurrent problem that this topic continues to land on our top 10 technology hazards list. Through our accident investigation services we often gain unique insight into the root cause of such reprocessing failures . Sometimes it's because there has been a change to the process without the appropriate oversight. These incidents tend to createhigh visibility situations where hundreds, thousands or tens of thousands of patients are notified that they may have been exposed to contaminated instruments. For example, a facility switched to a different liquid chemical germicide for use in their automated endoscope reprocessor but failed to adjust the unit’s settings for the new indicated operating temperature . In another incident repairs were made to AERs and the facilities failed to to verify that the fluids going into the system are maintained at the required temperature. These things are particularly important because you can buy the best endoscope reprocessor, you can have the best technician handling the scopes, but if the oversight isn't there, if you don't have the appropriate processes, checks and balances in place, then it's very easy to run into serious problems.
Q: What can infection preventionists do to assist sterile processing departments?
A: Infection preventionists can help by periodically checking with sterile processing technicians to make sure that they are aware that the manufacturers' instructions exist, that they know how to find them, and are in fact using those instructions and applying them to the process correctly. It's a bit burdensome, perhaps, but it's probably the only way they can ensure that things are being done properly -- especially with staff turnover being so high in healthcare facilities.
Q: What do you believe to be manufacturers' responsibility?
A: For at least the last 10 years, the FDA has specifically emphasized the need for medical device manufacturers to provide at least one viable method for reprocessing a reusable medical device. They can specify a high-level disinfection or sterilization method, or whatever is applicable, but the reality is, the more options that the vendor provides for reprocessing, the better it is for the hospital. In some cases, what they're asking the hospital to do may not be practical. What we advise hospitals to do when they are buying medical instruments and equipment, is to review the reprocessing information that is available from t he manufacturer and consider that in their purchasing decisions. I've been to some hospitals where the reprocessing technicians first became aware that they were being given a new instrument to reprocess when it was presented to them dirty from the OR. That is just not the way to do things. Ideally, the central sterile department should be involved in the overall purchasing decision so that these personnel would understand what the requirements are for reprocessing that new device being considering for purchase. I think the awareness of device-related reprocessing issues is definitely being raised, and the FDA workshops and the AAMI/FDA summit have been helpful in getting the word out that there are instruments whose cleanability was a secondary consideration in their design. For example, at the FDA/AAMI summit someone showed a suction probe that had been cut open and how it would be virtually impossible to remove the debris. Fortunately I think it is a relatively rare thing today for an instrument to be designed like that, but the more that this concern is publicized, the more likely it is that manufacturers will ensure there is very diligent consideration of proper design for cleanability as products are being developed.