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 weve 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 units 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.
Q: The participants at last year's FDA/AAMI Summit on Reprocessed Medical Devices were stumped on how to define "clean" and "cleanability" -- what does it tell you about the processes to which personnel ascribe?
A: Anyone in the central sterile field knows that there's a fundamental tenet -- if you can't clean something you can't sterilize it -- that's well accepted. But the general concept of what's clean has never been really fully defined or standardized. Most facilities I have spoken with look at the instruments during the cleaning stage of reprocessing and if they look clean then they are considered clean. Well, many instruments have crevices and surfaces that are not easily visible for inspection so how do you make that judgment? For instruments with lumens they may flush the lumens with water or saline and if nothing is coming out, assume that it is clean -- but is that really an accurate indication of whether all of the internal surfaces are clean? I was very happy to see that the FDA and AAMI were emphasizing the concern about cleanability and pursuing ways to define what is an acceptable level of cleanliness in a reprocessed instrument. There are some interesting technologies being considered to quantify clean -- whether they will be practical for day-to-day cleaning I don't know. However, there are people who are researching this and I think what will trickle down from that research will be some very good ideas about how to design instruments better to avoid debris build-up and how to validate that designs are effective at enabling cleanability. The research will also hopefully lead to better ways to verify that these instruments have been cleaned before they go into an automated endoscope reprocessor.
Q: How to you address the dichotomy that exists between automation versus manual cleaning?
A: Certainly there are arguments on both sides of the automation versus manual cleaning debate. I think ECRI Institute's general perspective is that automated cleaning is probably the preferred way to go. The reasoning is that a manual process is unfortunately subject to human failures; it's also subject to the technician being pressured by the OR staff to turn an instrument around faster. Manual processes also are subject to variances in how consistently a person do a particular task day to day as well as variances between people. -- With an automated system you can eliminate a lot of that variability. But of course automated systems can fail as well. It's important that if you have an automated system you ensure that it is reliable, that it is properly maintained, and that it can't be easily circumvented at the operators discretion. When the central sterile staff are being pressured to turn devices and equipment around faster, if the automated system allows you to short-cut the process, the situation can be as much of a concern as the variability in manual reprocessing. We generally advise hospitals to go with automated systems if they have the choice. Automated endoscope reprocessors have been shown to be effective and I know there are some machines today that actually include automated washing, which has been demonstrated to FDAs satisfaction to be equivalent to or possibly better than a manual process.
Q: What about the potential for technicians to eventually work around an automated system?
A: When the ECRI Institute performs comparative studies of automatic endoscope reprocessors, for example, we look very closely at human factors design, we examine how easy is it to work around the intended approach and that factors into our judgment about the product. If we find that it is easy to bypass the safety features or alter process times that an AER designer included, we will down-rate the unit for that because we know this is a significant concern among users. We are very familiar with the reprocessing environment and know how much pressure there is, how noisy it is, how fatiguing it can be for the technician working there. If you give reprocessing technicians the opportunity, deliberate or not, to modify the process that an automated system provides, then there's not as much real benefit to using the automatic system in the first place.
Q: Whose responsibility is it to provide oversight?
A: We are familiar with problems that sometimes arise from poor interaction between central sterile teams and OR personnel. Ive seen facilities where an adversarial relationship exists between these teams. What we often find is that if both departments report to a common executive, these problems disappear or are at least effectively managed. I think turf wars can arise when you operational teams that need to collaborate but the operational managers or VPs have widely different areas of responsibility. While the leaders may share the common institutional mission, they also have their own more immediate agendas related to their areas of responsibility and budgets. So having everyone following the same reporting channel can be helpful in helpful in developing cohesion between the different groups. In the instance I mentioned where the OR reported to one executive and the central sterile reported to a different executive, we found that there was a lot of blame placing going on and that the particular hospital was really struggling to figure out how they could make things work better. The situation fostered a sense of competition rather than collaboration.. I know it sounds obvious, but when you are there and you hear the arguments coming from these folks you quickly realize that the sense of institutional mission has been lost.
Q: How critical is proper education and training? And when there are breaches in reprocessing practice, are they due to knowledge gaps or implementation gaps, or both?
A: Education is important in ensuring effective reprocessing at a couple of levels. In the case of the contentious central sterile and OR departments I mentioned previously, it was apparent that neither department understood the work that the other group was using and what is involved in doing that work. I think that lack of understanding fostered a lot of the resentment and contention that arose -- they wanted to know why the other group was being so unreasonable, yet they didn't understand each others situation. So just helping them better understand what is being required of the staff in each department can go a long way.. It has also been my experience in talking with central sterile departments that at one time the level of education of the technicians varies considerably. I believe that is changing today -- there is more pressure on hospitals and the department managers to ensure that their people have the appropriate credentials and ongoing training. They must ensure that their technicians are using equipment properly and understand the impact of failing to carry their responsibilities out properly.
Q: How can the ECRI Institute help?
A: There are a number of avenues through which the ECRI Institute can assist. In addition to providing consulting services we also invite hospitals to report to us problems they have with technology for investigation.. We also are a patient safety organization (PSO) for a number of states or regions that allow hospitals to report adverse events they might have experienced with medical devices. It allows them to participate in a non-punitive process that encourages reporting of adverse events without fear of litigation. to a centralized agency that pools and analyzes the data so that it can be used for ongoing quality improvement processes.. Through the PSO program we can help hospitals share wisdom gained from looking across many facilities and facilitate the development of best practices. The PSO concept came about because it was recognized that having hospitals report problems to manufacturers and FDA has not proven to be an effective way to track and identify causes of adverse events. Congress created PSOs to provide a forum free from legal discoverability to encourage free exchange of what is often considered sensitive information.
Q: What do you believe is critical to keep in mind for the future?
A: It is important to keep the concern of inadequate instrument reprocessing on hospital executives radar because they are dealing with a lot of complex issues, at a time when resources are in short supply. If you don't, the other challenges they are facing will quickly divert their attention. Providing reminders of the important need for this ongoing vigilance is key. The more hospital departments are vocal about the problems they are encountering with reprocessing, the better the chances are that device manufacturers, and agencies such as FDA and AAMI and ECRI Institute will be aware of what needs to change. Unfortunately because the topic may be viewed as dirty laundry hospitals may be deterred from talking candidly. However, unless the problem is addressed and really confronted publicly by all involved, I believe these issues will persist.