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By Jennifer Schraag
Experts share how flash sterilization is misused and what the industry can do to remedy the ongoing issues.
Several detrimental issues are continuing in the use of fl ash sterilization despite the push for safer use. Charles Hancock, REC, a medical device sterilization consultant and president of Fairport, N.Y.-based Charles O. Hancock Associates Inc. says hes deeply concerned about fl ash sterilization safety in todays hospitals. Ive observed in at least five different hospitals within the last three or four months, some practices with their fl ash sterilization which are highly questionable, he shares.
Hancock, who is a member of the Association for Advancement of Medical Instrumentation (AAMI) and serves on its sterilization standards committee, points out that the actions he has observed probably are not the intent at least of the management of the hospitals, yet the effect is extremely dangerous.
In 1996, the Food and Drug Administration (FDA) developed its guidance on the labeling of medical devices, which was concurrent with the AAMI document on labeling for manufacturers. The two documents were identical in wording at that time, according to Hancock. Since, both have evolved and manufacturers of medical devices who seek FDA clearance are now required to provide a validated method of cleaning and a validated method of sterilization, if they recommend that for a particular device.
Before that time there were many medical device manufacturers who didnt provide any kind of recommendation at all, Hancock points out. So the user was sort of hung out there to do whatever he might do. But, all of the devices that have been cleared by the FDA since April of 1996 have had a recommendation for sterilization.
Hancock says therein lies todays problem. Are those doing the actual flashing adhering to these recommendations? Hancock says they are not.
Unfortunately, what has happened is that many of the manufacturers of medical devices that have come from Europe have attempted to do testing that would satisfy both the European requirements and the FDA requirements here in the United States and North America. As a result of much of that testing, there are what are now termed extended cycle times recommended by some of these manufacturers. They can be 18 minutes for a pre-vacuum cycle. Ive seen recommendations for 22 and 28 minutes for gravity cycles. Ten minutes, 22 minutes, 28 minutes, theres a lot out there for 40 minutes Â
Now, the individuals out there responsible for sterilization in central processing are aware of this problem. They are aware of these recommendations because they demand the method of sterilization that the device manufacturers are recommending along with exposure times and other recommendations. Thats not true in the surgical suites. The people in operating rooms (ORs) are generally unaware of those recommendations and they are using the old fl ash cycles whatever it was someone set up years ago.
Even if they are following the other recommendations for monitoring, as I said Ive been in five hospitals where they are running four-minute cycles or 10-minute cycles in the OR for fl ash without any consideration as to what devices they are processing.
Hancock continues, I think this is a dangerous situation. And, there is no one in the OR who is responsible. There is no one who is following up to even determine whether the cycles that they are selecting are appropriate. They are signing off that Yes, indeed we did fl ash this, but no concern for whats in it or to what those device manufacturers are recommending. Therein, I believe is the source of the problem.
Different devices have varying cycle times and often manufacturer recommendations will reflect extended cycle times. Incidentally, in Europe, the cycle that is used for prions (a fairly common concern in Europe) is by default an 18-minute exposure. Hancock says there are a number of device manufacturers who are recommending routinely that that be the exposure time that is used. At least in the OR, no ones taking a look at that, he points out. It may or may not be the correct exposure time, but thats what the device manufacturer is recommending and that is what we say in all of our AAMI standards that the hospital should be using for their recommendation.
The point of fact is that particularly in the OR, no one is even looking at it. They are doing whatever they did years ago when they first set up the fl ash, and in some cases, that may have been done 20 years ago and nobody has really critically looked at what the situation is today. In some cases they are not even aware of what the time is, they just load the sterilizer and close the door and push the button and walk away. I think we have a dangerous situation.
As a potential remedy, Hancock says the responsibility of sterilization of anything in the hospital must be centralized, but he says he sees very little of this.
The expertise resides in central sterile (CS). The people in CS are aware of the changes in technology, they are aware of the concerns for cleaning, for sterilization, and they generally are on top of what the issues are. Thats not true in OR. In OR, that function is incidental to the many other tasks that they have. It is not their primary responsibility.
The decision for sterilization responsibility is one that should be elevated in the hospital administration, he declares. Today, you generally have CS with one set of rules, the OR has a different set, and truth be told, the pharmacy has still a different set. And if you have office-based practices that are associated with the facility, thats utter confusion and there is usually no one overseeing that.
There needs to be this centralization of expertise in the hospital. This one person who is responsible, whether that is out of CS or infection control. I personally think the infection control practitioner (ICP) should be the individual responsible, if they are qualified. Im not sure that there are a lot of them who really are qualified with respect to sterilization technology, but I think they should be because they are the ones who will essentially bear the fruit of whatevers being done here because if something does happen, they are the ones who are going to have to deal with it. If in fact the ICP is the one to hold the responsibility, (the hospital administration) must give them the authority, but give them the responsibility as well and put some teeth down so that they can make things happen. I think it should be a goal for every hospital to unify this responsibility.
Nancy Chobin, RN, SCPDM, SPD/CS educator for Saint Barnabas Health Care System in New Jersey, says the sterile processing manager is the one who is responsible for overseeing all the sterilization that takes place in a facility. Whether they are performing sterilization in dental, in the OR, in labor and delivery, SPD needs to know what is being done and how it is being performed. The SPD Manager may not actually be performing the fl ash sterilization, but should be observing what they do and making sure they are complying with standards. The problem is that very often the operating room doesnt want the ' interference' or sterile processing doesnt know what it is they are looking for. Somebodys got to be in charge of all sterilization, she recognizes. Thats the whole reason why we have sterile processing people. They are supposed to be the experts in sterilization and they should be going out to these departments to see what they are doing and make sure that they are following the best practices.
Chobin says her system developed an audit that is conducted four times a year. Sterile processing personnel audit the fl ash sterilization records in the operating room to make sure they are complying that all the sterilization logs are signed, chemical indicators are there, the doctors name is there, etc.
Nancy L. Anderson, RN, MPS, CNOR, manager of surgical services at Avista Adventist Hospital located in Louisville, Colo., says good documentation is absolutely critical when using fl ash sterilization. She advises that each log entry include the date, personnel initials, patient information, the item sterilized, the reason for sterilizing the item, results of biological and chemical indicators, and the physical read-out from the autoclave.
Anderson also says that the 2006 edition of the Association of periOperative Registered Nurses (AORN)s Standards, Recommended Practices, and Guidelines state that documentation of the loads and the reason why the particular items are being flashed also must be included. They are becoming more stringent and requiring more justification if fl ash sterilization is used, Anderson adds.
Chobin elaborates, I think we have to focus on A.) Why are we doing it; and B.) If we are doing it, is it the appropriate use of fl ash sterilization. One confusing issue surrounding fl ash sterilization is the different types used (i.e. pre-vacuum or gravity). Hancock says this can play a role in making fl ash sterilization dangerous because the wrong process may be used with the wrong sterilizer.
If they are wrapping the same items that they are processing in pre-vac for one room and using the same technique in a gravity sterilizer, we have two different conditions, he explains. I see that mix and match taking place in some hospitals. The users dont know which sterilizer is a pre-vac and which one isnt.
As they transition from the old gravities to the newer pre-vacs, I think theyre headed in the right direction, but unless they do it all at the same time, theres the opportunity for someone to mess it up or get confused and process the wrong time in the wrong sterilizer. Ive seen that happen.
Perhaps the biggest issue encircling the use of fl ash sterilization concerns sufficient instrumentation being on hand to reduce the likelihood and the need for flash.
The new recommended practice from AORN on sterilization specifically states, flash sterilization should not be used as a substitute for insufficient instrumentation, Chobin, who served as a committee member for the latest revisions, affirms.
I think that is the core of the problem, she says. Anyone having problems with fl ash can put together a PI process that has documented their fl ash sterilization, and then utilize that documentation to help to prioritize their instrument purchases.
This has made a significant impact on reducing fl ash sterilization. It can be done. They just need to start the process. It is not impossible.
The second core of the problem is the need to have manufacturers instructions for every device that is processed regardless of whether it is processed in the OR or in sterile processing.
So when you are flash sterilizing a device, now if its a basic instrument thats one thing, but very often its the other stuff the stuff we dont have back-ups for. What happens if you dont have that information? Can OR comply with the device manufacturers instructions? If the instructions require ultrasonic cleaning, could the device function be properly cleaned if the OR does not have one? And if we deviate from that, what about the liability? And if youre deviating because you dont have enough instruments, is that justification for deviation from the manufacturers instructions for processing?
Chobin stresses that the general public is going to begin to catch on to these practices and facilities ultimately will be forced to answer to them. She explains, If I deviate from my established policies because its a true, bonafide emergency, then in a court of law there is going to be some consideration for that. But when we have a policy, and we dont follow it because the device/set is needed right away so we take shortcuts (resulting in poor or inadequate cleaning) or there is insufficient instrumentation The bottom line is the attorney for the plaintiff is going to present to the jury that the only reason why the facility did this is because they were trying to save money. There isnt any jury that is going to have any sympathy for a facility that does not have sufficient instrumentation to process them correctly and safely.
Patient safety has to remain the No. 1 consideration. Facilities can ensure safety by achieving adequate cleanliness prior to flashing and by protecting the sterility of flash items during transport.
The first patient safety issue is proper decontamination because if we didnt clean it right, why even bother putting it in the fl ash sterilizer? Were deluding ourselves, says Chobin. Thats the bottom line. You cant take something and hold it under running water; you cant take something and think that a complex device, just because we are wiping it off with alcohol, that were going to get it clean.
The second issue is transfer of the device from the fl ash sterilizer to the point of use. Protection of the goods that you are processing is essential, Hancock stresses. The breakdown that occurs is usually in the transport of the goods from the sterilizer to the point of use. The closer that sterilizer is to the point of use, the fewer things that can go wrong. The further away the sterilizer is from the point of use, the greater the care that should be used in protecting the goods that have been sterilized.
Anderson points out that this is one area where the industry is working harder to make the process safer. They are providing containers that ensure sterility from the autoclave to the field, she says. However, Chobin says she sees a lot of misconception, specifically in the operating room, on the proper usage of the fl ash containers. She says this stems from many not understanding the difference between a pre-vacuum cycle and gravity cycle. When you use a container, they may require different exposure times; that biological testing should be performed inside the container so that you are simulating what is happening inside the container when you put instruments inside, she explains. Again, this is where the sterile processing manager should offer training and guidance. SPD should be overseeing all BI testing. And if the operating room needs assistance, the SPD manager needs to provide it.
Anderson says all personnel who will be involved with fl ash sterilization in the facility should undergo continuing education at the time of orientation and bi-annually thereafter. Hands on, preferably, she adds.
According to Chobin there are two specialties, in particular, that are more apt to misuse fl ash sterilization: orthopedics and ophthalmology.
In orthopedics, the issues consist of booking cases back-to back, not letting our needs be known to the vendors (e.g. we need three total knee sets today, but the vendor will bring in one set and were expected to use that same one over and over again). This results in the set being reprocessed for each patient with little time in between. Most likely the first patient gets a wrapped, sterile set and the other two patients get a flashed set.
This is totally unacceptable. I really feel the patient has the right to know that the set(s) were not processed in the same manner as the first patient of the day. As a patient, I may not want to have my surgery there. And does the surgeon know this? Maybe he wouldnt want this for his patient.
Chobin said an attorney in Baltimore contacted her regarding a lawsuit on the use of fl ash sterilization of implants. When I lecture to ORs, I tell them all the time, if and when this case comes to court this is going to bring the whole issue of fl ash into the public setting, so you might as well start looking at your fl ash practices now. This is a big issue, especially if you are talking about buying additional instruments, but you need to start attacking it.
You need to keep the proper records. I dont know of any risk manager, quality assurance or infection control manager who does not whole-heartedly support additional instrumentation when instruments are being routinely fl ash sterilized. With proper recordkeeping, OR management can show administration which sets/devices are needed for purchase; Look, I had to sterilize my arthroscopy set 19 times this month. With this documentation, purchases of additional instruments can be prioritized.
Ophthalmology is the other practice that may soon face trouble concerning the use of fl ash, according to Chobin. She explains. Because of the high cost of ophthalmology instrumentation, they rarely have sufficient instruments for their cases. The eye cases can be as short as 15-30 minutes, which adds to the problem. Thats the first problem. The second problem, it may sound amazing, but theres a significant number of ophthalmology people whether they are nurses or physicians who do not feel that eye instruments need to be cleaned. I have observed eye instruments just being 'wiped off' with alcohol and then fl ash sterilized between patients. The rationale given is that eye surgery is bloodless. Some facilities dont want to wash them because theyre afraid the detergent residue may cause a reaction in the patient. Well, that can be resolved with proper training and thorough rinsing.
Something is going to happen to an eye patient and thats going to cause change to occur, she asserts. We have got to quit skirting around the fl ash issue and we have got to start addressing it.
Nobody ever said we shouldnt flash, she adds. There is always going to be a need for flash sterilization. Things happen. Something gets dropped, something gets contaminated; that can be well documented. But when we have a patient who is scheduled at 7:30 a.m., you get a set thats been cleaned correctly, its been sterilized correctly and from there on we go down hill. Hurry, hurry, hurry, we need it now, we need it fast, get it in the fl ash sterilizer, the doctors waiting. Thats where we have the problem. Now, that second patient has the right to the same standard of care as the first patient. They dont have that. The third patient has the right; they dont have it. Its not fair. Its not ethical, and yet it continues to happen.Â
News on Flash:
AAMIs extensive standards are ever-evolving. The latest update concerning sterilization, ST-79, is expected to publish this month (June). While Charles O. Hancock, REC, member of the AAMI sterilization standards committee, couldnt comment on the exact verbiage of the new document he says it will be a fine tuning of provisions. The ST-79 is a compendium of steam sterilization processes, so well have one document that consolidates all of the steam sterilization processing into one document. That will be advantageous because hospitals will need only buy the one document and have all of the steam sterilization practices available to them. It was done intentionally for that reason. The old ST-33 will go away as just a fl ash document, he adds.Â