The Food and Drug Administration (FDA) recently added laparoscopic and endoscopic electrosurgical accessories to its list of critical reprocessed single-use devices (SUDs) whose exemption from pre-market requirements has been terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a pre-market notification (510(k)). The items will now require submission of supplemental validation data to ensure that these devices are substantially equivalent to new devices, in accordance with MDUFMA. The action became effective Sept. 29, 2005, but manufacturers still have until June 29 to submit the supplemental validation data for the devices or their devices may no longer be legally marketed.
The FDA ultimately determined that endoscopic and laparoscopic electrosurgical accessories are potentially high risk devices when reprocessed. The Federal Register notice reads:¹ The agency has determined that these devices should be considered high risk devices when reprocessed because they include features, such as narrow lumens, that could impede thorough cleaning and sterilization and because these devices contain materials, coatings, or components that may be damaged or altered by reprocessing. Therefore, these devices have the potential for a high risk of infection or inadequate performance when reprocessed.
This is a step in the right direction in terms of industry players recognizing the challenges that laparoscopic instruments present, according to medical device designer and surgical safety advocate Jim Schneiter. Residual bio-burden trapped inside the lumen of a conventional lap instrument can cause a deep organ SSI (surgical site infection), he reiterates. (See Part I of Designed to Kill? in the May issue of ICT for his further explanations on the relationship between deep organ SSIs and laparoscopic instruments).
He says this occurs by residual bio-burden that accumulates on the operating rod and inside the throat of the lumen. During a surgical case, as the surgeon opens and closes the jaws of the instrument causing the operating rod to rub against the throat of the lumen some of the residual bio-burden can break loose from the operating rod and/or lumen and be deposited in the patients deep organ cavity. As this bio-burden begins to decompose in the patients deep-organ cavity, it can release endotoxins, which can in turn stimulate cytokine production, he points out.
Schneiter cites the Center for Disease Control and Prevention (CDC)s report on surgical infections, which states, Many gram-negative bacteria produce endotoxins, which stimulate cytokine production. In turn, cytokines can trigger the systemic inflammatory response syndrome that sometimes leads to multiple system organ failure. One of the most common causes of multiple system organ failure in modern surgical care is intra-abdominal infection.
However, Mark Salomon, senior vice president of corporate development with Ascent Healthcare Solutions Inc., says the reprocessing of laparoscopic instruments is completely safe.
The FDA has taken extraordinary steps to regulate this industry, he asserts. The office of device evaluation within the FDA has considered every aspect of medical device reprocessing including cleaning effectiveness, functional effectiveness, packaging security, and of course sterilization compliance.
Salomon also says that the cleaning challenges the internal lumens present are easily conquered. Nationally and internationally recognized scientific tests, like bio-burden testing, identify if there is any residual left on the device, he explains. The bio-burden test is routinely used by the manufacturers to ensure the bio-burden from their manufacturing lines has no affect on the patient. We routinely inoculate the most difficult areas of the laparoscopic instruments like the internal lumen of the shaft and use tests like the bio-burden test to validate that our re-processing process can routinely get the device clean and ready for an industry-standardized sterilization cycle.
Ascent obtains efficacy validation data on the cleanliness/sterility of its reprocessed laparoscopic instruments, according to Salomon. Once we have proven our cleaning methodologies and the sterilization cycle are effective to the FDA, every single batch of products is monitored to ensure every perimeter of the cleaning and sterilization cycles are met. The same applies to functionality of the devices, he says. In addition, Salomon says every device is characterized into similar designs and, he says, We validate the safety and efficacy of each design category to ensure absolute safety for the patient.
Salomon continues, If you are cleaning reusable devices, definitely seek out the cleaning instructions from the manufacturer, he offers. Ever since 1996, the FDA has required every manufacturer of reusable devices to provide validated cleaning instructions.
Thanks to the FDA, medical device reprocessing has moved to a whole new level in this country. The clinical user and even the consumer should know that the reprocessed device now presents itself at the same level of safety and efficacy as the original device. Again, thanks to the FDA, clinical users now have the opportunity to purchase the same instrument at half the cost and know that it is as safe and efficacious as the new device. That allows healthcare to be more efficient, environmentally conscious, and able to use the savings to improve the level of services somewhere else in their facilities.
But he warns, If you are cleaning single-use devices you are on your own. Unless you have an expert in complying with FDA regulations and are willing to register with the FDA and get your processes within FDA compliance for essentially manufacturing laparoscopic instruments, you should outsource, he offers. That is why nearly 94 percent of the nations top 17 honor roll hospitals, according to US News & World Report, outsource their reprocessing to member companies of the Association of Medical Device Reprocessors (AMDR).
Schneiter on the other hand isnt convinced. He suggests, as a fi rst-line defense, that healthcare organizations can reduce the risk of a deep organ SSI caused by a contaminated laparoscopic instrument by not using any laparoscopic instrument that does not have a flush port. Research has shown that non-ported accessory devices cannot be as reliably cleaned as ported devices regardless of the cleaning method used.² Bio-burden cannot be removed from instruments that dont have a fl ush port, including those instruments with a sealed shaft, Schneiter adds.
Salomon affirms that most laparoscopic instruments are essentially all built the same. There are differences in the way the handles actuate, as an example, but the general design is the same, he says.
To effect change, Schneiter designed the Clear Flush® Laparoscopic Instrument as an industry alternative to facilitate higher safety standards in the reuse of laparoscopic instruments. The device is now sold by BOSS Instruments Ltd.
The second action Schneiter offers in the fi ght against deep organ SSIs is to stop using any laparoscopic instruments where cleaning and sterilization validation has not been clearly documented. The infection control manager and risk manager should require independent laboratory validation and documentation from all vendors of laparoscopic instruments utilized in the healthcare facility, he says. The vendors independent laboratory validation should follow the Association for Advancement of Medical Instrumentations (AAMI) protocol for cleaning and sterilization validation and must prove that bio-burden can actually be removed from inside the instrument prior to sterilization. If the vendor cannot provide the validation, why would you use the instrument on your patients?
According to researchers of a study that followed the outcomes of 6,000 laparoscopic procedures, improvements in instrument design and clean-ability must focus in particular on the reproducibility of cleaning results. The study was designed to examine the clinical suitability of laparoscopic instruments in terms of function and hygiene.³ The researchers found that after 100 cycles, traces of proteinaceous material in the eluate was found on every fourth instrument inspected (eight of 32); and half of them (four) gave a positive reading when tested with a hemoglobin pseudoperoxidase test stick.
Gaylyne Marshall, RN, CNOR, clinical education specialist for STERIS Corp., adds that every manufacturer of a surgical instrument should be able to provide thorough training for their products. This should include in-service with hands-on training as well as visual aids and videos, and should cover all aspects of cleaning and reassembly of the device, she asserts.
Healthcare organizations also could switch exclusively to single-use, disposable laparoscopic instruments for each and every procedure, Schneiter offers. While expensive, the use of disposable laparoscopic instruments will ensure a clean, sterile, moisture-free instrument for every patient, he says. More importantly, the use of disposable instruments will eliminate the risk of a deep organ SSI caused by a reusable instrument that is difficult, if not impossible, to clean.
Unfortunately, this isnt practical in todays healthcare system. In a perfect world, developing a full range of sterile disposable surgical instruments would virtually eliminate the risk of infection, Marshall recognizes. Unfortunately, this is currently an expensive alternative and is problematic for hospitals due to reimbursement issues.
1.) Food and Drug Administration (FDA). Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data. Federal Register: Sept. 29, 2005. Volume 70, Number 188. 56911-56925. http://a257.g.akamaitech.net/7/257/2422/01
2.) Alfa MJ, Nemes R. Manual versus automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures. J Hosp Infect. 2004 Sep;58(1):50-8.
3.) Fengler TW, et.al. The clinical suitability of laparoscopic instrumentation: A prospective clinical study of function and hygiene. Surg Endosc. 2000 Apr;14(4):388-94.
There are three elements in laparoscopic instrument reprocessing that must be accomplished on every reprocessing cycle to eliminate the risk of a contaminated instrument:
1. The instrument must be designed to be flushed free of bio-burden prior to sterilization. Decontamination is the first and most important step in the sterilization process. Inadequate flushing and removal of organic debris from inside the instrument has the potential to allow for residual bio-burden to be sequestered in bodily fluids that may be contaminated with gram-negative bacteria. You can sterilize it but you may fail to destroy microbial endotoxins that are heat-stable. As every reprocessing technician knows, If it isnt clean, it cant be sterile!
2. The instrument must be designed to ensure 100 percent bacteria kill on every sterilization cycle. Failure to achieve 100 percent bacteria kill during the sterilization cycle has been documented to result in deep organ surgical infections in laparoscopic patients. The instrument must be designed to ensure that the sterilizing agent achieves and maintains total internal surface contact throughout the entire sterilization cycle to ensure 100 percent bacteria kill on every reprocessing cycle.
3. The instrument must be designed to be moisture free after every sterilization cycle. Residual moisture trapped inside the lumen of a one-piece laparoscopic instrument after the sterilization cycle has the potential to colonize and grow waterborne pathogens, resulting in a contaminated instrument. While a skilled technician can remove bio-burden from inside the lumen and operating rod of a take-a-part lap instrument, after it has been re-assembled and sterilized, it is very difficult to remove the residual moisture that becomes trapped inside the assembled instrument during steam sterilization.
Source: Jim Schneiter