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If you own a Steris System 1 tabletop liquid chemical processor, you have until Aug. 2, 2011, to buy a replacement, says the Food and Drug Administration, which issued a safety advisory — not a recall — warning that it hadn't approved or cleared the SS1 in its currently marketed form and that it couldn't guarantee that the company's claims about its safety or efficacy were accurate.
Sterile processing educator Nancy Chobin, RN, AAS, ACSP, CSPDM, says you shouldn't delay in making the switch. "People need to take this seriously," she cautions, noting that while the FDA won't penalize facilities, lawyers may use the agency's warnings as an invitation to take legal action against those that continue to use the SS1. More importantly, she says, "we have to do what's right for the patient."
As you survey your reprocessing options for flexible endoscopes on the next 2 pages, Ms. Chobin offers the following guidelines to ensure your endoscopes are compatible with the device and chemicals you use to process them.
- Make a list of all the devices you're processing in the SS1, including their catalogue numbers.
- Determine whether you need to sterilize the items or if you can move them to a high-level disinfection process instead. For flexible endoscopes, this is a given: High-level disinfection between uses is the minimum requirement.
- Contact the scopes' manufacturer(s) and request the most up-to-date information on the scopes you use. If you use scopes from more than 1 manufacturer, don't assume that just because 1 model is validated for a certain reprocessor or chemical, they all are.
- Are all of your scopes compatible with the same reprocessing systems? If you find that not all the scopes you have can be processed in the same device, consider replacing some scopes so they can all go in the same reprocessor, instead of implementing more than 1 reprocessing system.
- If all of your scopes can't be transitioned to a reprocessing system you already have, you'll need to investigate the options and purchase a new system.
- Consider what changes you'll need to make to accommodate new reprocessing equipment. For example, if you switch to glutaraldehyde, there are ventilation and personal protection equipment requirements you must meet, says Ms. Chobin.
A final caution: Your scopes might take a beating when you first switch to a new system. "When you switch to a new chemical after your scopes have been exposed to a particular chemical over a very long period of time, there can be an antagonistic reaction to this type of material," says Ms. Chobin, recalling what happened when facilities started switching from glutaraldehyde to gas plasma in the 1990s.
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Flexible Endoscope Reprocessing Options |
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Optreoz Low Temperature Sterilization System from 3M. Currently under FDA review and not yet approved for sale in the United States, this new ozone and hydrogen peroxide-based low-temperature sterilization technology could offer a single solution to what has historically required 2 or more sterilization technologies, says 3M. Developed by Canada-based manufacturer TS03, the technology would let you sterilize a wide range of general surgical instruments, rigid channeled devices, and both simple and complex flexible endoscopes. Optreoz has been cleared in Canada. www.mmm.com/infectionprevention EvoTech Endoscope Cleaner and Reprocessor from ASP. The EvoTech makes endoscope reprocessing a totally automated process by eliminating the tedious and sometimes inconsistent manual cleaning required when using traditional AERs, says the company. The device doesn't eliminate the need for bedside pre-cleaning, but does save your staff the extra step of manually cleaning endoscopes before placing them in the EvoTech ECR when selecting cycles that include a wash stage. The automated process gives both physicians and patients confidence that the scope used has been consistently cleaned, says ASP. www.aspjj.com/alternatives Sterrad NX Sterilization System from ASP. Endorsed by leading medical device manufacturers, the Sterrad NX provides fast, gentle, low-temperature sterilization of surgical instruments. With more than 15,000 systems installed worldwide, ASP says its Sterrad systems have a solid performance and safety record and are environmentally friendly, as they don't require aeration or ventilation. The only byproducts of use are oxygen and water vapor. www.aspjj.com/alternatives LIC Parametric Release Instrument Processor from Langford IC Systems. The liquid chemical Parametric Release Instrument Processor system is unique in that the technology eliminates the need for connectors and is designed to process a variety of medical instruments, including but not limited to endoscopes, in a single chamber. It delivers the 3 critical steps required to process a reusable medical instrument: integrate cleaning to less than 2 micrograms of protein per square centimeter; sanitize to greater than 10-6 with no surviving microorganisms; and rinse the germicide residue with sanitized rinse water without compromising the sanitizing step. $110,000, www.licsystems.com Advantage Plus from Medivators. This fully automated, computer-based endoscope reprocessor, which uses single-shot Rapicide PA peracetic acid disinfectant, features individual channel connectivity and blockage monitoring as well as continuous leak testing and detergent and alcohol flush. Its ergonomic design incorporates large, dual, asynchronous reprocessing basins, a barcode reader and hands-free lid operation. Other features include simple touchpad controls and a large flat-screen display. $57,500 for unit with compressor, www.minntech.com/medivators CER-1 and CER-2 from Medivators. These compact, semi-automated endoscope reprocessors are designed to quickly reprocess 1 or 2 flexible, immersible endoscopes per cycle. The systems feature simple push-button operation and can be placed on a countertop or Medivators' mobile cart (optional). Compatible with a variety of high-level disinfectants, the CER systems include lid locks that prevent disinfectant exposure during the reprocessing cycle. CER-1: $11,780 (when used with Rapicide) or $12,180 (when used with other HLDs); CER-2: $19,220 (Rapicide) or $19,620 (other HLDs); www.minntech.com/medivators DSD-201 from Medivators. With 2 fully independent and asynchronous reprocessing basins, this automated endoscope reprocessor allows for quick high-volume endoscope turnaround. The system has user-programmable reprocessing cycles to accommodate a variety of high-level disinfectants and an enhanced sensor package that monitors all cycle parameters to ensure complete endoscope disinfection, says the company. It also has a log printout that documents all cycle parameters and an optional built-in leak tester. $33,650, www.minntech.com/medivators Reliance Endoscope Processing System from Steris. Eliminates staff exposure hazards associated with aldehyde-based high-level disinfection solutions and processors through the use of a generated oxidizing chemistry. Its single-use chemistry ensures the efficacy of every cycle, and its dual-scope processor safely accelerates throughput, says Steris. EPS features include "boot" technology for virtually connector-less scope reprocessing, a process indicator to detect an effective dose of high level disinfection solution, one-touch processor decontamination cycles, optional washing phases and single or dual scope processing options. $41,973, with automated leak testing, air compressor and countertop available as additional options, www.steris.com/products/view.cfm?id=3683 Amsco V-PRO 1 Plus Low Temperature Sterilization System from Steris. With a large rectangular chamber that can process more devices per cycle than other low-temperature sterilization systems, the V-PRO 1 Plus helps accelerate processing and enhance productivity, says the company. The 28-minute non-lumen cycle processes devices such as telescopes, light cables, cameras and batteries, while the 55-minute lumen cycle sterilizes lumened instruments such as trocars and cannulas. Other features include a simple one-touch control, environmentally friendly sterilant (vaporized hydrogen peroxide) and low utility use, and 24/7 remote monitoring capability that enables predictive maintenance and helps optimize equipment uptime. $172,500, www.steris.com/vpro1plus System 1E Liquid Chemical Sterilant Processing System from Steris. Running a 23-minute cycle, Steris' newly FDA-approved System 1E provides fast reprocessing of cleaned, reusable, immersible, heat-sensitive critical and semi-critical devices. The liquid chemical sterilant processing system uses 2 pre-filters, UV irradiation and a MaxPure filter, working in harmony with S40 Sterilant Concentrate as a validated process. Steris says the system's use-dilution is gentle on delicate instruments, including multi-channel flexible endoscopes, has neutral pH and rinses safely down the drain. www.system1e.com OER-Pro from Olympus. The new OER-Pro reprocessor can clean and disinfect 2 flexible endoscopes in just 29 minutes, allowing for quicker turnaround and increased throughput in your facility. Designed to be compatible with Olympus endoscopes, the OER-Pro automatically flushes the endoscope channels, eliminating a manual step during reprocessing. The system uses Aldahol, a high-level disinfectant with 3.4% glutaraldehyde and 26% isopropanol and features charcoal filters to reduce your reprocessing staff's exposure to chemical vapors. Keep track of who reprocessed your scopes and when with the radio-frequency identification management system that records the scope serial numbers, staff member and time and date of reprocessing. $29,000 to $34,000, www.olympusamerica.com/reprocessing |
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