The medical device industry is increasingly relying upon the use of bioabsorbable implants, and that trend will continue to grow. In fact, the bioabsorbable stent market alone is expected to reach $2.4B by 2021, up from $400M in 2016, according to a 2016 MarketsandMarkets report. Traditional sterilization methods, however, have typically posed significant problems for implants like bioabsorbable stents and related FDA Class II and Class III medical devices.
Because REVOX room-temperature sterilization is a recent innovation in industrial disinfection, medical manufacturers are often curious about how vaporized peracetic acid (VPA) could be used in the process without damaging their products. REVOX co-inventor Mason Schwartz says he occasionally encounters some initial misunderstandings about the chemical reaction, and he notes that it’s crucial to differentiate liquid PA from vaporized PA, which is used in the REVOX process.
On-site placement and operation of the REVOX vaporized peracetic acid (VPA) sterilization units are safe, simple, and efficient.
Available large-capacity units can eliminate inefficiencies associated with off-site processing, such as long turnaround times, external quality processes, and the need to maintain large inventories. In-production-line - or JUST-IN-TIME STERILIZATION™ - may further optimize your efficiencies.
To assess the effectiveness of any sterilization process, scientists use a unit of measure called sterility assurance level, or SAL. This figure expresses the probability of a single item in a batch being non-sterile after being subjected to a sterilization process. An effective process has a very low SAL, meaning that there is an extremely small likelihood of any infecting microbes surviving the sterilization.
Medical manufacturers often find the sterilization process to be a big production and logistical challenge. Long lead times, rigid batch amounts, and log-jams at the sterilization contractor can bring production to a halt and leave the customer dissatisfied. So, a sterilization solution that lets manufacturers avoid these problems stands as a big leap forward.
That’s where REVOX® Sterilization Solutions’ unique capabilities come in.
Like all manufacturers, medical device companies are constantly looking for ways to optimize their production efficiency. Because patient safety and FDA compliance are top priorities, effective and dependable sterilization is a crucial part of the manufacturing process. However, many medical device manufacturers currently rely on off-site contract sterilization services that introduce inefficiencies, added costs, and risks into the production cycle.
Medical device manufacturers are constantly looking for ways to improve their production efficiency. For many of them, off-site contract sterilization is a tedious and costly proposition. Because of the long lead-time involved in contract sterilization, companies are forced to assemble large batches of product before they can be processed; this extra inventory consumes valuable warehouse space. Likewise, shipping these large batches across the country adds significant transportation costs, greater work-in-process (WIP) inventory, and delayed customer shipments.
Hydrogen peroxide (H2O2) is a powerful chemical sterilizing agent, and for more than twenty years hospitals, laboratories, and manufacturing processes have been using it in vaporized form (VHP) for decontamination. It’s a potent oxidant, which means it’s effective in killing a wide range of pathogens, spore-forming bacteria, and other microbes.
Low temperature sterilization is often the only option for manufacturers of heat-sensitive products, and until recently, manufacturers only had one option for room temperature sterilization; gamma irradiation. Gamma irradiation is most often used to sterilize disposable surgical instruments; metal, plastic, and rubber items; and liquid pharmaceuticals.
For companies that produce class III devices, the FDA requires not just sterilization of their products but depyrogenation as well. Up until now, that has limited the materials available to product design because of the typical methodologies used to achieve this additional step. But thanks to the REVOX® Sterilization room-temperature, peracetic acid-based sterilization method, medical device, biotech, and pharmaceutical companies now have another, innovative choice when it comes to eliminating the risk of pyrogens.
It’s been over two decades since the FDA approved a new novel method for industrial sterilization. Beginning in the early 1990s—when the last method was given the green light—the agency has become much more stringent in its standards for granting approval. In May, Cantel Medical Corp.’s REVOX Sterilization Solutions process ended that long innovation drought when OsteoSymbionics announced FDA 510(k) clearance of ClearShield™, its Class II cranial implant, which uses REVOX’s groundbreaking sterilization technology.
Learn more about Alternative Sterilization Methods from Mason Schwartz, Contract Sterilization Manager and Co-inventor of the REVOX™ Sterilization Method at MD&M Minneapolis at the Minneapolis Convention Center on October 29. Gain insight on the impact of traditional and novel sterilization methods in fostering innovation and efficiency, including:
LITTLE FALLS, N.J. and CLEVELAND, May 28, 2014 -- Cantel Medical Corp. (NYSE: CMN) and OsteoSymbionics, a leading designer and manufacturer of innovative, patient-specific craniofacial implants, are pleased to announce FDA (U.S.
Biologics lack viable options for sterilization and REVOX® Sterilization Solutions is striving to change that. Peracetic acid vapor sterilization (PAA) is the latest approach in biologics sterilization. It differs from other methods by offering true room temperature sterilization, without the use of heat.
Innovators within the biologics industry segment seem to be uniformly frustrated at the lack of viable sterilization options for their products, accepting aseptic processes as the “next best thing” to sterilization.
The definition of room temperature depends on your source, and you will find a variety of descriptions: 18 - 23°C (64 - 73°F), 20 to 23.5°C (68 – 74.3°F), and 20 to 25°C (68 - 77°F). The most common of these ranges is 20 to 25°C (68 - 77°F).
Room temperature is important in sterilization because as a rule of thumb, chemical reactions double every 10°C. For sensitive materials this means possible compatibility issues; the lower the temperature is during sterilization, the lower the possibility for compatibility issues.
Are the Current Sterilization Options Limiting Your Innovation?
The REVOX™ Sterilization Solutions team recently had the opportunity to sit down with a panel of medical device design experts to educate them on our unique sterilization technology.
Learning more about our capabilities spurred a discussion around the impact that legacy sterilization methods have had on their design capacities and the resulting inefficiencies. Sterilization is often an after-thought when creating a new device; however, it can become a design obstacle which can hinder innovation.
Room Temperature Process Enhances Innovation Potential for Medical Device Manufacturers
LITTLE FALLS, N.J., Feb. 25, 2014 -- Cantel Medical Corp. (NYSE: CMN) announces that the REVOX® Sterilization Solutions business is now registered to the EN ISO 13485:2003 quality standards. The room temperature, Peracetic Acid/Hydrogen Peroxide (PAA) vacuum vapor process enables effective sterilization of heat and/or chemical sensitive medical, drug delivery, diagnostic, and implantable devices that may not be well-suited to other sterilization processes.
Many factors affect sterilization; concentration of the sterilizing agent, temperature, pH, relative humidity, cleanliness of product, whether organic or inorganic matter, innate resistance & population of microorganisms, plus duration of exposure or time.
With so many variables at hand, there is a need to define an industry-wide accepted methodology that characterize sterilization in terms of correlation between duration that achieves sterilization under a standardized set of conditions.
The sterilization process plays a big part in the materials selection of products as part of the product development process. Consider the following key points for sterilization during the product design phase that will greatly enhance downstream supply chain development:
I recently came across several requests on sterilization development for the European market. While each project requires unique regulatory development considerations, the following is a general overview on this topic for the European market.
There are situations when changing the sterilization method of a single-use medical device is required or provides a benefit. Some situations that may warrant this include:
(1) Cost advantages and simplicity of having all products sterilized with same method
Unless I have large product volumes, it’s not worth my while to install an onsite sterilization system, right?
Not necessarily. The decision on whether to go with contract sterilization or an in-house system is based on several factors which include, along with product volume, what types of sterilization methods your product can handle, how fast you need it sterilized, and how much control you want over your product.