Smartline to Manufacture World-First Digital Solution
Smartline is introducing a new data management system for the company’s leading endoscope drying cabinets that will combine expertise around compliance and software development.
CleanPath software, the solution being fast-tracked, will deliver Smartline’s customers the ability to track medical devices’ location, operator activity and validate cleaning of sensitive surgical equipment.
“Australia’s manufacturers like Smartline Machinery are well-placed to gain a competitive edge through product and service differentiation,” said Dr Jens Goennemann, the Managing Director of the Advanced Manufacturing Growth Centre, whose team is supporting CleanPath’s development through $150,000 in co-funding.
“Smartline Machinery will be first to market with an offering that will help their clients meet increasingly tough standards in Australian, European and US markets, as well as increase Smartline’s earning potential through servitisation.”
By 2022, these markets will have to meet standards under AS4187 and EN 16442, with stricter requirements around monitoring and recording parameters such as temperature, pressure and humidity.
The new data system allows for remote monitoring of medical equipment and devices, and the possibility of creating new roles for high-skilled technicians at Smartline’s headquarters, providing services such as value stream mapping and infection control reports.
This solution, delivered by Smartline Machinery, illustrates the critical role servitisation plays in enabling Australian manufacturers to enter the global supply chain through adding value beyond only production.
“What we’ve done is pioneered beyond basic-type product and are now going into higher-technology products utilising RFID, database and cloud-hosted technologies, and the ability to do remote services and tailored customer support into new and emerging markets, which is supported by our patented technology,” explained Will Smart, Managing Director and founder of Smartline Machinery.
The company has an installed base of around 350 endoscope cabinets in Australia and 180 overseas. Established in 1996, Smartline Machinery provides a range of solutions for the healthcare and medical markets, and manufactures products including sinks, tables, loanset and CSSD equipment, trolleys and IV poles.
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Smartline Products Officially 'Australian Made'
Smartline has reaffirmed our dedication to being Australian owned, made and serviced.
It was with great excitement that the business was recently licensed as Australian Made, with the ability to use the iconic green and gold kangaroo logo on our key product ranges.
Smartline’s RotaScope, SlidaScope, Lineardry, SmartSink, SmartPack and SmarTrack have all been licensed by Australian Made Campaign Limited and the Australian Made logo can now be used across these product ranges.
The license comes shortly after Smartline’s RotaScope and SlidaScope Endoscopy Drying and Storage Cabinets received the highest level of Certification of Compliance with the European Standards EN16442.
After months of extensive testing by independent assessor Biotech-Germande, both forced air-drying cabinets were awarded Certificates of Compliance to EN16442 across all 9 applicable requirements.
Smartline Leads Industry with EN16442 Compliance
Smartline has become the only endoscope storage cabinet manufacturer to receive compliance with European Standards EN16442 across the 9 applicable requirements.
After months of extensive testing by independent assessor Biotech-Germande, both Smartline Machinery’s RotaScope and SlidaScope forced air-drying cabinets have been awarded Certificates of Compliance to EN16442.
The Certificates of Compliance further detail that Smartline Machinery’s cabinets comply with not just one, but the nine applicable requirements under the standards.
EN16442 is widely regarded as the most stringent standards globally for the storage of Thermolabile Endoscopes, and has been accepted within the Australian medical industry as the preferred standards, with all endoscope storage cabinets to be compliant by January 2022.
The requirements laid out by EN16442 aim to prevent the spread of superbugs enabling endoscope to be safely reprocessed and stored.
Smartline’s General Manager Ross Norman said: “We are excited to announce that after months of research, development and investment, followed by extensive independent testing, our RotaScope and SlidaScope storage cabinets have surpassed competitor products.
“It is our understanding that we are the only manufacturer of endoscope storage cabinets to have reached compliance across all 9 relevant areas of the EN16442 Standards, ensuring our cabinets are leading the way for the industry.”
Smartline’s Design & Estimating Manager Brett Best, who project managed the development of the cabinets, travelled to Biotech-Germande’s headquarters in France earlier this year to deliver Smartline Machinery’s RotaScope and SlidaScope storage cabinets and oversee the testing.
“It has been a comprehensive process to have every aspect of our cabinets’ processes analysed by Biotech-Germande, including testing across a diverse range of scope families covering major endoscope manufacturing brands Olympus, Fujinon and Pentax,” Brett said.
Smartline's Managing Director Will Smart said: “Smartline Machinery is committed to evidence-based practice and we are pleased that the independent testing by Biotech-Germande has proven that our cabinets surpass current industry standards.”
All Smartline RotaScope and SlidaScope cabinets are sold as EN16442 compliant, while the Smartline’s modular designs mean many of the company’s existing cabinets can be ungraded to meet EN16442 Standards.
Smartline’s forced air-drying cabinets are also TGA-approved.
SMARTLINE'S BIOTECH-GERMANDE COMPLIANCE CERTIFICATE TO EN16442
- Maintaining microbial quality of the endoscopes during storage.
- Cross contamination between endoscopes during storage.
- Endoscope Drying function of cabinet.
- Contamination levels on inside surfaces of cabinet.
- Endoscope Channel Aeration.
- Cabinet Information Readability.
- Airborne microbial contamination inside of cabinet.
- Air Exchanges.
- Cabinet Cabin Pressure Positive.
Smartline wins Sunshine Coast Business Award
martline Machinery is incredibly proud and honoured to have been named 'Building & Manufacturing Business of the Year' at the Sunshine Coast Business Awards 2017.
Smartline Machinery is Australian owned and manufactures innovative medical equipment and healthcare solutions that can be found in hospitals and medical centres in every state and territory in Australia and are distributed to 52 countries internationally.
Since being founded in 1996, Smartline Machinery has sought to lead the healthcare industry nationally and internationally with the development of quality, innovative products with a range currently including hospital equipment, trolleys, storage solutions, height adjustable tables, sinks and sterile storage.
Congratulations to the entire team, whose hard work and dedication is seeing Smartline grow in leaps and bounds.
The Future of Endoscopy Storage
The Gastroenterological Society of Australia (GESA) revealed its Consensus Statements on infection control in Endoscopy during Australian Gastroenterology Week on the Gold Coast on August 22.
The statements follow several overseas outbreaks of Carbapenemase-Producing Enterobacteriaceae (CPE) and were created by a committee of experts in a bid to offer advice on best practice.
The Consensus Statements also provide a clear indication of what will be included in the forthcoming updated Infection Control in Endoscopy Guidelines.
Of the nine statements, three directly relate to and solidify the cutting-edge work that Smartline Machinery has been undertaking in the area of Endoscopy Storage.
Statement 4 states: “Quality control is fundamental to the delivery of efficient and safe endoscopic procedures, and incorporates proof of process.”
This is something Smartline Machinery has been striving for with the development and advancement of our RFID Scope Data Monitoring and Display System which tracks and records the full washing and storage cycle of each individual scope from washer to patient.
Each scope stored in our RotaScope or SlidaScope Endoscopy Cabinets has an individual RFID Scope Tag which is used to track, record and report on the scope’s wash status and history.
This extremely high level of record keeping and accountability is something Smartline is very passionate about and proud to be pioneering. We are proud to offer washer to patient validation.
The GESA Consensus Statements also reaffirm the use of forced air-drying cabinets, like Smartline’s Rotascope and SlidaScope Cabinets which utilise HEPA-filtered Air Drying.
Statement 7a reads: “All endoscopic instruments, except those in sterile packaging, should be stored in TGA-approved forced air drying cabinets.” Smartline's TGA number is ARTG 140018.
Statement 7b states: “Endoscopes stored in TGA-approved forced-air drying cabinets may be used for a period of up to 7 days without reprocessing, unless otherwise stated by the manufacturer.”
Smartline’s Data Management System assists this with countdown timers for each scope and printed scope validation labels with ‘Expiry Date and Time’ information.
Smartline’s clients will also be pleased to learn that many of Smartline’s existing cabinets can be upgraded with Air Drying and Data etc to meet these standards at a much lower cost than investing in a completely new cabinet/s.
In the opening speech for the Consensus Statements announcement at GESA AGW 2017, Associate Professor Benedict Devereaux said compliance for all flexible endoscopes must be reached in forced air-drying cabinets by January 2022.
For more information on upgrades and/or how our products can help you achieve best practice, give the Smartline Sales Team a call on +61 7 5478 99 77 or email firstname.lastname@example.org.
Sterilisation Standard for Australia & NZ 2016
In 2016, AS4187 – Sterilisation Standard for Australia and New Zealand was updated and now includes Endoscopy. The result of the inclusion in AS4187 is significant to Endoscopy departments, as it now requires scopes to be treated much more sensitively - as either a sterile instrument or a high level disinfected instrument. Smaller scopes, such as ENT and Bronchoscopes, may now be low temperature sterilised after being washed – then stored wrapped in a basket until use like any other sterile instrument.
This update affects the entire process of washing, handling, and storage of scopes. Scopes may still be manually washed but automatic washers (AER) isbest practice is for washingscopes. Scopes are to be contained when moving between areas and transported in containers, clean tubs etc. Scopes should have improved storage, ventilated and/or HEPA airflow cabinets.
Currently GENCA guidelines remain as best practice until AS4187 and EN16442 are adopted and implemented in 2020.
Older guidelines do allow use of “no air cabinets” if they are of non-porous material construction, vertical hanging and suitably vented (all older scope cabinets by Smartline meet this standard at entry level).
GENCA has noted that cabinets with airflow are best practice, as a dry scope is far less likely to grow bugs post-processing. However, these sites MUST be upgraded to meet the new EN16442 Standards by the year 2020.
Smartline recommends that new facilities consider investing in cabinets that can be upgraded to future proof the design and suitability of the cabinets purchased to meet EN 16442 by 2020, rather than the alternative of paying the premium now to have fully compliant EN16442 Cabinets immediately.
Smartline RotaScope Cabinets comply with current standards, and are designed to easily be upgraded later to attain EN16442 compliance – via an electronic module with various environmental monitoring devices for pressure, temperature and humidity (added via an upgrade kit at some stage between now and 2020).
This “Staged Implementation” allows the cabinets with air to meet current best practice under GENCA, but will also allow the upgrade to meet EN16442/AS4187 requirements. The cost of the cabinets without EN16442 certification is considerably less, making the capital spend more attractive now.
Staged Implementation allows centres to utilise fully functioning cabinets now that still dry and function as per the EN16442 requirements (dry scopes in less than 3 hours), but the additional expense of the EN16442 electronics is not required. Smartline has developed a process to make the transition easier, lower cost and guaranteed to work effectively to meet the final 2020 requirements. Once fitted with the EN upgrade kit, cabinets are calibrated and issued with a Certificate of Compliance (renewed annually).
Many sites which have Smartline RotaScope cabinets built in 2014 onwards may also be eligible to have EN16442 upgrades completed to bring them up to standards. This allows Smartline to provide value, and continue to service existing clients. Sites will be evaluated on a case by case basis, as they will require various stages of implementation of data, air and eventually the EN16442 upgrade kit. Upgrades are very competitive and ease the cash flow of sites over the period, to ensure compliance is achieved as required.
In mid-2017 a new series of drawer style horizontal storage cabinets will be released with the same upgradeable specifications to finally meet EN16442. These clean, safe and competitive “SlidaScope” cabinets are currently under compliance testing and almost ready for release.
Please chat with the specialist product team at Smartline Machinery today, to discuss the options in more detail. Smartline Machinery is an Australian Company supporting the needs of the Australian Marketplace and providing better Value Options to attain a validated outcome.