We are committed to continuous improvement and we strive to provide you with products that meet and often exceed expectations.
As part of our commitment to you and to ensure that we are delivering the high level of service that you would expect from Timesco, we have collated many of our frequently asked questions regarding single use laryngoscopes below. We hope that you will find this useful however, please do not hesitate to contact us with any further questions that you may have and our dedicated customer support team will be happy to help. You can reach us by calling us on: +44 (0) 1268 297710, emailing us at: firstname.lastname@example.org or via live chat.
IS IT POSSIBLE TO RECYCLE TIMESCO SINGLE USE BLADES AND HANDLES?
Yes – Our Callisto Blades are manufactured from stainless steel and a selection of plastic polymers.
How? It is possible to remove the metal spatula and recycle the metal. The plastics may also be recycled once removed. However, it is unlikely to be convenient or viable at the hospital site so we recommend that the hospital engage with a waste management and recycling company to build a program for this.
As most new stainless steel consists of 25% scrap recycled material, there is a signiﬁcant value to any recovered stainless steel and this could reduce the cost of waste management to the hospital as the waste management/recycling company can cover some costs from the value in the steel. The plastics in disposable handles may also be recycled by a suitable recycling partner.
WHY ARE TIMESCO SINGLE USE BLADES AND HANDLES NOT STERILE?
Application: Laryngoscopes have been considered semi or non critical as they do not come into contact with sterile tissue or the vascular system. As such, a blade or handle that has not been used on another patient is not required to be sterile, only clean or clinically clean.
Recent guidelines advise that once used on a patient, reusable blades and handles must be sterilized or subjected to high level disinfection. Single use blades and handles are to be disposed of after use.
Other Considerations: There are implications to adopting sterile products that also need to be considered. Sterile products will have an expiry date dictated by the sterilization process, this is often 2-3 years and so this limits the date by which a product must be used by.
Timesco clinically clean blades and handles do not have an expiry date (unless dictated by the expiry of a preloaded battery). A sterile device will be a higher risk class for regulatory purposes, either 1A or 2A. This requires a higher degree of vigilance and control. This also brings forward the implementation date for UDI (Unique Device Identiﬁcation) tracking for the device, bringing an overhead of marking, tracking and recording the use of the device.
HOW DO I DECIDE BETWEEN SINGLE USE AND REUSABLE PRODUCTS?
Convenience: Single use blades are supplied clinically clean in pouches and are immediately ready for use. Reusable blades are required to be cleaned, disinfected and decontaminated before ﬁrst use and after each subsequent use.
Storage: Single use blades are stored in the packaging they are supplied in, no additional packaging required. Reusable blades will need to be packed into sterilization pouches (or other sterile packing) for storage and transit before use.
Transport: Single use blades require minimal transport. Reusable blades need to be transported from the reprocessing /sterilization site to theatres and trolleys.
Maintenance & Inspection: Single use blades require no maintenance, simply inspect at the point of use and check the expiry date on the product packaging – the Callisto blade and preloaded handle sets (with batteries) have a 2 year shelf life). Reusable blades will need to be tested after each reprocessing / sterilization cycle before transport to the point of use and then inspected again prior to use.
Wear & Tear: Single use blades and handles are used once and discarded after use. Reusable blades and handles will deteriorate over time. Fibre optic bundles will break down with repeated reprocessing and handling. Ball bearings may become worn over time. Thorough inspection of blades is required after each reprocessing cycle. Worn or damaged blades will need to be replaced.
Tracking & Tracing for Infection Control: Single use blades are to be disposed of after use therefore tracking and tracing is not essential; users may record the lot number for quality control purposes if required.
To ensure traceability to individual patients, tracing of each reusable blade should be adopted. This can be very diﬃcult unless the blade is uniquely and indelibly marked. Realistically, this requires laser marking a unique code on to the blade; a system that needs to be adopted to record all use and handling of each blade to the patient level. Bar code readers are one method of an electronic recording system, but this is both costly to implement and very labour intensive. RFIDs cannot be used as aﬀordable versions do not withstand the autoclave cycle.
Quality: Single use blades are now comparable in design and performance to their reusable counterparts.
A quality reusable blade should provide a high level of performance and reliability, but now, no more so than their single use counterparts.
Disposal: There are costs associated with the disposal of single use blades, recycling and waste management programs can reduce the impact. Reusable blades have a low cost of disposal as high quality blades should last between 5-10 years.
Environmental Issues: There are potential land ﬁll and incineration implications from single use blade disposal, recycling and waste management programs can reduce the impact. There are minimal disposal implications from reusable blades, but there are considerable impacts due to chemicals, eﬄuents, energy and water consumption.
Costs: Unit costs can easily be allocated to each patient with single use blades. Whole of life cost may need investigation to understand the true ongoing cost of reusable blades. Studies have indicated that this can be far in excess of the costs of single use blades with all aspects considered.
ARE SINGLE USE LARYNGOSCOPE BLADES AND HANDLES BAD FOR THE ENVIRONMENT?
The Metal Spatula: Timesco Callisto laryngoscope blades are manufactured from a combination of stainless steel and a selection of polymers. The blade spatula is stainless steel and is of type 210 surgical steel. It is corrosion resistant and the steel can be recycled if a suitable recycling program is in place. With suitable decontamination and harvesting from the other materials in the blades, they may be recycled. In fact, most stainless steels are made from 60% recycled steel (25% old scrap, 35% new scrap from production) and 40% new raw materials.
Callisto blades may be considered to be made from around 50% recycled material. If the blade is sent to landﬁll after use, stainless steel has no damaging eﬀects on soil or water and so is very environmentally friendly at the end of life, whether disposed of or recycled.
The Plastics in The Blade: The block is made of Delrin, a high-performance acetal resin and the light pipe is made from Acrylic. Both of these materials are in very low volume in the overall blade construction. These plastics may be incinerated, but removing them in a hospital environment from the metal spatula to allow incineration is unlikely. If the complete blade is sent to land ﬁll then the Delrin and Acrylic will break down over time but have low impact on soil and water. We recommend a recycling program to allow the stainless steel to be removed and recycled and the plastics to be either recycled or incinerated.
Plastics and Batteries in The Handles: Our Callisto handles are available with preloaded button cell batteries. The batteries are alkaline and are safe for disposal in incinerators. The patented, easy access design facilitates the quick removal of batteries into a separate battery disposal waste stream if required. Over 90% of the material in our single use handles is plastic, either Polycarbonate (PVC) or Acrylic/Makralon. These can be incinerated in hospital waste or sent to land ﬁll. The plastics are not biodegradable and so are often incinerated as they are contaminated waste. Our handles are made with as low a plastic content as possible to reduce the cost of disposal and any negative environmental impact.
Alternatives to Single Use: The choice of opting for a single use system or a reusable version is ultimately one for the user and the various departments within a hospital or clinical environment.
To assess the overall environmental impact, the alternatives must also be considered. Due to growing concerns on infection control and guidelines and protocols surrounding the same, the alternative to single use is to decontaminate and reprocess reusable blades and handles or use high level disinfection. This requires them to be manually washed to remove any deposits or debris and then be decontaminated in a washer/disinfector which requires disinfectants and a signiﬁcant volume of water and electricity. Once fully disinfected, the blades & handles will require autoclaving or gas plasma sterilization. Both will require either water or chemicals and electricity.
The full impacts of these processes is diﬃcult to determine precisely but with an expected life cycle of 5-10 years (possibly more) for reusable blades and handles, the overall environmental impact needs to be considered for the full life of the product
Autoclaving once a day, every day for 10 years could be as high as 3,000 cycles. This also does not include any associated impacts of the movement of the blades and handles across various departments, packaging into sterilization pouches and the overhead of environmental factors by reprocessing staﬀ, lighting, heating, power etc., but it is clear that reprocessing in itself has a considerable environmental impact that should also be carefully considered.
HOW DO TIMESCO DELIVER A RELIABLE, QUALITY PRODUCT?
Research & Development: It starts with an understanding of the users’ needs, the conditions under which the product will be used and all other influences aﬀecting the speciﬁcation of the product. This is handled through close relationships with all stake holders in the use, maintenance and procurement of our devices.
Technical Speciﬁcations: Detailed speciﬁcations are produced to ensure any manufactured parts and devices are to speciﬁc tolerances and controlled parameters. Our devices are designed by us, for us and controlled by us.
Material Selection: Understanding the exact application of each device means careful selection of the materials for manufacture. Each material is tested repeatedly to ensure it is ﬁt for purpose. We do not select materials purely on the lowest cost. We understand that our products are intended to improve and save patients lives. We do not make short cuts on speciﬁcation or materials.
Manufacturing Control: Each manufacturing and assembly process is rigorously controlled. We also validate and test at each production stage. Any product that fails is rejected at that stage, not at the end of the assembly line.
Post Manufacturing Inspection: Before ﬁnal packing, each product is tested again to a detailed, documented testing schedule. This eliminates sub-standard product leaving the factory. We also validate and test all packaging materials, boxes and cartons to ensure the product is not damaged in transit from our factories to our warehouse and quality control departments.
Batch Testing: On receipt at our quality control department, each batch is tested again against our inspection documentation. We test products for ﬁt, function, form and application as well as cosmetic flaws and packaging issues. If the test batches fail, we will quarantine and reject the stock. We do not expect our customers to be our quality control.
Handling & Processing: Approved product is then processed to our inventory. All product handling is carried out to minimise any damage or risk to the product in either storage or transit.
Ongoing Validation: We continue to validate materials and processes on a regular basis. This helps us to stay ahead of potential changes in materials and requirements. Timesco have quality systems in place, including ISO, CE and are FDA approved worldwide.
Customer Feedback & Post Market Vigilance: We listen. Any feedback is processed through our Customer Care Team to ensure, if there is a product complaint, it is escalated through our quality and design teams.
Reinvestment in Research & Product Development:
Continued investment into research and product development helps us stay ahead of the curve. We have been leading and pioneering the single use laryngoscope blade and handle market in the UK for over 15 years. Repeated internal critique of our products has helped us to produce a portfolio of products that are respected worldwide for quality, consistency and reliability. It is an ongoing task to keep improving our products with repeated innovation.