Sterimedix; Keeping its Eye on the Ball
Sterimedix is a medical device manufacturer in Worcestershire, supplying a range of more than 250 instruments for ophthalmic surgery to over 60 countries worldwide. Constant investment in tooling has optimised accuracy and productivity in their wide range of precision surgical instruments.
Sterimedix Limited designs, manufactures and supplies single use products for ophthalmic surgery. The instruments are generally used in cataract surgery as well as other ophthalmic procedures. Based in Redditch, Worcestershire in England they distribute their products worldwide to nearly 60 countries including Korea and Japan.
Like most medical device manufacturers, Sterimedix realises how critical it is for its instrumentation to be perfect; ready for the ophthalmologist to use for different surgical procedures, every time. With over 250 instruments in its range all providing a different function, Sterimedix has its work cut out inspecting the component parts and finished instruments for imperfections such as burrs.
Sterimedix’s wide range of ophthalmic surgical instruments include: retrobulbars for injecting anaesthetic into the muscle cone – shown in Figure 1.0 and the tip itself in Figure 1.1.
Irrigating/aspirating handpieces for removing cortical debris or viscoelastic substances, while maintaining the anterior chamber during cataract procedures – shown in Figure 2.0
Olive tipped capsule polisher, designed for polishing and cleaning and residual cortex from the capsular bag. Shown in Figure 3.0 and the tip itself in Figure 3.1.
All of the instruments in the Sterimedix range are critical for successful surgical procedures. For example, burrs are a constant worry for Sterimedix because any instrumentation with burrs can cause irreparable damage to the eye where fluid and tissue can be dragged from the eye inadvertently.
Most of the instruments are manufactured using alloys such as stainless steel and silver solder. During the manufacturing process of the instruments a variety of methods are used to form them into the desired configurations including soldering, pressing, machining and polishing. What makes these methods impressive is the size of the instruments with diameters of the tubular components as little 0.1mm and wall thicknesses down to microns. Most of the manufacturing methods are completed under magnification through stereo microscopes. With surgeons using the instruments working under x20 magnification, it makes sense for these precision instruments to be inspected under the same objective intensity.
For example, the olive tipped capsule polishers, designed for polishing and cleaning are soldered at Sterimedix. Both the olive tips and the tubular components are supplied separately. It is, therefore, essential that both the tubular and olive tip components are fully inspected before any manufacturing and soldering takes place. Any burrs on the olive tip during the polishing of the residual cortex may even tear the fine membrane sack which must remain intact to accommodate the artificial lens which is implanted at the end of the procedure. If any burrs are left on the inside of the olive tips, it will restrict the tissue removal so the procedure will take longer or could be almost impossible where tissue is unable to pass through the tip.
It is critical that the eye retains a constant pressure during surgical procedures and so when using the irrigating/aspirating handpieces for removing cortical debris and maintaining the anterior chamber, a burr-free instrument is critical – any burrs on the tip may compromise the integrity of the eye anatomy and most surgeons would refuse to continue to use the instrument.
Magnification is used at most stages of the manufacturing process where accuracy and precision are vital in the production of such critical instrumentation. For example, before the components are assembled it is essential for Sterimedix to inspect the components in goods-in, especially if there is little established history with the supplier. The critical inspection process utilises a Mantis Elite stereo inspection system to inspect for burrs and surface marks from machining.
David Bailey, Technical Director of Sterimedix explains the importance of using the Mantis Elite for the inspection at goods-in.
“We have invested in the Mantis Elite to inspect the components coming into our goods-in department. Historically, we have found we have to inspect 100% of the components coming in, especially if we have limited history with our suppliers. Once we have a recorded history with reliable suppliers we use batch inspection, however this is still a lengthy process but extremely valuable in providing consistently precise instrumentation.
“The Mantis Elite allows our inspectors to maximise the use of their hands when turning and rotating the component. With other magnification systems, we have found we have to spend needless time aligning the binocular head to see the product clearly. However, with the Mantis Elite and its viewing head, we can see the component instantaneously. The eyepieceless viewer allows our inspectors to see the components in stereo and the clarity is important for inspecting the surface for imperfections where slight marks make the parts unusable”.
The Mantis Elite from Vision Engineering is a patented eyepieceless stereo microscope with long working distances, wide field of view and a large depth of field. With 24 LEDs the Mantis Elite provides the operator with bright, white illumination for inspecting medical devices where clarity and shadow free illumination is critical. Available with objectives up to x20, the Mantis Elite is a stereo viewer offering great versatility with an interchangeable turret allowing operators to inspect at low magnification (x2) to higher magnification (up to x20) instantaneously. The advantage of this feature means operators can inspect a medical device component under relatively low magnification for routine observations, and then switch the turret allowing inspection to be conducted under higher magnification, if there is an area requiring greater inspection and attention.
What makes the Mantis Elite a good investment is the eyepieceless viewer, maximising both accuracy and productivity because operators do not suffer the fatigue they would with a microscope utilising a conventional binocular eyepieces. The eyepieceless viewing head employs patented optics where the apparent focal length of the image viewed through Mantis is exactly the same as the true focal length from the eyes to the subject. This not only allows for easy sample manipulation, but also avoids the need for the eyes to refocus when switching views between Mantis and the subject.
Sterimedix is an innovative company working closely with changes in technology in ophthalmic surgery to modify and invent their precise instrumentation, usually with continuous improvement on size considerations and functionality with demand for tools to be smaller with increased efficiency.
With investment in both tooling and management systems like ISO 13485:2003 and ISO 3001:2000 they can trace their instruments with a quality and production history. Continual improvement on procedures and processes in the manufacture of their wide range of ophthalmic instrumentation maintains CE certification together with United States FDA registration, Korean FDA and Health Canada. Sterimedix are now recognised as a global company operating to regulations implemented around the world. With forward thinking design and investment in tools like the Mantis, Sterimedix has maximised their efficiency and productivity becoming leaders in the design and manufacture of ophthalmic instrumentation meeting the demands of both their distributors and customers.