As medical device technology continues to advance, a new report by Visiongain [1] predicts the global medical devices market will reach $398bn in 2017 and that strong growth will continue driven by the introduction of innovative devices into the market and also by the demand generated by illnesses associated with an ageing global population.

These medical products, such as implants, instruments and aids, not only need to be sterile, but they also have to be free of contamination from production processes. This is where MecWash’s aqueous cleaning systems are providing the perfect solution for many companies in this sector.

MecWash has a long history of supplying aqueous parts washers to the medical sector. MecWash began working with a major manufacturer of surgical implants many years ago and has since installed several machines that meet their exacting requirements. This relationship prompted MecWash to investigate the sector further.

MecWash now serves many medical customers in the UK and overseas, both OEMs and sub-contract manufacturers, with highly respected names such as A-Dec and Sorin in the USA and Advanex Europe and WTI in the UK all using the Tewkesbury based company’s component washing systems to ensure they have industry leading parts cleanliness.  

A-Dec (USA), one of the world's leading manufacturers of dental instruments, chairs, delivery systems, and dental lights, purchased two new MecWash aqueous parts washing systems to meet their dual objectives of optimum part cleanliness and becoming a zero-discharge industrial wastewater manufacturer. 

The new equipment, which includes Midi and Duo aqueous parts washers coupled with an Aqua-Save Junior water recycling unit for each system, meet the new environmental regulations while attaining industry leading parts cleanliness.  

Chas Stark, A-Dec manufacturing engineer, says: “Clean components are integral to ensuring that quality. At the same time, we are committed to environmental quality. These new MecWash parts washing systems allow us to meet the highest component cleanliness standards and helps A-Dec conduct its manufacturing operations in a manner that is environmentally responsible and consistent with that of a good corporate citizen and neighbour.”

Another satisfied customer is Advanex Europe which makes products used in a variety of sectors including medical, and these must be manufactured to meet the stringent requirements demanded by the health sector. The firm makes medical coil springs and metal pressings that are used in metered dose inhalers, auto injection systems and nasal sprays.

MecWash’s AVD aqueous cleaning machine proved it was more than capable of meeting Advanex Europe’s stringent cleanliness requirements. Rob Newham, Head of Coil Thread, says: “We trialled several companies to achieve improved cleanliness for our parts; MecWash was not only able to supply the most suitable equipment, it also provided the correct chemical formulated to our requirements, achieving fantastic results that were beyond our expectations.”

In the USA, medical device growth is the largest in the world and Sorin Group (USA) is a global company and leader in the treatment of cardiovascular diseases. During cardiac surgeries, surgeons utilize protective caps to cover tubing and connectors in medical operating rooms and a key step in the manufacturing of these plugs is to ensure cleanliness. It is crucial that these caps are cleaned thoroughly prior to use and meet very exacting cleanliness standards as they are essential to protect patient health.  

To streamline manufacturing, ensure the highest cleanliness standards, and optimize resource, Sorin has selected MecWash Systems’ Duo aqueous cleaning system which not only meets the United States Food & Drug Administration’s requirements for cleaning agents used in operating rooms but also Sorin’s own rigorous standards. 

Due to the success of the MecWash Duo, which was installed in Sorin Group’s Arvada, Colorado facility, return on investment for bringing the cap cleaning process in-house was made within the first year of operation.

Another medical device company that uses MecWash’s proven technology is WTI (UK). Established in 1989, the company manufactures wire thread inserts for medical equipment that meet a number of internationally recognised standards. 

Andy Mason, WTI’s managing director, said: “We were looking for a new cleaning system to provide us with a higher degree of product cleanliness and to help increase production capacity.  Seeing the Duo demonstration convinced us without a doubt that it was the best system for our particular requirements.” 

John Pattison, managing director at Tewkesbury-based MecWash, explains: “The medical devices market is showing continuous growth driven by various factors such as an ageing population, innovations in medical devices, changing lifestyles and increasing awareness about medical conditions and available treatments.

“As many of the devices being manufactured for use in the medical sector are going to be used inside someone’s body, for example replacement knee or hip joints, stringent cleanliness standards are quite rightly in place to protect a patient’s health.

“Our aqueous cleaning systems can provide numerous benefits for companies supplying components to the medical sector in terms of effectiveness, minimal surface residue and easier validation of cleaning methods as well as peace of mind that they are meeting the highest possible standards with their own cleaning regime.

“MecWash systems ensure the necessary cleanliness can be achieved reliably, consistently and cost-effectively regardless of whether it is implants, surgical instruments or many other medical products.

“If any contaminated products are released, this exposes the manufacturer to substantial liabilities so cleaning in this sector is among the most critical of processes.  

“Our component cleaning systems offer faster cleaning and reduced human labour as they can be pre-programmed so they will work just by the press of a button and systems also take up less space and use less water than other methods so they offer real efficiency savings as well,” he added.

Crucially they also guarantee that parts have undertaken a consistant process, which manual cleaning can never do.

MecWash also employs a PhD chemist to develop bespoke formulations of wash fluid to best meet the requirements of each individual customer and to ensure they meet customers’ detailed surface chemistry needs.

John adds: “MecWash understands that all of our customers have their own specific requirements, issues and objectives – we work closely with them throughout all stages of the project to ensure we achieve the best results possible, rather than offering a ‘one size fits all’ approach.”

John adds: “Typically manufacture of medical products requires careful consideration of the size and configuration of the processing equipment and suitable cleaning techniques. Manual cleaning may be adequate for bench-scale production but large-scale manufacture will be better served by a high quality system such as the ones we offer.  The built-in process controls that this provides demonstrate consistant quality to process auditors.

“Our systems can also be configured to offer good loading patterns for a wide variety of components with tailored baskets,  racking, fixtures or using automation.

“As a company, we pride ourselves on being able to provide bespoke systems to meet any needs so I would urge anyone interested in finding out more to contact us or visit our website,” he added.

Pictured is a MecWash AVD aqueous cleaning machine installed at Advanex Europe to ensure components meet the highest standards of cleanliness.

[1] Visiongain report can be found here.