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November 28, 2018

Colorful Cleanrooms and Cochlear Implants

Does Paint Color Create a Better Contamination-Controlled Environment?

Conceptual image about human hearing

Just a couple of decades ago, the concept of biohacking – deliberately blurring the biological line between man and machine – was little more than just that: a concept, confined mainly to the avant garde of science fiction and futurism. And this was with good reason. When we think of enhancing human abilities with the aid of technology, images of superheroes and cyborgs frequently come to mind – larger than life characters drawn from the pages of Marvel comics and from Hollywood. But in a new era where the routine hyper-connectedness of an IoT world meets the drive of the growing transhuman movement, body modification in pursuit of ultimate wellness and physical excellence is becoming increasingly mainstream. Just last year a review of – shall we say – ‘cutting edge’ biohacks was published in Digital Trends, among which an antenna transplanted onto the occipital bone allowed a patient with achromatopsia (complete color blindness) to ‘hear’ colors, and a prosthetic camera was attached to a human eyeball to deliver the ultimate in ‘point of view’ movie experience.(1) And of course there are the perhaps less ‘cool’ (we say less shocking) blood test implants wherein a fistful of sensors, a radio transmitter and a power source are implanted to constantly monitor lactate, glucose, and ATP, recharging through an external battery patch on the patient’s skin. And while RFID chips or biomagnetic implants are still on the other side of the acceptability edge for most of us, there are some devices that we accept more readily. Let’s think about cochlear implants, for instance…

Outside of ‘hearing colors’, the ability to hear sounds is something that we often take for granted. And as such few of us take the time to consider the complexities of the auditory system.

While we are not as gifted in terms of hearing as other species – say, bats or elephants – the human ear is nonetheless a remarkable system. Sound waves are fundamentally simple vibrations that travel through the air and are collected by the pinna – the soft fleshy part of the ear – on either side of the head, to be channeled into the ear canal. Separating the outer ear from the middle ear is the eardrum, a membrane stretched across the end of the ear canal that vibrates with incoming waves. These vibrations in turn move a chain of small bones – the malleus, incus, and stapes – thereby transferring the vibrations into the inner ear. And this is where the magic happens. Situated therein is the cochlea, a fluid-filled chamber that famously resembles a snail-shell, in which the vibrations of the stapes bone stimulate hair follicles that respond to pitch and frequency. Each hair cell responds to a very specific frequency and generates impulses that are detected by the auditory nerve and relayed thereafter to the brain. Within the auditory cortex – sited on the superior temporal gyrus of the brain’s temporal lobe – the data stream of nerve impulses is decoded as meaningful sound. And for those of us with moderate to good hearing, this all happens almost instantaneously.

However, for numerous reasons, our sense of hearing can fail.

Conductive problems of the outer ear could be caused by a build-up of wax or an eardrum perforation; issues with the middle ear – sensorineural hearing loss – could be caused by damage to the hair follicles within the cochlea; and it is also possible to experience a mixture of both types of hearing loss. And in the case of moderate to profound hearing loss, cochlear implants are generally recommended by doctors to patients. But what are these implants and how are they different from ‘hearing aids’?

A relatively new device, the cochlear implant was first invented only 36 years ago by a Professor Graeme Clark, a surgeon at the University of Melbourne, Australia.

Implanted into test patient Graham Carrick, the device successfully restored hearing to the subject for the first time in 17 years, propelling the invention into the public spotlight and toward commercial success. Within three years, Clark’s invention had received U.S. Federal Food and Drug Administration (FDA) approval, becoming the first multiple-electrode device to be approved by any regulatory body worldwide and arguably creating the first cyborg in the field of electronically-enhanced audiology.

But its journey to widespread acceptance has not been without controversy. A cochlear implant is so much more than an over-the-ear hearing aid.

Surgically implanted into the patient, part of it resides within the body converting the digital signals it receives from the sound processor worn behind the ear into electrical impulses. These impulses are then transmitted via an array of electrodes within the cochlea to the auditory nerve before being reinterpreted by the brain as sound. All of which seems straightforward but problems associated with surgical intervention do exist, not the least of which include cerebrospinal fluid leakage, tinnitus, or perilymph fluid leaks. Moreover, given the proximity of the surgical site to the facial nerve which runs through the middle ear the risk of temporary or even permanent facial paralysis exists.

Although the benefits of the device are myriad – better hearing in noisy environments, ability to hear confidently on the phone, reconnection with music, enhanced safety through clearer interpretation of ambient and background noise – there have been recalls of the device too. In 2010, the Advanced Bionics HiRes 90K Cochlear Implant was recalled due to users experiencing ‘severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.’(2) In this case, ‘explantation’ – the surgical removal of the device – was required, causing additional pain and suffering to the users. And in 2011 the Cochlear Nucleus C1512 Implant was recalled due to the tendency of the device to shut down abruptly and cease to function. The cause of the failure was reportedly related to moisture affecting one of the twin electrodes causing a failure in one or more diodes. Moreover, according to a legal brief filed by Shoop, a product liability law group based in Beverley Hills, CA, the fact that the moisture did not originate from the user’s body indicated a manufacturing failure, and potential risk of contamination and infection.(3)

Part of the reason cited for these failures could be the fact that unlike here in the United States the European Union has no centralized governing body that regulates medical devices before they get to market.

As regular readers of this blog will recall, medical devices such as these implants are regulated by the Federal Food and Drug Administration, along with tools such as testing strips, anesthesia delivery systems, diagnostic meters, stents, pacemakers, and the like. But given a report recently released in the United Kingdom, we have to wonder whether our own safeguards are sufficient. According to a report published last week, an investigation by The Guardian, the International Consortium of Investigative Journalists, and the British Medical Journal caused the Royal College of Surgeons to comment that ‘urgent and drastic changes to the rules around medical devices […] are needed to protect patients.’(4) According to the report, medical devices are failing patients in very serious ways including breaking apart within the body, misfiring, and implant migrations that resulted in internal damage and/or bleeding. Part of the reason cited for these failures could be the fact that unlike here in the United States the European Union has no centralized governing body that regulates medical devices before they get to market. In one way, this provides a positive outcome to the patient with new medical devices becoming available three full years before they do here in the U.S. But Professor Derek Alderson of the Royal College of Surgeons feels that losing this advantage is a price worth paying to ensure increased patient safety: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”(5)

So for the meantime, continued regulation by the FDA of devices like cochlear implants which are manufactured in contamination-controlled environments continues to seem like a very sound idea.

And speaking of cleanrooms and contamination-controlled environments there is one element we’re willing to bet you have not considered: decoration.

But let’s just take a moment to do so. Ok, we’re not talking about self portraits of Van Gogh (presumably without his ear) or even about those motivational prints of kittens seeing tigers in the mirror, but we are talking about wall decoration – in the form of paint. Bear with us to see where we’re going with this…

Anyone who has ever indulged in home renovation or decoration knows the pain of the home improvement store sticker shock. The fistful of paintbrushes and rollers, a couple of reels of painters’ tape, some plastic dropcloths (if you are sufficiently forward-planning), and twinset gallons of paint and primer can set you back more than you’d imagined. But this pales in comparison with the cost of paint products specially formulated for the cleanroom environment. Where the average gallon of home improvement store paint will set you back around $25, the cost of a water-based, acrylic epoxy for the contamination-controlled environment comes in at three times that cost. Why? Because these products need to be corrosion and chemical resistant, must contain low levels of volatile organic compounds (VOCs), must be low offgassing, and – because they are also used on the floor – they have to resist abrasion via physical impact. In addition, the paint must also repel stains and be able to withstand the use of all common solvents used in the cleanroom.

Remember Advanced Bionics who we mentioned in association with the cochlear implant recall of 2010? Their ISO Class 7 cleanroom is 29,000 square feet in size. And with a gallon of specialist paint covering only 400 square feet…well, you can do the math. Painting the cleanroom is a seriously expensive investment.

And this may be part of the reason why color choice is important. To date, cleanroom paint manufacturers have borrowed liberally from Ford’s famous maxim regarding the color of his Model T: the paint can be any color as long as it’s…white. But, if a recent design award is anything to go by, times may be changing. For 2018, the recipient of the Creative Prize award issued by Cleanroom Awards for the ‘best ideas in innovation, sustainability, and energy efficiency in cleanrooms, goes to MED-EL GMBH of Innsbruck, Austria, for their ‘well considered colour concept in their clean rooms where cochlear implants are produced.’(6) The winners of this internationally juried 3,000 Euro prize won for their development of ‘a whole world of colour in which the employees feel very comfortable.’(7)

Perhaps, given the myriad regulations and constraints of the cleanroom environment, the color of the interior may not seem to be so important. But before we are tempted to scoff at prioritizing employee comfort through paint color choice let’s also reflect that MED-EL are not only multi-year winners of the prize but are also European pioneers in the field of cochlear implant (CI) technology having developed and commercialized the world’s first micro-electronic multi-channel implant. Now with 1900 employees and 30 subsidiaries worldwide, this husband and wife created company has grown into a leader in implantable hearing solutions. From SONNET – the world’s lightest audio processer – to BONEBRIDGE – an active bone conduction implant system – MED-EL certainly seems to be leading the way in cochlear implant technology. And if the price of innovation is a corporate consideration of employee comfort, well, we think they must be doing something right.

Do you work in a cleanroom? Is it sterile and white? Would you prefer it to be a different color? Let us know your thoughts in the comments below!

References:

  1. https://www.digitaltrends.com/cool-tech/coolest-biohacking-implants/
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95925
  3. https://www.losangelesproductliabilityfirm.com/product-recalls/cochlear-implant-recall/cochlear-ci512-recall/
  4. https://www.bbc.com/news/health-46337937
  5. ibid
  6. http://cleanroom-award.com/eng.html#creative-prize
  7. http://cleanroom-award.com/eng.html#die-idee
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