Regulating implants: how to ensure safety
As the implant market expands and new innovations become a reality, the challenge of regulating these new technologies is getting harder. With biohacking implants already being performed in tattoo studios, how will regulators ensure the safety of patients? Abi Millar reports.
n 2016, entrepreneur Steven Northam had a radiofrequency identification (RFID) implant placed in his left hand. The chip, which enabled him to open his office door simply by waving his hand, gave him the inspiration for what would become BioTeq.
“I did it for a bit of fun really – a quirky party trick,” he says. “My main business interest is in startup investments, so it was clear that the idea of fitting a microchip in my hand was going to turn into a business.”
A human biotech implant company based in Hampshire, UK, BioTeq now provides implants not just for door entry systems, but also for storing data (like a digital business card). Northam says the customer base is wide and varied.
“It ranges from those who just love tech to those who feel it provides them with some sort of benefit or convenience,” he says.
Beyond that, the company is making inroads into the realm of assistive technology, for instance helping disabled people enter their homes. It is also looking to create chips for visually impaired people, which trigger audible or touch sensory cues, and implantable GPS trackers for those with learning disabilities.
“The ethical debate here is quite complex, given the need for consent and who can give this in certain instances,” says Northam. “Our stance is that if it improves someone’s wellbeing and day-to-day life then it’s a good thing. These devices are already being used in the market and a range of further developments will be released in 2020.”
Transhumanism and biohacking
Many of the people who opt for such procedures class themselves as ‘transhumanists’, meaning they seek to augment their bodies via technology. Some kookier examples include compass chips that vibrate every time the wearer faces north, magnets that allow them to sense whether their microwave is running, and implanted cyborg antennae that allow them to ‘hear’ colours.
These practices, a subset of what is called biohacking, are regarded as leftfield currently, but many practitioners are convinced we’ll all be using biohacking implants further down the line.
“I suspect human-based technology implants will become much more commonplace, as with most technology,” says Northam.
From this perspective, getting an RFID chip implanted isn’t too far removed from getting an IUD or even contact lenses. The trajectory over the last few decades has been towards a greater acceptance of implantables, with more and more people having devices of some kinds in their bodies.
“Biohacking is when people experiment with implantable devices such as such as magnets, microchips or electronic devices,” says Catherine Joynson, assistant director of the Nuffield Council on Bioethics.
“Sometimes biohacking is carried out for medical purposes. For example, the project #OpenAPS is developing ways of connecting a continuous glucose sensor and insulin pump to form a closed loop system that automatically maintains safe glucose levels in people with diabetes.”
Are they medical devices or not?
The big question here is, are these kinds of implants medical devices? Currently, the MHRA does not classify them as such, as they have no defined medical purpose.
“This means that there is currently no regulation as such around human microchips,” says Northam. “We expect this will change in due course, and our driver is to provide a high level of quality control.”
While similar procedures have been cropping up in tattoo studios (most of them safe and reputable), Northam would not recommend that people go down that route.
“There’s nothing stopping anyone putting anything in their body legally, as long as it’s their own choice,” he says. “As a company we only provide implants conducted by a medical doctor under medical conditions and provide a local anesthetic for this – tattoo studios cannot administer such drugs.”
Professor Tom Joyce is a biomedical engineer at Newcastle University. He has brought to light a number of implant-related scandals, including flaws in metal hip replacements that left thousands of patients in pain. He points out that, when it comes to regulating implantables, it isn’t necessarily as straightforward as saying ‘that’s a medical device and that isn’t’.
“As someone interested in the regulatory aspects of medical devices, I’d begin by asking if the biohacking implant has a medical purpose,” he says. “If it has no medical purpose then, in general, all those complicated medical device regulations do not apply. However, given the very reasonable desire to protect people, some items have been defined as medical devices despite not having a medical purpose.”
Two common examples might be breast implants and coloured contact lenses – while their purposes are cosmetic, they are regulated as medical devices.
“You might also want to ask yourself if toothpaste is a cosmetic, as it whitens teeth, or a drug, as it contains fluoride, or a medical device, as it cleans and thus protects teeth through an abrasive action,” says Joyce. “Depending on content and product claims, and your regulatory authority, toothpaste can be any of the three.”
How should they be regulated?
Of course, regulations will vary from country to country, and in some parts of the world they’re very lax. In India, for instance, the majority of medical devices are completely unregulated. While the picture is now changing – all implanted devices will be subject to regulation from April 2020 – the industry is reportedly wary and confusion abounds.
“Devices implanted into the human body… may pose potential risk (and) must be strictly controlled... This will regulate and make sure that devices that are implanted in the body are not rushed into the market, bypassing critical testing that would protect consumers," said S. Eswara Reddy, the Drug Controller General of India.
Even within the EU, emerging types of devices pose problems from a categorisation standpoint. As Joynson points out, biohacking raises questions about liability and responsibility in the event that something goes wrong.
“For example, while a user might be held responsible for modifying an implant counter to the manufacturer’s instructions, the possibility of hacking the implant might be attributed to a security vulnerability for which the manufacturer might be liable,” she says. “The UK Department of Health and Social Care has said that a new EU Regulation on medical devices will improve the cybersecurity of connected medical devices.”
When it comes to regulating these implants, Joyce thinks that lip fillers might serve as a useful pointer.
“Although having no medical purpose, after many’ botched’ operations, often blamed on ‘unqualified’ beauticians, it was said that the people fitting them had to be regulated and lip fillers have become medical devices,” he says. “But this is a slow process and, as shown with current EU medical device regulations, take years to be agreed and brought into effect. So I think any change for biohacking implants could be slow in coming.”
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