The last thing I expected on my arrival at healthcare company Abbott’s medical devices manufacturing plant in Bayan Lepas, Penang, was to be asked my shoe size, much less receive a pair of brand new shoes.

But the fresh footwear was compulsory before I could be allowed further into the company’s only manufacturing site for pacing devices in Asia.

Senior site director, operations, HT Eow explains that it is for hygiene and cleanliness purposes as street shoes carry a lot of dirt, and possibly, germs, on them.

“All our employees change their shoes when they come in to work – they have their own lockers at the employee entrance to keep their street shoes and work shoes.

“And all visitors have to wear shoe covers. Those who come quite often, like some of our colleagues who come for training, will have their own pair of shoes kept for them here,” he says.

“It’s like a hospital, when it comes to the focus on hygiene and cleanliness,” he adds with a smile.

Hygiene and cleanliness are essential elements to the plant as they manufacture pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and leads, as well as multi-lead trial cables for spinal cord stimulation and printed circuit boards for the pacemakers.

As all those devices are meant to be placed in the body, it is vital to ensure that they are made in an environment that is as clean or sterile as possible.

In particular, pacemakers, ICDs and leads are devices meant to treat and monitor the heart for the long term, meaning that they are expected to spend years in a patient’s body.

In fact, the leads, which connect the pacemaker or ICD with the heart muscle, are expected to remain in the patient for the rest of their lives, as the heart tissue will eventually grow to enclose the tip that is embedded within them.

Keeping it clean

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Workers are grouped into cells, each of which assembles one particular device model.

The pacemakers, ICDs, ICMs and printed circuit boards are manufactured within one area at the plant.

The general production area is a class 8 clean room, while the packaging area is a class 7 clean room as the end product has to be sterile.

This means that the general production area has no more than 3,520,000 particles of 0.5 micrometres in size per cubic meter of air, while the packaging area has a maximum of 352,000 particles of 0.5 micrometres in size per cubic meter of air.

For comparison, our regular room air is classified as class 9, which should have no more than 35,200,000 particles of 0.5 micrometres in size per cubic meter of air.

These particle levels are maintained through high efficiency particulate air (Hepa) filters, which continually filter the air in the clean room.

The class 7 clean room is additionally maintained through positive pressure airflow from inside the room to outside.

Eow notes that their microbiology department tests all the factory’s clean rooms once a month for their particle levels and once a week for microbes.

“They also randomly test a different finished product every month for microbes,” he says.

In order to maintain this level of cleanliness, employees have to change shoes yet again to another personal pair that is kept in the changing or gowning area, before entering the production area.

They also have to cover their hair with a cleanroom cap (similar to a shower cap) – men also have to cover their moustaches and/or beards – and don a buttoned-up calf-length hooded coat with disposable gloves after washing their hands thoroughly with soap and water.

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A worker checking that his personal grounding device is working before entering the manufacturing area for pacemakers, ICDs, ICMs and printed circuit boards for the pacemakers. — TAN SHIOW CHIN/The Star

Most importantly, they must ensure that their personal grounding device is attached properly and touching their skin.

This is critical, says Eow, in order to ensure that the workers do not create any electrostatic discharge (via static electricity) that might affect the electronic parts of the products.

In fact, the final step before they enter the work area is to test that their grounding device is working properly.

The gowning procedure for the lead manufacturing area, which is located on another floor of the plant, is equally vigorous, although employees need not use a grounding device in this section.

In order to maintain the particle levels between the class 8 and class 7 clean rooms, employees who enter the class 7 clean rooms need to undergo an air shower to help remove particles, including microorganisms, on them and their clothes.

This compulsory step is enforced by the fact that the air shower cubicles are the only way to enter the class 7 clean rooms.

Meanwhile, the products to be packaged are passed between the two clean rooms via double-door pass-through chambers that act as an intermediary between the two areas.

These chambers have a Hepa filter and a mechanism that only allows one door to be opened at a time, thus helping to maintain the cleanliness level of the class 7 clean room.

Heart products

For production, workers are assigned to groups, known as cells, that are in charge of assembling a particular model of pacemaker, ICD, ICM, lead and printed circuit board.

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Metal is connected to silicon during this step in lead manufacturing. Highly trained and skilled workers are the heart of the precise production of these medical devices.

While some components of the pacemakers and ICDs are manufactured elsewhere and brought to the factory to be assembled, Eow notes that they produce the headers for the pacemakers and ICDs, as well as the printed circuit board for the pacemakers, themselves.

The header is where the leads are plugged into the pacemaker or ICD, while the printed circuit board is the “brain” of the pacemaker.

These components, he says, are both for internal use, as well as export to other Abbott factories in the United States and Puerto Rico.

The leads, meanwhile, are the “nervous system” of the pacemakers and ICDs, according to Eow.

“They bring information from the heart muscle, in which their tip is embedded, to the printed circuit board, which will analyse the information and instruct either the pacemaker or the ICD to discharge, if necessary.

“And the leads will bring the electrical impulse to the heart muscle to pace or reset the heart rhythm back to normal,” he explains.

As the leads are the most permanent part of either pacemaker or ICD – as they will remain in the body for the rest of the patient’s life – they are generally of universal design.

This means that they are usually compatible with most pacemaker or ICD models in the medical devices industry.

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A worker refers to the realtime magnified image of the titanium pacemaker case she is sealing inside the chamber to ensure sterility. Much of the assembly process requires work at the micron level, requiring the use of microscopes.

This is in case the patient is required to change their pacemaker or ICD model as technology or their heart condition evolves over time.

“Flexibility and strength is also very critical as the leads will move with the heart muscle as the heart beats,” says Eow.

Meanwhile, the ICM is the latest product to be manufactured by the Penang factory, beginning in August 2018.

“Its job is to monitor heart rhythm 24/7 in patients with suspected heart abnormalities and it comes with an app in the smartphone, which it ‘talks’ with.

“The app will send the information to the doctor, and based on the data, the doctor will be able to diagnose the patient’s heart condition and take the necessary corrective steps,” he explains, adding that their ICM is as small as a pen-drive and is the slimmest device of its kind to date.

Eow notes that for each device, every step of the manufacturing process has quality control with each individual product checked multiple times throughout the manufacturing process.

“All products are 100% tested to ensure there are no reliability issues, because you have to imagine, it is life-changing technology – the moment you put the device in someone’s body, it has to last for years.

“It’s not something you can just change, like a handphone or a computer, this is something that has to stay in the body for years, even for life – that’s what’s at stake here,” he says.Lead, pacemaker, ICD, cardiac device, medical device, Abbott, Star2.com