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Augmented reality could change the way we carry out minimally invasive surgery

Over the last few decades, minimally invasive surgery (MIS) has replaced open surgery as the preferred method across many medical fields.

Augmented reality could change the way we carry out minimally invasive surgery
The integration of AR into MIS means surgeons would not solely rely on endoscopes.
Credit: MONOPOLY919 via Shutterstock.

Previous technological attempts at expanding the view during MIS have involved adopting surgical scene reconstruction techniques. However, most existing techniques have yet to demonstrate consistent performance capabilities. Consequently, greater emphasis has recently been directed towards developing the pre-existing technology of augmented reality (AR).

AR allows the user to see the real world overlaid with a layer of digital content. It can address the visual shortcomings of MIS by expanding the field of view for surgeons. Furthermore, as healthcare systems globally are still overburdened with the additional pressures of the COVID-19 outbreak, new hospital measures of limiting viral transmissions between physicians and patients are highly sought after. Surgeons opting for MIS could strongly benefit from AR when performing procedures that would normally have been an open surgery. Advancements and wide-spread adoption of AR in MIS can thus limit patient exposure to aerosolized viral particles.

AR will improve the planning and mapping of MIS

AR could be one of many approaches to reducing this burden on hospitals by indirectly controlling the spread of the coronavirus. MIS reduces surgeons’ exposure to aerosolized coronavirus particles. Open surgery also typically involves a longer hospital stay, which may increase nosocomial virus transmission and increase pressure on resources and hospital bed capacity.

Research from the University of Alberta and the University of Salento found AR could be particularly useful in laparoscopic surgery and surgical planning. The integration of AR into MIS means surgeons would not solely rely on endoscopes. Instead, AR projections of scans can be superimposed on patients in real-time to aid planning and increase accuracy when placing devices. For patients, this could reduce the chances of trauma and scarring while also accelerating postoperative recovery.

AR may not be embraced across all surgical procedures, as its use is strongly dependent on the rigidity of the organs or tissues involved in the operation. For example, AR has found relative success in neurosurgery for both the brain and spine as the structures are rigid, which helps the surgeon differentiate between the augmentation and the actual scene. On the other hand, AR and other types of image-guided surgery are unlikely to be used for abdominal MIS as organs and tissues are less rigid. Instead, traditional endoscopic views will continue to be relied upon for these procedures.

The future of MIS

AR has the potential to improve the accuracy of minimally invasive procedures, and in turn, reduce surgical errors. Worth nearly $4bn in 2018, the global AR market will reach $76bn by 2030, growing at a compound annual growth rate (CAGR) of 24%, according to GlobalData estimates. AR in MIS is currently still being researched. ProjectDR is one of the software platforms exploring how AR can improve visualization in the operating theatre. ProjectDR projects medical scans directly onto a patient body and can even provide segmented images if the surgeon selects this function. AR’s use for MIS is still in the early stages, but GlobalData expects this technology to significantly impact the healthcare industry over the next few years.

Source: https://www.medicaldevice-network.com

 

Medical Devices: Is there Life After Death?

Medical devices—is there life after death? It’s probably not the type of question that one thinks of as it pertains to medical devices. Or even office equipment. But all electronic equipment, computers, fax machines, lab equipment, phones, copiers, monitoring equipment, scanners, and anything else with a hard drive, does have a life after it is no longer in use.

That’s a problem.

Technical Intelligence is Everywhere

Because technology is constantly evolving and improving, electronic equipment has become smarter, more powerful, smaller and less expensive. Logging in to a device to automate tasks, store and retrieve data, and provide a customized experience with your personal preferences is easy. From medical devices to office machines, the functionality of is contained on tiny circuitry—and in most cases so is patient data, correspondence, passwords, billing information, accounting records, network information, scanned document images, and other sensitive information.

Even your bathroom scale probably knows things about you that other people don’t.

What Happens to Equipment When It’s Gone?

Once the lifespan of office equipment and medical devices ends, there are a few paths that the equipment can take. While some corporations have closets filled with old hard drives, broken laptops, and outdated phone systems, many medical device manufacturers, distributors, and end users are turning towards re-use as an environmentally sound option for their discarded medical equipment.

It can be a good option. Non-invasive medical equipment can easily be re-sold and re-used by the next owner, who often reaps the benefit of paying less than the cost of new. Blood pressure cuffs, lab furniture, stainless steel items, cables, and shielding can work simply fine, long after they have been replaced with newer items by the original owner.

Corporations, manufacturers, laboratories, health systems and educational facilities face a huge challenge when disposing of electronic equipment that has any type of memory, however. All sensitive data must be securely removed before recycling, reusing or reselling. Patient data, research data, financial records, names, dates, and location can reside in obsolete medical devices and laboratory equipment. The data remains intact as long as that equipment can still be taken apart and accessed—that includes imaging equipment, scanning devices, test equipment, sonography equipment, personal medical devices, personal equipment, computers, servers, tablets, printers, fax machines, mobile phones, portable hard drives, CDs, and back up devices.

Most recycling/resale companies claim to wipe all of their customer’s important data before it is thrown away, recycled, or resold.

But What If It’s Not?

According to the 2018 Cost of a Data Breach Study conducted by the Ponemon Institute and IBM Security, the average cost of a data breach of up to 100,000 records is approximately $3.86 million.

News about cyber hacks is fairly common but the less publicized problem of data breaches brought on by misinformed original owners still exists. In 2010, photocopiers that were used to copy sensitive medical information were sent to be re-sold without wiping the hard drives. Three hundred pages of individual medical records, containing drug prescription and blood test results were still on the hard drive of the copiers sitting in a warehouse for resale. The U.S. Department of Health and Human Services settled with original owner of the copiers for HIPAA violations to the tune of $1,215,780.

Following this news, CBS News purchased two photocopiers from an office equipment reseller, and discovered that the copiers were still loaded with confidential documents from its original owner—a Buffalo, New York police department. In 2015, a computer at Loyola University that contained names, Social Security numbers, and financial information for 5800 students was disposed of before the hard drive was wiped.

One of the biggest dangers that a data breach of any size can affect is a loss of trust. If the media picked up a news story about your device being resold with recoverable patient data or research data, the resulting press could be a nightmare. Even a small medical practice or lab can face fines and law suits if data gets released or lost.

Recycling: The End of the Road?

So that’s it. At the end of its life, you’ll recycle your equipment and that will be the end of it, right?

Wrong.

Many recyclers try to recoup the value of electronic waste by improperly salvaging parts and selling them outside of contracted terms. Often recyclers will merely “delete” data rather than erasing or overwriting it, raising the possibility that a hacker could recover proprietary company data. In 2019, financial institution Morgan Stanley hired a vendor to scrub devices from two data centers that closed in 2016, but the vendor had left some client data on the devices. Some of those servers and hardware were then sold to recyclers and are now missing.

Recycling and the Environment

There’s actually another potential risk with recycling. Currently, 25 states require that all devices with electronic circuitry be recycled by qualified electronic recyclers and not end up in a landfill. Besides the potential problem of a data breach, the fines for improper disposal of electronic equipment are huge. According to a 2018 article in E-scrap News, The Home Depot was fined $28 million for improper disposal of batteries. Comcast has agreed to pay California $25 million for improper disposal of mainly electronic waste.

In 2015, the non-profit group, Basel Action Network (BAN) investigated electronic waste recyclers by embedding GPS trackers in devices left at recycling companies. Some of those secret devices, still inside equipment with personal data on them, got stored in warehouses and made their way overseas for improper dismantling and smelting.

Electronic waste contains mercury, lead, cadmium, polybrominated flame retardants, barium, and lithium, while the plastic casings contain polyvinyl chloride. The health effects of electronic waste being melted down in China and India, where it is often sent by recyclers, includes birth defects, and damage to the brain, heart, liver, kidneys, nervous system and reproductive system.

Electronic Afterlife: A Permanent Solution

Knowing that the sensitive information contained on the circuit boards could be easily recovered if your devices got into the wrong hands, it is imperative that the chips themselves be destroyed. Destroying obsolete and defective devices protects your business, your reputation, and your accounts.

HIPAA compliance requires that a 3rd party providing Electronic protected health information (ePHI) destruction services must be a contracted “HIPAA Business Associate” This agreement requires that a third party handle your ePHI with the same care and protection that your organization provides. The specific requirements for the physical handling of data media is outlined by The Office of the National Coordinator for Health Information Technology in its Security Risk Assessment Tool.

Choosing a Vendor for Device Destruction

No matter what the reason for disposing of medical and other electronic devices, you need to meet two primary objectives: Your product is destroyed in such a manner that it can never be reused or identified as coming from your organization and the resulting materials from the destruction process be disposed of in an environmentally appropriate and regulatory compliant manner.

De-manufacturing of your devices accomplishes three important destruction objectives.

  1. The circuit boards are removed for specialized handling, shredding and recycling.
  2. Batteries are removed for separate environmentally required recycling.
  3. Other materials such as plastics and metals are separated for further specialized recycling.

Shredding the circuit boards assures that nothing short of a laboratory-based reconstruction effort could ever recover your proprietary information. Shredding should be performed in a highly secure environment. The shredded particles should then sent to precious metal refining facilities where the shredded material is smelted and the valuable metals recovered. By using a U.S. EPA Universal Waste Destination facility for Electronics, this recycling process assures you that all proprietary information is destroyed.

When choosing an electronic waste disposal vendor, look for one that is a Federal EPA licensed facility, ISO 9001,14001 and 45001 certified and R2 (Responsible Recycling) certified. They should provide you with detailed certificates of destruction for all devices, by serial number. Compliance documentation, including secure tracking information should be available to you 24/7/365 as well.

By performing vendor due diligence to ensure that your devices are properly de-manufactured and destroyed, you will eliminate the unauthorized and uncontrolled re-marketing of your devices, destroy all sensitive data that may be on the circuitry, and comply with all regulatory and industry environmental standards for disposal.

That’s the only way to get an absolute guarantee that your devices have no more life left in them.

Source: https://www.medtechintelligence.com/column/medical-devices-is-there-life-after-death/

Disposable endoscopes set to disrupt the reusable endoscopes market

The development and implementation of single-use, or disposable, medical devices is becoming more widespread. GlobalData has identified that disposable devices are being increasingly used at the expense of reusable counterparts across most markets and therapy areas. One of the major reasons for this shift has been to prevent the spread of infectious diseases and to reduce the logistics required to sterilise reusable equipment. Reasons not to use single-use devices include environment concerns (minimising the production of waste) and the generally cheaper costs associated with reusable devices.

While the Covid-19 pandemic negatively impacted many medical devices markets in 2020, sales for disposable endoscopes defied this trend and experienced significant year-over-year (YOY) growth. This is because the use of disposable devices decreases the spread of infectious diseases. For example, YOY sales of Ambu’s disposable aScope bronchoscope increased by 50% in 2020 because there was an increased need for bronchoscopes due to the Covid-19 pandemic. However, the dramatic rise for disposable bronchoscopes surpassed the increase in sales for reusable endoscopes. GlobalData determined that YOY sales for reusable bronchoscopes increased only 22.5% due to the Covid-19 pandemic. This highlights the utility of disposable scopes during times of high patient volume and turnover.

Sales for Ambu’s aScope disposable bronchoscope are growing at a Compound Annual Growth Rate (CAGR) of 124%. Since 2014, there has been a 126-fold increase in sales of these disposable bronchoscopes. In contrast, GlobalData estimates that the global market for reusable bronchoscopes will grow at a rate of only 2.7% over the next ten years. Additionally, since the launch of Ambu’s aScope disposable rhinoscope in 2019, its sales grew by 441% in 2020 despite the Covid-19 pandemic. A 2017 study conducted by Perbet and colleagues and published in Annals of Intensive Care found that the cost of using Ambu’s single-use aScopes in intensive care units was not significantly higher than that of reusable scopes. This is because reusable scopes are associated with high costs for repairs and decontamination. This could explain the rapid update for disposable endoscopes at the expense of reusable scopes.

In December 2019, the FDA approved the first fully disposable duodenoscope, Boston Scientific’s EXALT Model D Single-Use Duodenoscope. This scope was granted Breakthrough Device designation, as it was the first and only single-use duodenoscope on the market approved in the US. Ambu launched its aScope disposable duodenoscope in 2020 and plans to release the aScope Duo2 in 2022.

GlobalData estimates the global value for 11 reusable endoscope markets to have been worth $6.76bn in 2020, growing at a CAGR of 7.5%. GlobalData expects the recent and future releases of multiple disposable endoscopes to act as a major disruptor to reusable endoscope markets. Companies that manufacture reusable endoscopes should expedite R&D related to the ease of re-sterilisation or begin to manufacture disposable endoscopes in order to remain competitive.

Source: https://www.medicaldevice-network.com/comment/disposable-resusable-endoscopes/

UK Medicines & Healthcare products Regulatory Agency (MHRA) approves the use of CoverScan MD

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has approved the use of CoverScan MD, an MRI-based technology that maps the effects of COVID-19 on several of the body’s key organs, developed by Perspectum.

Lyth Hishmeh, CoverScan study patient, said: “I’m thrilled to hear that CoverScan has been granted approval by MHRA. I cannot stress enough how much myself and a large number of people with Long-COVID have benefitted from CoverScan. For those of us with organ damage, it has accelerated our access to treatment by informing us exactly what organs need to be examined further, while for the rest of us, it has brought us invaluable peace of mind. This is a step in the right direction, and I hope everyone who is misfortunate enough to suffer from Long-COVID can benefit from this.”

Dr Melissa Heightman, consultant respiratory physician, UCL, and head of North London Long-COVID care services, said: “The MHRA authorisation of CoverScan is timely. UK experts and NICE are developing a COVID follow up pathway which provides equitable access and high-quality community-based triage with rapid access to diagnostics and multi-speciality services. We have seen over 800 patients in North London, and it would be very valuable for their clinical care to be able to access CoverScan results.”

Perspectum’s CoverScan MD technology enables healthcare providers to identify Coronavirus-related systemic organ damage through scans of patients’ hearts, lungs, livers, as well as other internal organs, and to assess the impact of SARS-CoV-2 infections. With the use of CoverScan MD, UK doctors will now have a technology to add to the arsenal of tools used to assess and evaluate patients with Long-COVID, while at the same time gain a greater understanding of its symptoms and long-term impact on different organ systems.

Long-COVID affects 10-30% of people who have symptomatic infection with Sars-CoV-2 and is defined as symptomatic disease lasting longer than 12 weeks. Patients typically have extreme fatigue, chest pain, breathlessness, muscle aches and brain fog, but there are many reported symptoms. Many of these patients have organ damage or impairment, and ways of managing this are currently being researched. Patients with Long-COVID are often unable to work for long periods of time, posing a significant burden to the economy and public services.

Source: https://www.med-technews.com/news/Covid-19-Medtech-News/imaging-service-for-long-covid-receives-mhra-approval/

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