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Improve Scientific Software with These UX Design Best Practices

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Those in the field of life sciences, from biotechnology and pharmaceuticals to life systems and medical technologies, are working with extreme urgency, searching for breakthroughs to conquer COVID-19. Accelerating the long and meticulous process of scientific R&D and drug development is more critical now than ever and fundamental to helping the world breathe a collective sigh of relief.

But there is a significant obstacle in the path of swift research and results: poorly designed scientific software.

With the advent of artificial intelligence and machine learning, scientists and researchers today do less manual lab work and rather rely heavily on software—a trend that helps speed new products to market. This intensive reliance on software means the applications that scientists use as part of their daily workflow need to deliver an exceptional user experience (UX) through, for instance, intuitive interfaces and minimalist design.

But, most scientific applications fall short.

In a 2016 TetraScience blog, then-CEO Alok S. Tayi asked why scientific software is so bad. “As consumers, we take for granted that our apps are easy to use and look good,” Tayi said. “Despite software being used in labs for the past three decades, there has been little improvement in the usability and aesthetic of scientific software.”

 

Complicated and Frustrating Applications Are Common

Scientists can’t do their best work or work quickly if the software tools they rely on are difficult and irritating to use. And there’s a lot of bad software out there. For instance, according to Science Direct, many wet lab scientists find bioinformatics applications hard to use. It’s ironic (and regrettable) that the social media and entertainment platforms researchers and scientists likely use in their personal lives have received far more investment and thought in terms of user-friendly design than the complex tools they use on the job to do vital work potentially of immeasurable value to society.

One of the reasons for the poor quality of and limited investment in scientific software is because of too heavy a focus on hardware. “Over the past half-century, science has advanced because of innovation in instrumentation,” Tayi wrote in his blog. “Greater sensitivity, higher throughput, and new functionalities have been the focus for manufacturers of instruments. Breakthroughs in detection limits and reductions in cost have supported faster and better science. Though these devices are powerful, a persistent focus on the hardware relegates the software to an afterthought. As a result, the quality and usability of scientific software wanes.”

 

So What Can Be Done to Improve the User Experience?

Until recently, the life sciences industry has simply accepted that scientific software is bad—often inexplicable and difficult to use. But that absolutely does not have to be the case. That’s one reason the National Science Foundation awarded $35 million to a pair of software institutes to fund efforts to build “the tools necessary for 21st-century research.”

Scientists and researchers should benefit from the same level of cutting-edge, immersive UX our digital society expects and is accustomed to in consumer devices and B2C applications. How? The key is to create ways to accurately prioritize, curate, and present to the user all this data. This is where UX can really move the needle.

 

Say Goodbye to Complex Interfaces and Cumbersome Interactions

Through intense collaboration with customers and end-users, software designers uncover the natural hierarchy of processes and data, and they pay it off in a way that allows scientific users to focus on solving real problems rather than navigating challenging interfaces. Naturally, introducing and aggressively rolling out these tools and processes means new UIs for users. The importance of good UX in shortening the learning curve and cutting down on use errors cannot be overstated.

Here are a few UX best practices to follow in order to create an exceptional user experience for life science and bio-pharma scientists dealing with expansive sets of highly complex and rapidly changing data.

Collaborate Across Teams

The practice of UX design must be treated with respect rather than looked at as an afterthought. To be truly valuable to a life sciences organization, UX needs to be integral to the creation of a software application (or digital medical device). It can’t be viewed simply as a task to complete—a box to check—at the end of the software development process.

Why? Every dollar invested in UX brings $100 in return. And, according to Strategic Data Consulting, UX investments made early shrink a product’s time to market by as much as 50%. Therefore, the UX team must be empowered and integrated from the outset into the software development process. And, of course designers and developers must be empowered to iterate quickly in order to improve scientific software.

Study Users

Examine their work environment, including wet labs, dry labs, and clinics. Explore in detail exactly how they work. Gain insight into their behavior and use this new understanding to create fully formed personas and detailed journey maps.

Prioritize Workflows

Create a hierarchy based on the knowledge you’ve gleaned about users from studying their behaviors and engaging in lengthy conversations with them. Prioritize task workflows based on criteria such as how frequently a screen will be used, and the importance of the data to both a specific task and to the business in general.

Understand Visual Design Trends

Some trends fade quickly while others gain widespread acceptance. The latter stick around, typically, because they work. Embrace trends wisely and design for longevity. In the vast majority of cases, scientific software UIs are meant to last a dozen years or more and will outlive any current design trends.

Prototype

User testing with high-fidelity prototypes can help designers identify more-complex interaction problems that might be missed with low-fidelity testing. And finding problems when there’s still an opportunity to address them—prior to initial release or during beta—is likely to improve the application’s reception when your target users finally get to dig into it to accomplish meaningful, highly precise, and sensitive work.

Listen to Users

You’ve now created software with a winning UX. Or have you? Examine user feedback to identify any needed improvements, and continuously refine the UX. What serves your users well now may not be adequate in the future.

 

Embracing UX Design Is Essential

For organizations focused on scientific research, development, technology transfer, and commercialization, a clean, frictionless user experience has gone from a “nice-to-have” to a “must-have.” Still, many life sciences organizations continue to lag behind those in other industries, such as financial services and retail in their embrace of UX design.

The Pistoia Alliance, a global, not-for-profit collaboration of life science companies, technology product and service providers, is among the organizations on a mission to better communicate the value of UX in life science R&D. According to the Alliance, “UX is a powerful tool for supporting the creation of effective and usable interfaces. Whilst UX is relatively widespread, the full potential of UX is still to be realized in the life sciences.”  

A true statement. Embracing UX design—integrating it early into the scientific software development process and adhering to industry best practices—is critical for improving researchers’ workflow. And doing so can provide much-needed support for scientists fighting the pandemic and working to improve the lives of humankind.

Medtech Unfiltered: Who Is Elizabeth Holmes?

The medical device and diagnostics industry is no stranger to scandal. Over the years we've seen medtech CEOs land in hot water over everything from sexual harrassment allegations to various forms of fraud. But none of these stories have been quite as bizarre as that of Theranos founder Elizabeth Holmes. In this week's edition of Medtech Unfiltered, News Editor Amanda Pedersen talks about the latest news regarding Holmes' trial, which is now slated to begin in March 2021.

 

Does Illumina Want Grail Back?

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Illumina could be interested in (re-)acquiring liquid biopsy startup Grail, according to a recent report from Bloomberg. The gene sequencing company could pay more than $8 billion for Grail which now has a valuation of $6 billion, Bloomberg reported citing people familiar with the matter.

The (rumored) deal comes about a week after Grail, which is known for its exorbitant financing rounds, announced that it was seeking to go public on the NASDAQ. Interestingly enough, the move for an IPO comes about four years after Illumina announced it was spinning Grail off into a separate company. Grail was formed withing Illumina in 2015.

As it stands now San Diego, CA-based Illumina has about 14.6% stake in Grail with about 98.3 million shares. Illumina’s ownership stake in Grail was once significantly higher. However, Grail reduced Illumina’s ownership stake when it raised $1 billion in a series B round. To date Grail has raised about $1.9 billion, having been backed by investors such as Bill Gates, Jeff Bezos, and Johnson & Johnson.  

Grail has been moving at a lightning pace in recent months. In May, the company raised $390 million in a series D round and said in a regulatory filing that it was planning to launch its Galleri product in 2021 as a laboratory-developed test.

Much has changed in the cancer detection/liquid biopsy space since Grail was spun-out from Illumina in 2016.

Guardant Health – often mentioned in the same circles as Grail, went public on a $238 million IPO in 2018. The Redwood City, CA-based company made medtech headlines in August after it received a nod from FDA for Guardant360, a liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.

Thrive Earlier Detection Corp. hopped on the scene in 2019 raising $110 million in its series A round. The financing broke Grail’s record of raising $100 million in a series A round. In July, the Cambridge, MA-based firm hit another homerun in fundraising, bringing in $257 million in its series B round.  

Liquid biopsy companies often have higher financing rounds because of the capital needed to fund their massive clinical trials. Some of these trials have had more than 100,000 patients.

Has Takeda Finally Found a Home for TachoSil Patch?

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Corza Health has signed an agreement to acquire Takeda Pharmaceutical’s TachoSil Fibrin Sealant Patch for about $414.3 million (€350 million).

TachoSil is a surgical patch that controls bleeding. The patch brought in about $160 million for Takeda in its fiscal year that ended March 31st. Upon close, Corza Health said it will acquire the assets and licenses that support the development and commercialization of TachoSil, while Takeda maintains ownership of the manufacturing facility in Linz, Austria.

Takeda has entered into a long-term manufacturing services agreement, under which it will continue to manufacture TachoSil products and supply them to Corza Health.

“This announcement continues Takeda’s strong momentum toward optimizing our portfolio for growth by delivering highly-innovative medicines and transformative care in our chosen business areas, as well as meeting our leverage targets,” said Costa Saroukos, CFO, Takeda, in prepared remarks.  As we continue to streamline and simplify our portfolio, Takeda is confident that we have found the right partner in Corza Health as the next home for TachoSil.”

Previously Johnson & Johnson’s Ethicon was set to acquire TachoSil for about $400 million. However, both J&J and Takeda walked away from the deal because of anti-trust concerns in April of this year.  

Corza Health, however, doesn’t have an extensive portfolio like J&J and shouldn’t run into any anti-trust concerns. The company is relatively new, having been formed in 2019 as a partnership between private equity firm GTCR and healthcare industry veteran Gregory Lucier.

Balancing Sterile Barrier Packaging and Sterilization Requirements

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From left: Jeremy Elwell, senior principal engineer for Oliver Healthcare Packaging; and Brian McEvoy B.Sc. MBA, senior director for global technologies for STERIS Applied Sterilization Technologies

In July, packaging and sterilization experts explored the complex relationship between sterile medical device packaging and sterilization methods in the webinar, “Sterile Barrier Packaging: The Impact of Sterilization Modalities.” Jeremy Elwell, senior principal engineer for Oliver Healthcare Packaging, explored the design and development of sterile barrier systems, while Brian McEvoy B.Sc. MBA, senior director for global technologies for STERIS Applied Sterilization Technologies, provided high-level overviews of ethylene oxide (EO), irradiation, and vaporized hydrogen peroxide (VHP) sterilization methods.

During the event, Elwell and McEvoy answered a number of attendee questions, and we asked them to expand upon those answers and address any additional questions we couldn’t include in the hour-long webinar. We encourage you to log on to the now-on-demand event for their presentation. 

 

How can we mitigate risk when performing accelerated aging testing using sterilized samples?

Elwell: In any packaging verification study, it is important to understand the performance capabilities of your selected materials. It is also important to properly set up your test protocols per industry standards. You can reduce risk by performing higher-intensity feasibility testing prior to a verification study or by leveraging existing data. In some cases, it may be feasible to shorten the duration of accelerated aging conditioning by increasing temperature or changing Q10 levels (per ASTM F1980); however, a proper analysis must be performed since this may cause additional risk to both the packaging and device materials.

 

Is the maximum dose study also applied in E-beam sterilization? 

McEvoy: Per ISO11137, the impact of maximum dose will be assessed in all three irradiation modalities: Gamma, E-beam, or X-ray.

 

Is coated Tyvek more compatible with extreme conditioning (2x EO sterilization + accelerated aging) more than uncoated Tyvek?

Elwell: While coated Tyvek does improve some aspects of a seal, both types of sterile barrier systems have been tested and proven to withstand extreme conditions.

 

Have you seen a greater effect on the packaging materials after being sterilized with Gamma versus E-Beam? 

McEvoy: We have not observed anything specifically, since testing is conducted by our customers, and often we are not privy to the results and outcomes. To our knowledge, packaging materials tend not to be of primary concern here...it’s usually a material associated with the product itself. 

 

If a product is sterilized in a two-tray system (a sealed tray inside a sealed tray), would the product still be considered sterile if the outer tray is opened? 

Elwell: If appropriate verification and validation testing is performed, and the labeling of the inner tray meets the necessary requirements, the inner tray in this situation would be considered sterile as long as the sterile barrier is still intact. 

 

Is seal creep a higher risk in Gamma irradiation or EO Sterilization when using a film to 1073B Tyvek Pouch?   

Elwell: Seal creep is a higher risk with EO sterilization because it includes sterilization cycles with a combination of heat and vacuum while gamma irradiation does not. The risk can be mitigated if the recommendations discussed in the webinar are followed. 

 

Is it appropriate to sterilize samples from a process qualification (OQ/PQ) before testing them?

Elwell: Typically, sterilization is not part of the OQ/PQ process since outputs from the OQ/PQ process are used for in process monitoring (unless you plan to perform in process monitoring using post sterilization samples in ongoing production). Activities after the packaging process (sterilization, distribution, storage, etc.) should be addressed through the design verification process and tied back into a minimum specification as identified by the OQ/PQ process. For more information, reference ISO 11607 part 1 and part 2.

 

Does printing directly on Tyvek impact the porosity of the sterile packaging?

Elwell: Printing on medical grade Tyvek is not anticipated to significantly impact the porosity of the substrate. Tyvek is a fibrous material. When ink is applied to Tyvek in a printing process, it is laid on the surface of the exposed fibers and does not typically “fill in" and block off the breathability of the material. To demonstrate this, Oliver Healthcare Packaging conducted a porosity study using a Gurley Hill porosity tester. Samples of Tyvek were printed on an offset process with a full lay down of ink (worst case scenario). Porosity was then measured in the printed area and compared to an adjacent area of unprinted Tyvek. Values were reported in Gurley seconds (number of seconds required for 100 cubic centimeters of air to pass through 1.0 square inch of the material). Results indicate the full lay down of ink has little impact on the porosity of the Tyvek. The study is available from Oliver Healthcare Packaging upon request.

 

What is considered sufficient seal strength?

Elwell: This has been an ongoing discussion in the industry. Please refer to our Developing a New Industry Standard for Seal Strength Testing webinar by Geoff Pavey, Oliver Technical Fellow. 

 

Is there a recommended packaging design (e.g., flexible pouch design or rigid blister with top lid design) to use when the packaging will be subjected to E-Beam or Gamma radiation sterilization?

Elwell: Most of the materials we reviewed in the webinar are compatible with both E-beam and Gamma. For more information regarding compatibility, you can reference AAMI TIR 17 or watch the webinar recording. However, it is more likely that packaging design selection will be based on device requirements and end user needs.

 

For the validation of a new EO cycle, is it appropriate to evaluate a worst case to represent a packaging configuration family?

McEvoy: Generally speaking, it is feasible to perform sterilization validations per product family. However, every aspect of the packaging system and packaged device needs to be addressed. Some recommended factors to consider are density of packed product/pallet load, similarity of device design, packaging configuration and materials, pack out pattern, labeling, and IFU placement.

 

With the incorporation of electronics into medical devices, what are the best sterilization modalities? 

McEvoy: Radiation can have an impact on sensitive electronic components. This would need to be assessed and (radiation) shielding/attenuation opportunities could be explored. VHP as a surface sterilization would be an effective method.

 

Is there a difference between a standard VHP and a VHP Plasma process for sterilization?  (Or are these the same?)

McEvoy: A number of providers in healthcare sterilization and room decontamination offer variants of VHP solution, e.g., VHP combined with other chemicals or processes. Plasma is one such variant where the plasma is suspected to assist removal of sterilant in the aeration phase, which is necessary as VHP-plasma tend to use higher concentrations of sterilant than non-plasma VHP. 

 

If I am lowering EO concentration and increasing the EO dwell time, do I need to repeat aging studies?

McEvoy: Adjusting these parameters will have an effect on EO product residuals, with a likely reduction due to lower concentration. Increase of dwell time will add more time to the overall process at a temperature elevated beyond ambient. The additional time would still have a process falling below the max times of the original process, and thus, likely to be an effect but should be reviewed and have risk assessed in the change management process. 


Is there more risk to my packaging in an EO-CO2 mixture than EO-Nitrogen cycle? 

McEvoy: We have no information/data of such an impact. Both CO2 and N2 are inert gases. EO:CO2 mixed gas processes are conducted over a wider pressure scale where a portion of the process is conducted above atmospheric pressure. Would need to assess the impact of that pressure differential.

 

What will be the predominant sterilization method for titanium / steel implants in 3 to 5 years?  

McEvoy: Implants have enjoyed the benefits of radiation processing particularly with Gamma. Likely, over the coming years, X-ray will provide a beneficial alternative and necessary capacity: same penetration and bulk processing options without the reliance on cobalt radiation sources.   

 

Does Nitrogen injection time play a crucial role in diluting process in EO sterilization? We can't see this time on our report—is it important to place this time in the sterilization batch report?

McEvoy: The role of N2 is to assist in the dilution and removal of air. Air and EO form an explosive mixture. N2 is used to reduce the air concentration in the chamber to a level where an explosive atmosphere is not present upon the introduction of EO gas. 

Baxter and BioMérieux in Exclusive Distribution Pact for AKI Test

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Baxter International has signed an exclusive distribution agreement with bioMérieux for the NEPHROCLEAR CCL14 diagnostic test in both Europe and the U.S. The product is an acute kidney injury (AKI) diagnostic.

As part of the agreement, both companies will share in-country commercialization, while bioMérieux will retain control over the regulatory approval process. The companies didn’t disclose financial terms of the agreement.

“Baxter’s agreement with bioMérieux will allow us to introduce a new diagnostic offering to our Acute Therapies portfolio and offer clinicians a meaningful tool as they manage the complexities of AKI in their patients,” Reaz Rasul, general manager of Baxter’s Acute Therapies business, said in a release.

A recent study published in Intensive Care Medicine found that urinary CCL14 (C–C motif chemokine ligand 14), the novel biomarker measured by the NEPHROCLEART CCL14 test, is the most predictive of persistent stage 3 AKI, the most severe form of AKI, when compared with other AKI biomarkers (NGAL, CHI3L1, L-FABP, Cystatin C, Proenkephalin, KIM-1 and IL-18).

The multi-center international prospective observational study, titled “Identification and validation of biomarkers of persistent acute kidney injury: the RUBY study,” enrolled 364 patients in the intensive care unit with moderate or severe AKI (KDIGO stage 2 or 3), of whom 331 were available for the primary analysis. In the analysis cohort, 110 patients (33%) met the criteria for persistent stage 3 AKI.

Study investigators found the CCL14 biomarker had an AUC (95% CI) of 0.83 (0.78–0.87),6 which can be considered excellent and was significantly (p<0.05) greater than values for the other biomarkers tested.

Apple Continues to Go All in on Health

As speculated, Apple introduced the Apple Watch Series 6 on Tuesday, which includes a blood oxygen feature designed to offer users further insight into their overall wellness. The biggest takeaway from the event, as it relates to medtech at least, is that the Cupertino, CA-based company is no longer just dipping its toes into the medtech waters — Apple is all in on healthcare.

“Apple Watch Series 6 completely redefines what a watch can do,” said Jeff Williams, Apple’s chief operating officer. “With powerful new features, including a blood oxygen sensor and app, Apple Watch becomes even more indispensable by providing further insight into overall well-being.”

Apple Watch Series 6 is designed to expand the health capabilities of previous Apple Watch models with a new feature that conveniently measures the oxygen saturation of the user’s blood, so they can better understand their overall fitness and wellness. Oxygen saturation, or SpO2, represents the percentage of oxygen being carried by red blood cells from the lungs to the rest of the body, and indicates how well this oxygenated blood is being delivered throughout the body.

To compensate for natural variations in the skin and improve accuracy, the sensor employs four clusters of green, red, and infrared LEDs, along with the four photodiodes on the back crystal of Apple Watch, to measure light reflected back from blood. Apple Watch then uses an advanced custom algorithm built into the blood oxygen app, which is designed to measure blood oxygen between 70% and 100%. On-demand measurements can be taken while the user is still, and periodic background measurements occur when they are inactive, including during sleep. All data will be visible in the health app, and the user will be able to track trends over time to see how their blood oxygen level changes.

The ability to track blood oxygen level changes is especially helpful in the age of COVID-19, as the virus can sometiems cause silent hypoxia, which is when a patient's blood oxygen saturation levels are found to be lower than expected without the patient exhibiting breathlessness.
The reveal led to a lot of excitement Tuesday, even for my dog, Addison.

New Apple Watch clinical research

Apple said it is working with researchers to conduct three health studies that include using Apple Watch to explore how blood oxygen levels can be used in future health applications. This year, Apple will collaborate with the University of California, Irvine, and Anthem to examine how longitudinal measurements of blood oxygen and other physiological signals can help manage and control asthma.

Separately, Apple plans to work with investigators at the Ted Rogers Centre for Heart Research and the Peter Munk Cardiac Centre at the University Health Network, one of the largest health research organizations in North America, to better understand how blood oxygen measurements and other Apple Watch metrics can help with management of heart failure. Finally, investigators with the Seattle Flu Study at the Brotman Baty Institute for Precision Medicine and faculty from the University of Washington School of Medicine will seek to learn how signals from apps on Apple Watch, such as heart rate and blood oxygen, could serve as early signs of respiratory conditions like influenza and COVID-19.

Implications of the Apple Watch Blood Oxygen app for Masimo

The release of a blood oxygen app on the Apple Watch does create some new competition for Masimo, Mike Matson, a medtech analyst at Needham & Co., said he does not expect it to have a material impact on the sales of most of Masimo's products because the Apple Watch is a consumer product and "potentially less accurate than medical-grade products offered by [Masimo]."
Matson also noted in a report on Tuesday that Masimo filed a against Apple for patent infringement and trade theft in January. While it could take years for that lawsuit to be resolved, the latest Apple Watch reveal could have a potential upside for the medtech company down the road in the form of royalties, should the case be resolved in Masimo's favor.

The Fight to Standardize COVID-19 Antibody Tests

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A new collaboration will help define the threshold for standardizing COVID-19 antibody tests. Siemens Healthineers is teaming up with the Centers for Disease Control and Prevention and the Joint Research Centre (JRC) of the European Commission on the research project.

Antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins.

Here’s where Siemens comes in. The Erlangen, Germany-based company will develop a process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block the virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.

"One barrier to antibody test adoption is we don't currently have an established process to determine immunity," Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers, said in a release. "Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity. Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves."

Recently, Siemens won EUA for the ADIVA Centaur COV2G and Atellica IM COV2G semi-quantitative Sars-CoV-2 IgG antibody tests.  These semi-quantitative don’t display the precise measurement but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

With these tests, the company began to change the conversation surrounding antibody tests.

Antibody Tests

COVID-19 Antibody testing has been controversial during the pandemic – mostly because of issues with accuracy.

Chembio Diagnostics, one of the first companies to receive an emergency use authorization (EUA) for an antibody test during the pandemic, had the designation revoked. The Medford, NY-based company recently announced it would pursue EUA for a new test the DPP SARS-CoV-2 IgM/IgG.

Chembio said the test provides results in 15 minutes from finger stick, venous whole blood, plasma, or serum samples.

The firm also revoked EUA of Autobio Diagnostics Co.’s Anti-SARS-CoV-2 rapid tests for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2 due to performance concerns with the accuracy of the test.

The plan to standardize antibody tests come at the time when there are about 29.6 million cases of COVID-19 across the globe with 936,079 deaths, according to data from worldometers.info. The web site shows that about 21.4 million people have recovered from COVID-19.  

Don't Ignore OEM Disinfectant Guidelines on Medical Imaging Devices

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The Medical Imaging & Technology Alliance (MITA) sent a letter to FDA calling attention to recent reports of inappropriate cleaning agents and disinfectants being used on medical imaging devices amid the COVID-19 pandemic. The letter urges the agency to issue a clear communication to the public about the importance of following the original equipment manufacturer (OEM) guidelines regarding the use of cleaning agents and disinfectants on medical imaging devices.

“Imaging devices include manufacturer guidelines for proper cleaning and disinfection,” said Patrick Hope, executive director of MITA. “It is essential — especially in the context of a viral pandemic — to follow these expert guidelines to ensure patient safety and the ongoing performance of these devices.”

Failure to follow manufacturer guidelines may cause damage to the product, leading to otherwise unnecessary repairs, irreversible damage, or downtime for the machine, potentially leading to delayed care. To underscore this problem, MITA highlighted a recent example of an ultrasound probe that was cleaned with a non-OEM approved disinfectant, resulting in significant damage to the lens material and necessitating replacement of the part.

The letter also raised concerns that certain cleaning products are being marketed as effective against COVID- 19, leading to the use of these products without proper verification and validation. 

“Given the public health emergency, it is incumbent on the government, manufacturers, and users to prevent imaging devices from becoming vectors of COVID-19 disease transmission. As patients return to care, we want them to trust that imaging devices have been appropriately cleaned and disinfected according to OEM processes each time and every time,” Hope said. 

Mita called for FDA to take immediate action to communicate to the public the importance of following manufacturer guidelines for cleaning and disinfecting medical imaging devices. The full letter can be read here.