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    [title] => Vascular Dynamics Announces Initial Enrollment in Rigorously Designed Hypertension Trial
    [short_title] => 
    [summary] => CALM-2 Trial studies effectiveness of unique Endovascular Baroreceptor Amplification device.
    [slug] => vascular-dynamics-announces-initial-enrollment-in-rigorously-designed-hypertension-trial
    [body] => Vascular Dynamics Inc. (VDI), a privately held medical device company focused on minimally invasive device-based solutions for cardiovascular conditions, has enrolled the first patients in a U.S. Food and Drug Administration (FDA)-approved best-in-class pivotal clinical trial. The CALM-2 study is designed to establish safety and efficacy of the novel endovascular baroreceptor amplification (EVBA) procedure using the unique MobiusHD device as a treatment for drug-resistant hypertension.
 
Over 100 million people in the United States have hypertension, which is recognized as the most important single risk factor for cardiovascular morbidity and death. Existing pharmacological interventions are effective for some, but more than half of those treated with antihypertensive medications continue to have uncontrolled high blood pressure.
 
“I am optimistic that device-based treatments, such as EVBA with the MobiusHD implant, may be able to provide effective solutions for patients who have not benefited from drug-based treatments,” said professor Bryan Williams, co-principal investigator of the trial and chair of Medicine at University College London, director of Research at UCL Hospitals, and chairman-elect of the European Council on Hypertension of the European Society of Cardiology.
 
Baroreceptors are specialized nerves located in the carotid artery, which detect changes in stretch of the arterial wall and signal the brain to control blood pressure. The baroreceptor mechanism, or baroreflex, is an essential component for the body’s natural regulation of blood pressure. VDI is developing the first minimally invasive technology designed to use this natural blood pressure control system to address uncontrolled hypertension. The MobiusHD is a flexible self-expanding device that reshapes the carotid sinus following endovascular implantation. It is intended to amplify the baroreflex while maintaining pulsatility.
 
Results published in The Lancet from an open-label, proof-of-concept trial (CALM-FIM) using VDI’s EVBA approach to treat patients with resistant hypertension were positive, showing significant reductions in blood pressure through six months, greater than the 24-hour ambulatory blood pressure reductions reported to date for alternative devices used to treat hypertension.1 These results led to the design and development of a rigorous pivotal clinical trial intended to generate conclusive evidence confirming the safety and efficacy of this unique device for resistant hypertension patients.
 
The CALM-2 (Controlling And Lowering blood pressure with MobiusHD) pivotal trial is a prospective, randomized, sham-controlled, double-blinded study targeting patients with drug-resistant hypertension. Lessons learned from numerous clinical trials of first-generation device-based approaches to hypertension were incorporated into the CALM-2 study protocol to provide a best-in-class clinical trial design. The CALM-2 trial is targeting enrollment of up to 300 patients at leading institutions across the United States and Europe. The first patients were enrolled in July 2018 at the Center for Clinical Research at Southern Illinois University Medicine and The Lindner Research Center at The Christ Hospital Health Network.
 
“Enrolling the first patients in the CALM-2 trial is an important step toward offering a new treatment option for this large patient population with resistant hypertension and the associated health risks,” stated Gregg Stone, M.D., co-principal investigator of the CALM-2 trial and director of Cardiovascular Research and Education for NewYork-Presbyterian Hospital/Columbia University Medical Center and co-director of Medical Research and Education at the Cardiovascular Research Foundation.
 
VDI’s recently appointed president and CEO Ed Roschak said, “We are putting the right team and processes in place to successfully complete this landmark trial and to develop compelling clinical evidence to support future FDA approval.”
 
Vascular Dynamics develops minimally invasive platform technologies for treating patients at risk of life-threatening cardiovascular events and underserved by conventional treatments. Focused initially on uncontrolled hypertension, VDI was approved to participate in the FDA's Expedited Access Pathway (EAP) program. EVBA treatment with the MobiusHD implant system has received a CE Mark for the treatment of hypertension in the European Union. The MobiusHD system is not commercially available in the United States.

The MobiusHD device is limited in the United States to investigational use only.
 
References
1. Spiering, W, Williams, B, Van der Heyden, J…, Endovascular baroreflex amplification for the resistant hypertension: a safety and proof-of-principle clinical study, The Lancet 2017. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-08 10:13:00 [updated_at] => 2018-10-08 10:22:48 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["284775","283022","293408","291642","281278","297184","277320","279548","297010","297145","282690","281299","280635","277744","282688","279015","283697","282390","296562","282544","277759"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2018-10-08/vascular-dynamics-announces-initial-enrollment-in-rigorously-designed-hypertension-trial/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277320 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165549 [primary_image_old] => [slider_image_id] => 165549 [banner_image] => 0 [title] => Masimo's Pulse CO-Oximeter with Integrated NomoLine Capnography Wins CE Mark [short_title] => [summary] => Continuous oxygenation and ventilation monitoring with upgradeable rainbow parameters in a compact, standalone device. [slug] => masimos-pulse-co-oximeter-with-integrated-nomoline-capnography-wins-ce-mark [body] => Masimo announced the CE marking of the Rad-97 Pulse CO-Oximeter with integrated NomoLine capnography. With this clearance, Rad-97 is now available both within and outside the United States in three configurations: Rad-97, Rad-97 with integrated noninvasive blood pressure, and now Rad-97 with NomoLine capnography. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion SET pulse oximetry, upgradeable rainbow technology, and NomoLine capnography in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.
 
Rad-97 with NomoLine capnography features an integrated ISA CO2module with NomoLine sampling lines for sidestream capnography, with an adapter for intubated patients—meeting continuous monitoring and capnography needs in a single device. Rad-97 with capnography displays continuous end-tidal carbon dioxide (EtCO2) values with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate. With both integrated capnography and Masimo acoustic respiration rate (RRa) available on a single device, clinicians have the flexibility of choosing the most appropriate respiration monitoring method for each patient.
 
Rad-97 combines its portable, compact form factor with a high-resolution, multi-touch color display that allows clinicians to easily customize the device for each monitoring use case—bringing rainbow SET measurements and capnography measurements to care areas where a small footprint or high portability is desired. Rad-97 features built-in enterprise WiFi capability, allowing it to connect wirelessly to supplemental patient monitoring systems including Masimo Patient SafetyNet*, facilitating automatic data transfer to hospital electronic medical record (EMR) systems. The easy-to-use, intuitive interface helps to simplify charting workflows for vital sign monitoring and patient data capture.
 
“We’re delighted to bring the full family of Rad-97 products to markets outside the United States,” said Joe Kiani, founder and CEO of Masimo. “We believe Rad-97, with its versatility and customizability, will play an especially important role in helping hospitals improve their monitoring capabilities with convenient, easy-to-use device and technology solutions—ultimately helping to improve patient care and safety.”
 
Rad-97, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine capnography have received FDA 510(k) clearance and are also available in the United States.
 
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-10 09:26:00 [updated_at] => 2018-04-10 09:31:31 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["267309","268994","265816","260352","268603","260494","271912","262587","266990"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277744 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165734 [primary_image_old] => [slider_image_id] => 165734 [banner_image] => 0 [title] => FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices [short_title] => [summary] => Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness. [slug] => fdas-expansion-of-510k-program-seeks-to-end-predicate-testing-for-some-devices [body] => The U.S. Food and Drug Administration published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.
 
Such criteria could include FDA-recognized consensus standards and criteria established by the FDA guidances. In an FDA Voice blog, FDA Commissioner Scott Gottlieb, M.D. noted that the voluntary pathway will “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology” the FDA is being asked to evaluate.
 
"The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients. As part of these efforts, we’ve proposed a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said Dr. Gottlieb.
 
Substantial equivalence is rooted in a comparison between a new device and a predicate device, which is a legally marketed device to which a new device may be compared because it has the same intended use and similar enough technological characteristics. But predicate devices are sometimes decades old. The FDA believes performance criteria can facilitate this comparison.
 
Under this approach, if a predicate device meets certain levels of performance on characteristics relevant to its safety and effectiveness, and a new device meets or exceeds those same levels of performance on the same characteristics, the FDA could find the new device to be as safe and effective as the predicate. Instead of requiring direct comparison testing between the two devices, the FDA could support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device.
 
The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 10:08:00 [updated_at] => 2018-04-13 10:18:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["264451","277759","277496","263022","277521","277503","276758","275121","274327","272984","272970","272745","262289","266483","276264","264919","266487","270745","268909","262206","273584","269239"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277759 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165741 [primary_image_old] => [slider_image_id] => 165741 [banner_image] => 0 [title] => FDA Finalizes Guidances to Speed Development of Next-Generation Sequencing Based Tests [short_title] => [summary] => FDA is leveraging new tools and policies to advance creation of genetic and genomic-based tests and help ensure validity. [slug] => fda-finalizes-guidances-to-speed-development-of-next-generation-sequencing-based-tests [body] => The U.S. Food and Drug Administration finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.
 
“As disease detection technologies rapidly evolve, so too must the FDA’s approach to reviewing these new innovations,” said FDA Commissioner Scott Gottlieb, M.D. “The new policies issued today provide a modern and flexible framework to generate data needed to support the FDA’s review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies.”
 
NGS works by looking at a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of developing a genetic disease and, in certain cases, may help to inform treatment decisions. Unlike traditional diagnostics that typically detect chemical changes associated with a single disease or condition, NGS can look at millions of DNA changes in a single test to help determine the cause of a person’s disease or condition. Availability of these types of tests plays an important role in the advancement of the field of precision medicine.
 
The first guidance issued, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics,” describes an approach where test developers may rely on clinical evidence from FDA-recognized public databases to support clinical claims for their tests and help provide assurance of the accurate clinical evaluation of genomic test results. The guidance describes how product developers can use these databases to support the clinical validation of NGS tests that they are developing. These public databases may include resources like ClinGen, which is maintained by the National Institutes of Health (NIH). Using FDA-recognized databases will provide test developers with an efficient path for marketing clearance or approval of a new test.
 
The second guidance issued, “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)–Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases,” provides recommendations for designing, developing, and validating NGS-based tests used to diagnose individuals with suspected genetic diseases. It describes what the FDA would look for in premarket submissions to determine a test’s analytical validity, including how well the test detects the presence or absence of a particular genomic change.
 
“The rapid adoption of NGS technologies in research and clinical settings is helping to identify countless new genetic variants. However, information about genetic variants is generally stored in a manner that is not publicly accessible. Today’s release of the FDA’s final guidance on genetic variant databases will help change this paradigm by encouraging data sharing and the accumulation in public databases of evidence supporting the clinical validity of genomic tests to help provide an even more efficient path to market,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
 
Issuance of these final guidances is based on extensive feedback from the public and stakeholders who are developing NGS-based technologies, and the guidances serve as a continuation of the FDA’s work creating regulatory efficiencies in the development and review of NGS tests. In 2017, the FDA took several actions to streamline the development and review of a variety of genetic-based tests—authorizing a third-party option for conducting reviews NGS tumor profiling tests and making clearance recommendations to FDA, as well as outlining standardized development criteria for carrier screening tests to allow for their marketing without prior agency review. FDA also established such criteria for genetic health risk tests and proposed to allow their marketing after a one-time agency review.
 
As NGS technologies continue to evolve, the FDA remains dedicated to adapting our regulatory review capabilities and leveraging our authorities to the fullest extent in order to make innovative and accurate testing technologies available to patients as efficiently as possible. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 11:04:00 [updated_at] => 2018-04-13 11:08:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["277744","264451","277496","265107","277521","277503","276758","275121","274327","272984","272970","272745"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279015 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Erin Wright, Validation Product Manager, MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166430 [primary_image_old] => [slider_image_id] => 166430 [banner_image] => 0 [title] => Software Validation: How It Should Be Done [short_title] => [summary] => With vague guidance from FDA, device makers need to ensure they are using best practices. [slug] => software-validation-how-it-should-be-done [body] => Software validation—the mere mention of it is enough to give a quality, IT, or validation professional a sinking feeling, if not a headache. Why? Because as most who have done it know, it can be one of the most resource-intensive, time-consuming, and costly compliance activities for regulated companies.
 
Under 21 CFR Part 11, organizations that operate under the auspices of the U.S. Food and Drug Administration (FDA) are required to validate electronic systems that create, modify, maintain, archive, retrieve, or transmit electronic records required by predicate regulations. Medical device firms must also comply with 21 CFR 820, a predicate rule that similarly requires software validation.
 
The perennial and problematic challenge comes from the fact that while the FDA requires validation, it does not specify how companies should go about the validation process. What the FDA wants is evidence that a company has documented how it intends to conduct validation and prove that it has done it the way it said it would. The objective of validation is to ensure the software will work as expected and specified. So, the question remains, “How do you conduct validation properly and successfully?”
 
In its guidance on “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” the FDA states, “We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.” In addition, the agency recommends that companies base their approach on a justified and documented risk assessment.
 
This doesn’t give much in the way of specific direction. As such, most companies are left erring on the side of caution when it comes to validation, and they validate much more than is necessary. The result is a validation process that takes months to accomplish. This often delays an organization’s ability to go live with new software or upgrade existing software. This causes the company to work with out-of-date software that can hinder its ability to optimize processes and stay up to date on the most recent security updates and other features.

Best Approach to Software Validation
In the Part 11 guidance, the FDA alludes that taking a risk-based approach cuts down the time it takes to conduct validation. Risk assessment is the key. Validation is a process that helps ensure life science companies are doing what they need to do to remove or mitigate risk. In fact, the argument can be made that most regulations are in place to remove risk along the product lifecycle, from the design and development through the use by consumers. A current trend among software suppliers, particularly those that create cloud-based software, is to provide their users with “canned” validation methodologies or scripts that are intended to cut time for the user. It is a step in the right direction, but it is not enough and can even put users at greater risk.
 
A simplified example in such a scenario would be a supplier providing a risk assessment for the software stating that “exporting a document is low risk.” Again, this is not enough and may introduce risk for the company because it all depends on how the software is actually used, not necessarily on how the supplier intended it to be used.
 
For instance, exporting documents may be low risk as a software feature, but if those documents are intended for regulatory submission, it suddenly increases the risk of the software to the company because of how it’s using the software. Another company may just export documents to a desktop for the purpose of sending those documents to employees via email. It’s the same software functionality, but a significantly different impact of failure for each company. This is why regulated companies can’t rely on supplier software risk assessments alone, since suppliers can’t take into account a company’s business practices.
 
It’s important to leverage the supplier validation documentation, but it can’t be the only step of the risk assessment. Risk must be assessed by functionality and usage, not just one or the other. A properly executed risk assessment will focus on the user’s critical business processes (CBPs), not just on the software.
 
Once risk assessments for individual CBPs have been determined, a validation approach for each area can be conducted. The following best-practice approach outlines three types of validations that can be utilized with a risk-based process. 
 
  1. High: Complete/comprehensive testing required. All usage scenarios must be thoroughly tested. This is similar to the “traditional” approach to validation.
  2. Medium: Testing of the functional requirements per the CBPs required with sufficient assurance that each item has been properly characterized.
  3. Low: No formal testing needed.
 
If a company understands its true risk of software adoption based on its CBPs, validation no longer needs to be an all-or-nothing activity. It can be done with surgical precision, cutting down the validation time from months to days or even hours. Companies can leverage their suppliers’ documentation, but they must properly assess their own software usage in relation to their regulatory requirements.
 

Erin Wright, MasterControl’s validation product manager, spearheads the efforts pertaining to the development of the company’s Validation Excellence Tool (VxT), which streamlines the risk-assessment process and greatly reduces validation time. She joined MasterControl in 2013 as a professional services consultant and worked closely with hundreds of regulated companies, including the FDA’s Center for Drug Evaluation and Research (CDER), Ancestry.com, Abbott Point of Care, Institute for Transfusion Medicine (ITxM), and the University of Utah, in conducting custom validation implementations. Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers. She graduated summa cum laude from West Chester University with a degree in psychology. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-26 09:11:00 [updated_at] => 2018-04-26 09:16:56 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["265305","265154","265280","276277","265289","278641","278237","278234","277967","277759","277744","277521","277503","277496","276758"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279548 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166772 [primary_image_old] => [slider_image_id] => 166772 [banner_image] => 0 [title] => FDA Clears 3M's Biological Indicator System with 24-Minute Readout for Steam Sterilization [short_title] => [summary] => 24-minute results for steam sterilization helps facilities streamline workflow and provide higher standard of care. [slug] => fda-clears-3ms-biological-indicator-system-with-24-minute-readout-for-steam-sterilization [body] => Sterilization departments are on the front line of defense in the fight against surgical site infections. To help facilities increase patient safety and provide a higher standard of care, 3M is excited to announce FDA 510(k) clearance for its 3M Attest Super Rapid Biological Indicator (BI) System for Steam, which now provides BI test results in just 24 minutes. The new 24-minute system is attainable through a software upgrade to existing 3M Attest Auto-reader 490 and 490H units.
 
The software upgrade enables all customers who have existing hardware to receive the benefit of a 24-minute readout at no extra charge. In addition, the upgrade provides an added benefit of Any-Well technology. Each upgraded BI Auto-reader will have the ability to read both steam and vaporized hydrogen peroxide (VH2O2) BIs simultaneously in any incubation well. These innovations enable facilities to simplify, standardize and streamline their sterilization department’s workflow to help ensure every instrument is safe for patient use and keep surgeries on schedule.
 
“When we received FDA clearance for the Rapid Readout BI System for VH2O2 in July 2017, it was a logical leap to extend that technology to steam sterilization,” said Srini Raman, 3M Business Director of Device Reprocessing. “But we didn’t stop there. We worked to combine steam and VH2O2 BI readouts into one system to help customers streamline workflow processes, as well as support patient safety initiatives by enabling facilities to realistically implement every load monitoring.”
 
The new 24-minute results for steam BIs, coupled with the dual-reader technology, builds upon the Attest brand advantage by helping to reduce risk and enhance efficiency by working to standardize and simplify sterilization processes. Customers will also be able to use the same 3M BIs and test packs already available in the market today, allowing for an easy and smooth transition. All Attest Auto-readers will also continue to provide connectivity with the 3M Attest Web App and primary instrument tracking systems for digital record keeping. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-05-01 10:56:00 [updated_at] => 2018-05-01 11:00:52 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["267309","266990","268994","264451","267178","269560","277320","266619","265816","268603","269153","279504","279103","279015","278641","278237","278234","277967","277759","277744","277521"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277320 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165549 [primary_image_old] => [slider_image_id] => 165549 [banner_image] => 0 [title] => Masimo's Pulse CO-Oximeter with Integrated NomoLine Capnography Wins CE Mark [short_title] => [summary] => Continuous oxygenation and ventilation monitoring with upgradeable rainbow parameters in a compact, standalone device. [slug] => masimos-pulse-co-oximeter-with-integrated-nomoline-capnography-wins-ce-mark [body] => Masimo announced the CE marking of the Rad-97 Pulse CO-Oximeter with integrated NomoLine capnography. With this clearance, Rad-97 is now available both within and outside the United States in three configurations: Rad-97, Rad-97 with integrated noninvasive blood pressure, and now Rad-97 with NomoLine capnography. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion SET pulse oximetry, upgradeable rainbow technology, and NomoLine capnography in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.
 
Rad-97 with NomoLine capnography features an integrated ISA CO2module with NomoLine sampling lines for sidestream capnography, with an adapter for intubated patients—meeting continuous monitoring and capnography needs in a single device. Rad-97 with capnography displays continuous end-tidal carbon dioxide (EtCO2) values with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate. With both integrated capnography and Masimo acoustic respiration rate (RRa) available on a single device, clinicians have the flexibility of choosing the most appropriate respiration monitoring method for each patient.
 
Rad-97 combines its portable, compact form factor with a high-resolution, multi-touch color display that allows clinicians to easily customize the device for each monitoring use case—bringing rainbow SET measurements and capnography measurements to care areas where a small footprint or high portability is desired. Rad-97 features built-in enterprise WiFi capability, allowing it to connect wirelessly to supplemental patient monitoring systems including Masimo Patient SafetyNet*, facilitating automatic data transfer to hospital electronic medical record (EMR) systems. The easy-to-use, intuitive interface helps to simplify charting workflows for vital sign monitoring and patient data capture.
 
“We’re delighted to bring the full family of Rad-97 products to markets outside the United States,” said Joe Kiani, founder and CEO of Masimo. “We believe Rad-97, with its versatility and customizability, will play an especially important role in helping hospitals improve their monitoring capabilities with convenient, easy-to-use device and technology solutions—ultimately helping to improve patient care and safety.”
 
Rad-97, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine capnography have received FDA 510(k) clearance and are also available in the United States.
 
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-10 09:26:00 [updated_at] => 2018-04-10 09:31:31 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["267309","268994","265816","260352","268603","260494","271912","262587","266990"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277744 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165734 [primary_image_old] => [slider_image_id] => 165734 [banner_image] => 0 [title] => FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices [short_title] => [summary] => Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness. [slug] => fdas-expansion-of-510k-program-seeks-to-end-predicate-testing-for-some-devices [body] => The U.S. Food and Drug Administration published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.
 
Such criteria could include FDA-recognized consensus standards and criteria established by the FDA guidances. In an FDA Voice blog, FDA Commissioner Scott Gottlieb, M.D. noted that the voluntary pathway will “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology” the FDA is being asked to evaluate.
 
"The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients. As part of these efforts, we’ve proposed a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said Dr. Gottlieb.
 
Substantial equivalence is rooted in a comparison between a new device and a predicate device, which is a legally marketed device to which a new device may be compared because it has the same intended use and similar enough technological characteristics. But predicate devices are sometimes decades old. The FDA believes performance criteria can facilitate this comparison.
 
Under this approach, if a predicate device meets certain levels of performance on characteristics relevant to its safety and effectiveness, and a new device meets or exceeds those same levels of performance on the same characteristics, the FDA could find the new device to be as safe and effective as the predicate. Instead of requiring direct comparison testing between the two devices, the FDA could support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device.
 
The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 10:08:00 [updated_at] => 2018-04-13 10:18:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["264451","277759","277496","263022","277521","277503","276758","275121","274327","272984","272970","272745","262289","266483","276264","264919","266487","270745","268909","262206","273584","269239"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277759 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165741 [primary_image_old] => [slider_image_id] => 165741 [banner_image] => 0 [title] => FDA Finalizes Guidances to Speed Development of Next-Generation Sequencing Based Tests [short_title] => [summary] => FDA is leveraging new tools and policies to advance creation of genetic and genomic-based tests and help ensure validity. [slug] => fda-finalizes-guidances-to-speed-development-of-next-generation-sequencing-based-tests [body] => The U.S. Food and Drug Administration finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.
 
“As disease detection technologies rapidly evolve, so too must the FDA’s approach to reviewing these new innovations,” said FDA Commissioner Scott Gottlieb, M.D. “The new policies issued today provide a modern and flexible framework to generate data needed to support the FDA’s review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies.”
 
NGS works by looking at a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of developing a genetic disease and, in certain cases, may help to inform treatment decisions. Unlike traditional diagnostics that typically detect chemical changes associated with a single disease or condition, NGS can look at millions of DNA changes in a single test to help determine the cause of a person’s disease or condition. Availability of these types of tests plays an important role in the advancement of the field of precision medicine.
 
The first guidance issued, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics,” describes an approach where test developers may rely on clinical evidence from FDA-recognized public databases to support clinical claims for their tests and help provide assurance of the accurate clinical evaluation of genomic test results. The guidance describes how product developers can use these databases to support the clinical validation of NGS tests that they are developing. These public databases may include resources like ClinGen, which is maintained by the National Institutes of Health (NIH). Using FDA-recognized databases will provide test developers with an efficient path for marketing clearance or approval of a new test.
 
The second guidance issued, “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)–Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases,” provides recommendations for designing, developing, and validating NGS-based tests used to diagnose individuals with suspected genetic diseases. It describes what the FDA would look for in premarket submissions to determine a test’s analytical validity, including how well the test detects the presence or absence of a particular genomic change.
 
“The rapid adoption of NGS technologies in research and clinical settings is helping to identify countless new genetic variants. However, information about genetic variants is generally stored in a manner that is not publicly accessible. Today’s release of the FDA’s final guidance on genetic variant databases will help change this paradigm by encouraging data sharing and the accumulation in public databases of evidence supporting the clinical validity of genomic tests to help provide an even more efficient path to market,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
 
Issuance of these final guidances is based on extensive feedback from the public and stakeholders who are developing NGS-based technologies, and the guidances serve as a continuation of the FDA’s work creating regulatory efficiencies in the development and review of NGS tests. In 2017, the FDA took several actions to streamline the development and review of a variety of genetic-based tests—authorizing a third-party option for conducting reviews NGS tumor profiling tests and making clearance recommendations to FDA, as well as outlining standardized development criteria for carrier screening tests to allow for their marketing without prior agency review. FDA also established such criteria for genetic health risk tests and proposed to allow their marketing after a one-time agency review.
 
As NGS technologies continue to evolve, the FDA remains dedicated to adapting our regulatory review capabilities and leveraging our authorities to the fullest extent in order to make innovative and accurate testing technologies available to patients as efficiently as possible. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 11:04:00 [updated_at] => 2018-04-13 11:08:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["277744","264451","277496","265107","277521","277503","276758","275121","274327","272984","272970","272745"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279015 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Erin Wright, Validation Product Manager, MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166430 [primary_image_old] => [slider_image_id] => 166430 [banner_image] => 0 [title] => Software Validation: How It Should Be Done [short_title] => [summary] => With vague guidance from FDA, device makers need to ensure they are using best practices. [slug] => software-validation-how-it-should-be-done [body] => Software validation—the mere mention of it is enough to give a quality, IT, or validation professional a sinking feeling, if not a headache. Why? Because as most who have done it know, it can be one of the most resource-intensive, time-consuming, and costly compliance activities for regulated companies.
 
Under 21 CFR Part 11, organizations that operate under the auspices of the U.S. Food and Drug Administration (FDA) are required to validate electronic systems that create, modify, maintain, archive, retrieve, or transmit electronic records required by predicate regulations. Medical device firms must also comply with 21 CFR 820, a predicate rule that similarly requires software validation.
 
The perennial and problematic challenge comes from the fact that while the FDA requires validation, it does not specify how companies should go about the validation process. What the FDA wants is evidence that a company has documented how it intends to conduct validation and prove that it has done it the way it said it would. The objective of validation is to ensure the software will work as expected and specified. So, the question remains, “How do you conduct validation properly and successfully?”
 
In its guidance on “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” the FDA states, “We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.” In addition, the agency recommends that companies base their approach on a justified and documented risk assessment.
 
This doesn’t give much in the way of specific direction. As such, most companies are left erring on the side of caution when it comes to validation, and they validate much more than is necessary. The result is a validation process that takes months to accomplish. This often delays an organization’s ability to go live with new software or upgrade existing software. This causes the company to work with out-of-date software that can hinder its ability to optimize processes and stay up to date on the most recent security updates and other features.

Best Approach to Software Validation
In the Part 11 guidance, the FDA alludes that taking a risk-based approach cuts down the time it takes to conduct validation. Risk assessment is the key. Validation is a process that helps ensure life science companies are doing what they need to do to remove or mitigate risk. In fact, the argument can be made that most regulations are in place to remove risk along the product lifecycle, from the design and development through the use by consumers. A current trend among software suppliers, particularly those that create cloud-based software, is to provide their users with “canned” validation methodologies or scripts that are intended to cut time for the user. It is a step in the right direction, but it is not enough and can even put users at greater risk.
 
A simplified example in such a scenario would be a supplier providing a risk assessment for the software stating that “exporting a document is low risk.” Again, this is not enough and may introduce risk for the company because it all depends on how the software is actually used, not necessarily on how the supplier intended it to be used.
 
For instance, exporting documents may be low risk as a software feature, but if those documents are intended for regulatory submission, it suddenly increases the risk of the software to the company because of how it’s using the software. Another company may just export documents to a desktop for the purpose of sending those documents to employees via email. It’s the same software functionality, but a significantly different impact of failure for each company. This is why regulated companies can’t rely on supplier software risk assessments alone, since suppliers can’t take into account a company’s business practices.
 
It’s important to leverage the supplier validation documentation, but it can’t be the only step of the risk assessment. Risk must be assessed by functionality and usage, not just one or the other. A properly executed risk assessment will focus on the user’s critical business processes (CBPs), not just on the software.
 
Once risk assessments for individual CBPs have been determined, a validation approach for each area can be conducted. The following best-practice approach outlines three types of validations that can be utilized with a risk-based process. 
 
  1. High: Complete/comprehensive testing required. All usage scenarios must be thoroughly tested. This is similar to the “traditional” approach to validation.
  2. Medium: Testing of the functional requirements per the CBPs required with sufficient assurance that each item has been properly characterized.
  3. Low: No formal testing needed.
 
If a company understands its true risk of software adoption based on its CBPs, validation no longer needs to be an all-or-nothing activity. It can be done with surgical precision, cutting down the validation time from months to days or even hours. Companies can leverage their suppliers’ documentation, but they must properly assess their own software usage in relation to their regulatory requirements.
 

Erin Wright, MasterControl’s validation product manager, spearheads the efforts pertaining to the development of the company’s Validation Excellence Tool (VxT), which streamlines the risk-assessment process and greatly reduces validation time. She joined MasterControl in 2013 as a professional services consultant and worked closely with hundreds of regulated companies, including the FDA’s Center for Drug Evaluation and Research (CDER), Ancestry.com, Abbott Point of Care, Institute for Transfusion Medicine (ITxM), and the University of Utah, in conducting custom validation implementations. Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers. She graduated summa cum laude from West Chester University with a degree in psychology. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-26 09:11:00 [updated_at] => 2018-04-26 09:16:56 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["265305","265154","265280","276277","265289","278641","278237","278234","277967","277759","277744","277521","277503","277496","276758"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279548 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166772 [primary_image_old] => [slider_image_id] => 166772 [banner_image] => 0 [title] => FDA Clears 3M's Biological Indicator System with 24-Minute Readout for Steam Sterilization [short_title] => [summary] => 24-minute results for steam sterilization helps facilities streamline workflow and provide higher standard of care. [slug] => fda-clears-3ms-biological-indicator-system-with-24-minute-readout-for-steam-sterilization [body] => Sterilization departments are on the front line of defense in the fight against surgical site infections. To help facilities increase patient safety and provide a higher standard of care, 3M is excited to announce FDA 510(k) clearance for its 3M Attest Super Rapid Biological Indicator (BI) System for Steam, which now provides BI test results in just 24 minutes. The new 24-minute system is attainable through a software upgrade to existing 3M Attest Auto-reader 490 and 490H units.
 
The software upgrade enables all customers who have existing hardware to receive the benefit of a 24-minute readout at no extra charge. In addition, the upgrade provides an added benefit of Any-Well technology. Each upgraded BI Auto-reader will have the ability to read both steam and vaporized hydrogen peroxide (VH2O2) BIs simultaneously in any incubation well. These innovations enable facilities to simplify, standardize and streamline their sterilization department’s workflow to help ensure every instrument is safe for patient use and keep surgeries on schedule.
 
“When we received FDA clearance for the Rapid Readout BI System for VH2O2 in July 2017, it was a logical leap to extend that technology to steam sterilization,” said Srini Raman, 3M Business Director of Device Reprocessing. “But we didn’t stop there. We worked to combine steam and VH2O2 BI readouts into one system to help customers streamline workflow processes, as well as support patient safety initiatives by enabling facilities to realistically implement every load monitoring.”
 
The new 24-minute results for steam BIs, coupled with the dual-reader technology, builds upon the Attest brand advantage by helping to reduce risk and enhance efficiency by working to standardize and simplify sterilization processes. Customers will also be able to use the same 3M BIs and test packs already available in the market today, allowing for an easy and smooth transition. All Attest Auto-readers will also continue to provide connectivity with the 3M Attest Web App and primary instrument tracking systems for digital record keeping. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-05-01 10:56:00 [updated_at] => 2018-05-01 11:00:52 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["267309","266990","268994","264451","267178","269560","277320","266619","265816","268603","269153","279504","279103","279015","278641","278237","278234","277967","277759","277744","277521"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedSearches] => Array ( [0] => Taxonomy Object ( [className] => Taxonomy [id] => 64229 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => taxonomy [taxonomy_tag] => technologies ) [1] => Taxonomy Object ( [className] => 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