On Dec. 30, the FDA posted an announcement that it is aware that Medline has issued a letter to affected healthcare providers recommending certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits be removed from use related to a potentially high-risk device issue.
The announcement said, “On December 16, 2024, Medline sent all affected customers a Medical Device Recall letter recommending the following actions:
Immediately check your stock for the affected item number and the affected lot numbers listed above.
Confirm whether you received product with the incorrect white macro drip chamber. Fluid Delivery Sets with white macro drip chambers should be discarded. The image below shows the difference in drip chamber colors and should help in identifying impacted devices.
If you have received the correct Fluid Delivery Set with a grey micro drip chamber, the product can be safely used.
Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”
According to the FDA, the reason for the early alert is Medline’s identification of Fluid Delivery Sets that were not assembled correctly with a white macro dip chamber vs. the required gray micro drip chamber.
“The macro drip chamber delivers three times more fluid per drop than the micro drip chamber,” the announcement added. “As a result, using a Fluid Delivery Set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling (edema), shortness of breath, increased blood pressure, and/or death.”
Medline has not reported any injuries associated with this issue.
These fluid delivery sets with drip chambers are provided as components convenience kits. Fluid delivery sets prevent air from entering into the IV tubing and regulate the solution’s flow rate.
The Centers for Medicare & Medicaid Services is attempting to cover anti-obesity medications under Medicare Part D and Medicaid, the agency announced Nov. 26.
Under the Contract Year 2026 MA and Part D proposed rule (PDF), CMS is choosing to follow conventional medical thinking that obesity is a disease. As such, the agency is then able to reinterpret a statute that excludes weight loss drugs from coverage.
“During my time as CMS administrator, I heard from countless people about how this coverage exclusion is a barrier preventing people from treating obesity living healthier lives,” said CMS Administrator Chiquita Brooks-LaSure during a press conference.
Medicare has long claimed it does not have the authority to cover anti-obesity medications, which is why the agency is attempting to reinterpret the statute. They say this new approach is better aligned with existing policies, like covering drugs used to treat AIDS wasting and cachexia. In Medicaid, the reinterpretation would allow states to determine whether to cover GLP-1 drugs.
For individuals that are considered overweight but not obese, the drugs would not be covered.
Critics, meanwhile, say radical uptake of GLP-1 drugs for weight loss would be far too costly on the healthcare system. Officials declined to say if semaglutide would be a selected drug under the drug price negotiation program through the Inflation Reduction Act.
CMS projects that 7% of the Part D population, or approximately 3.4 million Americans, would be newly eligible for coverage of anti-obesity medications, increasing by 1% each year.
The agency expects Part D coverage will increase costs by $24.8 billion in Part D and $14.8 billion in Medicaid. Though the policy could create savings in the long-term, CMS did not assume downstream savings in the proposed rule.
Because of Inflation Reduction Act’s $2,000 out-of-pocket cap and the premium stabilization demonstration, officials downplayed fears of surging premiums. The total HHS budget sits at $2.1 trillion.
“We do not expect any short term impact on premiums from this proposal, and in fact, this proposal provides a significant savings for people who currently may be paying out of pocket for these medications,” said CMS Deputy Administrator and Director for the Center for Medicare Meena Seshamani, M.D
“This action will not only save money but will more critically save lives by significantly driving down obesity rates and improving health outcomes for millions — including the millions of Black and Brown Americans who are disproportionately and unfairly shouldering the burden of the obesity epidemic,” said the Health Equity Coalition for Chronic Disease following the announcement.
The proposed rule also reworks prior authorization and utilization management, guardrails for AI safety, provider directories through the Medicare Plan Finder and new requirements of brokers.
The new regulation may be one of the last major efforts of the Biden administration to revamp healthcare before leaving office.
After the comment period concludes, the rule would need to be finalized in Trump’s next term, said a CMS senior official, hinting the current administration would not try to rush to rubber stamp the rule. If the rule was finalized before Trump takes office, it would be subject to rescission under the Congressional Review Act, which could threaten the policy’s implementation permanently.
It wouldn’t be surprising to see Trump scuttle the plan to cover weight loss drugs, given the incoming administration’s desire to slash the federal budget and regulations, as well as potential HHS Secretary Robert F. Kennedy Jr.’s aversion to the drugs. That might be a welcome development for insuresrs footing the bill.
“The excessive prices drugmakers command for GLP-1s have enormous cost consequences for consumers, taxpayers and employers, said the Alliance of Community Health Plans in a statement. “There are limited long-term studies of these drugs on patients with obesity, particularly those who do not have diabetes or other related chronic conditions.”
A host of new actions addressing prior auth is proposed in the rule. They include prohibiting a MA plan from reopening an approved authorization for inpatient hospital admission and other clarifications of existing enrollee liabilities.
The rule codifies the benefits MA plans must cover and better determines the guardrails these plans must follow when determining internal coverage. These changes are designed to simplify coverage criteria for medically necessary determinations. Also codified is a provision mandating MA plans enact a utilization management committee for plan policies.
Prior auth changes were informed by utilization management audits conducted by CMS this year. The agency found that Medicare Advantage plans overturn 80% of denials on appeal, but only 4% of claims decisions are appealed.
Following up on an executive order last month requiring the feds to make sure AI tools don’t result in inequity in health care organizations, today’s rule mandates MA plans cover services equitably and does not discriminate, no matter if a decision spawns from an AI system or not.
The rule also overhauls provider directories.
Right now, the Medicare Plan Finder, which allows beneficiaries to shop for MA and Part D plans, does not include any information on provider directories, though it can be found on a MA plan’s website.
“This can be cumbersome for individuals when they must search the Medicare Plan Finder, as well as a plan’s website, to find provider network information,” said CMS in a fact sheet.
Under the proposed rule, searchable provider information must be given from MA plans to CMS for the Medicare Plan Finder.
But wait, there’s more.
Biden addresses behavioral health in this rule, too, by limiting cost sharing to be equal or less than traditional Medicare. They are pushing for 20% coinsurance for mental health, psychiatric and outpatient substance abuse services. There would also be zero cost sharing for opioid treatment program services. CMS is asking for public comment on how to best implement these policies with minimal upheaval.
“In response to concerns that cost sharing in other service categories will be raised in response to this movement in behavioral health, we also emphasize that the extent to which organizations may shift costs to services utilized by certain groups of enrollees is limited by statutory and regulatory requirements that ensure beneficiaries can access needed health services regardless of their health condition,” CMS added.
The agency also wants to expand its definition of broker “marketing”, as CMS continues to receive complaints of shady tactics meant to deceive consumers, even as CMS has denied more than 1,500 TV ad submissions. This allows CMS to review more ads before they go to air.
Agent and brokers would also be required to discuss a consumer’s eligibility for the low-income subsidy and Medicare savings program, as well as provide more information on Medigap.
CMS is hoping to make a series of technical changes to the medical loss ratio calculation. Part of that incentive, it appears, is to crack down on unhealthy consolidation in the MA market.
“In addition to the proposed changes, we are issuing a request for information on potential policies that CMS could adopt regarding how the MA and Part D MLRs are calculated in order to enable policymakers to address concerns surrounding vertical integration in MA and Part D,” the proposed rule says.
CMS is concerned MLR reporting is less transparent when these organizations are involved.
In response to backlash from the FTC and media outlets that pharmacy benefit managers allegedly push patients toward expensive brand drugs, the rule reinforces language mandating formularies include access to generics and biosimilars. The rule includes several transparency measures for Part D plans and sponsors.
October 9, 2024- Jesse Schafer, executive director of the Healthcare Industry Resilience Collaborative, said he believes the impact of the IV solutions shortage will be similar to what healthcare experienced during Hurricane Maria. “Recovery may take months, and market supply will be highly constrained. Conservation and use of alternatives will be essential.”
HIRC member sentiment in early October suggested a high level of provider concern, an expectation of 4-6 months for recovery, and constrained alternative sources.
“My opinion is that the recovery time frame will exceed existing inventory if demand remains unchanged,” Schafer said. “Users of all IV fluids must conserve. Less use by all means more product for the patients that need it most.”
“In my experience, Baxter has been transparent and forthcoming,” said Schafer. “At the same time, the situation is serious and hospitals must activate their incident response teams and conservation measures.”
B Braun, another leading IV fluids supplier, is manufacturing 24/7 to help meet the need. Other alternative suppliers include Fresenius Kabi and ICU Medical.
A majority of surveyed providers indicated stockpiling. “This is instinctive and understandable,” Schafer said. “However, any excess in the form of hoarding will only exacerbate anticipated shortages.”
Hospitals will likely need to implement firm conservation strategies and alternate therapies where possible. “Unfortunately, this is not a new experience where nature struck the IV fluids market,” Schafer said. “As such, most hospitals have existing plans and experience.”
Schafer said one-third of surveyed provider members have already implemented conservation strategies. “In my opinion, all providers should be doing this now to reduce the risk of future shortages.”
Some of the most common mitigation strategies included:
General:
Deliver IV fluid based on patient need
Regularly assess patients receiving IV infusions
Consider clinical alternatives (e.g. IV push, intramuscular, subcutaneous or intra nasal doses)
Convert all possible medications from IV to oral (PO) form
Use premixed antimicrobials, if available
Limit utilization of parenteral nutrition (PN)
Use the smallest possible indicated volume
Use smaller bag sizes for slower rate infusions where practical
Use sterile water vials or saline vials for reconstituting IV medicines instead of using large volume fluid bags
Do not use IV fluids for non-IV administration
Avoid practice changes that require additional fluids
Avoid spiking bags or opening overwrap until you are certain that IV fluid will be administered
Surgical
Minimize fasting to reduce need for fluid replacement
Avoid priming of IV giving sets until certain of IV fluid requirements
Pharmacy
Consider premixed and ready to use IV products
Leverage 503B sources when available
Supply Chain
Ensure backorders are registered and allocations are filled
Explore all alternative sources to maximize inventory
Consider signage at point of use to alert clinicians for the supply disruption
Hospital leaders can prioritize mitigation efforts to ensure minimal disruption to patient care through frequent cross-functional communication internal and external, patient-centric conservation strategies, and maximizing available inventories without hoarding. “Stand up a cross-functional response team that bridges clinicians, pharmacy, and supply chain,” Schafer said. Near real-time analytics and periodic status updates to inform decision makers will be important, as will opening all available communication channels.
Hospitals and health systems can use this as an opportunity to strengthen their supply chain resilience by prioritizing resiliency in their sourcing decisions,” Schafer said. “Consider implementing the HIRC resiliency badging program as a specific strategy to measure and elevate resiliency in sourcing strategy. This program rigorously assesses supplier operational and resiliency maturity. Suppliers with this badge have proven the capacity to more often predict, resist, and recover from disruption. We encourage all strategic suppliers to pursue this badge and for all providers to inquire if their trading partners have this designation. Having a badge does not eliminate disruption. Disruptions are inevitable, which is why resilient partnerships are key.”
AHA President and CEO Rick Pollack Oct. 7 sent a letter to President Biden urging the Administration to take immediate actions to increase the supply of IV solutions for hospitals and other health care providers that are struggling with shortages following the closure of a Baxter manufacturing plant as a result of Hurricane Helene.
“Our members are already reporting substantial shortages of these lifesaving and life-supporting products,” Pollack wrote. “Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation and minimize the impact on patient care.”
The letter includes a number of specific actions the AHA is asking the Administration to take to support hospitals’ ability to care for patients and communities. In addition, the AHA invited the White House and agency experts to join the association in a forum to communicate directly with hospitals and health systems to “inform each other in real time on the status of the situation while we work together to mitigate the impact on patients.”
Retailers import a significant amount through ports paralyzed by the strike of longshoremen who walked off their jobs at 14 ports from Maine to Houston on Tuesday (Oct. 1). A strike won’t hurt holiday sales, but could be a broader supply chain problem if it continues.
Steve Lamar, CEO of the American Apparel & Footwear Association, said the ports are critical for the retailing industry. Last year, the East and Gulf Coast ports accounted for 53% of all U.S. apparel, footwear and accessories imports amounting to more than $92 billion in value, he said.
Walmart reportedly imported 47,700 containers through the impacted ports from September 2023 through September 2024. Home Depot imported 21,200 containers, Dollar General’s container imports totaled 11,000 and Amazon imported 9,000 containers in the same period through the ports now under strike.
Dana Telsey, CEO of Telsey Advisors, said apparel retailers and big box operators brought in goods early in anticipation of the strike. She said lessons learned from 2020 pushed them to be proactive. Telsey said if the strike is resolved soon there would be little impact on consumer prices and inventory levels. But if the strike drags on for several weeks, it will be a major headwind for retailers in rising shipping costs and eventually higher prices for consumers, perhaps pushing inflation back up.
She said supply chain disruptions raise the cost of doing business at a time when many retailers are already treading water.
Kevin Williamson, CEO of RJW, which moves goods in the retail sector, estimates most packaged foods and consumable companies have anywhere from 8 to 16 weeks of inventory, but if the strike drags on their manufacturing operations would be disrupted without key ingredients from Europe. Williamson said grocery is is impacted because ingredients like olive oil and fruit are sourced from Europe through the East Coast ports.
‘SELF-INFLICTED WOUND’
Matthew Shay, CEO of the National Retail Federation, said there will be a ripple effect for retailers and holiday sales, and the shutdown could take the supply chain months to recover
“Though many retailers have worked months in advance to mitigate the impact of any slowdown through measures such as rerouting goods toward West Coast ports, NRF has urged the White House to use all available options to limit the impact of the strike. We’re finally turning the corner on inflation, we know that the job market and the overall economic activity have moderated from the highs over the last several years, and this is the last thing we need as a self-inflicted wound as we go into the fourth quarter of the year,” Shay said.
Costco CEO Ron Vachris said a limited amount of food and sundries arrive via cargo shipments, and its imports are primarily non-food items. He said Costco has contingency plans in place and ordered holiday items in advance. The retailer also could look at moving goods to different ports. Costco said contracts have locked in freight rates for now, but if a disruption does take place those prices could go up.
Walmart echoed that sentiment.
“We prepare for unforeseen disruptions in our supply chain and maintain additional sources of supply to ensure we have key products available for our customers when and how they want them,” Walmart spokeswoman Blair Crowell noted in an email.
AUTO, PHARMA ISSUES
Adam Kamins, an economist at Moody’s Analytics, estimated the strike could have a financial impact of approximately $2 billion a day. He based that analysis on the number of goods flowing through their ports daily. He said the longer the ports stay closed the more dire the implications for the overall U.S. economy.
He said the most significant issues will be in the food and automobile industries that rely heavily on the impacted ports. If the strike drags on, Kamins expects prices will increase, feeding inflationary pressures again. Another industry that could be impacted by a lengthy strike is pharmaceutical who largely use the East Coast ports to ship generic drugs and active pharma ingredients to the U.S. from India. He said without the active pharma ingredients the drugs can not be produced in the U.S.
Analysts at Sea Intelligence estimate the East Coast ports would handle 2.3 million containers in October. That translates to 74,000 shipping per day. The value of that daily freight is around $3.7 billion based on a MDS Transmodal estimate of $50,000 per container. The analysts estimate a one-day strike would take five days to clear. A week-long strike cause disruptions until mid-November.
The strike comes on the heels of Hurricane Helene that delayed port operations in Charleston and Savanah, as well as power losses at intermodal facilities across the southeast. This event created ocean, trucking and rail carrier congestion across the Southeast and Gulf ports.
The Conference Board estimates a week-long strike could cost the U.S. economy $3.78 billion. The shuttered ports handle $3 trillion annually in U.S. international trade. An analysis by J.P. Morgan estimated the daily cost of a port strike by East and Gulf Coast port workers would cost the U.S. economy between $3.8 billion and $4.5 billion per day as operations slow.
BusinessManufacturingRetail by Kim Souza (ksouza@talkbusiness.net)
CMS has updated guidance for hospitals interested in converting to a rural emergency hospital, a Medicare designation that was made available Jan. 1, 2023.
REHs are a provider type established by the Consolidated Appropriations Act, 2021, to address concerns over rural hospital closures and provide rural facilities a potential alternative to closure.
Since 2005, 106 rural hospitals have shut down, with another 86 facilities no longer providing inpatient services, according to data compiled by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. Of those, 37 closures have occurred since 2020.
Here are 16 things to know about REHs, including designation requirements, qualifying facilities, conditions of participation and how many hospitals have converted to REHs.
1. The designation aims to curb rural hospital closures by offering them a chance to close infrequently used inpatient beds and focus on outpatient and emergency department services.
2. CMS defines “rural emergency hospitals” as “facilities that convert from either a critical access hospital or a rural hospital with no more than 50 beds and do not provide acute care inpatient services, with the exception of post-hospital extended care services furnished in a distinct part unit licensed as a skilled-nursing facility.”
3. In exchange for giving up their expensive inpatient beds and focusing solely on emergency and outpatient care, rural emergency hospitals receive a 5% increase in Medicare payments as well as an average facility fee payment of about $3.2 million a year.
4. Conversion to the designation allows hospitals to continue providing emergency services, observation care and, if elected by the hospital, additional medical and health outpatient services, that do not exceed an annual per-patient average of 24 hours.
5. REH services include all covered outpatient department services required or elected to be provided by the REH, including relevant radiology, laboratory, outpatient rehabilitation, surgical, maternal health, and behavioral health. Copayments for REH services are based on the standard Hospital Outpatient Prospective Payment System rate (excluding the 5% increase).
What facilities qualify to be a REH?
6. Eligible CAHs and small rural hospitals can apply to enroll as REHs for free. Existing CAH or hospital enrollment ends once REH enrollment is approved.
7. A facility must meet the following requirements to qualify as an REH:
Enrolled in Medicare; and operating as a CAH as of Dec. 27, 2020; or operating as a small rural acute care, tribally operated, or Indian Health hospitals with no more than 50 certified beds as of Dec. 27, 2020, and either located in a rural county or treated as being located in a rural area.
Facilities that were enrolled by Dec. 27, 2020, but closed after that date, can still qualify if they re-enroll in Medicare and meet REH requirements.
What requirements must REHs meet?
8. Once enrolled as an REH, a facility must meet the following requirements:
Must not exceed an annual per patient average length of stay of 24 hours of services.
Must meet staff training and personnel requirements, which include:
A staffed emergency department 24 hours a day, 7 days a week, with staffing requirements like those for CAHs
A physician, nurse practitioner, clinical nurse specialist, or physician assistant available to provide REH services in the facility 24 hours a day.
Must have a transfer agreement in effect with a Medicare-certified Level I or Level II trauma center.
Must not provide any inpatient services, except those delivered in a distinct part unit licensed as a skilled nursing facility.
Hospitals must have a clinician on-call at all times and available on-site within 30 or 60 minutes depending on if the facility is located in a frontier area.
Emergency departments must be staffed 24 hours a day, seven days a week by an individual competent in the skills needed to address emergency medical care. This individual must be able to receive patients and activate the appropriate medical resources to meet the care needed by the patient.
Hospitals must develop, implement and maintain an effective, hospital-wide, data-driven quality assurance and performance improvement program, and it must address outcome indicators related to staffing.
The annual per-patient average lengths of stay cannot exceed 24 hours and time calculation begins with registration, check-in or triage of the patient and ends with the discharge of the patient from the hospital.
Hospitals must have an infection prevention and control and antibiotic stewardship program that adheres to nationally recognized guidelines.
Arkansas Eureka Springs Hospital
Helena Regional Medical Center
South Mississippi County Regional Medical Center (Osceola)
St. Bernards Five Rivers Medical Center (Pocahontas)
Georgia Blue Ridge Medical Center
Irwin County Hospital (Ocilla)
Taylor Regional Hospital (Hawkinsville)
Kansas Mercy Hospital (Moundridge)
South Central Kansas Medical Center (Arkansas City)
Kentucky Crittenden Community Hospital (Marion)
Louisiana Assumption Community Hospital (Napoleonville)
Michigan Sturgis Hospital
Minnesota Mahnomen Health Center
Mississippi Alliance Healthcare System (Holly Springs)
Green County Hospital (Leakesville)
Jefferson County Hospital (Fayette)
Panola Medical Center (Batesville)
Perry County General Hospital (Richton)
Sharkey Issaquena Community Hospital (Rolling Fork)
Missouri Parkland Health Center (Bonne Terre)
Nebraska Friend Community Healthcare System
New Mexico Guadalupe County Hospital (Santa Rosa)
Oklahoma Elkview General Hospital (Hobart)
Harper County Community Hospital (Buffalo)
Stillwater Medical-Blackwell
Stillwater Medical-Perry
Tennessee Tristar Ashland City Medical Center
Texas Anson General Hospital
Crosbyton Clinic Hospital
Falls Community Hospital and Clinic (Marlin)
St. Luke’s Health-Memorial Hospital – San Augustine
St. Mark’s Medical Center (La Grange)
11. The REH program is still very new, but more rural hospitals are pursuing the designation after doing financial analyses and seeing the progress made by some of the program’s inaugural class.
Insights from five rural hospital leaders
12. Brooke Kensinger, CEO, MercyOne Elkader (Iowa) Medical Center: The REH program is still very new, and just as it took time for the hospital community to warm up to the critical access hospital designation, this will be no different. Hospital leaders and community boards are learning more about the pros and cons of this option, and whether it is truly the best path at this time for their community. We expect that as healthcare leaders and board members across the country continue to evaluate this program, there will be improvements made — similar to the CAH program — to better ensure access to care.
13. Dierdra Sorrell, MSN, RN, CEO, Clifton-Fine (Star Lake, N.Y.): For our hospital, with an inpatient census of one for the most part, [the REH designation] made a whole lot of sense. We really struggle with getting the inpatient census since we’re in a very remote location and the closest hospital to us is about a 50-minute drive.
15. Donald Lloyd, II, President and CEO, St. Claire Healthcare (Morehead, Ky.): We must realize that it is not economically possible to sustain a full service acute care hospital in every rural community. Such a realization takes great political courage but also clinical creativity to meet the community’s needs. CMS and state Medicaid agencies must establish payment methodologies that sustain institutions in low volume and safety-net environments.
16. Jeff Thompson, MD, CEO Emeritus, Gundersen Health System (La Crosse, Wis.): Although more rapidly changing the payment system away from fee-for-service will help, the best hope and most progress is to change the behavior of the large systems and universities to view rural areas not as referral pipelines but as citizens and providers that need real population healthcare partners. Not closing, but re-focusing the work of rural providers and rural hospitals that have already been shifting to outpatient work [will help].
September 10, 2024- Owens & Minor, Inc. announced a new partnership with Google Cloud that combines Owens & Minor’s deep expertise in optimizing the healthcare supply chain with Google Cloud’s Vertex AI platform to help drive meaningful enhancements for QSight®, an industry-leading cloud-based clinical inventory management system from Owens & Minor. By partnering with Google Cloud, Owens & Minor will strengthen QSight’s existing inventory management capabilities while laying the foundation for future platform and service innovations with the potential to dramatically improve the QSight customer experience.
The partnership between Owens & Minor and Google Cloud will focus on enhancing QSight’s ability to help hospitals and health systems optimize how they manage the thousands of medical-grade supplies, high-value surgical implants and human tissue products required for patient care. For providers, the implications of inefficient inventory management can reach beyond the stockroom and into the operating room, including a risk that expired products are used in patient care and inventory loss if products expire before they can be used.
Enterprise healthcare providers also face increasing pressure to deliver high-quality care while managing costs and optimizing efficiency — with less support from clinical staff. However, traditional clinical inventory management systems may lack the real-time visibility and predictive capabilities needed to effectively oversee complex healthcare supply chains, which can increase costs and lead to higher workloads for clinical staff.
July 8, 2024- Ansell Limited announced it had successfully completed the acquisition of Kimberly-Clark’s Personal Protective Equipment (KCPPE) business. This strategic acquisition strengthens Ansell’s position as a global leader in personal protection solutions, expands its product portfolio, and enhances its service capabilities to meet customer needs across industries and geographic markets.
As part of this agreement, Ansell will acquire the Kimtech™ brand of scientific PPE for customers in laboratory and cleanroom environments and the KleenGuard™ brand of safety PPE for customers in industrial environments. In addition, Ansell will add two new capabilities to its Ansell Services portfolio: The RightCycle™ Program, a sustainable solution for the disposal of non-hazardous personal protective equipment (PPE) waste, and APEX™, a best-in-class approach to cleanroom customer change management and contamination control.
As part of a transition services agreement, Kimberly-Clark Corporation will support the KCPPE business over the next year to allow sufficient time for a successful integration into Ansell. During this transition period, customers can continue to request Kimtech™, KleenGuard™, The RightCycle™ Program and APEX™ products and services from Kimberly-Clark Professional. Customers will be notified promptly when Ansell can begin taking orders.
New device combines Ethicon’s proven Gripping Surface Technology (GST) and 3D-stapling technology for greater staple line integrity
CINCINNATI, OH – May 27, 2024 – Ethicon*, a Johnson & Johnson MedTech** company, today announced the U.S. launch of the ECHELON LINEAR™ Cutter. It is the first linear cutter to market with combined innovative and proprietary technologies – 3D-Stapling Technology and Gripping Surface Technology (GST) – two advanced capabilities proven to enable greater staple line security, which can help surgeons reduce risks and support patient outcomes. Backed by science, this first-of-its-kind surgical stapler delivered 47% fewer leaks at the staple line to help reduce surgical risks. i,*** Its unique design provides surgeons with the option to keep the device halves locked, or to separate them, offering more control of the device placement when navigating the differing needs of each patient’s anatomy.i,ii,****,*****
In colorectal surgery, an anastomosis is a critical part of the procedure in which two ends of the colon are connected with staples after part of the organ has been resected or removed due to damage or disease. If this connection is faulty or weak, an anastomotic leak may occur, which can lead to lengthier hospitalization, increased healthcare costs, and/or death.iii,iv Studies show the mortality rate associated with anastomotic leaks can range from 10% to 15%.v The risk of death can be 3- to 8-times greater if an anastomotic leak is present.vi,vii
“Today, surgeons are treating an aging population as well as patients who are increasingly obese and presenting with comorbidities that can negatively impact surgical outcomes. This requires surgeons to manage various tissue types and navigate difficult-to-access anatomy, raising the risk of complications,” said Sandeep Makkar, Global President of Ethicon Energy and Endomechanical. “Informed by surgeon experience, we’re pleased to add the new ECHELON LINEAR™ Cutter to the portfolio given its first-of-its-kind design to provide surgeons with greater control, while also leveraging our proven GST and 3D-stapling technologies to help reduce surgical risks.”
Complications associated with colorectal surgery can be severe, with anastomotic leaks remaining the most serious due to the dramatically increased associated risks of postoperative mortality and the need for a permanent stoma.iii “As a leader in MedTech, it’s imperative that we continue innovating with purpose to help solve for the challenges surgeons are facing and make a profound impact along the continuum of care,” Makkar added.
Dr. Shekar Narayanan, board-certified colon and rectal surgeon and Chief of Surgical Oncology at Community Health Network, added: “The most critical safeguard of a successful operation is managing surgical risks wherever possible, and the advanced technologies behind ECHELON devices help our surgical team to do that.”
“The combined technology of an ECHELON stapler plus GST reloads and 3D Stapling are remarkable in their ability to stabilize and compress tissue and reduce slippage, all of which are critical factors in reducing the potential for complications during colorectal surgery,” he continued.
The ECHELON LINEAR™ Cutter is the latest colorectal surgical solution added to the ECHELON portfolio, bringing forward similar stapling capabilities in advancing staple line security as ECHELON CIRCULAR™ Powered Stapler and ECHELON™ 3000. ECHELON LINEAR™ Cutter will soon be added to a clinical and real-world evidence program for advanced stapling that includes the publication of nine peer-reviewed studies in seven countries spanning more than 700 hospitals and over 46,000 patients, as clinical evidence is generated post-launch.
The design and development of the ECHELON LINEAR™ Cutter was informed by input from surgeons, as well as Ethicon’s deep understanding of the properties of living tissue and its interaction with devices. It’s these insights – coupled with a purpose-driven approach to innovation – that have resulted in the product’s greater device control, staple line integrity and staple consistency, ultimately helping to drive improved patient outcomes.
Ethicon partners with hospitals, surgeons, and surgical staff to capture the learnings gained from performing countless procedures to address unmet clinical needs and deliver on the transformative promise of digital surgery. Its latest technologies and state-of-the-art training connect the vast knowledge, resourcefulness, and deep experience across the continuum of care for more informed decision making and better connectivity on behalf of patients pre- and post-operatively.
About Ethicon’s Gripping Surface Technology (GST) and 3D-Stapling Technology ECHELON Gripping Surface Technology (GST) is designed to stabilize and compress the tissue where it is needed, resulting in lower potential of tissue slippage versus traditional linear cutters. 3D Stapling Technology has offset staple legs designed to distribute tissue compression load more evenly over a greater surface area and reduce potential leak pathways. Together these advanced stapling technologies offer exceptional staple line integrity across the broadest range of tissue thicknesses giving surgeons more flexibility to meet their needs in the OR.
About Ethicon At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically-differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visit www.ethicon.com to learn more about us.
About Johnson & Johnson MedTech At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit https://thenext.jnjmedtech.com.
Cautions Concerning Forward-Looking Notices This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Ethicon Endo-Surgery, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Ethicon Endo-Surgery, Inc., nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
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*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners. **Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment. Dr. Matthew Albert is a paid consultant for Ethicon. He has not been compensated for any media work. Dr. Shekar Narayanan is a paid consultant for Ethicon. He has not been compensated for any media work.
Footnotes: *** Benchtop testing on porcine colon measuring staple line leak rate at 30mmHg, comparing rates of 52.8% for Medtronic GIA with TriStaple, Ethicon Linear Cutter, and Proximate Linear Cutter to 27.7% for Echelon Linear Cutter (n=36, p<0.001) **** Surgeon usability evaluation of one-handed positioning and placement when the halves are locked. ***** Greater control supported by a surgeon usability evaluation = 65% agreed, n=37.
i Ethicon. Echelon Linear Cutter (Cornerstone) Staple Line Leak Claims Testing. 1/28/2022. Windchill #500897557 Ethicon. ii Echelon Linear Cutter (Cornerstone) Customer Usability Claim Summary Report. 7/15/2022. Windchill #501027381 iii Trencheva K, Morrissey K, Wells M, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257: 108. iv Schiff A, Brady BL, Ghosh SK, et al. Estimated Rate of Post-Operative Anastomotic Leak Following Colorectal Resection Surgery: A Systematic Review. Journal of Surgery and Surgical Research. 2016;2(1): 060-067. v Hyman, Neil MD; Manchester, Thomas L. MD; Osler, Turner MD; Burns, Betsy NP; Cataldo, Peter A. MD; Annals of Surgery: February 2007 – Volume 245 – Issue 2 – p 254-258 doi: 10.1097/01.sla.0000225083.27182.85 vi Gessler B, Eriksson O, Angenete E. Diagnosis, treatment, and consequences of anastomotic leakage in colorectal surgery. Int J Colorectal Dis .2017. 32:549–556. DOI 10.1007/s00384-016-2744-x vii Turrentine F, Denlinger C, Simpson V. Morbidity, Mortality, Cost, and Survival Estimates of Gastrointestinal Anastomotic Leaks. J Am Coll Surg. 2015. DOI: /10.1016/i.jamcollsurg.2014.11.002
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The third-party trademarks used herein are trademarks of their respective owners.
In 2024, the tariff rates on syringes and needles will increase from 0% to 50%. For certain personal protective equipment, including certain respirators and face masks, the tariff rates will increase from 0–7.5% to 25% in 2024. (ADELART/GettyImages)
To boost domestic medical supply manufacturing, the Biden administration is hiking up tariffs on syringes, needles, medical and surgical gloves and personal protective equipment from China.
The tariffs are designed to combat artificially low-priced exports coming in from China, the federal government said in a fact sheet released yesterday.
“American businesses are now struggling to compete with underpriced Chinese-made supplies dumped on the market, sometimes of such poor quality that they may raise safety concerns for health care workers and patients,” the White House said.
President Biden directed his Trade Representative to increase tariffs under Section 301 of the Trade Act of 1974 on $18 billion of imports from China.
In 2024, the tariff rates on syringes and needles will increase from 0% to 50%. For certain personal protective equipment (PPE), including certain respirators and face masks, the tariff rates will increase from 0–7.5% to 25% in 2024. Tariffs on rubber medical and surgical gloves will increase from 7.5% to 25% in 2026.
“These tariff rate increases will help support and sustain a strong domestic industrial base for medical supplies that were essential to the COVID-19 pandemic response and continue to be used daily in every hospital across the country to deliver essential care,” the federal government said.
The federal government and the private sector have made “substantial investments” to build domestic manufacturing for these and other medical products, according to the government.
The American Medical Manufacturers Association cheered the move to raise tariffs on Chinese medical supply imports.
“This signifies a pivotal moment in America’s quest for self-reliance and true resilience, particularly in personal protective equipment (PPE) and critical medical products,” the organization said in a statement.
“The White House understands that domestic manufacturers face an onslaught of underpriced, subpar Chinese imports. By sidelining high-quality American manufacturers, cheap Chinese imports threaten the safety of our healthcare workers and patients,” Eric Axel, the executive director of AMMA said in a statement.
Axel added, “Our member companies can compete with manufacturers globally. All they ask is for a level playing field because they have no doubt that American ingenuity and quality will win out.”
In November, the FDA began investigating reports of China-made plastic syringes breaking and leaking. In March the agency confirmed the quality issue and the following month it issued a recommendation that consumers and healthcare providers stop using plastic syringes made by certain Chinese manufacturers.
The U.S. government also is raising tariffs for other sectors including steel and aluminum, semiconductors, electric vehicles, batteries, critical minerals, solar cells and ship-to-shore cranes.
