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Why Post-Launch Monitoring is Critical for Long-Term Medical Device Success

NNPA NEWSWIRE — Post-launch monitoring is a strategic function that shapes device safety, performance, and regulatory standing long after market entry. Real-world data surfaces what pre-market testing cannot catch, and manufacturers who invest in robust surveillance are better equipped to act on emerging issues, extend product longevity, and earn trust with clinicians and patients.

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By Cristal Dyer

Post-launch monitoring enables medical device manufacturers to detect safety issues, track real-world performance, and maintain regulatory compliance after a product reaches the market. Pre-market trials are limited in size and scope and cannot fully account for the diversity of patients and clinical conditions encountered in everyday practice.

Continuous surveillance provides the data needed to respond quickly when problems arise and sustain device effectiveness long term.

According to the FDA, its Medical Device Reporting system logs over two million adverse event reports each year, a volume that reflects how much about a device’s real-world behavior remains unknown at launch. Those reports represent real patients and real clinicians encountering issues that no trial protocol could fully anticipate.

A device that performs flawlessly under controlled study conditions can behave very differently across varied populations, clinical settings, and years of continuous use. For manufacturers, building strong post-launch surveillance means staying ahead of those variables and having the evidence to act when it matters most.

Why Can’t Pre-Market Testing Predict Real-World Performance?

Pre-market trials are basically a starting point for understanding how a device behaves. They rely on a fairly small, carefully selected group of patients in controlled conditions, and that means there are real limits to what they can tell you about device effectiveness across diverse populations.

Clinical practice is naturally more unpredictable, with patients of varying ages, health histories, and medical complexity. Trials simply cannot replicate that variety.

Several real-world factors can actually affect how a device performs after launch:

  • Patients with multiple co-existing conditions that weren’t represented in trials
  • Clinicians with varying levels of training and familiarity with the device
  • Differences in clinical environments, equipment, and standard procedures
  • Long-term wear and tear that short-duration studies can’t capture

Post-launch analysis is what gives manufacturers a clear picture of how a device performs once it’s in the field. Real-world data can surface trends, like a higher-than-expected failure rate, for instance, or a usability problem that only appears in specific patient groups, and catching those trends early really does make a difference.

Protecting Patients and Staying Compliant

Regulatory bodies like the U.S. Food and Drug Administration expect manufacturers to keep monitoring their devices after market entry. Medical device monitoring is typically a formal requirement in most major markets, and the data collected feeds directly into safety decisions and risk management updates.

Consistent monitoring gives manufacturers the data they need to act on performance issues before they escalate.

Monitoring Strategies That Support Compliance

There are several tools manufacturers typically use to stay on top of post-market performance, and each one captures a different type of data. Each approach generates specific findings that help manufacturers spot and respond to emerging issues.

Some common monitoring strategies include:

  • Complaint management systems that log issues reported by clinicians and patients
  • Post-market clinical follow-up studies that track outcomes in real-world patient populations
  • Device registries that collect long-term performance data across large groups of users
  • Vigilance reporting systems that flag adverse events to regulators in near real-time

When manufacturers identify a problem, they can use that monitoring data to trigger corrective action: a design change, a manufacturing update, or revised instructions for use. Acting quickly on that data is what keeps devices safe and keeps manufacturers in line with their regulatory obligations.

What Does Post-Launch Monitoring Mean for Your Bottom Line?

Manufacturers that invest in strong post-market surveillance tend to see returns that go well beyond regulatory compliance. Long-term medical success depends on a device continuing to perform reliably in practice, and that only happens when manufacturers actively track performance data and act on it.

Frankly, the commercial case for monitoring is just as strong as the safety case.

Reputation and Product Longevity

A device that consistently delivers safe, effective results builds trust with clinicians and the health systems that use it. That trust translates into continued adoption, stronger referrals, and a longer commercial lifespan.

Post-market performance data can actually support the marketing of next-generation medical devices, since real-world evidence is a powerful tool in any commercial strategy.

AI-enabled devices really deserve special attention here. These devices learn from data, so their performance can shift as patient populations and clinical environments change over time. Monitoring inputs and outputs on an ongoing basis is the only way to catch that kind of drift before it affects patient outcomes.

Frequently Asked Questions

How Long Should Post-Launch Monitoring Continue After a Device Reaches Market?

Post-launch monitoring typically continues throughout the device’s commercial life. Regulatory frameworks in most markets require ongoing surveillance for as long as the device remains available to patients, and some obligations can continue even after a product is withdrawn from sale.

Who Is Responsible for Post-Market Surveillance?

The manufacturer typically carries the primary responsibility for setting up and running post-market surveillance. Regulators set the requirements and review submitted data, so in practice, it is a shared system with the manufacturer handling day-to-day operations.

How Does Post-Launch Monitoring Differ Between the FDA and EU Medical Device Regulation Frameworks?

The EU Medical Device Regulation framework, introduced in 2021, places significantly stricter demands on manufacturers than earlier EU rules, including more frequent reporting and written surveillance plans. The U.S. Food and Drug Administration’s approach is similarly comprehensive, yet uses different reporting timelines and documentation requirements. Manufacturers operating in both markets need to manage these separately.

Can Post-Launch Data Be Used to Support a New Indication or Labeling Update?

Yes, real-world evidence gathered through post-market surveillance can actually support regulatory submissions for expanded indications or updated labelling. Manufacturers often use this data to strengthen their clinical evidence base over time, and regulators in many markets actively encourage this kind of evidence generation.

The Foundation of Long-Term Device Success

Post-launch monitoring is a strategic function that shapes device safety, performance, and regulatory standing long after market entry. Real-world data surfaces what pre-market testing cannot catch, and manufacturers who invest in robust surveillance are better equipped to act on emerging issues, extend product longevity, and earn trust with clinicians and patients.

From complaint systems to post-market clinical follow-up studies, the right monitoring infrastructure defines a device’s lifespan. Visit our website to explore practical guidance and build a monitoring strategy that delivers long-term medical device success.

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Black Press

OP-ED: How Does Your State Rank for Pre-K?

BLACKPRESSUSA NEWSWIRE — “Other states should take note: Georgia proves that state-funded preschool with well-qualified teachers, pay parity with K-12, small classes, and strong continuous improvement systems can be scaled as a universal program,” said NIEER director Steve Barnett. “With new initiatives to support quality, Georgia can expect increased enrollment, but leaders should also actively promote increased enrollment.”

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Photo: iStockphoto / NNPA.
Photo: iStockphoto / NNPA.

Georgia’s state-funded pre-k program for 4-year-olds was recently recognized as the largest state-funded preschool program in the nation to meet all 10 quality benchmarks, and the first universal program to do so. Georgia’s recognition is the top finding in the National Institute for Early Education Research’s new 2025 State of Preschool Yearbook. The yearbook provides an annual snapshot of state-funded preschool across the country. Forty-four states and the District of Columbia fund preschool programs.

Only five additional states meet all 10 of NIEER’s research-based benchmarks for quality —Alabama, Hawaii, Michigan, Mississippi, and Rhode Island—in this year’s report. None of those programs have the reach of Georgia Pre-K. NIEER’s benchmarks measure essential preschool quality indicators, including teacher qualifications, class sizes, early learning standards, and program assessments.

“Other states should take note: Georgia proves that state-funded preschool with well-qualified teachers, pay parity with K-12, small classes, and strong continuous improvement systems can be scaled as a universal program,” said NIEER director Steve Barnett. “With new initiatives to support quality, Georgia can expect increased enrollment, but leaders should also actively promote increased enrollment.”

Nationally, state support for preschool education hit record highs in enrollment and funding in 2024-2025. The pace of growth slowed, however, compared to the prior year, and many states continue to lag behind pre-pandemic enrollment levels. Preschool enrollment increased by 44,000 children nationally, reaching almost 1.8 million, including 37% of U.S. four-year-olds and 9% of three-year-olds. California, Colorado, Michigan, Minnesota, and Missouri contributed the most to increased enrollment, adding more than 52,000 new seats.

States spent nearly $14.4 billion on preschool in 2024-2025. Including federal and local dollars, total spending was almost $17.7 billion. Three states each spent more than $1 billion last year: California ($4.1 billion), New Jersey ($1.2 billion), and New York ($1 billion). Together, these three states account for 45% of all state preschool spending. Texas adds almost another $1 billion.

Spending increased by $434 million, or 3%, adjusted for inflation. Twenty-eight states increased preschool funding, including Michigan and New Jersey, which each added more than $100 million. “Not only does preschool access vary by which state a child happens to live in, but so does the quality of that preschool experience,” said Allison Friedman-Krauss, lead author of the report. “Only high-quality early care and education programs support children’s development enough to result in lasting academic and other gains that ultimately deliver savings for taxpayers.”

A record six states met all 10 of NIEER’s recommended quality standards, with Alabama doing so for the 20th consecutive year. Georgia joined this list this year after improving its teacher-to-child ratio from 1:11 to 1:10 and lowering maximum class sizes to 20. Several states met 9 of 10 benchmarks, including New Mexico, which is working toward universal access for both three- and four-year-olds. Once New Mexico requires all lead teachers to have a bachelor’s degree in early childhood education, it will be on par with Georgia in terms of both quality and quantity.

Not all states moved forward. Twenty states enrolled fewer preschoolers in 2024-2025 than the prior year, with enrollment dropping by more than 1,000 children in Arizona, Florida, New York, Ohio, Oklahoma, and Wisconsin. Seventeen states spent less on preschool than the prior year, adjusted for inflation, with Arizona, North Carolina, Oregon, and Texas seeing the largest percentage declines. Additional information about the State of Preschool Yearbook, including individual state profiles and maps, graphs, and state rankings, can be found at www.nieer.org.

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Leaders to Gather at African American History Museum for Voting Rights Call to Action

BLACKPRESSUSA—Rep. Jonathan L. Jackson, Bishop William J. Barber II, and a coalition of congressional, faith, and civil rights leaders gather Tuesday outside the National Museum of African American History and Culture, days after founding director Lonnie G. Bunch III announced his retirement. March On for Freedom 2026 National GOTV Bus Tour launches ahead of the 2026 midterms.

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WASHINGTON — Rep. Jonathan L. Jackson, D-Ill., Bishop William J. Barber II, and a coalition of congressional, faith, and civil rights leaders are scheduled to gather Tuesday outside the National Museum of African American History and Culture for a National Voter Registration Day event and to launch a national get-out-the-vote bus tour.
The September 15 gathering comes a week after Lonnie G. Bunch III, the museum’s founding director and the first Black person to serve as secretary of the Smithsonian Institution, announced his retirement. Organizers say participants will recognize Bunch’s work while calling attention to what they describe as an ongoing struggle over how Black history is preserved and presented.
The event runs from 1 to 3 p.m. on the grounds outside the museum, 1400 Constitution Ave. NW.
Organizers argue that the history preserved inside the museum cannot be separated from the fight to secure and protect the ballot, a line running from emancipation and Reconstruction through Jim Crow, the Civil Rights Movement, and the passage of the Voting Rights Act.
The gathering also marks the launch of the March On for Freedom 2026 National GOTV Bus Tour, a voter registration and mobilization campaign organized by the Registration Nation Action Fund and national partners. Andrea Pringle, the fund’s founder and CEO, is expected to join Jackson and Barber on Tuesday, along with clergy, civil rights advocates, labor leaders, and voting rights organizers. Additional members of Congress will be announced.
Starting in the nation’s capital during the 55th Annual Legislative Conference, the tour will travel across the South ahead of the November midterms. Stops include HBCUs, churches, and communities where organizers plan to register voters and provide information about early voting, voter protection, and Election Day participation. Media is asked to RSVP HERE to attend.
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Black Press

Port of Oakland, Army Corps Sign Historic Harbor Design Agreement

OAKLAND POST — Oakland Port Commission President Stephanie Dominguez Walton called the agreement a historic milestone that will support thousands of jobs. “Today marks a historic occasion for the Port as we sign the inaugural Design Agreement for the Turning Basin Widening Project, which will keep Oakland competitive,” said Walton.

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The U.S. Army Corps of Engineers (USACE) San Francisco District and the Port of Oakland commemorated the signing of the inaugural Design Agreement for the Oakland Harbor Turning Basins Widening Project during a ceremony aboard the USS Potomac at Jack London Square. (L-R) Major General Jason Kelly, USACE Deputy Commanding General for Civil and Emergency Operations, Oakland City Councilmember Carroll Fife D-3, Oakland Mayor Barbara Lee, Oakland Port Commission President Stephanie Dominguez Walton, Alameda Mayor Marilyn Ezzy Ashcraft, Port of Oakland Executive Director Kristi McKenney, U.S. Representative Congresswoman Lateefah Simon D-12, Lt. Col. Virginia Brickner, and commander of the USACE San Francisco District. Photo by Carla Thomas.
The U.S. Army Corps of Engineers (USACE) San Francisco District and the Port of Oakland commemorated the signing of the inaugural Design Agreement for the Oakland Harbor Turning Basins Widening Project during a ceremony aboard the USS Potomac at Jack London Square. (L-R) Major General Jason Kelly, USACE Deputy Commanding General for Civil and Emergency Operations, Oakland City Councilmember Carroll Fife D-3, Oakland Mayor Barbara Lee, Oakland Port Commission President Stephanie Dominguez Walton, Alameda Mayor Marilyn Ezzy Ashcraft, Port of Oakland Executive Director Kristi McKenney, U.S. Representative Congresswoman Lateefah Simon D-12, Lt. Col. Virginia Brickner, and commander of the USACE San Francisco District. Photo by Carla Thomas.

A $642 million project designed to accommodate larger cargo ships and strengthen the Port of Oakland’s position as a major Pacific trade gateway moved a significant step closer to construction on Aug. 27.

The U.S. Army Corps of Engineers (USACE) San Francisco District and the Port of Oakland commemorated the signing of the inaugural Design Agreement for the Oakland Harbor Turning Basins Widening Projectduring a ceremony aboard the USS Potomac, the presidential yacht once used by President Franklin D. Roosevelt.

The project will widen the Port’s Inner and Outer Harbor turning basins, allowing today’s increasingly larger and longer vessels more space to safely maneuver and turn around. The current basins are narrow, creating delays and operational inefficiencies.

Oakland Port Commission President Stephanie Dominguez Walton called the agreement a historic milestone that will support thousands of jobs.

“Today marks a historic occasion for the Port as we sign the inaugural Design Agreement for the Turning Basin Widening Project, which will keep Oakland competitive,” said Walton.

The agreement advances the project into its preconstruction engineering and design phase following years of planning and collaboration.

Lt. Col. Virginia Brickner, commander of the USACE San Francisco District, said the signing represented tangible progress toward construction.

“We are moving forward. We are showing progress,” Brickner said.

Major General Jason Kelly, USACE Deputy Commanding General for Civil and Emergency Operations, said dredging is critical for maritime dominance, supply chains, and economic competitiveness.

“Dredging sustains our national economic infrastructure,” he said. “The future demands more, the taxpayer deserves more, and together we’re going to deliver.”

For U.S. Representative Congresswoman Lateefah Simon (D-CA-12), the Port project will support jobs beyond its completion. “This will impact workers and businesses, and every shipping container represents multiple jobs.”

Oakland Mayor Barbara Lee described Oakland as a gateway to international markets and spoke on earlier efforts to deepen Oakland’s shipping channel to 50 feet. While serving in the California Legislature, Lee helped bring together labor, business, environmental advocates and Port officials to resolve disputes surrounding dredging and environmental protections.

“We want the Port to remain competitive economically,” Lee said, excited about both protecting the environment and generating sustainable jobs in the region. “We want to make sure that we create good-paying union jobs, and that the Port continues to not just survive, but thrive.”

Port of Oakland Executive Director Kristi McKenney said economic growth is dependent on investments in the Oakland Harbor’s infrastructure.

“This investment and staying competitive will fuel our economy for years to come,” said McKenney.

The Port of Oakland, with its partners, supports more than 98,000 regional jobs and $174 billion in annual economic activity. The Port oversees the Oakland Seaport, the Oakland San Francisco Bay Airport (OAK), and nearly 20 miles of waterfront, including Jack London Square.

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Black Press

Democratic Clubs Interview Candidates for Oakland School Board

OAKLAND POST — For the first time, the interviews were jointly sponsored by the John George Democratic Club, Wellstone Democratic Renewal Club, Oakland East Bay Democratic Club, Black Women Organized for Political Action (BWOPA), Niagara Democratic Club, Block by Block Organizing Network and Oakland African American Chamber of Commerce.

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(L-R) Sylvia Williams, Mike Hutchinson, Kathryn Camp
(L-R) Sylvia Williams, Mike Hutchinson, Kathryn Camp

Local Democratic clubs and community organizations interviewed candidates running for Oakland school board in the November elections, including incumbents Jennifer Brouhard in District 2, Mike Hutchinson in District 4 and Valarie Bachelor in District 6.

For the first time, the interviews were jointly sponsored by the John George Democratic Club, Wellstone Democratic Renewal Club, Oakland East Bay Democratic Club, Black Women Organized for Political Action (BWOPA), Niagara Democratic Club, Block by Block Organizing Network and Oakland African American Chamber of Commerce.

The Democratic clubs interviewed only registered Democrats.

John George and Wellstone endorsed Brouhard and Bachelor. Neither endorsed Hutchinson.

In District 4, Wellstone ranked Sylvia Pfeiffer Williams first and Kathryn Camp second. John George ranked Camp first and Williams second.

Hutchinson, an Oakland native and Oakland public schools graduate, highlighted his record.

“I was in board leadership and chaired the Budget and Finance Committee,” he said. “We passed balanced budgets and paid off the state loan early, which allowed us to finally leave state receivership after 22 years.”

Hutchinson said the district faces a financial crisis requiring changes in board leadership and district policies.

“We need a different majority so we can get back on track, end school closures, and manage our resources better,” he said.

Williams taught adult education in Oakland for 18 years.

Williams said her philosophy “comes from the disability justice world, to center the needs of the most vulnerable. When we center the needs of the most vulnerable, we create environments, systems, and learning experiences in which everyone can thrive.”

Williams framed potential school closures as an equity issue.

“Are we thinking about closing schools up in the hills?” she asked. “Or are we thinking about closing schools where communities are in crisis right now?”

Camp, a Bay Area native and Oakland resident of 25 years, has a son in second grade.

“Our kids are only getting one shot at a great education, and I’m running to bring pragmatic, student-centered leadership that restores trust, builds responsibility, and delivers results for every child,” she said.

On her website, Camp pledged accountability and transparency. “As a proud OUSD parent, I know our schools need more than promises – they need fiscal responsibility, equity, and meaningful action guided by long-term strategy,” she said.

“That means protecting classrooms, supporting teachers, using resources wisely, and making decisions that reflect clear priorities and real accountability,” said Camp. “It also means bringing people together and providing the kind of steady leadership that can navigate complex systems, ask hard questions, and stay grounded in what matters most: student outcomes, thriving schools, and a district that works for the communities it serves.”

Wellstone’s Education Committee said it opposed Hutchinson because he frequently challenged the board majority and superintendent.

“He also claims that the teachers’ contract is illegal that a grand jury should be called. He is not endorsed by the teachers’ union; he has been disruptive and non-collaborative at meetings,” and he has been absent 26% of the time, the committee said.

“He claims that the teachers’ contract is illegal and that a grand jury should be called,” the committee said. “He takes individual credit for accomplishments, including paying the state loan, when in fact these changes came from the work of the entire board, or were the result of following through on policy.”

Next week: District 6 school board candidates.

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Black History

Nuna Phillips-McKee Celebrates 100 Years: ‘A Century of Faith, Family and God’s Amazing Grace!’

OAKLAND POST — Nuna’s life has been one of Christian service. A longtime member of Wings of Love Maranatha Ministries, now Incredible Church, she serves as director of Community Services and is actively involved in the church’s Food Ministries.

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Nuna Phillips-McGee, far right, will be celebrating her 100th birthday with sisters (l. to. r.) Donna Hayes, Ida Williams, Sandra Phillips and Enis Harrison. Photo by Carol Dossman.
Nuna Phillips-McGee, far right, will be celebrating her 100th birthday with sisters (l. to. r.) Donna Hayes, Ida Williams, Sandra Phillips and Enis Harrison. Photo by Carol Dossman.

Nuna Phillips-McKee will reach an extraordinary milestone on Sept. 24 —her 100th

birthday, marking a century filled with faith, family, service, laughter and the amazing grace of God.

Born Sept. 14, 1926, in Oakland, Nuna has witnessed a world of change during her lifetime, yet the values that have guided her remain constant: a deep faith in God, devotion to family, a strong work ethic and a heart for serving others.

She enjoyed a distinguished career as a civil servant for more than 40 years, demonstrating the dedication, dependability and strength that have characterized so much of her life.

Nuna’s life has been one of Christian service. A longtime member of Wings of Love Maranatha Ministries, now Incredible Church, she serves as director of Community Services and is actively involved in the church’s Food Ministries.

Through the years, she has continued to help meet the needs of others—not merely with food, but with kindness, compassion and a genuine desire to serve. Her ministry reflects a simple principle by which she lives: when God blesses you, you bless others.

Nuna is the proud mother of one son, whose memory she carries in her heart, and the beloved grandmother of three grandchildren, as well as six great-grandchildren and one great-great-grandchild.

At 100, she has the rare blessing of seeing several generations of her family carrying forward a legacy that began long ago.

She remains the loving, intelligent, witty, and, when the occasion calls for it, delightfully sassy Nuna that her family and friends know so well. Her contagious laugh, quick wit and youthful spirit have endeared her to generations of relatives, church members and friends.

Nuna was born into the large and loving Phillips family of seven sisters and one brother, with bonds that formed in childhood and have remained precious throughout the decades. Their shared love, faith, and family traditions have continued to be a source of joy, strength and countless treasured memories.

As family and friends gather for this special occasion, they will celebrate far more than a number. They will celebrate 100 years of prayers prayed and answered; 100 years of lessons learned and wisdom shared; 100 years of family, faith, laughter and love; 100 years of serving God and serving others.

Most of all, they will celebrate a life that stands as a testimony to God’s faithfulness through every season.

Nuna’s century-long journey can be summed up in the words chosen to commemorate this remarkable occasion: “100 years of God’s amazing grace.”

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Black Press

D.A. Ursula Jones Dickson: Terminix to Pay $3.15 Million Over Illegal Disposal of Pesticides, Customer Records

OAKLAND POST — District attorney investigators examining Terminix facilities throughout California between 2021 and 2024 found hundreds of pesticides and other hazardous-waste items that had allegedly been disposed of unlawfully, according to Jones Dickson’s office.

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Alameda County District Attorney Ursula Jones Dickson. File photo.
Alameda County District Attorney Ursula Jones Dickson. File photo.

Alameda County District Attorney Ursula Jones Dickson announced a $3.15 million settlement with Terminix International Inc. and Rentokil North America Inc. over allegations that the pest control companies illegally disposed of pesticides and hazardous waste and mishandled confidential customer records.

The settlement was reached by Jones Dickson, 28 other California district attorneys and the Los Angeles city attorney. The companies are collectively identified as Terminix in the settlement.

District attorney investigators examining Terminix facilities throughout California between 2021 and 2024 found hundreds of pesticides and other hazardous-waste items that had allegedly been disposed of unlawfully, according to Jones Dickson’s office.

The investigation also found instances in which Terminix allegedly failed to properly manage and dispose of private customer records, violating California laws intended to protect confidential consumer information.

Terminix cooperated with prosecutors after being notified of the alleged violations, the district attorney’s office said. As part of the settlement, the company agreed to strengthen its policies and procedures governing the handling and disposal of pesticides, hazardous materials and customer records.

The new requirements are intended to prevent prohibited waste from being placed in ordinary trash receptacles or sent to facilities not authorized to receive it. Terminix must also improve safeguards for confidential customer information before records are discarded.

Terminix operates five Alameda County locations under the Terminix and Western Exterminator Company names. The facilities are located in Hayward, Pleasanton and Union City.

Alameda County will receive $160,000 from the statewide settlement for civil penalties and reimbursement of investigative costs.

The agreement resolves the prosecutors’ claims against the companies and requires Terminix to maintain stronger waste-management and privacy protections at its California operations.

Jones Dickson announced the settlement Sept. 4.

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