Recycle Plastic Shopping Bags Reject Bans

As many know, Cuyahoga County Council enacted a regulation effectively banning single use plastic shopping bags to commence on Jan. 1, 2020. This ban would restrict consumer choices and burden businesses in the affected municipalities.

Interestingly and correctly, some Cuyahoga County communities are already opting out of the excessive and restrictive mandate. Imposing bans or fees on plastic shopping bags, though perhaps well intended, misses the mark in many ways.

Brown paper grocery bags are a suggested alternative. They hold stuff well, but these old-fashioned friends tear easily and get soggy. For these reasons, paper bags are less likely be reused at home as trash can liners (or for doggy doo), which means higher sales of wastebasket liners that are made of, you guessed it, plastic.

The cost to grocers of providing paper bags is approximately double that of plastic. More resources go into manufacturing and shipping paper bags, and the manufacturing process causes more pollution and waste. Producing plastic bags has become more efficient and more environmentally friendly.

Sturdy, reusable plastic shopping bags are an alternative and are symbols of environmental responsibility everywhere, right? Actually, wrong! A report published just days ago from the U.K. suggests that the movement to sell and reuse heavy duty plastic bags has been an utter failure. The report states the volume of plastics has increased and the movement has failed to establish a pattern of reuse. Thats right, the monster bags sold as bags for life are reported to function as bags for a week and are doing more harm than good.

Reusable bags, whether heavy plastic or cloth, should come with imprinted health warning labels. Reusables, particularly when kept in a hot car during summer, can become breeding grounds for bacteria. It is recommended to wash fabric bags and to disinfect reusable plastic bags after each use, dry thoroughly and store in a cool, dry place.

It is widely recommended to use separate bags for raw meats, seafood and poultry. In fact, the USDA and others recommend placing these foods in separate plastic bags to prevent juices from contaminating other foods. Another recommendation is to discard worn out reusables that are permanently soiled when in doubt, throw it out!

Bills have been introduced in both the Ohio House and Senate that would restrain municipalities from enacting local taxes and bans on auxiliary containers. Existing anti-littering laws would be clarified to include auxiliary containers. This is being promoted by environmental ideologues as a violation of home rule in Ohio.

In reality, the legislators sponsoring these bills are farsighted and seek to prevent Ohio from becoming a patchwork of local plastic restrictions and regulations. Consumers and businesses in Ohio should have consistent, uniform and easy-to-understand regulations. I fully support House Bill 242 and Senate Bill 222.

In closing, I highly recommend recycling single use plastic bags. It is very easy to take them back to grocery stores that have conveniently placed recycle receptacles.

Kathy JohnsonChardon Township

This letter is in response to Barbara Partingtons letter to the editor printed in your publication on Dec. 5, 2019, misleadingly alleging Quid Pro Quo Geauga Style.

Ms. Partington falsely alleged that the Probate/Juvenile Courts attempt to pay a law firm for one of their attorneys, Bill Seitz, to teach a complicated portion of the Courts Ohio Supreme Court approved CLE seminar was somehow quid pro quo.

Of course this assertion is absurd: the Probate/Juvenile Court was billed by the law firm, not their attorney Mr. Seitz personally; and since he is not a partner at the law firm, Mr. Seitz is a salaried employee and, therefore, does not receive a penny of the amount billed to the Court for the firms participation in the Courts CLE course.

Neither Judge Grendell nor Mr. Seitz would ever use public funds for which they are entrusted for personal gain. Ever.

The CLE course was pre-approved by the Ohio Supreme Court and 42 attorneys in attendance received credit for their attendance. The particular topic taught by Mr. Seitz required legal research.

While Ms. Partington questions why the Court would choose an attorney whose limited law firm bio does not happen to list juvenile law as one of his areas of practice, Mr. Seitz taught on statutory and Ohio Supreme Court Rules affecting the Juvenile Court, and he has been a lecturer for nearly 20 years, teaching judges at Judicial Seminars for Appellate Courts, Federal Courts, and local attorneys. Mr. Seitz is a well-recognized lawyer with over 40 years in legal practice, and 19 years in the Ohio Legislature, who is in great demand for his knowledgeable teaching at the local, state and national levels.

The Court was confident that his extensive legislative knowledge and legal teaching experience would ensure that the complicated legal topic would be taught accurately and in an engaging way. Not surprisingly, attendees at the Courts CLE course rated Mr. Seitz most highly of all the speakers.

Regarding whether the other instructors at the CLE course were compensated, two of the instructors work for the Court and were, therefore, compensated by their normal salaries. One instructor taught as part of his normal job responsibilities for the State Treasurer, who does not charge others for the opportunity to promote his offices programs. The other instructor is a consultant for the Court who chose not to ask for additional compensation since his topic was adjunct to his consulting services for which he is already paid by the county.

Simply put, the law firm invoiced the Court for legitimate services rendered by one of its highly qualified attorneys, for a CLE course approved by the Ohio Supreme Court and for which approximately 40 attorneys are even more prepared to represent Geauga County residents in our Probate/Juvenile Court.

Kimberly LaurieCourt AdministratorGeauga County Probate/Juvenile Court

The Salvation Army of Geauga County is encouraging the community to give generously this season during the 2019 Red Kettle campaign.

Volunteers from the Geauga Rotary and youth members of the Interact Clubs and Chardon National Honor Society can be found ringing the bells during the month of December at various Walmart, Drug Mart and Giant Eagle locations across Geauga County, as well as Starbucks and Yours Truly in Chagrin Falls.

All donations placed in Geauga County Red Kettles are used to help families in Geauga County with emergency assistance for home heating costs, past due rent or transportation costs to work or medical appointments. These emergency services are funded year-round through the donations brought in by the Red Kettle campaign.

Forget your cash? New this year, scan the Kettle Pay tag to instantly donate via NFS enabled smartphone. Your donation makes a difference and the money raised stays local to help our neighbors.

Shop, then stop . . . at the Red Kettle this year.

Kathleen PoyarTreasurer, Salvation ArmyGeauga Service Unit

I wish the Protect Geauga Parks group knew Judge Tim Grendell the way that I do. Judge Grendell works tirelessly to ensure that Geaugas parks can be enjoyed by all of Geaugas residents.

In my opinion, Protect Geauga Parks represents a vocal minority that portrays Judge Grendell in an unfair and unflattering light, and attempts to smear him with unfounded claims for purely political reasons.

The residents of Geauga County should not be fooled.

Rev. Morris EasonRussell Township

It appears that many cannot think clearly enough to understand that they are not thinking clearly.

West Geauga parent Stephanie Anderson, an attorney (what?) said she was outraged (was her child outraged also?) at social studies teacher Wesley Rogges use of the two characters, calling it insensitive and inappropriate. If I were the teacher, I would invite Stephanie to class as a guest speaker.

It also appears that Stephanie is a member of the language, thought and speech police. Alert! Gaslighting, Targeting and Trigger Warnings! Students should not be sheltered from differing opinions while at the same time wanting to shelter students from differing opinions?

Mark Twain said he never let schooling interfere with his education. Maybe Tim Misny could intervene. Where is this parent going to send her child to law school? She seem to be a helicopter/snowplow parent. What would the ACLU think about this imbroglio/debacle/quagmire? Political sardonic cartoons/Ron Hill Edutoons? Censorship?

The First Amendment has five parts: Freedom of Speech, Religion, Press, Assembly and Petition. I highly recommend inquiring:thefire.org(Foundation Individual Rights Education). Education NOT schooling involves: I disapprove of what you say but defend your right to say/write it. Voltaire.

The history of intellectual growth and discovery clearly demonstrates that the need for unfettered freedom, the right to think the unthinkable, discuss the unmentionable and challenge the unchallengable. A poets work is to name the unnameable to point at frauds to take sides start arguments shape the world and stop it from going to sleep (Salmon Rushdie). The satirist Voltaire took great pleasure and enjoyment from ridiculing, bewailing, mocking and scorning the absurdities of human behavior and attitudes.

David A. HancockChester Township

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Letters to the Editor - Geauga Maple Leaf

By Marcelo Trevino, President, Global Regulatory Affairs and Quality Systems, TregMedical Compliance Services

[Editor's Note: This article has been updated to reflect the Dec. 10, 2019, publication ofISO 14971:2019]

Historically, risk management has been a complex subject, with different stakeholders assigning different values on the probability and severity of harm. In medical devices, its high importance has necessitated ISO 14971 providing a generic risk-management framework applicable to all medical devices, from design and development through production and post-production activities.

The third edition of ISO 14971 in addition to an updated companion report, ISO/TR 24971 provides clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles. European directives and regulations do not provide enough guidance on additional steps to take in the risk management process, nor on the acceptability of residual risks, so this standard represents the state of the art.

The new European EU MDR and IVDR require manufacturers to implement a quality management system that incorporates risk management. While Annexes Z have been prepared to harmonize the risk management standard with the European Medical Device and In Vitro Diagnostic Medical Device directives, as well as the new European regulations, ISO 14971:2019 waspublished on Dec. 10,2019,without including these Annexes, for now.

Risk Management Process Steps in ISO 14971:2019

While most of ISO 14971:2019s risk management concepts are not new, below is a summary of the risk management process as defined in the standards third edition:

Step 1: Risk Management Plan A risk management plan outlines all risk management activities to be conducted over a medical devices life cycle, including criteria for risk acceptability based on regulations, international standards, state of the art, and stakeholder concerns. Activities to verify implementation and effectiveness of risk control measures, as well as information to be collected during production and postmarket activities, also must be included in the plan. A risk management report is created after review of the plan execution.

Step 2: Risk Assessment The risk assessment step includes risk analysis and risk evaluation.

Risk Analysis: The medical devices intended use is documented, an essential step to determine the devices appropriate use. Reasonably foreseeable misuse errors (including abnormal use) and correct use are considered and documented. Usability engineering is applied to consider all risks and reduce them by adding controls, as needed.

Additionally, device characteristics that can affect safety are identified. Reasonably foreseeable events that can contribute to hazardous situations taking into account intended use, reasonably foreseeable misuse, and safety related characteristics all are relevant inputs in this hazard analysis. Finally, the risk of each identified hazardous situation is estimated, taking into account severity of harm and the probability of its occurrence.

Risk Evaluation: During this phase, risks are assessed using criteria for risk acceptability defined in the risk management plan. If the risk is deemed acceptable, it becomes the residual risk; otherwise, risk control activities are performed. The evaluation is documented as part of the risk management file.

Step 3: Risk Control Risk is reduced to an acceptable level. This can be done by designing the device to be inherently safe, ensuring that hazardous situations cant occur. If this is not feasible, then protective measures are implemented in the device design to reduce the probability of occurrence and the severity of a hazardous situation or harm. When protective measures do not sufficiently reduce risk, safety information is provided to device users in instructions, warnings, and contraindications. User training can also be incorporated. It is important to ensure that risk control measures do not incorporate new risks or influence other risks.

Risk mitigation measures are implemented, verified for effectiveness, and documented. Residual risks are then evaluated using risk acceptability criteria. If the risk is deemed unacceptable, more risk control activities need to be implemented. When risk controls are not feasible, a benefit-risk analysis can be conducted to determine whether benefits of using the medical device outweigh its residual risk. Depending on the outcome, the device may need to be modified, or its intended use limited.

Step 4: Evaluation of Overall Residual Risk The contributions of all individual risks together are analyzed to ensure that several small risks do not create an unexpected big risk. The method and criteria for acceptability of overall residual risk is documented in the risk management plan to ensure an objective evaluation takes place.

It is important to note that the criteria for acceptability of overall residual risk can differ from the criteria of acceptability of individual risk based on the organizations procedure to determine acceptable risk. Residual risks inherent in a devices use after all risk control measures have been implemented must be disclosed to users, allowing them to make an informed decision whether to use the device or find alternatives, considering the patients condition.

Step 5: Risk Management Review This step comprises conducting a review of the risk management plan to ensure it was properly executed and documenting that the residual risk is acceptable. This review is documented in the risk management report, providing evidence that the plan was effectively executed, the objectives were achieved, and that methods to collect production and post-production information are established.

Step 6: Production and Post-Production activities This step includes four phases, each with detailed activities to be implemented:

Summary of Changes from ISO 14971:2019

These are the new definitions in ISO 14971:2019:

Benefit: Positive impact or desirable outcome of the use of a medical device in the health of an individual, or a positive impact on patient management or public health.

Benefitscan include positive impact on clinical outcome, the patients quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.

It is important to note that the risk-benefit analysis requirements are not expected to change.

Reasonably foreseeable misuse: Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.

Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users.

Reasonably foreseeable misusecan be intentional or unintentional.

State of the art: Developed state of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.

Thestate of the artembodies what is currently and generally accepted as good practice in technology and medicine. Thestate of the artdoes not necessarily imply the most technologically advanced solution. Thestate of the artdescribed here is sometimes referred to as the generally acknowledgedstate of the art.

Other definitions from ISO 14971:2007 such as those for harm, manufacturer, user error, and in vitro diagnostic medical device were updated with minor wording changes

Comparing ISO 14971:2019 with ISO 14971:2007 / EN ISO 14971:2012

Underlined sections above constitute title changes new to the third edition. The main body of the standard includes 10 clauses instead of nine, as well as three informative Annexes Annex A: Rationale for requirements, Annex B: Risk Management Process for Medical Devices, and Annex C: Fundamental Risk Concepts.

A summary of the most relevant changes incorporated to the standard can be found below:

Conclusion

ISO 14971:2019 provides a thorough process for manufacturers to identify medical device hazards, assess risks, control risks, and monitor the effectiveness of risk controls throughout the life of a device. This new edition, consisting of 10 clauses and three annexes (informative), is aligned with the general safety and performance requirements within the new EU MDR and EU IVDR; it is expected to become a European harmonized standard and therefore represents the state of the art.

While the existing changes are aimed at clarifying concepts and no changes have been made to the overall process to conduct risk management, manufacturers still need to consider device-specific standards. These can be used in addition to ISO 14971 to control specific risks associated with some unique device categories to demonstrate how risks can be reduced to acceptable levels.

It is anticipated that some organizations will have to spend some time updating references to the previous standard in existing quality system documentation. ISO 14971:2019 cancels and replaces ISO 14971:2007.However, a transitional period of three years following official publication is a common practice to allow stakeholders to successfully transition to the new edition.

About The Author

Marcelo Trevino is the President, Global Regulatory Affairs and Quality Systems, at TregMedical Compliance Services, a life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for medical device companies.

Marcelo has 23+ years experience in quality and regulatory affairs, serving in multiple senior leadership roles with different organizations while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, amongothers. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDD/MDR, MDSAP). Mr. Trevino holds a B.S. degree in Industrial and Systems Engineering and an MBA in Supply Chain Management from the W.P. Carey School of Business at Arizona State University. He is also a certified Quality Management Systems Lead Auditor by Exemplar Global.

He has experience working on Lean Six Sigma Projects and many Quality/Regulatory Affairs initiatives in the US and around the world including Third Party Auditing through Notified Bodies, Supplier Audits, Risk Management, Process Validation and remediation activities.

Additionally, he is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and holds Certificates in Environmental & Sustainability Management Regulatory Affairs Management from University of California, Irvine.

He regularly publishes articles to assist corporations in their quest for exceptional quality and regulatory compliance.

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Analyzing The changes To Risk Management Standard ISO 149712019 - Med Device Online

View this article online at https://www.fedsmith.com/2019/12/12/should-care-about-grand-challenges-public-administration/ and visit FedSmith.com to sign up for free news updates

In November, the National Academy of Public Administration (NAPA, or the Academy) announced theGrand Challenges in Public Administration.

NAPA described the Grand Challenges as An Agenda for the Future of Governance and said:

As the world moves quickly from the industrial age into the information age, new challenges have arisen and demands on government have increased. But the public sector has often been in a reactive mode struggling to adapt to a rapidly evolving international, economic, social, technological, and cultural environment. Over the next decade, all sectors of society must work together to address the critical issues of protecting and advancing democracy, strengthening social and economic development, ensuring environmental sustainability, and managing technological changes. And governments at all levels must improve their operations so that they can tackle problems in new ways and earn the publics trust.

You might be asking what the Grand Challenges are, and may even be wondering why you should care what NAPA says, or about these issues NAPA has described in such agrandway.

NAPA is a congressionally-chartered not-for-profit organization that was established to evaluate the structure, administration, operation, and program performance of federal and other governments.

They were chartered to anticipate problems governments may face and recommend corrective actions. A key provision of the charter is foreseeing and examining critical emerging issues in governance, formulating practical approaches to their resolution. The Grand Challenges are thus squarely in the wheelhouse of NAPA, and are a crucial means of fulfilling the charter granted by Congress.

NAPA has more than 900 Fellows, each nominated by their peers and subject to a rigorous review prior to standing for election. The Academy is a nonpartisan organization, and does not engage in any partisan activities.

The great strength of NAPA is the extensive background of its Fellows. The Fellows come from state, local, federal and international government, academia, other not-for-profit organizations, and the private sector. What they have in common is experience in the operations of government, with a rich understanding of what does and does not work.

The Academys bylaws lay out in great detail the qualifications for election as a Fellow. In addition, the bylaws require Fellows to adhere to the highest standards of personal integrity, honesty, and decent human behavior and to Avoid any situations in which personal gain appears to be in conflict with official or professional duties. The Academy has been recognized for more than 50 years as a source of unbiased, nonpartisan analysis.

The Academy identified the Grand Challenges following extensive public outreach, where they sought input from Fellows, people in government and industry, and the public.

A committee chartered by NAPAs Board of Directors (of which I am serving as Chair) reviewed all of the input and arrived at the following list of Grand Challenges, which were approved by the Board of Directors and announced at NAPAs annual meeting in November.

Each of the Grand Challenges lives up to the name. NAPA sorted them into four groups, each covering a wide array of challenges.

Protecting and advocating for democracyhas been core to the United States since our founding. Without free and fair elections, there is no democracy. The public service is vital to delivery of the countless services the American people rely upon. None of that happens at only the local level, or the national level, or within a single agency. As NAPA described it, In the 21st Century, no significant public problem fits entirely within one government agency, or even one level of government, and our federal system presupposes that all levels of government have an important role to play in the democratic process.Effective problem solving usually requires federal, state, and local governments to work successfully together, and often with the private and nonprofit sectors.And yet, we have not prioritized the building of collaborative capabilities to develop and implement effective policies and programs across levels of government and sectors of society.

Social and Economic Developmentare essential for all Americans to reap the benefits of this great country. Social equity, meaningful work for everyone, and resilient communities that can deal with challenges such as natural and man-made disasters are basic requirements for a strong society. Unpinning all of the Grand Challenges is the need for responsible fiscal policies that ensure our tax dollars are spent wisely.

Ensuring Environmental Sustainabilityis about the natural resources we need, the changing climate and its effects on the global economy, severe weather patterns, and habitability of many areas. Modern water systems may seem fairly basic, but water policy experts are clear that we will face increasing demands on the limited supply of fresh water available in our country. Fresh water is essential for economic and physical well-being.

Managing Technological Challengesis a growing issue that we are just begging to grapple with. As more and more personal information, including all of our financial and health records, are online, privacy and data security are issues that could affect everyone in the United States and around the world. Finally, the growth of Artificial Intelligence (AI) will present issues such as the ethical use of AI, how AI will affect the public service, risks of AI, and how AI can be harnessed to provide vital government services.

None of the Grand Challenges have easy solutions. They will be issues that we have to deal with for many years to come, and they are likely to affect everyone in the United States. NAPA is not claiming to have the solutions, nor is the Academy planning to take on each of the challenges.

Some, like issues relating to public service and new approaches to public governance and engagement, are issues the Academy has worked on for years. Moving forward, we expect the Academy to take an active role in dealing with many of the Grand Challenges. We also need many more people to become engaged, express their views, and add their insights to those of the Academy and other organizations that are addressing these issues.

There is much more information on the Grand Challenges, including detailed descriptions of each, on theAcademys Grand Challengessite.

2019 Jeff Neal. All rights reserved. This article may not be reproduced without express written consent from Jeff Neal.

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Why You Should Care About the Grand Challenges in Public Administration - FedSmith.com