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Japan's consumption of medical devices makes it an attractive market for global medical device manufacturers. But manufacturers hoping to sell their devices in Japan must pay careful attention to the revised Pharmaceutical Affairs Law (PAL). It aligns Japan's regulatory requirements more closely with those of other advanced nations. In this article, we examine the changes, challenges, and benefits of the revised PAL.


After the financial slowdown in the mid-1990s, Japan's economic fortunes have begun to increase—and so has the country's appetite for medical devices. In 2004, medical devices constituted an estimated $19 billion–market in Japan, larger than all other Asian markets. During the next few years, as Japan's economy continues to grow, imports of foreign medical devices are expected to grow by 5–8% annually and continue to represent 10% of the world market for medical devices.1


Despite the favorable prospects for exporting medical devices to Japan, all foreign medical manufacturers must still contend with a legal requirement stipulating that all medical products be registered with the Japanese Ministry of Health, Labour, and Welfare (MHLW), Japan's equivalent of FDA. This law has become increasingly instrumental to Japan's device market because products grandfathered in prior to 2005 must comply with the revised PAL when their existing Shonin (regulatory approval) expires. Manufacturers will also have to deal with the PAL when they need to make a significant change to a product that would require premarket clearance. In Japan, medical device manufacturers and importers are also expected to demonstrate certain behaviors associated with corporate social responsibility. Hence, the Japanese government requires foreign device manufacturers to maintain a physical presence in Japan so that remedies for identified safety problems with a device can be applied immediately.

Amended Legislation for Medical Devices

The PAL is the most important legislation for foreign device firms hoping to sell products in the Japanese market. In July 2002, the Japanese House of Representatives passed the amended PAL, which is applicable to all medical devices, drugs, quasidrugs, and cosmetics entering the Japanese market. It became effective April 1, 2005, and has the following objectives:

  • To enhance safety measures for medical devices sold in Japan.
  • To strengthen postmarketing safety measures for medical devices.
  • To align Japan's medical device regulatory system with prevailing international systems.

In order to apply for the necessary regulatory clearance to market a device, manufacturers outside of Japan must appoint a marketing authorization holder (MAH) as their representative in Japan. The MAH may be a subsidiary of the manufacturer through common ownership or may be an independent entity, but the manufacturer must establish a detailed contract with the MAH in accordance with the requirements of the amended PAL and related ministerial ordinance (MO).

If a manufacturer wishes to have its subsidiary or sales office as the MAH, then the subsidiary must be licensed as an MAH by the appropriate prefecture (comparable to county) government in Japan in accordance with MOs 135 and 136. This enables the MAH to be accredited by MHLW to apply for PAL certification. Only these legal license holders can apply for and hold PAL certification of medical devices. For a foreign manufacturer to become an MAH on its own, it must be accredited as a special MAH by the Pharmaceuticals and Medical Devices Agency (PMDA), an executive arm of MHLW also known as Kiko. The manufacturer must also nominate a representative in Japan.

Under the amended PAL, foreign manufacturers of all classes of medical devices are also required to obtain foreign manufacturing accreditation for their manufacturing facilities. This accreditation can only be obtained by applying through the MAH to PMDA. MO 2 outlines the requirements for accreditation. Manufacturers that sold products in Japan before the PAL was amended may have been granted temporary foreign manufacturing accreditation, which means they can delay their application for accreditation until 2008. After 2008, foreign manufacturing facilities must be reaccredited under the new regulation (MO 2).

The Quality Management Systems Ministerial Ordinance on Medical Devices and In Vitro Diagnostics (MO 169, also known as the QMS ordinance), implemented in 2005, lacked certain requirements integral to ISO 13485:2003. These requirements, which outlined management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation, and analysis of data, were not mandatory in Japanese regulations until April 2007. Therefore, it is possible that early accreditation assessments to MO 169 did not include these elements. Manufacturers with a current Japanese QMS and those submitting new applications should ensure that these requirements are properly satisfied in time for surveillance visits.

Another key change brought by the revised PAL is that Class II medical devices, which are designated as controlled medical devices, have now shifted from ministerial-level approval to designated third-party approval (see Table I). In other words, MAHs for Class II medical devices can obtain a certification of product conformance from a registered third-party certification body rather than directly from PMDA. This change allows manufacturers to get their products certified faster and also tap into the technical expertise of third-party certification bodies. However, only certain designated Class II medical devices can benefit from the third-party approval process. A Japanese Industrial Standard (JIS)—a mandatory performance standard—must be established for a medical device to be eligible. In many instances, the mandatory JIS standard is equivalent to an IEC standard, such as the second edition of IEC 60601-1. Class II devices for which no JIS standard has been established may not use a third-party certification body and must apply to PMDA directly.

Out of the 4044 total device types identified by MHLW, only 1785 are designated as Class II, and less than half of those are currently designated as controlled medical devices eligible for third-party approval. The JIS conformity assessment standard and essential requirements are designated by MHLW by device type, which enables third-party assessment of such Class II devices. Article 41 of the revised PAL requires the minister to establish necessary standards after seeking the opinion of the Pharmaceutical Affairs Food and Sanitation Council (also called Bukai). The list of devices eligible for third-party approval is continually growing as MHLW approves additional essential-principles checklists.

An application for a Class II device license requires an assessment of the quality management system of the device manufacturer (including foreign manufacturers) to the requirements of MO 169. This ordinance is based entirely on ISO 13485:2003, with some additional requirements for the Japanese market. Manufacturers of Class II active medical devices may include or exclude requirements for design and development depending on the designation by MHLW. This assessment may be carried out by local assessors trained on Japanese requirements and qualified by the third party. Some third parties, because of the location of their audit staff, must dispatch their assessors from Japan and coordinate logistics, including travel and lodging for the audit team and its translators.

Obtaining a device license also involves an evaluation of the technical documentation for the medical device. This is similar to the requirements outlined in the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices document. Japanese regulations may also require additional information, such as proof of compliance with the JIS performance standard. The MAH is required to present this information in Japanese to the third-party assessor.

Selecting a Third-Party Approval Body

There are a variety of services provided by third parties. By carefully choosing a third-party approval body, an MAH can take advantage of additional accreditations and services that the third-party organizations offer. Some third parties allow the supporting documents, which demonstrate a device's conformity to the applicable JIS or IEC standards, to be assessed in English (to deliver a degree of confidence) before undergoing a costly translation process. Foreign manufacturers may want to consider this service when their original technical file has already been approved by another public health authority. Allowing supporting documents to be assessed in English would ensure that all requirements of the Japanese regulations are included in a device's technical file, since some requirements may be specific to the Japanese regulatory system.

A medical device company should also consider testing requirements when choosing its third party. Not all JIS standards are based on IEC requirements. If a device has already been tested for markets outside of Japan, it is possible that some of the mechanical and engineering decisions can be made based on previous tests, especially if the device is not electrical (nonactive) or if a switching power supply is used. (It is important to note that the electrical system in Japan is 100 V ac at both 50 and 60 Hz.)

Manufacturers that want to market devices in Japan should consider that marketing goal in their design phase and incorporate flexibility into their design to meet the country's requirements. This gives them a better opportunity to have EN (European Union), NRTL (United States and Canada), and JIS testing done simultaneously. Although additional samples and time may be needed to complete the JIS testing, a third party that is accredited in all of the company's current and anticipated sales markets can minimize redundant tests whenever possible.

As mentioned, the revised PAL brought with it a requirement to manufacture under an audited quality management system, which ensures conformity with JGMP requirements. When a device manufacturer chooses a third party, it should also consider the location of the JGMP-qualified auditors and whether the JGMP audit can be combined with the quality management system audits required by the United States, Canada, and the European Union.

FDA's accredited persons inspection program audits to 21 CFR 820 requirements, but the program is only open to those companies that are not under FDA scrutiny (i.e., increased FDA attention owing to nonconformities, product recalls, etc.). Because low-risk device manufacturers are only periodically audited by FDA and these audits cost very little, the only incentive for FDA establishments to use a third party for inspections is the predictability of the audit.

The European Union allows an ISO 13485–based audit to meet Annex V requirements under the Medical Devices Directive and Annex IV under the In Vitro Diagnostic Directive. The Canadian Medical Devices Conformity Assessment System is strictly based on ISO 13485. Therefore, many manufacturers maintain an ISO 13485 registration with many clauses and elements similar to JGMP requirements. As a result, third parties that offer accreditations for all of these regulatory programs can offer integrated audits, which are less time-consuming, less intrusive, and potentially less costly to the manufacturer.

Other considerations the MAH should make in choosing a third party are experience, trust, and the MAH's relationship with the organization. Bear in mind that all applications for device licensing to a third party can only be made through the MAH located in Japan to the third-party certification body in Japan. However, the value of local support for foreign manufacturers is worth considering in understanding the requirements these manufacturers must meet.

The Goal of Alignment

As indicated, one of the goals of the revised PAL was to align Japan's medical device regulatory system with those of other advanced nations, namely those of the United States and the European Union. Because these nations produce and consume the majority of the world's medical devices, the regulatory practices in these regions are generally the ones accepted and adopted by device manufacturers worldwide. Just as with the regulatory systems from these regions, Japan's revised PAL allows third parties to conduct assessments of Class II medical devices for certification to market and sell in a particular region. Both EU and U.S. health authorities also require an audit of each manufacturing location to ensure that the quality system conforms to GMPs. The last similarity is the identification of an in-country representative—the MAH in Japan, the agent in the United States, and the authorized representative (AR) in the European Union. The biggest difference is that the MAH, as the name implies, takes over ownership and responsibility for certification, whereas the AR and the agent work on behalf of the manufacturer.


Although the revised PAL aligns more closely with general international requirements for medical devices, demonstrating conformance with the PAL still requires manufacturers to invest time and effort to understand its requirements. Once the regulatory process is defined, manufacturers must still contend with the challenges and cost of device-specific processes for reimbursement, distribution, and packaging. However, if the Japanese medical device market continues to grow and maintains its need for foreign medical devices, meeting PAL and MHLW requirements may be a worthwhile investment for device manufacturers.

Steve McRoberts is Underwriters Laboratories' (UL) global principal engineer for medical regulatory programs. Seiko Ohyama is a lead engineering associate working for UL-Japan Inc. Tara Kambeitz is the global marketing manager for UL's medical business unit. She can be reached at [email protected].

1. U.S. International Trade Commission, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets, March 2007; available from Internet:

Copyright ©2008 Medical Device & Diagnostic Industry

Wed, 12 Oct 2022 12:00:00 -0500 en text/html
Killexams : Benefits of ISO 13485 Certification for Medical Device Manufacturing

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers achieve both those aims and others.

Parts of the ISO 13485 process involve identifying and documenting processes. For example, company representatives must find all processes that have even a minor connection to manufacturing. Next, they must create written procedures to establish which elements could introduce risks to the product.

Those threats could range from contaminated equipment to poorly trained personnel. After bringing attention to the risks, company representatives must name and describe measures to mitigate the potential issues.

ISO 13485 does not spell out the specific measures for device manufacturers to take. However, the certification gets people in the mindset that quality happens at every stage of manufacturing and that ongoing efforts enable maintaining high standards.

Reducing the Likelihood of Longstanding Issues

Another component of ISO 13485 requires ongoing managerial reviews to determine whether previously implemented controls work as expected or if further tweaks would get better results. Unfortunately, some leaders see these evaluations as box-checking exercises and feel under excessive pressure to get them done.

However, gathering relevant data and creating processes to keep that information up-to-date and accessible can make it easier to carry out thorough, non-rushed reviews related to ISO 13485. 

For example, looking at customer feedback, audit results, new regulatory requirements, and any details of corrective actions taken so far can help decision-makers verify whether quality controls related to ISO 13485 have the desired effects.

Additionally, these periodic reviews Boost the chances of catching issues that could lead to faulty products or operational efficiencies. They encourage better visibility that limits the likelihood of an unaddressed issue causing long-term problems.

Increasing Marketplace Competitiveness

The most exact version of ISO 13485 requires that certified companies insist that any subcontractors conform to the standard, too. That means the commitment to quality extends beyond a particular organization. Many potential customers appreciate that, knowing that working with any new company poses challenges. ISO 13485 reduces many of them with its emphasis on quality.

Also, since ISO 13485 is an internationally recognized standard, it can help in cases where company leaders want to expand into other countries and boost their chances of success. Certification assists organizational leaders in conveying that they take quality seriously.

It’s vital to convince stakeholders of efforts to prioritize quality since medical devices directly affect people’s lives. Minimizing the chances of harm and increasing positive outcomes helps potential customers build trust in a company and decide it makes sense to work with or purchase from them.

Helping Products Stay on the Market Without Issues

Statistics indicate that approximately 4,500 medical devices and drugs get taken off the market owing to recalls. Just as managerial reviews of ISO 13485 processes can prevent persistent issues, a certified company is less likely to experience problems that lead to getting products pulled from shelves. In addition to the lost profits that such events cause, recalls can permanently damage the public’s reputation, making many people perceive a troubled brand as unsafe.

However, corrective and preventive actions get built into the ISO 13485 framework, helping company representatives identify and tackle problems faster than they otherwise might. It’s also advantageous that getting certified can help create and maintain a culture of personal responsibility within the organization.

Once an employee understands that a single missed step or ignored protocol could cause quality issues that affect a whole organization, they’ll likely become more conscious of their behaviors and choices made while working.

Plus, if a company does experience a recall, being ISO 13485-certified should make it easier to target where things went wrong and prevent future issues. Doing those things should bolster public trust and reassure people that a device manufacturer has its operations under control.

ISO 13485 Certifications Strengthens Medical Device Companies

The medical device sector is a high-pressure industry where people praise innovation as long as it doesn’t sacrifice user safety. Moreover, manufacturers must respond to demand spikes, as instances like the surge in ventilator needs during the COVID-19 pandemic showed.

Getting an ISO 13485 certification can help a company make positive, permanent quality and process improvements. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational resilience. It’s not right for every organization, but the associated benefits make it well worth consideration.

Tue, 20 Sep 2022 12:01:00 -0500 en text/html
Killexams : How Much Money Do Medical Assistants Make? Medical clinic worker helping elderly patient in wheelchair with paperwork © Prostock-studio/Shutterstock Medical clinic worker helping elderly patient in wheelchair with paperwork

A lot of moving pieces are required to make a medical clinic run smoothly, and each position is of great value. From nurses and physician assistants to laboratory technicians and medical assistants, it takes a team to heal. 

If you're just starting out in the workforce or looking to make a career change, you may consider healthcare, which is truly indispensable. Medical workers have the job security that has seemingly slipped away from other fields, and the industry continues to add more jobs every year than any other field (via Hospital Careers).

Location, education, and experience are all contributing factors to how much money you'll make in any position. But, wherever you reside and whatever credentials are on your resume, you can begin serving in healthcare as a medical assistant fairly quickly with an accurate prediction of how much money you'll make. 

How Much You Can Expect To Make As Medical Assistant

Man handing paycheck © Andrey_Popov/Shutterstock Man handing paycheck

You'll recognize a medical assistant as the kind face who ushers you to the test room when you're a patient. They're responsible for taking vitals, recording medical notes, assisting physicians with exams, and sometimes giving injections or drawing blood (via Indeed). They help the test flow smoothly and are a key piece in your doctor's appointment.

So, how much do these healthcare professionals make? According to LiveAbout, the median annual salary for a medical assistant is $33,610. Again, location and experience affect the pay scale for medical assistants, and the annual salary can range from nearly $50,000 to around $26,000.

Medical assistants aren't required to have formal education beyond a high school diploma to work in the field, but those with training from a vocational school are more likely to be hired by employers, per LiveAbout. Here's what you'll need to consider when becoming a medical assistant.

How To Become A Medical Assistant

Medical assistant studying at laptop © Vincent B David/Shutterstock Medical assistant studying at laptop

A degree is helpful in becoming a medical assistant, but, if you don't yet have one, you can gain valuable skills as an entry-level assistant while working to earn a medical certification (Indeed). This will help you get your foot in the door if you're interested in starting ASAP.

Many online medical assistant certification programs are flexible, so you can go at your own pace. According to Verywell Health, the top overall online certification program is the Herzing Diploma in Medical Assisting, which can be completed in about 10 months. The best accelerated program is through the U.S. Career Institute, and you can wrap it up in as little as four months. 

Whichever route you take in starting your career as a medical assistant, keep in mind that your work environment will be an office setting, and you'll be sitting at a computer screen for portions of your shift. Strong communication skills, attention to detail, and a good bedside manner are all key to success in this role. 

With job security, the ability to relocate, and the opportunity to help heal others, medical assistant may just be the role you've been seeking.

Read this next: Ways To Care For Your Mental Health If You Can't Afford Therapy

Sun, 09 Oct 2022 02:15:00 -0500 en-US text/html
Killexams : New GHA Certification Helps Medical Tourism Facilitators Build Patient Trust

WEST PALM BEACH, Fla., Sept. 28, 2022 /PRNewswire/ -- Global Healthcare Accreditation (GHA) announces the launch of a new certification program for medical travel facilitators to assist in building patient trust.

GHA's Medical Travel Facilitator Certification focuses on validating the capacity of medical tourism facilitator companies to provide appropriate services to clients that enhance safety and patient experience along the entire medical travel patient journey as appropriate to the facilitator company's business model.

Medical travel facilitators have for many years played an important role as intermediaries between patients and healthcare providers. Their services include providing information about the medical provider, handling travel logistics, and ensuring a smooth care journey. For many patients, the medical travel facilitator is the main motivator or reason why they choose a specific destination provider. However, medical travel facilitation is an unregulated industry; therefore, it is not always easy for patients to distinguish between a facilitator with experience and high-quality partnerships versus another that has a beautiful website but little experience – or worse, is not focused on the patient's best interests.

According to Wiliam Cook, Global Healthcare Accreditation's Director of Business Development and Marketing, "The Medical Travel Facilitator Certification provides a trusted third-party validation that demonstrates to patients and healthcare providers that a facilitator's services meet the highest standards and align with international best practices. Patients no longer have to rely on anecdotes or unverified testimonials to make medical travel decisions, they can look to the Medical Travel Facilitator Certification as a metric to evaluate and validate a facilitator's capacity to provide the requisite services to ensure an excellent patient care journey."

The Medical Travel Facilitator Certification is conducted conveniently online, includes access to training, and evaluates a facilitator across 15 key competencies, including business ethics, sustainability and quality improvement, financial transparency, client services, oversight of contracts and agreements, and risk management, which underline a company's capacity to deliver excellent services.

For medical travel facilitator companies, the benefits of this certification include:

  • Enhance patient care experience along the entire care continuum

  • Provide a framework on which facilitators can implement or strengthen sound operational policies, procedures, and processes that align with global best practices

  • Offer a third-party validation that builds trust and confidence with prospective clients and health buyers

  • Increase brand awareness and visibility

  • Mitigate risks and vulnerabilities for clients and for the facilitator business

"Expect an increasing number of patients to look for accreditation or certification as the determinant in selecting a medical travel agent," said Bill Cook. "GHA's Medical Travel Facilitator Certification assures patients that a facilitator has been vetted by a globally recognized third-party accreditor, affirming that the company has the required protocols, processes, and staff training to deliver a safe and high-quality treatment journey and experience."

Visit to learn more about GHA's Medical Travel Facilitator Certification.

About Global Healthcare Accreditation

Founded in 2016, Global Healthcare Accreditation is the only accrediting body focused solely on medical travel and well-being services. GHA's international standards and professional norms for medical travel were developed in consultation with leading global experts in the industry, including providers, insurers, and employers committed to establish best practices in medical tourism, health tourism, and well-being, which support providers in validating quality and patient experience, increasing visibility, and implementing a sustainable business model for providers along the entire medical travel care continuum. GHA received ISQua's International Society for Quality in Health Care External Evaluation Association (IEEA) accreditation in 2019.

Organizations interested in contacting Global Healthcare Accreditation (GHA) can make a request at |

SOURCE Global Healthcare Accreditation

Tue, 27 Sep 2022 21:02:00 -0500 en-US text/html
Killexams : ACLM's new online directory helps patients to connect with lifestyle medicine-certified clinicians

The American College of Lifestyle Medicine has launched a new searchable online directory to help patients identify and contact clinicians in their communities who are certified in the rapidly growing field of lifestyle medicine. The clinician directory is located at

Lifestyle medicine is an evidence-based medical specialty that utilizes therapeutic lifestyle interventions as a primary modality to treat chronic conditions such as cardiovascular disease, type 2 diabetes and obesity. There are six pillars of lifestyle medicine: a whole-food, plant-predominant eating pattern, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection. According to the World Health Organization, 80 percent of heart disease, stroke and type 2 diabetes and 40 percent of cancer could be prevented, primarily with improvements to diet and lifestyle.

Since the first lifestyle medicine certification test was held in 2017, the number of certified diplomates has grown to 2,004 physicians and 778 nonphysician health professionals. Certification signifies that clinicians completed a minimum of 30 hours of lifestyle medicine continuing education (CE/CME), gathered at least 10 hours of in-person CE/CME from a lifestyle medicine conference and passed rigorous certification exams.

However, it is often challenging for patients to easily determine which clinicians in their areas are certified to practice lifestyle medicine. ACLM's new "Find a Lifestyle Medicine Clinician" directory allows patients to filter their searches by distance radius from a street address or zip code and by clinician type, such as lifestyle medicine physicians or other lifestyle medicine health professionals, lifestyle medicine coaches, international lifestyle medicine clinicians or lifestyle medicine intensivists.

Clinicians are increasingly embracing lifestyle medicine as the foundation of all health care and patients are increasingly tired of addressing only the symptoms of chronic disease with ever increasing, costly medications and procedures instead of addressing the root causes of their illnesses. ACLM's new directory of lifestyle medicine-certified health professionals is a useful resource to help connect patients to clinicians who are recognized for achieving a high competency at prescribing and supporting evidence-based, lifestyle behavior interventions. Everyone deserves access to the therapeutic benefits of lifestyle medicine and this directory is another important step in expanding that access to people whose health may greatly benefit."

Cate Collings, MD, FACC, MS, DipABLM, ACLM President

Tue, 04 Oct 2022 08:35:00 -0500 en text/html
Killexams : OH, OCTC partner for certified medical technician program

Oct. 4—Owensboro Health and Owensboro Community & Technical College will partner this fall to launch a new Certified Medical Technician program.

The program, funded by a $325,000 grant from the Kentucky Council on Postsecondary Education, aims to train 45 new CMTs before June 30, 2023.

Three groups of 15 students each will follow a "work and learn" model, which will deliver selected students the opportunity to work at OH while earning four OCTC healthcare career credentials.

Credentials include the State Registered Nursing Assistant, Phlebotomy Technician, Certified Medical Technician and Cardiopulmonary Resuscitation certificates.

OH will select the student participants and hire them as patient care technicians prior to the start of classes.

Additionally, OH will pay educational release time for the students to attend classes during the program, which is to last about three months.

Students who successfully complete the program may pursue advanced career opportunities at OH as applicable.

Mark Marsh, president and CEO of Owensboro Health, and Dr. Scott Williams, president of OCTC, both praised the collaborative endeavor.

"Owensboro Health is proud to collaborate with OCTC on this innovative approach to developing the next generation of healthcare workers and providing them with new pathways to career success and fulfillment," Marsh said. "This outstanding program is another example of how our communities are meeting the region's most vital challenges through teamwork and creativity."

"OCTC is grateful to CPE for this opportunity, and we are excited to partner with Owensboro Health to help meet their current and future direct patient care hiring needs," Williams said. "We are proud to be a part of this novel, public-private collaborative approach to help address the healthcare workforce shortage."

LaTasha Shemwell, the program's designated success coach, will provide personalized services to help with enrollment, course registration and any other needs.

"It's an amazing opportunity," she said. "Within that three-month time span, these individuals are receiving free training (through) this work and learn program; they're applying to work through the hospital and (receive) free training from us, and they will also get paid for their training through the hospital."

Shemwell said she wants to make sure students can flourish by having what they need.

"My goal is just to make sure that they have the resources to succeed," she said. "We're going to deliver out loaner laptops, so that we can make sure that they have that access to do their work from home when needed."

Incentives will be offered at certain milestones, Shemwell said, which includes $250 gift cards after completing CNA coursework and passing the license exam, along with successfully completing phlebotomy coursework and phlebotomy clinical.

"I will be encouraging them every step of the way through all those milestones," Shemwell said. "Life happens and challenges happen, but (I) just (want) to be that positive voice of reasoning and encouraging them that they can do this."

The program is scheduled to begin Oct. 24 and conclude Jan. 28 for the first group of students.

Other groups will begin in January and April 2023, respectively.

For more information, contact Shemwell at or 270-686-4455.

Wed, 05 Oct 2022 12:29:00 -0500 en-US text/html
Killexams : Board-Certified Orthopedic and Spine Surgeon Dr. Jaswinder Grover Joins Harvard MedTech’s Medical Advisory Board

LAS VEGAS, Nev., October 11, 2022--(BUSINESS WIRE)--Jaswinder Grover, MD, Board-certified orthopedic and spine surgeon with more than 25 years of experience in the medical field, has been appointed to the Medical Advisory Board of Harvard MedTech.

"Dr. Grover’s breadth of experience in orthopedics, spine surgery and medical technology/devices will provide an important perspective in how workers are treated and recover from workplace injuries," noted Gerry Stanley, M.D., Chief Medical Officer, Harvard MedTech. "Our Medical Advisory Board will benefit greatly from his years of managing the care of employees who have suffered workplace trauma as well as his years of insight in medical device and medical technology development."

Harvard MedTech is an innovative digital health company that is tapping the new science of how the brain works to alleviate the effects of trauma, including pain, PTSD, anxiety, depression and sleep disorders. The company’s Vx® Therapy platform integrates specially designed virtual reality experiences, psychosocial support, digital engagement, and proprietary AI algorithms to retrain neural pathways in the brain. The therapy has been proven to Boost treatment outcomes in worker’s compensation patients and others suffering from pain and trauma.

Dr. Grover is Founder and owner of the Allegiant Institute and Smoke Ranch Surgery Center. He is a member of the American Medical Association, UCLA Aesculapian Society, Nevada Orthopedic Association, and Clark County Medical Society.

The purpose of the Harvard MedTech Medical Advisory Board is to foster industry-wide innovation around Vx® Therapy in the treatment of workplace trauma. Vx® Therapy is a disruptive approach that uses virtual reality, behavioral coaching and artificial intelligence to alter the brain’s experience of pain, without drugs or unnecessary surgery. Each member’s specific expertise lends a particular lens on pain management which has been determined to have significant strategic importance, as Harvard MedTech works to make the world a better place by alleviating human suffering.

"I will be most interested in focusing on how Harvard MedTech’s Vx® Therapy can provide an alternative solution to pharmacologic approaches to the pain, depression and anxiety associated with workplace injuries, and in patients in general," Dr. Grover stated. "This is a therapy that can provide a cost-efficient alternative with long-term benefits for workers."

"We are excited to have Dr. Grover join our Medical Advisory Board, both for his outstanding clinical expertise and experience and for his insights as an extremely successful physician entrepreneur," said Shan Padda, Chief Executive Officer and founder of Harvard MedTech. "His practice is one of the best run practices, operationally and administratively, that I have seen in the market. Physicians are important partners for us as we accelerate the rollout of our solution, and Advisory Board members like Dr. Grover will help us ensure that our program design is optimized for physician involvement and oversight."

About Harvard MedTech

Harvard MedTech’s Vx® Therapy model is unique in that it is the first to fully integrate digital technologies with behavioral health interventions in a virtual application that can be managed in the patient’s home. This virtual engagement drives higher compliance, better patient satisfaction and maximal outcomes. It also allows the solution to be affordable and scalable at a population health level. This non-invasive and non-pharmacological approach also provides data that is trackable for a clear assessment of its value to patients and health care providers. Visit for more information.

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Tue, 11 Oct 2022 02:03:00 -0500 en-US text/html
Killexams : Who will dispense medical marijuana in Alabama and what will they need to know?

The qualifications of the dispensers who will manage the sales of medical marijuana products in Alabama are still to be determined for the state’s new industry.

In some states, pharmacists dispense medical cannabis products. It’s unclear whether that will be the case in Alabama. Nothing in the law or regulations passed so far indicates that pharmacists will be involved.

Pharmacist Sam Blakemore of Birmingham, a member of the Alabama Medical Cannabis Commission, is spearheading the development of qualifications for certified dispensers.

Blakemore said there is an expanding body of science about medical cannabis and that certified dispensers need a solid base of knowledge even if they are not pharmacists.

“Understanding the science is going to be a big part for these certified dispensers in the foundational education because I want them to understand how this stuff works,” Blakemore said. “Then they’ll be able to deliver appropriate consultations to the patient and/or be able to refer them back to the physician. So I think the more pharmacology, the more science that these certified dispensers have, the better off everybody is.”

Alabama became the 37th state to legalize medical cannabis when the Legislature approved a bill last year. It will be an intrastate business, with cannabis grown and products made in Alabama. The legislation created the 14-member AMCC for oversight.

On Sept. 1, the AMCC began accepting requests for license applications for cultivators, processors, transporters, testing labs, dispensaries, and integrated companies performing multiple functions. The AMCC expects to issue licenses next summer. Products are expected to be available late next year or in 2024.

Doctors who receive training in medical cannabis will be able to recommend the products to treat more than a dozen symptoms and conditions, such as chronic pain, nausea from chemotherapy, muscle spasticity, depression, and panic disorder. Patients will receive a medical cannabis card to buy the products at licensed dispensaries. Alabama could initially have as many as 37 dispensaries in cities and counties that approve them by resolution or ordinance, a process happening now.

The AMCC has approved regulations for dispensaries and some of the qualifications for the certified dispensers who will manage them. Certified dispensers must have a minimum two years of education or experience in biology, chemistry, pharmacology, medical cannabis, or a similar field. They must complete a foundational course in medical cannabis and receive at least 10 hours of continuing education a year.

Blakemore, pharmacy manager at Peds Rx Pharmacy Solutions, the outpatient pharmacy at Children’s Hospital in Birmingham, is working on what the training course will include. Blakemore has experience in similar work; he created a course for pharmacy technicians at Lawson State Community College and teaches continuing education for pharmacists and pharmacy techs.

Although three-fourths of states have legalized medical cannabis, marijuana remains a Schedule I drug under federal law, the same category as heroin, LSD, and methamphetamine.

The illegal status of marijuana under federal law raises questions for some about involvement in state-approved medical cannabis programs, including concerns from banks about providing services for the industry. Pharmacists in Alabama have concerns.

“There are still so many unanswered questions about this issue,” Leisa Johnson, director of communications and marketing for the Alabama Pharmacy Association, said in an email. “As the professional organization for pharmacists and technicians, we are awaiting guidance from the regulatory board.”

The Alabama Board of Pharmacy has not announced a policy on the involvement of pharmacists in the medical cannabis industry. Jim Ward, the board’s lawyer, said he would respond to questions from after discussions with the board. Minutes from the board’s meetings say the board has received numerous questions about whether a pharmacist can own a dispensary or dispense medical marijuana.

Blakemore notes that pharmacists have played a role in other states. The Louisiana Board of Pharmacy issues specialty licenses for pharmacies to dispense medical marijuana. Minnesota, New York, and Connecticut are among other states where pharmacists have been involved.

States that allow pharmacists to dispense medical marijuana have generally relied on U.S. Department of Justice guidance issued in 2013 known as the Cole memo, Blakemore said. The memo said the DOJ did not consider taking enforcement action against states a priority as long as states set up tight regulatory structures to prevent abuses of medical cannabis, such as the distribution of marijuana to minors and criminal enterprises profiting from the industry.

The National Community Pharmacy Association issued a one-page summary on the issue of pharmacists and medical cannabis in 2017.

At the Peds Rx pharmacy, Blakemore dispenses two cannabis-based medicines approved by the Food and Drug Administration. He dispenses Marinol for pediatric patients to treat nausea and vomiting caused by chemotherapy. It contains a synthetic form of THC. He dispenses Epidiolex for pediatric patients with epilepsy. It contains cannabidiol, or CBD.

“I’ve seen people benefit by taking those medications,” Blakemore said. “I’ve also had patients that openly told me, ‘I am taking marijuana.’ So I think big picture is we know people use marijuana. We know people use cannabis. Would you prefer that they continue to do so on the black market? Or would you prefer that it be regulated? I’d prefer that it be regulated.”

Blakemore said Sativex, which contains roughly equal parts of THC and CBD, is used in about 30 other countries for Parkinson’s and other motion disorders and has undergone clinical trials in the United States.

The illegal status of marijuana under federal law has limited the research in the United States. But Blakemore said there are good information resources. One is the Minnesota Department of Health’s annual review of medical cannabis studies, last updated in May. Wolters Kluwer is a company that provides research data to medical professionals through Lexicomp and that publishes “Medical Marijuana: A Clinical Handbook.” The University of Mississippi has been a key hub for marijuana research.

Blakemore said certified dispensers need an understanding of the human body’s endocannabinoid system and the properties of cannabis. He said THC and CBD are only two of more than 120 substances known as phytocannabinoids in the plant.

“There’s other chemical structures coming down the pipeline,” said Blakemore, who has a doctorate in pharmacy from Samford University and is a licensed pharmacist in five states. “That’s where the future will be. There is a lot of research that still needs to take place as to how these chemicals can help with disease state management.”

While Blakemore wants dispensers to have a strong foundation in the science, he also wants them to know their limitations, such as when to defer to doctors on questions such as drug interactions.

“There’s language in the rules and regulations that certified dispensers should understand their level of knowledge and they shouldn’t cross it,” Blakemore said. “They should know when to refer a patient back to a physician.”

Licensed medical cannabis dispensaries will be distinct from retail drug stores. Entry will be restricted to patients with medical cannabis cards or registered caregivers. Dispensaries cannot sell to out-of-state residents or deliver. They must have surveillance cameras as part of a cohesive security plan and maintain 60 days of video footage. A certified dispenser and a security guard must be on duty at all times a dispensary is open.

Blakemore said it is important to get the regulations correct and build the trust of the public and the medical community. He compared it to the growth in familiarity and comfort level during the nine years he has managed the Peds Rx pharmacy.

“Going through that process of opening up a pharmacy, trying to build up the patient volume, trying to educate the prescribers on what we do, what services we can provide, that’s the same kind of expectation I have for a lot of these dispensaries,” Blakemore said. “They’re going to have to earn the trust of the community. Education is the only way to do that.”

Blakemore said he is convinced there can be public benefit if the medical cannabis program is set up correctly.

“This product really can help if done right,” Blakemore said. “I think I can speak for the commission members. We’ve dedicated a lot of time to really consider all the factors. We just want to help the citizens of Alabama that are sick and can use the product have a reliable, quality product and have access to it.”

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Thu, 22 Sep 2022 18:56:00 -0500 en text/html
Killexams : EQS-News: Vitruvia Medical AG: Successful certification of FFP 2 masks with medical approval of LT technologies

EQS-News: VITRUVIA MEDICAL AG / Key word(s): Product Launch/Market Launch
Vitruvia Medical AG: Successful certification of FFP 2 masks with medical approval of LT technologies

30.09.2022 / 09:52 CET/CEST
The issuer is solely responsible for the content of this announcement.

Successful certification of FFP 2 masks with medical approval

of LT technologies

LT technologies has successfully passed the certification of the FFP2 masks with medical approval.

The TechMed Mask is a particle-filtering half mask for protection against aerosols, including viruses and particles. It is excellent for use in infection control and protects the wearer and those around them.

As LT technologies maintains a certified quality management system in accordance with the DIN EN ISO 13485:2016 standard, the respiratory protection mask was also certified in accordance with type IIR DIN/EN 14683:2016-10 in addition to TÜV Rheinland in accordance with DIN/EN 149:2001+A1:2009. This makes us one of the few manufacturers worldwide to produce masks with this double certification.

This FFP2 mask gives LT technologies a unique selling point. To date, there is no tm mask on the German market. The company is thus able to establish itself uniquely in Germany with its application in the medical sector and is optimally prepared for the next Corona wave. We assume that this aspect will become even more important. Supply bottlenecks from Asia have shown that European production is increasingly being used, if it is available.

LT technologies has already received the first orders. The FFP2 mask with medical approval will mainly be for hospital use, but the end user will probably also prefer this medical protection. From October 2022, we will produce the masks in-house "Made in Germany".

Further information about LT technologies GmbH &Co KG can be found on the home page :

About Vitruvia Medical AG :

Vitruvia Medical AG is a Swiss holding company with a focus on repair, production and trade of medical devices as well as surgical instruments.

Vitruvia thus combines innovative and sustainable solutions for medical-technical progress, customer benefit and economic success.

30.09.2022 CET/CEST Dissemination of a Corporate News, transmitted by EQS - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Thu, 29 Sep 2022 20:00:00 -0500 en text/html
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