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Exam Code: NCPT National Certified Phlebotomy Technician (NCPT) basics November 2023 by team

NCPT National Certified Phlebotomy Technician (NCPT)

Exam Details:
- Number of Questions: The number of questions in the National Certified Phlebotomy Technician (NCPT) test can vary, but it typically consists of around 100 to 150 multiple-choice questions. The exact number of questions may depend on the certifying organization or program.

- Time: Candidates are usually given a specific time limit to complete the NCPT exam, which is typically around 2 to 3 hours. It is essential to manage time effectively to ensure all questions are answered within the allocated time.

Course Outline:
The NCPT certification program covers various courses related to phlebotomy. While the specific course outline may vary depending on the certifying organization (e.g., NCCT - National Center for Competency Testing), the test generally covers the following key areas:

1. Anatomy and Physiology:
- Overview of human anatomy and physiology, with a focus on the circulatory system, veins, and arteries.
- Understanding blood components and their functions.

2. Phlebotomy Techniques and Procedures:
- Proper techniques for venipuncture (blood drawing from veins) using various methods (e.g., vacuum tubes, butterfly needles).
- Capillary puncture (fingerstick and heelstick) techniques.
- Specimen collection, handling, and transportation protocols.

3. Infection Control and Safety:
- Standard precautions for preventing the transmission of infections.
- Personal protective equipment (PPE) usage and disposal.
- Proper hand hygiene and disinfection techniques.

4. Equipment and Supplies:
- Knowledge of different phlebotomy equipment (needles, syringes, tubes) and their appropriate use.
- Understanding the purpose and types of additives used in blood collection tubes.
- Proper labeling and identification of specimens.

5. Patient Communication and Interaction:
- Professional and effective communication with patients during the phlebotomy process.
- Patient education and addressing their concerns or questions.
- Techniques for dealing with difficult or anxious patients.

6. Quality Assurance and Legal/Ethical Considerations:
- Quality control measures and procedures in the laboratory.
- Compliance with relevant laws, regulations, and professional standards.
- Maintaining patient confidentiality and privacy.

Exam Objectives:
The objectives of the NCPT test typically include:
- Assessing the candidate's knowledge and understanding of phlebotomy techniques, procedures, and best practices.
- Evaluating the candidate's understanding of anatomy, physiology, and medical terminology relevant to phlebotomy.
- Testing the candidate's knowledge of infection control, safety protocols, and quality assurance in the phlebotomy process.
- Assessing the candidate's ability to interact with patients professionally and effectively during blood collection.
- Evaluating the candidate's understanding of legal and ethical considerations related to phlebotomy practice.

Exam Syllabus:
The specific test syllabus for the NCPT may vary depending on the certifying organization. However, the following courses are typically included:

1. Anatomy and Physiology:
- Circulatory system
- Blood components and functions
- Veins and arteries

2. Phlebotomy Techniques and Procedures:
- Venipuncture techniques
- Capillary puncture techniques
- Specimen collection, handling, and transportation

3. Infection Control and Safety:
- Infection prevention and control
- Personal protective equipment (PPE)
- Hand hygiene and disinfection

4. Equipment and Supplies:
- Phlebotomy equipment and their use
- Blood collection tubes and additives
- Specimen labeling and identification

5. Patient Communication and Interaction:
- Effective communication with patients
- Patient education and addressing concerns
- Managing difficult or anxious patients

6. Quality Assurance and Legal/Ethical Considerations:
- Quality control in the laboratory
- Compliance with laws and regulations
- Patient confidentiality and privacy
National Certified Phlebotomy Technician (NCPT)
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National Certified Phlebotomy Technician (NCPT)
Question: 45
Phil the New Phlebotomy Tech accidently stuck himself with a needle just used to
draw a specimen for a CBC. The patient is a young nun, who assures him, I
don"t have anything you need to be worried about. Phil the New Phlebotomy
Tech squeezes the site to promote bleeding, washes his puncture site, applies a bit
of antibiotic ointment and a bandage over the site, and promises himself to be
much more careful. What (if anything) has Phil done wrong?
A. Phil has not done anything wrong.
B. Phil did everything wrong!
C. Phil did not use tincture of iodine on his puncture site.
D. Phil did not notify his supervisor or otherwise report the injury as the
guidelines of his facility instruct.
Answer: D
Phil did not report the injury. Needle sticks must be reported immediately after
the occurrence. Each facility has guidelines on the proper reporting system. The
occupational health department of the facility will offer confidential counseling,
treatment and follow up care, if needed.
Question: 46
Between runs, Phil the New Phlebotomy Tech conducts control tests on new
shipments, and checks the lot numbers for designated factors. Phil understands
that this is part of his job duties. Which of the following is also part of Phil"s job
A. The clinical laboratory"s quality assurance plan.
B. JCAHO standards.
C. The hospital"s total quality management plan.
D. All of the above.
Answer: D
The quality control tests Phil conducts and the logs and lot number checking tasks
he completes when shipments are received are part of JCAHO (Joint Commission
on Accreditation of Healthcare Organizations) standards for clinical laboratories.
They are therefore part of a hospital"s total quality management plan, and,
ultimately, the clinical lab"s quality assurance plan.
Question: 47
Phil the New Phlebotomy Tech is working in the outpatient lab. A patient has
come in for a drug screening of urine. Phil places a tamper-proof urine collection
cup in the bathroom designated for drug screening. After receiving the urine from
the patient, Phil immediately examines the color of the urine, as well as noting the
temperature. He notes his observations and initiates the chain of custody form.
Why did Phil examine the color and temperature of the urine sample?
A. Phil is a curious fellow.
B. Phil is checking for evidence of tampering.
C. Phil is checking for signs of dehydration.
D. Phil is determining if drugs are present.
Answer: B
Phil is checking for evidence of tampering. Many chemicals, fluids, and
commercially available products can be used to skew drug-screening tests. Many
urine collection devices intended for this type of testing are not only tamper
proof, but made with a temperature sensitive strip to measure the temperature of
the urine. Acceptable urine temperature is about 95-99 degrees. Urine should also
be visually examined for color and turbidity. If Phil suspects tampering, he must
request a second sampling. A second sample may require direct observation of the
specimen collection process.
Question: 48
The word partglyc/o means:
A. Salt
B. Potassium
C. Glucose
D. None of the above
Answer: C
Glyc/o is a word root that means sugar or, more specifically, glucose. When large
amounts of glucose are stored in the body, they are directed to the liver where
they are converted to the storage substance known as glycogen.
Question: 49
The purpose of an incident report is:
A. To get your story in before the patient does.
B. Report an incident.
C. Tell on a co-worker anonymously.
D. Admit wrong doing in writing.
Answer: B
An incident is required for any kind of incident, it should be completed within
twenty-four hours of an occurrence. It is an internal document used to document
the details of an unusual event. Incidents are not only patient injuries, an incident
can be a visitor tripping, or missing patient belongings, or using the wrong
colored topped tube. Incidents reports are not an admission of guilt, simply a
report of the incident.
Question: 50
A ___________________ is a word part that comes at the beginning of a medical
A. Prefix
B. Suffix
C. Combining vowel
D. None of the above
Answer: A
A prefix is a word part that comes at the beginning of a medical term. A prefix is
a word part that adds meaning to a combining form to deliver it a more precise
definition. For example, the prefix pre- means before. Someone who is getting
prenatal care is getting care before the birth of a baby.
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Phlebotomists serve an essential, life-saving role in the healthcare system: collecting and processing blood samples from patients and donors. This in-demand role holds significant value on its own, but it’s also a great starting point for a more advanced career in healthcare.

It takes less than a year to become a phlebotomist, as it’s one of the many allied health professions that don’t require a bachelor’s degree. Phlebotomist requirements typically include a high school diploma and completion of a training program.

In turn, you gain valuable experience interacting with patients and working alongside a medical team. As you learn more about working in healthcare, you may discover related careers that match your interests.

Read on to learn how to become a phlebotomist and whether this role suits your interests.

What Is a Phlebotomist?

Phlebotomists draw blood to use for testing, donations, research or lifesaving procedures such as transfusions. Blood tests are a vital part of healthcare. Doctors order blood tests to diagnose and monitor medical conditions such as diabetes, allergies, cancer and autoimmune diseases.

Phlebotomists receive instructions on the type and quantity of samples to collect, which may include urine or other biological specimens. Before the procedure, they prepare patients and help calm any nerves. Afterward, they monitor patients for adverse effects such as bruising, dizziness or nausea.

Important Skills for Phlebotomists

Phlebotomist technicians employ different collection techniques for different patients. Most tests require venipuncture, or drawing blood from a vein. Other tests may only need a finger stick, while infants typically have blood drawn by a heel stick.

Phlebotomists should be gentle and efficient, especially if patients express discomfort about getting their blood drawn or if their veins are hard to find. They should also be methodical and organized, understanding the purpose of each sample and ensuring they collect the correct quantity.

Each sample must be clearly labeled, correctly stored and accurately entered into a database. To prevent contamination, phlebotomists sanitize their equipment and workspace. They may also update patients’ medical files.

Phlebotomist Work Environment

Most phlebotomists work full time, but their schedules depend on their employer. Some have night or weekend shifts. Phlebotomists typically work in hospitals or medical and diagnostic laboratories, but many work in ambulatory healthcare services, physician offices and outpatient care centers. They might travel between centers or visit patients’ homes.

How To Become a Phlebotomist

It takes less than a year to become a phlebotomist. While requirements vary by state, the process is generally straightforward.

Earn a High School Diploma

You can begin a career in phlebotomy with a high school diploma or the equivalent. It helps to take relevant courses in math, science, anatomy and physiology, and health.

Some phlebotomists begin working right away with on-the-job training. However, most employers prefer or require candidates to earn a phlebotomy certificate.

Complete a Phlebotomy Training Program

Phlebotomist training typically takes one to three months, depending on your program’s scope and your schedule. You can enroll in phlebotomy training classes at a community college, technical school or vocational school, and many offer flexible weekend and evening class times.

Programs incorporate classroom and hands-on education, covering medical terminology, collection techniques and safety protocol.

Some states require phlebotomists to complete their training through an approved, accredited program. Phlebotomy programs receive accreditation from professional organizations, including the American Society for Clinical Pathology and the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS).

Consider Professional Certification

Earning professional certification cements your skills and commitment to excellence. While you can choose from several certifying organizations, most require certification candidates to hold a high school diploma or GED® certificate, complete an accredited training program, demonstrate clinical experience and pass an exam.

Certified phlebotomists maintain their credentials by paying renewal dues and completing continued education credits. Keep memorizing to learn about different certification opportunities.

Determine State Requirements

Only four states—California, Louisiana, Nevada and Washington—require certification for phlebotomists. Other states may still stipulate that phlebotomists complete an accredited program to practice.

In California, for example, phlebotomists can pursue three levels of certification, each of which qualifies holders to perform a different collection technique.

Phlebotomist Salary and Job Outlook

Blood testing already serves an essential role in diagnosis and treatment, but demand for medical services is expected to increase as the U.S. population grows and ages. In turn, phlebotomists benefit from a steady job market.

The U.S. Bureau of Labor Statistics (BLS) projects an 8% growth in phlebotomist employment from 2022 to 2032, much higher than the 3% predicted growth across all occupations.

Phlebotomists earned a median annual wage of $38,350 in May 2022, according to the BLS. Those working in scientific research and development services reported the highest average earnings—a mean of $47,770 per year—followed closely by those in outpatient care centers and state government organizations.

Certifications for Phlebotomists

Even if your state or employer doesn’t require a professional certification, earning one can make you more marketable by demonstrating and enhancing your skills. Review the requirements for three common certifications below.

Phlebotomy Technician (PBT)

The American Society for Clinical Pathology (ASCP) offers several paths to PBT certification. Applicants must have completed an approved phlebotomy program within the past five years or have one year of full-time clinical experience. Programs may carry accreditation from NAACLS or approval by the California Department of Public Health, or they must meet minimum instruction requirements.

Applicants must pass an 80-question test and pay a $145 application fee.

Certified Phlebotomy Technician (CPT)

To earn the National Healthcareer Association’s CPT distinction, applicants must complete a phlebotomy training program or one to two years of supervised phlebotomy technician experience.

The two-hour certification test covers safety and compliance, patient preparation and blood collection. You can purchase a study guide or practice test to prepare, and the test itself costs $125.

CPTs must renew their certification every two years by completing continuing education credits and paying $179.

Phlebotomy Technician (RPT)

In addition to meeting phlebotomy education or experience requirements, RPT applicants need to complete 50 successful venipunctures and 10 skin punctures.

The American Medical Technologists (AMT) certification test covers broad medical skills, including time management, clerical duties, legal and ethical concerns and specimen collection. The test costs $125.

Professional Organizations for Phlebotomists

While professional organizations usually require a membership fee, joining one can pay off in the form of long-term career success. These groups provide a path to certification, create networking opportunities and help you stay abreast of new techniques or laws.

National Phlebotomy Association (NPA)

NPA supports continuing education through workshops, training programs and professional certifications, including a credential for phlebotomy instructors. The organization hosts a job board for full- and part-time positions in phlebotomy and other allied health professions.

American Society of Phlebotomy Technicians, Inc. (ASPT)

ASPT offers certification for working phlebotomy technicians and graduates of accredited programs. The organization extends its benefits to members of NHA, ASCP and AMT. Members gain access to cross-training workshops, continued education opportunities and nonprofit events. ASPT also hosts a phlebotomy refresher program and an EKG basic skills program.

Phlebotomy technicians pay a $65 test fee and a $35 membership fee.

National Healthcareer Association (NHA)

In addition to its professional certification, NHA creates immersive learning experiences for phlebotomy technicians. Available resources, geared toward students and educators, include practice drills, interactive games and quizzes.

NHA provides a job board, résumé review services and career planning advice for allied health professionals.

Frequently Asked Questions (FAQs) About Becoming a Phlebotomist

How long does it take to become a phlebotomist?

Because becoming a phlebotomist generally does not require a college degree, you can start this career in less than a year. However, earning certification may take longer.

What is required to be a phlebotomist?

Phlebotomists need to earn a high school diploma or the equivalent. Some receive on-the-job training, but most complete a short-term phlebotomy training program. Many pursue professional certification.

How long is phlebotomy school?

Phlebotomy school takes less than a year to complete—often one to three months. The duration depends on your schedule and the program’s curriculum. Some programs incorporate more robust training or additional clinical hours.

How much does a phlebotomist get paid?

Phlebotomists made a median annual salary of $38,350 as of May 2022, the U.S. Bureau of Labor Statistics reports. The highest 10% of workers earned more than $51,610.

Wed, 15 Nov 2023 19:42:00 -0600 Kayla Missman en-US text/html
Medical Imaging: The Basics of FDA Regulation


Image courtesy of SIEMENS (Malvern, PA)

Medical imaging is playing a large and increasing role in modern healthcare delivery. Physicians and other healthcare professionals routinely rely on the diagnostic information provided by advanced imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) in their clinical practices. Surgeons, interventional cardiologists, and interventional radiologists employ a variety of state-of-the-art techniques to guide percutaneous treatments and interventions. Understanding FDA's regulatory construct that governs medical imaging is crucial to manufacturers operating in this exciting and challenging environment.

Regulation of Existing Imaging Technologies

Devices used in medical imaging are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Medical Device Amendments of 1976 and subsequent related amendments.1,2 Most existing medical imaging technologies are considered non-510(k)-exempt Class I and Class II medical devices by FDA, making them eligible for clearance under the 510(k) pathway.

Under this pathway, new medical devices that are substantially equivalent to existing, legally marketed Class I and Class II devices in terms of intended use, indications for use, and technological characteristics may be cleared for the U.S. market. The legally marketed devices with which comparison is made are referred to as predicate devices.

Under the 510(k) pathway, a next-generation imaging technology may be found substantially equivalent. However, the intended use and indications for use of the device must remain essentially unaltered. Intended use generally refers to the overall purpose of a device. The indications for use define the particular conditions or locations to which the device is to be applied. Also, any technological differences in comparison to the predicate device must not raise new questions of safety or effectiveness. However, if a new intended use or indication for use is sought, or if the technology employed raises new questions of safety or effectiveness when compared with the predicate, the new device is designated as Class III and requires a premarket approval (PMA) application. The PMA process requires a demonstration of safety and effectiveness prior to the granting of marketing approval.

Advanced imaging techniques, such as those used in the Gemini GXL from Philips (Andover, MA), are changing healthcare delivery.

Existing imaging devices use a variety of technologies to obtain diagnostic information or guide therapeutic procedures. These devices may be broken down into modalities that use and those that do not use ionizing radiation to form medical images.

Imaging Devices Using Ionizing Radiation. X-rays are the oldest form of medical imaging. They generate images, known as radiographs, by using ionizing radiation. The majority of the equipment used to produce, control, and process x-rays to generate radiographs is Class I or Class II. real classification (depending on the type of device) ranges from Class I 510(k)-exempt products such as diagnostic x-ray tube housings, which produce the x-ray beam, to Class II non-510(k)-exempt solid-state x-ray imagers or digital flat panels.

X-ray devices are representative of the product evolution that is possible in the 510(k) pathway. Such devices have become progressively more sophisticated, moving from purely analog imaging methods (i.e., the x-rays pass through the body part being imaged and directly onto a film, which is then processed for interpretation) to modern digital methods (i.e., the x-ray strikes a detector system, which then converts the received x-rays into an image). This evolutionary change was made possible by successive technological improvements in predicate devices over time, all generally cleared via the 510(k) pathway.

A notable exception is digital mammography, for which FDA has required PMA approval. The original designation of digital mammography as Class III is attributed to both its indications for use (detection of breast cancer) and the application of new technology to that indication. Currently, there is serious consideration being given to downclassifying it to Class II.

Fluoroscopy, which is closely related to x-ray imaging, allows both static and dynamic x-ray imaging. Like x-ray, fluoroscopy is a long-established imaging process that has undergone considerable technological advances since 1976, all essentially within the 510(k) pathway. Modern digital fluoroscopic equipment, which allows for image processing and manipulation, would have been technically impossible in 1976. Yet it is now considered Class II and subject to a variety of special controls.

CT scanners existed prior to 1976 and were placed into Class II by the original medical device classification panels. As for x-ray and fluoroscopic technology, the 510(k) path allowed CT technology to progress from fairly simple single x-ray source-and-detector configurations to the sophisticated spiral and multidetector technologies available today. FDA regulations describing what constitutes a CT scanner for regulatory purposes are fairly typical of the general nature of such regulations in medical imaging. A CT scanner is defined as

[A] diagnostic x-ray system intended to produce cross-sectional imaging of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis component parts and accessories.3

The FD&C Act is not the only FDA regulation applicable to x-ray, fluoroscopy, CT scanners, and other medical imaging devices that emit ionizing radiation and certain other types of energy. The Radiation Control for Health and Safety Act of 1968 (subsequently incorporated into the FD&C Act at Sections 531–542) addresses such devices. It authorizes FDA to promulgate performance standards for these radiation- and energy-emitting products to minimize unnecessary emission and exposure.4 This legislation applies to any ionizing or nonionizing electromagnetic or particulate radiation; or sonic, infrasonic, or ultrasonic waves emitted from an electronic product as a result of an electronic circuit. Accordingly, any imaging device that emits ionizing radiation marketed in the United States must meet FDA performance standards as well as gain 510(k) clearance.5 The content of the often-complex reports required to satisfy these requirements may be found in various sections of 21 CFR Parts 1000–1050.

Imaging Devices Not Employing Ionizing Radiation. A growing number of medical imaging products do not rely on ionizing radiation to produce images. Diagnostic ultrasound technologies also existed before 1976. Regulated as a Class II device, diagnostic ultrasound has incorporated a number of substantial technological advances since 1976. The result is a variety of features (i.e., color Doppler vascular imaging and 3-D imaging) that vastly Excellerate its diagnostic capabilities. Like advances in x-ray, fluoroscopy, and CT scanning, diagnostic ultrasound's considerable evolutionary progress has been possible within the 510(k) process. Notably, its Class II designation includes a variety of imaging transducers for both external and internal use, including intravascular ultrasound catheters used for imaging coronary arteries. In addition to the FD&C Act requirements, ultrasound equipment is also subject to FDA performance standards developed under the Radiation Control for Health and Safety Act, given the emission of ultrasonic waves from these devices.

MRI uses powerful magnetic fields in conjunction with radio-frequency pulses and sophisticated computer algorithms to produce detailed anatomic and functional images. Unlike the previous modalities, clinically usable MRI technology was not developed until the early 1980s and consequently had no predicate device when first brought to market. Because the risk to patients undergoing the then-new procedure was not well characterized, MRI was initially regulated as a Class III device and entered the market through the PMA process. Following the widespread clinical introduction of MRI, considerable clinical data were collected demonstrating the relative safety of the technique. Based on this well-defined risk profile, FDA reclassified MRI, MR spectroscopy, and related coils as Class II devices effective July 28, 1988, allowing them to gain marketing approval via the 510(k) pathway.

Related Imaging Management Equipment. In modern clinical practice, medical imaging devices are only part of the medical imaging enterprise. Images obtained by these devices must be captured, stored, and distributed for both primary interpretation and clinical review. This typically requires a picture archiving and communications system (PACS) together with a variety of related components.

PACS devices and their related components depend on computer workstation technology that was not available in 1976. There also was confusion among manufacturers as to whether these products were medical devices, and if so, how they were to be regulated. Culminating in a final rule issued on April 29, 1998, FDA clarified its treatment of PACS and related devices.6 Under these regulations, medical image storage devices and medical image communications devices are Class I exempt if they do not use irreversible compression. PACS devices, along with medical image digitizers (e.g., film scanners) and medical image hard-copy devices (e.g., film printers), are considered Class II and subject to 510(k) premarket notification. Accordingly, PACS devices, medical image digitizers, and medical imaging hard-copy devices require FDA clearance before they may be legally marketed.

Bringing a New Medical Imaging Device to Market

X-rays are the oldest form of internal medical images.

Given that the majority of medical imaging technology is subject to the 510(k) pathway or is even 510(k) exempt, it might appear that bringing new imaging devices to market is a relatively straightforward process. However, this may not be the case if a new product differs from its potential predicate devices in intended use or indications for use, or if it uses modified or new technology. Even if a new device is considered to present a low risk of patient injury, such changes can have a substantial effect on the product's path to market.

Alterations to an Intended Use or Indications for Use. A new imaging device's intended use is key to determining whether that new product is substantially equivalent to a claimed predicate device.7 If a new device's intended use is determined to be not substantially equivalent (NSE) to a predicate device, the new product is subject to an automatic Class III designation. In practice, the broad intended uses of medical imaging devices generally afford sponsors considerable latitude in identifying an intended use that is reasonably applicable to a new imaging product.

The 510(k) pathway allows sponsors some flexibility with a new device's indications for use. Generally, differences in a new device's indications for use as compared with its predicates' does not preclude a substantially equivalent determination. Of course, those differences must not alter the product's intended diagnostic or therapeutic effect. When examining whether such alterations exist, FDA looks to whether the change affects the device's safety and effectiveness compared with that of its predicates.

In practice, minor alterations in the indications for use for an existing imaging technology are often not viewed by FDA as altering a product's diagnostic or therapeutic effect. An example is limiting the application of a cleared imaging technology to a specific area of the body.

More-pronounced changes to a device's indications for use, such as incorporating disease-specific claims (i.e., cancer detection) where the predicate products made only general imaging claims, may cause difficulties in establishing substantial equivalence. In such instances, FDA could easily see the modified indication as affecting the device's diagnostic effect. A relevant example is FDA's treatment of digital mammography. The addition of a breast cancer–screening claim to a breast-specific refinement of digital imaging technology was a major factor in FDA's classification decision. In that case, FDA did require a PMA, even though similar, existing digital imaging systems without a specific cancer-screening indication had been subject to 510(k) clearance. The decision to require a PMA for digital mammography was difficult for many in the imaging community to accept. Nonmammography digital imaging systems with broad indications for use were routinely used in the diagnosis and management of cancer, despite the lack of an explicit cancer-related indication for use. Simply put, even the most established imaging technology may be subject to the PMA pathway if a new indication significantly alters that technology's established diagnostic effects.

Alterations to Device Technology. Assuming that the intended use of a new device is unchanged from its predicates and the indications for use do not alter its diagnostic or therapeutic effect, the substantial equivalence analysis shifts to the technology used to create the images. Should that technology be substantially similar to that of the new product's predicate devices, substantial equivalence is established.

However, if a new product's technology differs from that of the predicate devices, the question becomes whether the change could significantly affect safety or effectiveness. If the answer is no, as might be the case with a minor alteration to image manipulation capabilities or the algorithm by which those images were generated, the product is considered substantially equivalent. However, if the change in technology might significantly affect safety or effectiveness, the analysis moves to whether that change does in fact raise new questions of safety or effectiveness.

The analysis of whether new technological characteristics raise new concerns of safety or effectiveness is often the key question with innovative imaging products. Such products often use completely new methods to obtain diagnostic information. Even if such technology is unquestionably safe, the novel nature of a new device's technology may raise questions of effectiveness. For example, if the imaging technology does not impart energy of any kind into the patient or uses a type of energy whose risks are well characterized, FDA may question the technology's effectiveness. Whenever a new device's technological characteristics do raise new questions, the agency's substantial equivalence analysis ends with an NSE determination.

Consider instances where FDA accepts that no new questions of safety and effectiveness have been raised by a new imaging device's technology. A sponsor must still demonstrate that accepted scientific methods exist for assessing the new technological characteristics and present performance data obtained using those methods to prove substantial equivalence. In practice, clinical data are frequently necessary to establish that the technology has safety and efficacy comparable to its predicates. Designing and conducting clinical studies to demonstrate comparable safety and effectiveness may be difficult. Typically, it requires demonstration of the new product's clinical utility. This, in turn, generally requires the use of the new device to evaluate a specific clinical condition whose existence can be confirmed with a reasonable degree of confidence. This confirmation allows the sensitivity and specificity of the new imaging product to be compared with its predicate devices in a clinical setting in which the new device is to be used.

Approaches to a Not Substantially Equivalent Determination. Should FDA determine that the intended use of a new imaging device differs from that of its predicates, that its indications for use change its effect, or that it raises new questions of safety or effectiveness, agency policy requires that the new device be found NSE.

There are certain indications from FDA that an NSE determination is likely. These include a letter requesting additional information and containing questions that the sponsor cannot address with data that are either on hand or reasonably available.

There are several strategies for dealing with an NSE decision, depending on the underlying basis for the determination.

One potential reason for an NSE decision could be that the intended use has gone beyond the predicate device's intended use. For example, a particular indication for use, such as a claim that an imaging device can either screen for or characterize certain forms of cancer, may require the submission of extensive clinical data or a PMA prior to receiving marketing approval.8 Abandoning or modifying that particular indication, assuming that there were no agency questions with regard to the device's underlying technology, may allow the product to be cleared via the 510(k) pathway.

Similarly, it is not unusual for FDA to object to particular aspects of a new device's technology, such as a specific pulse sequence or imaging algorithm. Removing the portion of the new product's technology that has raised the agency's concern may often allow a substantial equivalence determination to be made on a modified, although less-capable, version of the device.

In instances where a novel new imaging device is low risk but NSE to a predicate device, de novo downclassification under Section 513(f)(2) of the FD&C Act may be an option. Under this pathway, the new device is downclassified into Class I or Class II and subsequently cleared by the agency. FDA will note that a particular device may be eligible for the de novo pathway in the letter notifying the sponsor of the agency's NSE decision. However, if the de novo pathway is being considered, the downclassification should be discussed well before any 510(k) notice is submitted.

To qualify for de novo downclassification, the new imaging device must meet the statutory requirements for inclusion in either Class I or Class II. Administratively, the sponsor must submit a written request for downclassification within 30 days of receiving an NSE letter. The request should include a description of the device, the rationale for the downclassification, and information to support the request. This submission should also discuss proposed general or special controls for the new product that can provide reasonable assurance of its safety and effectiveness.

In practice, clinical data are often necessary, and the downclassification request is typically prenegotiated with FDA. Submission of that request is usually made immediately following the agency's pro forma issuance of an NSE determination. These considerations notwithstanding, FDA has 60 days following the submission of the written request to downclassify the new device. If the agency finds that the product is properly classified in Class I or Class II, the device may be commercially distributed based on the information submitted as part of the de novo downclassification request. However, if FDA finds that the new device is appropriately in Class III, the new device is subject to the PMA process. Although attractive in concept, the de novo process is still used infrequently.

In instances where FDA will not consider either the 510(k) or de novo pathways for a medical imaging device, the PMA pathway is the only option to bring a new imaging device to market. Under the PMA paradigm, clinical trials are necessary to demonstrate that the device is reasonably safe and effective for its intended use and indications for use. As noted earlier, designing clinical studies for imaging products can be challenging, particularly demonstrating a new device's effectiveness and clinical utility. Depending on the particulars of the technology, these studies may have to demonstrate not only that the device can successfully detect a disease or condition with a certain sensitivity and specificity, but also that physicians and other healthcare professionals can use the information provided in a clinically useful manner. Even in instances where the clinical trials for a PMA are comparable in size and complexity with those needed for a 510(k) notice or de novo downclassification, sponsors of a PMA-pathway device are typically subject to substantially higher user fees and a preapproval manufacturing inspection.


FDA regulation of medical imaging devices may appear to some as deceptively simple, because the majority of imaging products are subject to the 510(k) pathway. However, when a sponsor is contemplating new or modified indications for use for an established imaging technology, a variation of established technology, or a totally new technology, the sponsor should fully and realistically explore the potential regulatory consequences.

When developing a substantial equivalence argument for such a product, it is often prudent to consider alternatives to the planned device in terms of intended use and technology, in case FDA initially rejects the claim of substantial equivalence. In considering these options, sponsors should also perform a realistic assessment of the resources available to design and develop clinical trials should clinical data be necessary for 510(k) clearance or should de novo downclassification or a PMA prove necessary.

John J. Smith is counsel at Hogan & Hartson LLP (Washington, DC) where he specializes in regulatory and scientific issues related to FDA marketing approval for medical devices. Smith can be contacted at [email protected].


1. Federal Food, Drug, and Cosmetic Act, Public Law 75-717, 52 Stat. 1040 (1938), 21 USC Sections 301–394.

2. Medical Device Amendments of 1976, Public Law 94-295, 90 Stat. 539 (1976; codified as amended in scattered sections of 21 USC).

3. Code of Federal Regulations, 21 CFR 892.1750.

4. Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 82 Stat. 1171 (1968).

5. Code of Federal Regulations, 21 CFR 1040.

6. Federal Register, 63 FR:23385, April 29, 1998.

7. “Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3),” Blue Book Memorandum (Rockville, MD: FDA, CDRH, 1986).

8. “Guidance for Industry: General/Specific Intended Use” (Rockville, MD: FDA, CDRH, 1998).

Copyright ©2006 Medical Device & Diagnostic Industry

Mon, 31 Jul 2006 11:59:00 -0500 en text/html
Privacy Basics: A Quick HIPAA Check for Medical Device Companies

Regulatory Outlook


HIPAA, which was enacted in 1996, had many different goals, including making insurance transferable upon leaving employment, enabling electronic billing for medical costs, and, the most famous result, the authorization of federal privacy rules for health information. The Department of Health and Human Services (HHS) then made two regulations: the HIPAA privacy rule, which regulates private health information, and the HIPAA security rule, which regulates the manner in which healthcare providers control and protect health information.

Covered Entities

The organizations controlled by the HIPAA privacy regulation are called covered entities. A covered entity is any healthcare provider that electronically bills for its services. This covers almost all healthcare professionals. It also means that most medical device companies are not covered entities. However, some medical device firms that sell to patients and bill Medicare may qualify as covered entities and be bound by HIPAA. For example, a company that sells insulin pumps to patients and bills Medicare would be a covered entity. Some companies may have a subsidiary that is a covered entity while the rest of the company is not covered; such companies are called hybrids. The company can wall off the subsidiary, which is a covered entity, so that only that part of the company is bound by HIPAA.

Covered Information

HIPAA defines the covered information as PHI, which is any health-related information that may identify a patient. HIPAA takes an expansive view of what may identify a person. There is a list of 18 identifiers. Besides the traditional identifiers such as name, address, phone number, social security number, etc., there are some device-related identifiers, such as serial number or date of service when the device was used, that have proven quite to difficult to deidentify.

Almost any information from a patient file has to be carefully scrutinized to be sure it is not PHI. The definition is wider in the United States than it is in the European Union (EU), where more-traditional identifiers are used. Member nations of the EU are governed by the EU Directive on Data Privacy.

Disclosure of PHI

Authorization is the term used for a patient to allow some disclosure or use of PHI. HIPAA determines authorized uses of PHI by covered entities and what disclosures of PHI may be made. The HIPAA privacy regulation outlines when a covered entity must obtain authorization from the patient or approval from an institutional review board (IRB) or privacy board.

Note that the EU uses the term consent for this document while HIPAA uses authorization. For device companies, there may be an informed consent document created to comply with FDA clinical rules or the HHS Common Rule. This consent document may have a HIPAA authorization built into it, but the HIPAA authorization is not called a consent.

With several exceptions, a covered entity may use PHI within its organization without restriction by HIPAA. However, when it discloses information outside its boundaries, the covered entity must comply with the HIPAA privacy regulation's limitations and authorization requirements. The covered entity may disclose to third parties without authorization for three HIPAA-specified activities: treatment, payment, or healthcare operations (TPO).

Treatment. Treatment refers to communication of PHI needed to treat the patient, such as information flow between the covered entity and another healthcare provider, e.g., another doctor who is treating the patient. A general practitioner and a specialist may discuss their joint patient for the purpose of treatment without activating any authorization requirements under HIPAA. This treatment exception could involve a medical device company. For example, if a technical representative from a medical device company takes part in a surgery to help use or train surgeons on the company's equipment, that participation is part of treatment and does not require an authorization. Although it is wise to notify the patient before exposing his or her data or personal information to a company representative, there is no specific HIPAA requirement to do so under these circumstances.

Payment. Payment refers to the process of obtaining payment from payers such as insurance carriers. Although covered entities routinely ask for consent to disclose information to payers, and there may be consent requirements at the state level, there is no need for a HIPAA authorization for billing.

Healthcare Operations. The term healthcare operations refers to the internal mechanics of running the covered entity. PHI may be transmitted as part of normal business operations. For example, the covered entity may use PHI for internal quality assurance improvement practice.

Business Associates

Sometimes a covered entity receives assistance in performing activities that involve the use or disclosure of PHI under HIPAA. The person or entity providing the help is called a business associate. A covered entity may enter a business associate agreement (BAA) with another person or company that is providing services to the covered entity with regard to TPO. For example, the covered entity might outsource its billing department to a third party. In such a case, the covered entity would engage that biller with a BAA.

It is very unusual for a medical device company to need a BAA with any covered entity. In the early days of HIPAA, covered entities were wholesale shipping BAAs to everyone they purchased from. Since then, HHS has made it clear that the normal relationship between a medical device provider and a covered entity does not require a BAA.

It is only when a medical device company is acting on behalf of a covered entity that it needs a BAA. One narrow example is when a covered entity is prescreening patient records in preparation for research. It can do that without an authorization. However, if the covered entity allows a third party, such as a device company, onto its property to do such preliminary searching on the covered entity's behalf, it may then need a BAA to protect the PHI that the device company will access.

Access to PHI

There are a number of access points to PHI for a device company. Some information is necessary for the device company to have and some is thrust upon it. Common ways to be exposed to PHI include the following.

Treatment. As a device company, you have a role in treatment. For example, as previously discussed, a device company representative may attend the real use of a device. Or, a doctor may call the OEM's technical services staff with questions about how a particular patient's anatomy or medical symptoms could affect the use of the company's device. Even though no name is given, the medical data may include HIPAA identifiers. Such treatment interactions between the medical device company and the covered entity are part of the treatment exception to HIPAA and therefore require no special authorization.

Accidental Exposure. A device company field representative may accidentally be exposed to PHI while at the site of a covered entity. For example, the representative might inadvertently see a patient chart while in a doctor's office. HIPAA calls this incidental disclosure. HIPAA allows such action without any repercussions under the regulation. Remember that PHI is still private and the company representative should not disclose what is accidentally seen to anyone else.

Clinical Trial or Other Research Information. There are three main routes for obtaining PHI from a covered entity for research: authorization, partial waiver from an IRB, or deidentification.

The most common way to obtain research data is through patient authorization. An authorization is built into the informed consent document in most medical device clinical trials. Once a company is in the process of having a patient sign a consent form, it is not much extra work to include the additional elements required for a HIPAA-compliant authorization. This method makes it possible to obtain wider access to use of the data. Most device companies want to harness the data to Excellerate future generations of devices and not just the immediate use. Such usage can be accounted for in a signed authorization.

A partial waiver means asking an IRB to allow PHI of a limited nature to be disclosed without a patient's authorization. For example, the site could strip out all directly identifiable information such as names, addresses, etc. The remaining identifiers might technically identify the patient, but the IRB may determine that the risk is low and allow disclosure without patient authorization. However, this process has proven difficult in practice simply due to the bureaucracy that has to be managed; companies have found the IRB interface to be too slow and laborious to use often.

Deidentification requires removing all 18 identifiers from the PHI, which can be difficult for device research. For example, because device serial numbers are often needed to correlate to other records, they are a hard identifier to do without. Similarly, dates of visits are often needed to correlate to device performance over time. However, deidentification is still a viable option for some research.

Compliance with FDA Regulations. A specific section of the HIPAA privacy regulation allows a covered entity to disclose information to a device manufacturer in order for the manufacturer to report to a public health agency, such as FDA. This exception is crucial because it allows a covered entity to communicate with a manufacturer to follow up on a complaint, provide data for a medical device report, track devices, or use information needed for quality system regulation compliance.

PHI after Disclosure

Once outside a covered entity, HIPAA rules no longer apply to this information. In fact, this must be stated in every HIPAA authorization. However, there are myriad state laws that control PHI in different forms, and if the PHI is obtained under a BAA, there are contractual obligations as well. Therefore, a device company should only take PHI when needed and must safeguard it, i.e., only those who truly need access to PHI should be allowed to see it. Device companies must also establish procedures to prevent accidental disclosure.


HIPAA has definitely made research more difficult for device companies. Each time that a company considers accessing PHI, it needs a thorough HIPAA analysis. Initially, device companies feared that the public health exemption was not broad enough and that covered entities would resist releasing the necessary PHI. However, over time, covered entities have cooperated and have generally allowed access to PHI that device companies need for compliance with FDA regulations. Therefore, life is more difficult with HIPAA, but certainly not impossible.

Copyright ©2009 Medical Device & Diagnostic Industry

Fri, 31 Jul 2009 12:00:00 -0500 en text/html
Fusing applied and basic medical research

Credit: Shandong first medical university

Housing a World Health Organization Collaborating Centre, Shandong First Medical University (SDFMU) has quickly become a leader in disease research and treatment. With innovative approaches to skin, parasitic, and rare diseases, it sets standards in many prevention and control methods.

Making huge steps in the early diagnosis and treatment of tumours, and radiation protection, the university is looking to spread its successful experience to developing countries in Africa and Asia, broadly benefiting human health.

The 2019 merger of Taishan Medical University, Shandong Academy of Medical Sciences, and several local hospitals in Shandong saw the establishment of SDFMU. With the main campus in the historic and cultural city of Jinan, capital of Shandong province, the university aims to make a big impact on higher medical education in Shandong and the nation. By integrating quality research, education, and clinical resources, it seeks to build a novel training system for innovative medical personnel, and become a first-class applied research university.

“We strive to build the largest medical research centre in the province within five years, and be ranked among the nation’s top 10 medical universities within 10 years, with some world-class academic programmes,” said Guang Ning, the president of SDFMU. “In line with the ‘Healthy China’ strategy, and the provincial strategy to integrate science and education, we want to become a model site for science-education integration, industry-university-research partnerships, and for system innovation.”

Medical research and disease prevention

Focusing on cutting-edge research in medicine and life sciences, SDFMU researchers are engaged in basic and applied research, targeting major diseases that threaten human health. The university has strong foundations in ophthalmic keratopathy, endocrine and metabolic diseases, leprosy, and tumour radiotherapy. Housing a number of advanced research platforms, including ministerial and provincial key laboratories, it has achieved innovative research results, bringing significant social and economic benefits.

Researchers from Shandong were pioneer in eliminating four infectious diseases that were major health threats in China in the last century, including leishmaniasis, filariasis, malaria, and leprosy. The work on these four diseases was lauded as by the World Health Organization (WHO).

Clinical service

With four general hospitals and five specialty hospitals, SDFMU has strong clinical service capacity. One of its general hospitals is ranked 16th in comprehensive strengths among hospitals of East China in the best hospital ranking produced by Fudan University. Two specialty hospitals were listed among the national top 10 in terms of Fudan’s ranking for reputation of clinical specialties. With the construction of the Proton Therapy Center at Shandong Cancer Hospital well underway, the university is to further enhance its research, teaching, and residency training capacities.

Talent training

As a pilot site for a national training programme of outstanding physicians, SDFMU has a strong clinical medicine programme, ranking among the global top 1% according to the Essential Science Indicators ranking. With a focus on medical sciences, the university has set up diverse programmes covering humanities, law, natural science and engineering, management, and education, featuring 44 undergraduate programmes.

With talent cultivation as a core mission, the university has established a comprehensive, multilevel training system. Its main campus in Jinan employs an elite education model, aiming to produce medical talents with solid academic backgrounds, superb medical skills, an innovative spirit, and a global vision. Its people are capable of leading future medical development, through joint training with renowned global universities.

The Tai’an campus emphasizes specialty education, focusing on cultivating talents with strong applied skills to meet local demand for medical services, and for professionals in fields short of capacity. Great efforts are made to enhance strengths, and develop medical technology and nutrition and health related subjects by encouraging deep integration of medical science with other disciplines, with the goal to make the university a key base providing much needed skillful medical professionals for Shandong.

International cooperation

Internationalization is part of the university development strategy, leading to partnerships with universities and medical institutions in 30-plus countries, such as Britain, the United States and Australia. In the past five years, the university has carried out more than 100 international cooperation projects, including those under the China-UK Global Health Support Programme, sponsored by the Ministry of Commerce, and the National Key Research and Development Plan of the Ministry of Science and Technology (MOST).

Since 2004, it has enrolled undergraduate and graduate international students from more than 20 countries and regions. It has also organized several training classes on prevention and treatment of common infectious diseases in developing countries, part of a MOST programme.

Wed, 23 Oct 2019 07:51:00 -0500 en text/html
883 Basic IC Plus from Metrohm

The 883 Basic IC plus completes the family of intelligent Metrohm ion chromatographs. Although it is the smallest family member, it satisfies high demands and offers an excellent price-performance ratio.

The 883 Basic IC plus allows anions, cations and polar substances to be determined in different matrices. The concentrations may be up to four orders of magnitude apart. The analysis is always reliable and precise.

The 883 Basic IC plus is designed for training in universities and schools. For this reason it is supplied with a practical textbook, which provides an introduction to the theoretical and practical aspects of ion chromatography. The 883 Basic IC plus is, however, also excellent for routine applications in water analysis, the food sector or the chemical industry. Wherever high performance at low cost is called for, the 883 Basic IC plus proves to be the ideal solution.

  • Intelligent ion chromatography
  • Analysis of anions, cations and polar substances over four concentration decades
  • Ideal for training and routine analysis
  • Takes up very little space, very compact design
  • Analyses can be automated
  • Practice-oriented textbook
  • Very easy operation
  • Excellent price-performance ratio
  • Includes MagIC Net Basic Software
  • Monitoring and control functions for system components and results
Tue, 14 Nov 2023 10:00:00 -0600 en text/html
Medical Detox

Not everyone with a substance use problem requires medical detox before entering a drug rehabilitation program, but those who have a physical dependency on a drug, or who would be risking their health to attempt to quit on their own, may benefit from beginning their addiction treatment with it.

While detoxification helps to eliminate the physical symptoms of addiction, most patients will need additional medical and psychological assistance. Quitting a substance doesn’t address the underlying causes of the initial addiction, which could be genetic, environmental, or behavioral. Also, there may be changes in brain chemistry as a result of long-term substance abuse that need to be addressed. Recovery usually involves treating the patient's mind as well as their body.

Tue, 24 Dec 2019 05:55:00 -0600 en-US text/html
Coalition of Kaiser Permanente Unions claim approval of contract by 98.5 percent without releasing vote totals

The Coalition of Kaiser Permanente Unions (CKPU) has announced the passage of the contract with healthcare conglomerate Kaiser Permanente. After three weeks of voting, the CKPU declared that the contract was voted through by 98.5 percent, but without releasing the vote totals. The official national announcement by the CKPU came after a week of union locals in the coalition announcing their own ratifications. 

Voting ended on November 3, and while several locals announced their own ratifications sooner, the CKPU did not announce the official national ratification until November 9. The four-year national agreement covers 85,000 healthcare workers at Kaiser across many job categories, from pharmacy to housekeeping, nursing assistants, phlebotomy, lab techs and kitchen staff. 

As of this writing, CKPU, nor any of the locals within the coalition, have posted any information about vote totals on their websites or social media accounts. Healthcare workers are concerned that they have not received any further information about the vote. 

With no official vote count, it is impossible to verify the claim that the contract passed with such high margins. Given the level of opposition voiced by Kaiser workers to their working conditions and wages, workers should demand a detailed breakdown of the totals for each local. It is a basic democratic right for workers to know just how many workers cast ballots for and against. If the CKPU is unwilling to provide such information, which all members are entitled to know, then there is no reason to accept the claim that the contract was passed at all.

When voting began, Kaiser workers were still not supplied with the full tentative agreement. Instead, the CKPU and its locals released brief highlights. Facing demands from workers for the full tentative agreement, the CKPU added an announcement to its website stating that the full TA would be available for workers to read at voting locations. The TA, a 75-page document, is not something that can be skimmed right before a vote and the attempt to hide the document from the membership is a clear indication that the TA was not as strong as the CKPU claimed. 

No doubt, after opposition from the membership and in response to the statement by the Healthcare Worker Newsletter demanding the release of the contract with adequate time for review, the full TA was released quietly on three union local websites. There were no social media posts made to highlight its release. 

Kaiser Permanente healthcare workers rally last year. [Photo: MorePerfectUnion]

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