OTC Medical Devices

Question 1

What comes to mind when you hear the term “OTC Medical Devices”?

Answer 1

Section 201 (h) of the Federal Food, Drug, and Cosmetic Act states a medical device is “an instrument, machine, contrivance, implant in vitro reagent that’s intended to treat, cure, prevent, mitigate, or diagnose disease.”

These devices can be directly purchased by the consumer and do NOT require a prescription for the sale to occur. Can be used in any setting, including outside of the home, if the consumer can properly use the device as directed by the product labeling.

Question 2

What is required on the principal display panel?

Answer 2

• Part of the label typically seen in a retail setting.
• For rectangular packages: one side’s height x width
• For cylinder packages: 40% of height x circumference
• For other shapes: 40% of the total surface area, unless a more prominent area is available.

Question 3

What is required on the statement of identity on the labeling for OTC devices?

Answer 3

• Must appear on the principal display panel
• Include the common name of device and a statement of its prinicpal intended action(s)
• Indications for use should be in the directions for use
• Statements must be bold, sized appropriately to other prominent text, and aligned parallel to the package base.

Question 4

What are the labeling requirements for the net quantity of contents statement?

Answer 4

• Must contain this statement in terms of weight, measure, numerical count or in a combination of numerical count and weight, measure, or size.
• Shall appear as a separate item on each principal display panel

Question 5

Where do we find the OTC Medical Device Disposal?

Answer 5

Device’s information for use should:
* Provide instructions on proper disposal of the device and any accessories.
* State if the device and/or accessories requires professional assistance for proper disposal of biological or biohazardous waste

Proper warnings and precautions regarding safe disposal should be present to help users understand differences between regular waste and biological waste.

Question 6

What are the three classes of OTC Medical Devices?

Answer 6

• Class I–> low risk, do NOT require premarket review
• Class II–> moderate risk, require premarket review
• Class III–> high risk, require premarket review

Question 7

Describe the characteristics of blood pressure monitors.

Answer 7

Self-measured blood pressure
* SMBP is when a patient regularly measures their BP outside the clinical setting.

Benefits of SMBP:
* Enhance accuracy of hypertension diagnosis
* Optimize blood pressure management
* Support patient adherence to treatment plans

Best Practices:
* Clinical guidelines recommend upper arm BP devices for SMBP due to their accuracy
* Validated wrist cuff BP devices are alternative when upper arm cuffs are not suitable, for example a patient’s arm circumference.
* Note: proper technique is essential when using a wrist cuff device to ensure accurate readings.

Prior to taking BP measurements patient should:
* Wait 30 or more minutes after smoking, exercising, consuming a meal, and drinking caffeine.
* Empty the bladder
* Sit comfortably in a quite area without distractions.

Question 8

How do you position a wrist bp monitor?

Answer 8

1. Wrap the cuff around your wrist
2. Place your elbow on the flat surface
3. Bend your forearm up with your wrist at the level of your heart
4. Keep your arm relaxed and hand resting against your body.
5. Do not move your arm until the measurements are complete.

Question 9

How do you position an upper arm BP monitor?

Answer 9

1. Keep your back supported
2. Keep feet flat on the floor
3. Sit with legs uncrossed
4. Keep arm supported, palm up, with muscles relaxed.
5. Position arm so cuff is at heart level
6. Put cuff on bare arm, above elbow at mid-arm

Question 10

Describe the characteristics of Pulse Oximeters.

Answer 10

Definition: a device that is placed on a fingertip and is used to estimate the oxygen saturation of the blood and pulse rate by using a light beam.

Limitations and risk of inaccuracy can result from:
* Poor circulation, skin pigmentation, skin thickness, tobacco use, and fingernail polish

Best practices:
* Ensure hand is warm and relaxed and located below the level of rhe heart
* Limit movement of where pulse oximeter is located
* Do not remove device until reading stops changing for a few second and displays one steady number.

Question 11

Describe the characteristics of OTC thermometers.

Answer 11

Types

Contact:
* Oral, tympanic, rectal, and topical
* MOA: determines temperature by direct contact with skin, ear, mouth, or anus,

Non-contact:
* MOA: uses an infrared beam to measure temperature
* Not as accurate as contact thermometers due to environmental factors like sunlight

Ensuring accurate temperature results:
* Wait over an our after heavy exercise or taking a hot bath
* Wait 20 to 30 minutes after eating, drinking, or smoking

Question 12

What are types of at-home tests?

Answer 12

General Wellness:
* Thyroid
* FIT Colon Cancer Screening
* Lyme Disease
* Indoor and Outdoors Allergy

Nutritional Health
* Food Sensitivity
* Food Allergy
* Metabolism
* Celiac Disease
* Vitamin D and Inflammation

Sexual Health
* STD
* Chlamydia and Gonorrhea
* HPV- Female
* Syphilis
* HIV
* Trichomoniasis
* Hepatitis C

Women’s Health
* 11 key biomarkers
* Fertility
* Perimenopause
* Post menopause

Men’s Health
* Testosterone
* 4 key biomarkers: DHEA, Estradiol, Free Testosterone

Heart Health:
* Cholesterol and Lipids
* HbA1c

Question 13

Describe cholesterol and lipid tests.

Answer 13

Tests screen for:
* Total cholesterol, calculated LDL, HDL, and triglycerides

Collection
* Finger prick sample

Who should get screened?
* Those with risk factors of heart disease
* Elevated blood sugar, sedentary lifestyle, obesity, family/personal history.

Question 14

Describe a Hep C test.

Answer 14

Tests check for:
* Exposure to Hep C virus

Collection:
* Finger prick sample

Who should get tested?
* Individuals who are current or former injection drug users, dialysis patients, HIV positive, have undergone body modification without sterile instruments, received a blood transfusion or organ donation before 1992, or recieved clotting factor replacement therapy prior to 1987.

Question 15

Describe the characteristics of a pregnancy test.

Answer 15

• A pregnancy test measures the human chorionic gondadotropin levels via. female’s urine.
• hCG is a hormone produced by the placenta when one is pregnant.

How to use:
* Hold test in urine steam or collect in urine cup and dip the test strip into the cup
* Most test produce a colored line, but will depend on the brand puchased.
* Test usually take approximately 5 minutes.
* It is recommended to test 1 to 2 weeks after your missed period.
* Depends on adherence to instructions and interpretation of results.

Question 16

Describe the characteristics of an ovulation test.

Answer 16

• Measures ovulation lutenizing hormone (LH) and Estrogen (via E3G) levels via a female’s urine.
• LH is a hormone produced by the pituitary gland. E3G is prodiced when estrogen is broken down and accumulates in urine around the time of ovulations.

How to use:
* Hold test in urine stream or collect in urine cup and dip the test trip into cup.
* Most test produce a colored line, but will depend on the brand. Test usually takes around 5 mins.

When to test?
* Kits come with multiple tests to measure over several days to assist patient with finding their most fertile period.

Test accuracy:
* Depends on adherence to instructions, but if done correctly test can detect LH and E3G 9 out of 10 times.

Question 17

Describe the characteristics of a COVID-19 Antigen Test.

Answer 17

• The presence of nucleocapsid protein antigen from SARS-CoV-2 is measured in the COVID-19 Antigen Test.
• Individuals greater than or equal to 15 years of age years of age and those 2 years or older when samples are collected by an adult.

Symptomatic testing:
* For those with COVID-19 symptoms within 7 days of symptoms onset.
* Requires 2 tests over 3 days, which is greater than or equal to 48 hours between tests

Asymptomatic testing:
* For those without symptoms or suspicion of COVID-19 infection
* Requires 3 tests over 5 days, with over 48 hours between tests.

How to use:
* Prepare test kit and solution–> wash hands and lay out all materials. Open test card and add 6 drops of liquid solution to top hole.

Collect the sample:
* Swab inside of both nostrils, circling each nostrol with swab at least 5 mins
* Insert swab into bottom hole of test card and rotate 3 times.

Close the Test Card:
* Fold test card over, sealing the swab inside
* Wait for 15 minutes, then read the results

Results:
* Positive= two line present
* Negative= one line in the control window
* Invalid= no lines or only one in the sample window (repeat test)

Question 18

COVID-19/Flu A&B 3-in-1 Rapid Test

Answer 18

• Presence of influenza A, influenza B, and/or SARS-coV-2 viral antigens/proteins

Indication:
* Individuals greater than or equal to 14 years of age or those greater than two years with an adult collected anterior nasal swab specimen.
* Only authorized for use in those with signs and symptoms of respiratory infection.
* Must test within first four day of symptoms onset when tested at least twice over three-day period with a greater than or equal to 48 hour period between tests.

How to use:
* Steps: swab, mix, drip, and wait
* Test: usually takes approximately 15 minutes to complete

Results:
* If control line is NOT visible after 15 minutes- the test has failed and should be considers invalid.
* If control line is visible and you do not see line at ‘A’, ‘B’, or ‘T’ means the result is negative.
* If control line is visible and any other single line or multiple lines on ‘A’, ‘B’, and/or ‘T’ appear, then the result is positive.

Question 19

Describe nebulizers.

Answer 19

Definition: A small machine that delivers liquid medicine into an inhalable mist/aerosol. Powered by an air compressor that plug into an electrical outlet.

Additonal supplies needed:
* Air compressor
* Mouthpiece or face mask

Types of Nebulizers:
* Jet nebulizer- uses compressed air to transform medication into a fine mist
* Mesh nebulizers- create a fine mist by passing medication through small mesh screen.
* Ultrasonic nebulizer- uses high frequency vibrations to generate a mist (slightly larger droplets than others).

How to use:
1. Wash hands
2. Connect hose to air compressor
3. Fill medicine cup and secure it tightly
4. Attach hose to the mouthpiece and medicine cup
5. Turn nebulizer on
6. Place mouthpiece or facemask
7. Breathe through your mouth until all the medication is used– typically takes between 5-20 mins to complete treatment
8. Turn off machine when finished
9. Clean medicine cup and mouthpiece/facemask, then air dry.

Caring for the device:
* After each use: wash the medicine cup and mouthpiece/facemask with warm water and air dry or clean paper towel
* Run air through machine for 20 seconds to ensure all parts are dry
* Once daily, include mild dish soap in the cleaning routine above.
* Once to twice weekly: (1) Add a step to the above to allow for a soaking period, (2) Soak the medicine cup and mouthpiece/facemask in 1-to-2 part ratio of distilled white vinegar to warm water ratio.

May clean outside device with warm, damp cloth as necessary. Never clean the tubing or the hose. The instructions will indicate the frequency of filter changes.

Question 20

Describe the Primatene MIST

Answer 20

• Only FDA-approved, OTC Asthma Medicine Inhaler–> AI: Epinephrine 0.125 mg/spray
• Indication: Temporary relief of mild intermittent asthma symptomms, such as wheezing, tightness of chest, shortness of breath.
• Seek medical attention if: (1) Symptoms do not improve within 20 minutes of use, (2) Symptoms worsen or if greater than 8 inhalations are needed in 24 hours, (3) greater than 2 asthma attacks occur weekly.
• Who should not use: (1) those not diagnosed with asthma. (2) If taking a monoamine oxidase inhibitor or have discontinued one within 2 weeks.
• Who should be referred: History of asthma hospitalization, heart disease, hypertension, diabetes, thyroid disease, glaucoma or seizures.
• Potential risks: Increased heart rate and blood pressure
• Stop use and contact provider if: asthma symptoms worsen OR rapid heartbeat, tremors, nervousness or seizures occur.
• Directions for use:
• Do not use more than 8 inhalations in 24 hours
• Wait 1 minute or longer between inhalations.

Question 21

Describe the Peak Flow Meter.

Answer 21

It is a portable hand-held device that meaures that lungs’ ability to push air out

Types of ranges:
* Low range= used for small children
* Standard range= older children, teenagers and adults

Manual and digital peak flow meters available.

Which conditions can this device help manage?
* Moderate to severe asthma
* Chronic bronchitis and emphysema

Normal peak flow meter readings determined according to:
* Age, height, sex

Traffic light system to assess and manage peak flow rates for asthma:
* Green zone: asthma is well-controlled, with readings between 80% and 100% of an individuals personal best reading.
* Yellow Zone: asthma control is declining, or a patient’s symproms are worsening, with readings between 50% to 80% or their personal best
* Red Zone: severe asthma situation, with peak flow readings falling below 50% of the patient’s best reading.

When should a person seek help medically?
* Yellow or red–> needs rescue inhaler immediately
* Red zone–> emergency care might be needed.

Proper cleaning:
* Use mild detergent and hot water
* To prevent dirt collection and germ/mucus build up.

Question 22

Describe the components of OTC Hearing Aids.

Answer 22

MOA:
* Amplify sounds

Indications and Accessibility:
* Adults > 18 year of age
* Individuals with mild to moderate hearing loss
* No prescription or hearing exam required

Benefits:
* Lower cost than prescription hearing aids
* Increased access for individuals who delay seeking professional help for hearing issues

Limitations:
* Not suitable for children and individuals with more complex hearing conditions
* Cost can be a limitation for some

When should a patient be referred to an audiologist or ENT specialist?
* Misshapen ear (from birth or due to trauma)
* Ear drainage within the last 90 days
* Sudden or rapidly worsening hearing loss within 90 days
* Dizziness (recent or long-term)
* Hearing loss in one ear or recent onset of hearing loss
* Excessive earwax buildup or foreign object in ear
* Pain or discomfort in the ear
* Note: if any of these symptoms develop after using OTC hearing aids, a referral should also be made

Question 23

Describe the Interprofessional Advanced Training Program.

Answer 23

A three hour competency-based, interprofessional advanced training program on over-the counter (OTC) hearing aids developed by University of Pittsburgh faculty is suited for both pharmacists and student pharmacists. The self-paced eLearning program will review epidemiology of hearing loss, laws, and regulations related to OTC hearing aids, and the pharmacists’ OTC hearing aid patient care process. At the end of this training, pharmacists will disvocer how to recognize, intervene, and refer patients with hearing loss to hearing health care.

Question 24

What is durable medical equipment (DME)?

Answer 24

Medical equipment that is…
1. Durable
2. Used for medical reasons
3. Commonly useful for those who are sick or injured
4. Used in a patient’s home
5. Expected to last longer than 3 years.

Examples:
* Blood sugar meters
* Blood sugar test strips
* Canes
* Commode chairs
* Crutches
* Walkers
* Wheelchairs and Scooters
* Nebulizer
* Transcutaneous Electronic Nerve Stimulation (TENS)

Question 25

Describe the components of crutches.

Answer 25

Purpose:
* Provide mobility support for individuals with injuries or disability affecting leg weight-bearing

Types:
* Underarm: lightweight and made of aluminum, these crutches offer adjustable height and cushioned handgrips
* Bariatric: designed to support up to 500 pounds, these heavy-duty crutches are made of steel and feature adjustable height for individuals needing more strength and durability
* Folding: compact and foldable, making them ideal for travel; are height adjustable and easy to store when not in use
* Forearm: ergonomically designed, lightweight crutches that distribute weight to the forearms, reducing hand strain and offer better long-term comfort

Question 26

Describe the components of canes.

Answer 26

Reason for use:
* Pain or arthritis, especially in hips and knees on one side
* Mild balance issues
* Foot or leg injuries on one side

Support provide:
* Up to 25% of an individual’s body weight

Considerations:
* All canes should have non-slip rubber tip for safety
* Handles should be curved, rounded or grips to improve balance and reduce hand strain
* Cane offer less stability compared to walkers

Question 27

Describe the components of walkers.

Answer 27

Reason for use:
* Pain or arthritis, especially in hips and knees on both sides
* Moderate balance and gait issues
* Weakness in legs

Support provide:
* Up to at least 50% of an individual’s body weight

Considerations:
* Front-wheeled walkers must have nonskid tips on the rear legs for safety
* Rolling walkers tend to weight more, ranging from 15-20 lbs., making them less convenient for travel
* Walkers most effective on flat surfaces and less suitable for uneven terrain

Question 28

What are the components of Transcutaneous Electronic Nerve Stimulation?

Answer 28

TENS is a small device that delivers an electronic current at or near the nerves to prevent or modify a patient’s perception of pain

MOA:
* Battery-powered device
* Uses electrodes to transmit electrical impulses through the skin’s surface

Treatment for:
* Back pain, diabetes-related neuropathy, peripheral artery disease (PAD), tendinitis, bursitis, osteoarthritis, fibromyalgia, osteoarthritis, fibromyalgia

Who should NOT use TENS units?
* If patient is pregnancy
* Has an implantable device (e.g. pacemaker)
* Cancer
* Epilepsy
* Deep vein thrombosis
* Heart disease

TENS units are generally safe, but patient should contact their healthcare provider if patient:
* Develops a skin rash
* Skin becomes itchy
* Experiences dizziness, headaches or nausea

Benefits of TENS units:
* Noninvasive
* Small and portable device
* Effectively relieves pain for many people
* Can use alone or in combination with pain relievers.

Question 29

Describe the characteristics of Compression Stockings.

Answer 29

How do they work?
* Improve blood flow by gently squeezing legs which helps move blood upward

Benefits include providing relief from:
* Aching or heavy legs
* Leg swelling
* Prevention of blood clots when less active or post surgery/injury

Pressure exerted by compression stockings are measured in millimeters of mercury (mmHg):
* Mild compression: rating of 8 to 15 mmHg
* Moderate compression: rating of 15-20 mmHg
* Firm compression: rating of 20-30 mmHg

Graduated compression: firmness gradually increased towards ankle

Uniform compression: consistent pressure across leg and commonly used during exercise