IHS 3400 Midterm Flashcards

Types of medical settings

1. ASC (Ambulatory Surgery Center): A modern healthcare facility where patients receive same-day surgical care. They don’t need an overnight hospital stay. It is designed to be less complex, minimally invasive, and low risk, allowing for faster recovery and lower costs.

2. Hospital Inpatient

3. Hospital Outpatient

4. Health Systems

Inpatient Vs. Outpatient

Review and memorize the chart.

Benefits of minimally invasiveness

• There is reduced trauma to the body

• Faster recovery times

• Lower risk of complications

• Less pain and discomfort

• Improved cosmetic outcomes

• Cost-effectiveness: This is due to shorter hospital stays, fewer complications, reduced need for follow-up care.

• The longer a surgery continues there is an increase in risk. For every 15 minutes there is a 13% increased risk, every 30 minutes 17% increase, every 60 minutes 37% increase.

Importance of administrators

They ensure that the entire system runs smoothly, efficiently, and ethically. Administrators manage the day-to-day operations of hospitals, clinics, and health systems. They manage the finances, ensure there is regulatory compliance and risk management, perform strategic planning and innovation, coordinate disaster preparedness, and manage crisis and emergency responses. 

What device is this?

Speed Bridge

Arthrex mission

Helping surgeons treat their patients better.

Medical Education

Benefits of the 3D CADaver:

• Consistent anatomy

• Pathology replication

• Help alleviate the lack of cadaver supplies

• Ensure the safety of nearby ongoers since cadavers undergo continuous x-ray and this causes x-ray radiation exposure to those not protected, so using the 3D CADavers improved the safety of others. 

• Cost-effective

510(k)

510(k):

• A premarket notification.

• You need to have a predicate device to get a 510(k). A predicate device is a device that is already marketed in the US and can use that comparison for the new device.

• You must provide proof that your device is substantially equivalent to the predicate device. Meaning it must have the same intended use and have similar technology.

• If the device wasn’t substantially equivalent, then the device would be placed in the class 3 category. If it was substantially equivalent, then the device would have the same class as the predicate.

• For a 510(k) it usually takes the FDA 90 days to approve/deny the 510(k).

FDA

• Food and Drug Administration

  • They regulate products like food, drugs, medical devices, vaccines and biologics, cosmetics, tobacco products, and dietary supplements.

Design/Quality/Regulation Phase

• Phase 1: Concept

  • What problem/need are we trying to solve?

• Phase 2: Planning

  • Where, when, how, with whom?

• Phase 3: Design

  • Which inputs will lead to the desired outputs?

• Phase 4: Validation

  • Are we sure?

• Phase 5: Launch

  • Do we consistently provide high-quality products?

• Phase 6: Post-market 

  • How do we monitor issues and trends?

Anatomical direction terms

• Directional Terms in Anatomy

  • Superior

  • Inferior

  • Posterior

  • Anterior

  • Lateral

  • Medial

  • Median Sagittal Plane

  • Transverse plane

  • Coronal (Frontal Plane)

  • Sagittal Plane

  • Supine

  • Prone

  • Dorsal Surface

  • Plantar Surface

  • Volar

  • Dorsal

  • Proximal 

  • Distal

  • Adduction

  • Abduction

  • Eversion

  • Inversion

  • Flexion

  • Extension

  • Supination

  • Pronation

  • Extension

  • Hyperextension

  • Flexion (Hand)

  • Dosiflexion 

  • Plantarflexion

  • Rotation

  • Circumduction

  • Protraction

  • Retraction

  • Elevation

  • Depression

Name the bones of the shoulder

1. Humerus

2. Scapula

3. Clavicle

4. Glenoid

5. Acromion

6. Humeral head

7. coracoid

How many teams are there in ortho research and what are they?

1. Operations

2. Clinical

3. Biomaterials

4. Biomechanics

HCP

Health care providers

ASC

Ambulatory surgery center

• A modern healthcare facility where patients receive same-day surgical care. They do not need an overnight hospital stay. ASC are designed to be less complex, minimally invasive, and low-risk, allowing for faster recovery and lower costs. 

  • Relationship tiers:

    • Strategic partner: long-term relationship, the most far-reaching, the best of the best.

    • Preferred supplies: strong relationship, earns the right to seeling opportunities because of performance and capabilities.

    • Approved supplier: seen as a transactional vendor, not emotionally connected, fundamental lack of respect and appreciation of value delivered.

Class categories

• Class I General Instruments

  • Exempt from FDA submission

  • Ex. Saw blades, scalpel

  • 74% of the device are exempt from doing a premarket notification process. 

• Class II 

  • Typically requires a 510(k)

  • Ex. Rods, screws, suture, bone anchors, PRP devices

• Class III (PMA or BLA)

  • Clinical data required

  • Ex. Synojoyny-hyaluronic acid 

  • A premarket approval (PMA) will be required unless there is already a similar device on the market that hasn’t been called for. If that happens, then that device will do a 510k instead. 

    • For a PMA it usually takes 180-320 days for the FDA to approve. 

    • For a PMA, the benefits of the device must outweigh the cons, the device can’t rely on another device so it has to be independent, and it must benefit a vast majority of the target audience.

Clinical research history and ethics

1947: Nuremberg Code- It was made in response to atrocities committed to prisoners by Nazis. The foundation of research is to protect the subjects’ rights in medical research. 

1964: Declaration of Helsinki- Patient’s health is always the doctor’s first consideration. Key element introduced: protection of vulnerable groups.

1976: Medical Device Amendments- Provided reasonable assurance of the safety and effectiveness of medical devices before they get to the market. Established 2 pathways for devices:  PMA and 510(k).

1979: Belmont Report- Basic ethical principals for conducting research that involves human subjects. Written in response to the infamous tuskegee syphilis study. 

1980: Investigational Device Exemption- Allows investigational device to be used to collect safety data and effectiveness data. 

What device is this?

Tightrope

What device is this?

Suture tape

What device is this?

Scorpion

What device is this?

Swivelock anchors

Joints of shoulder

Joints:

• Glenohumeral joint (ball & socket)

• Acromioclavicular joint (plane joint)

• sternoclavicular joint (saddle joint)

Orthopedic research

Technology Consultants

What does a tech consultant do? 

Use evidence based info to educate customers on the safe and effective use of our products and procedures and challenge their way of delivering value through improved treatment and patient outcomes. They inspire the adaptation of new tech to help surgeons treat their patients better” -Reinhold Schmieding

Legal Process

Patents and patient law

QARA

Quality Assurance and Regulatory Affairs

Product Lifecycle

• Risk increases as the product moves through the phases

• Processes at all phases must be defined and documented

• Results of studies must be recorded and reported

• The company is responsible for its vendors and service providers.

• QARA involved in process and product at each phase to ensure that all external and internal requirements are met, helping drive safety, reliability, repeatable outcomes, and continuous improvement.

Phase 1: Concept

Phase 2: Planning

Phase 3: Design

Phase 4: Validation

Phase 5: Launch

Phase 6: Post-market

Quality- All phases

Create a device that can be a solution to an issue from America or worldwide. The challenge/injury/disease can be anything, as long as you describe it in detail of what the challenge is and what the solution/goal is.

Purpose of Quality organization

to implement and maintain systems that ensure reliable, repeatable production for the integrity and preservation of the safety, identity, strength, purity, potency, and quality of the product for its intended use and throughout its useful life.

Purpose of regulatory affairs

to act as an internal and external liaison in order to facilitate the process at all stages of the regulated product lifecycle.

Internally, RA liasises at the interphase of R&D, clinical research, manufacturing, and marketing

Externally: it is the key interface between the compay and the regulatory authorities.