Biomaterials Standards and Organizations

Designed to describe the content, design, construction, and properties of existing devices.

Voluntary standards

Usually committee derived and set forth the test methods for conducting and interpreting a test of biomaterials or medical devices?

Voluntary standards

Criteria and rules that assure saftery and efficacy for a Class 2 med device?

Performance standards

What kin of standards are intended for FDA?

Performance standards

Describes the chemical, physical, and processing requirements needed to assure a favorable reproducible biological performace for a class 2 device?

Performance standards

Authority over medical devices and biomaterials of which these devices are made.

Regulatory standards

What are the 4 regularory authorities?

1. FDA cosmetic act

2. Medical device amendment

3. Safe med device act

4. FDA modernization act

What do regulatory standards assure?

that products meet standards that they are designed to achieve

Who do you apply for to get a clearance and approval for a med device?

FDA

FDA Regulatory Authority:

• Assure ________ and _______ of the device to protect the public

• _________ a drug/device by classifying the risk to the pt.

• ________ to assure no adulteration and company’s operations are in control.

• Publish performance standards for class ___ devices.

• Require permarket approval for class ___ devices.

• _______ _____ _____ regulation to report adverse effects

saftey and efficacy

classify

inspection

2

3

medical device reporting regulation

What happened in 1976?

Congress enacted the medical device amendmenets act to give FDA control over devices and provided 3 classes of devices

An instrument apparatus or implement machine intended for the use in diagnosis or treatment of disease and can affect body or man or other animals?

Device

Chemical mode of action?

Mechanical mode of action?

Drug

Device

Baby teething ring with water is what?

Class 2 intermediate risk med device

Accounts for 25% of all med devices and includes dental burs, tooth brush, denture adhesive, floss, bandages, handpiece, etc…

Class 1 med device.

Present the least risk to the pt

Class 1 med devices

Account for 65% of med devices and includes amalgam, dental implants, surgical instruments, catheters, contacts, etc…

Class 2 med devices

Present a moderate risk to the patient, may be life sustaining, but their performamce is known, so there is sufficent info to establish a performance standard to help assure saftey

Class 2 med device

Are class 2 devices new?

No!

Account for 10% of med devices and include any new devices such as TMJ prosthers, new implants, bone grafting, and is considered premarket approval.

Class 3 med device

Provide the most risk to patients.

Class 3 devices

Devices that are life sustaining, life supporting, implanted in the body, or those that are present a potenetial unreasonable risk to illness or injury and insufficent infomation exists

Class 3 med devices

A biomaterial that esposes a patient to no unwarrented or unexpected risk.

Saftey

Produces a significant palliative effect or alleviation of the patients condition it is used to treat or it it serves satisfactory during the med or surgical procedure which it is used

Efficacy

The ADA provifes certification and __________ programs.

acceptance

ADA standards are always submitted to what?

American national standards instituite to become national standards

The ADA is the offical US representative for what?

ISO technical committe

Concerned with dental workplace exposure to any hazards

OSHA

Documents drugs and other substances based on behavior and includes 8 host response tests

US Pharmacopeia (USP)

Establishes standards to ensure the quality of medicines for human and vet use and approriate info about medicines

Us Pharacopeia USP

Who is combined with USP and is the most recent lists of thousands of standards monographs?

National Formulary

All drugs of any demonstrated merit are publihsed in what?

National formulary

Sponsors the voluntary developemtn of standards on charcterisitcs and performance of materials, products, and systems

American society for testing and materials

What are the 3 sub committes of ASTM?

Specific materials

Biocompatibility issues

Medical specialty

What are the 2 standards for ASTM?

1. Definitions of terms and nomenclature

2. Standars for test methods, specifications, and performace for materials and devices

Will eventually supplant all national standards for biomaterials and med devices?

Interanational standards organization

ISO tC 150?

Implants for surgery

ISO TC 194?

Biolgocial measurement responses

Provides standards for dental devices and national standards?

ISO

Provides sources for bonding material?

USP

ADA seal of acceptance makes dental devices approved?

False

Sealants and amalgams are out of FDA authority?

False

Develops authoritive info about the appropriate use of medicines?

USP