Chapter 6- regulations and standards

Regulations and Standards

Regulation

Rules issued by administrative agencies that have the force of law.

Standard

A uniform method of defining basic parameters for processes, products, services and measurements.

Best Practice

A method or technique that has consistently shown results superior to those achieved by other means

Premarket approval (PMA)

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of class III medical devices.

Serious Injury

An injury or illness that is life threatening, resulting in permanent impairment of a bodily function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body structure.

MedWatch

The U.S. Food and Drug Administration’s safety information and unfortunate event reporting system that reports serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense or use.

Medicare

A federal medical insurance program that primarily serves those older than 65 years (regardless of income), people under 65 with certain disabilities and people of all ages with end-stage renal disease.

Medicaid

A federal and state assistance program that pays covered medical expenses for low-income individuals.

• H-Health

• I-Insurance

• P-Portability

• A-Accountability

• A-Act

The HIPAA privacy rule provides federal protections for individually identifiable health information held by covered entities and their businesses associates and gives patients an array of rights with respect to that information.

• PRIVACY RULE

• FEDERAL PROTECTION FOR INDIVIDUAL HEALTH INFORMATION

Standards (AAMI)

Voluntary guidelines representing a like-mindedness of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use.

Technical Information Reports (TIRS)

Reports developed by experts in the field that contain valuable information needed by the healthcare industry.

(Workbook) The agency may intervene in a matter of worker protection, even if there are no specific regulations covering the situations

Occupational Safety and Health Administration (OSHA)

(Workbook) This agency develops and enforces chemical regulations

U.S. Environmental protection Agency (EPA)

(Workbook) This agency imposes very strict labeling requirements on manufacturers of disinfectants used by Sterile Processing departments (SPDs)

U.S. Environmental protection Agency (EPA)

(Workbook) Healthcare regulations and standards establish

Minimum levels of quality and safety

(Workbook) Chemical indicators (CIs) are classified as

FDA Class II medical devices

(Workbook) Heart valves and pacemakers are example of

FDA class III medical devices

(Workbook) Standards and regulations help set the SPD’s levels of

Quality and safety

(Workbook) Medical device reporting is regulated by the

FDA

(Workbook) The U.S. department of transportation (DOT) enforces statutes relating to the transportation of

clean and soiled instruments between facilities

• C-CENTERS

• D-FOR DISEASE

• C-CONTROL AND PREVENTION

A federal agency that promotes health and quality of life by preventing and controlling disease, injury and disability and by responding to health emergencies

• PROMOTES HEALTH AND QUALITY OF LIFE

• PREVENTS AND CONTROL DISEASES, INJURY, AND DISABILITY

• RESPONDS TO HEALTH EMERGENCIES

I - INTERNATIONAL

S - STANDARDIZATION

O - ORGANIZATION

a non-governmental, international organization that brings together experts to develop voluntary, consensus-based standards. Gives state of the art specifications for products, services, and good practices.

• INTERNATIONAL ORGANIZATION

• DEVELOPS VOLUNTARY CONSENSUS BASED STANDARDS

• GIVES ART SPECIFICATIONS FOR PRODUCTS, SERVICES, AND GOOD PRACTICES

F- U.S. FOOD

D- AND DRUG

A- ADMINISTRATION

Responsible for ensuring that medical devices are safe and effective for patient care. Regulates the manufacture of all medical devices. Also regulates sterilants, high-level disinfectants, packaging materials, sterilizers, and quality monitors such as biological indicators (BIs).

Responsible for medical device classification and recalls.

• ENSURES THAT MEDICAL DEVICES ARE SAFE AND EFFECTIVE

• REGULATES THE MANUFACTURE OF ALL MEDICAL DEVICES

• REGULATES STERILANTS, HLD, PACKAGING, STERILIZERS, AND QUALITY MONITORS

A- ASSOCIATION FOR

P- PROFESSIONALS IN

I- INFECTION

C- CONTROL AND EPIDEMIOLOGY

Voluntary organizations whose members work to prevent HAIs.

D- U.S. DEPARTMENT

O- OF

T- TRANSPORTATION

A federal government agency dedicated to ensuring a fast, safe and efficient transportation system.

Transportation of minimally processed instrumentation for repair or reprocessing and the transportation of hazardous and radioactive wastes.

When soiled instruments are transported, DOT regulations for labeling and packaging must be followed.

• FEDERAL AGENCY

• DEDICATED TO FAST AND SAFE TRANSPORTATION SYSTEM

• TRANSPORTS PROCESSED INSTRUMENTATION FOR REPAIR OR REPROCESSING

• TRANSPORTS HAZARDOUS AND RADIOACTIVE WASTES

• DOT REGULATIONS FOR LABELING AND PACKAGING MUST BE FOLLOWED

W- WORLD

H- HEALTH

O- ORGANIZATION

An agency that works to further international cooperation in improving health conditions. Promote general health of people worldwide.

1. PROMOTE GENERAL HEALTH WORLDWIDE

2. WORKS FOR INTERNATIONAL COOPERATION IMPROVING HEALTH CONDITIONS

O- OCCUPATIONAL

S- SAFETY

H- HEALTH

A- ADMINISTRATION

Protect workers from occupationally caused illnesses and injuries.

S-SOCIETY OF

G- GASTROENTEROLOGY

N-NURSES

A- ASSOCIATES

A nonprofit organization dedicated to the safe and effective practice of gastroenterology and endoscope nursing. Established standards for effective processing of flexible endoscopes.

• NONPROFIT ORGANIZATION

• SAFE AND EFFECTIVE PRACTICE OF GASTROENTEROLOGY AND ENDOSCOPE NURSING

• ESTABLISHED STANDARDS FOR EFFECTIVE PROCESSING OF FLEXIBLE ENDOSCOPES

A- ASSOCIATION FOR THE

A-ADVANCEMENT OF

M-MEDICAL

I-INSTRUMENTATION

A nonprofit voluntary shared opinion organization whose membership is comprised of healthcare technology professionals. Is considered one of the major resources for healthcare guidelines.

• NONPROFIT VOLUNTARY

• COMPRISED OF HEALTHCARE TECHNOLOGY PROFESSIONALS

• MAJOR RESOURCES FOR HEALTHCARE GUIDELINES

E- U.S. ENVIRONMENTAL

P- PROTECTION

A- AGENCY

Regulatory agency responsible for minimizing greenhouse gases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing chemical regulations.

1. RESPONSIBLE FOR MINIMIZING GREENHOUSE GASES

2. REGULATES THE REUSE OF SOLID WASTES

3. CONTROLS INDOOR AIR POLLUTION

4. ENFORCE CHEMICAL REGULATIONS

T- THE

J- JOINT

C- COMMISSION

A private, independent, nonprofit organization that develops standards for healthcare facilities. TJC evaluate healthcare organizations and programs in the U.S. by conducting on site-surveys at least every three years.

A- ASSOCIATION

O- OF PERIOPERATIVE

R- REGISTERED

N- NURSES

AN organization consisting of periOperative nurses and others who are dedicated to providing optimal care to the surgical patients. Develops nationally recognized guidelines for the perioperative setting.

U- UNITED

S- STATES

P- PHARMACOPEIA

N- NATIONAL

F- FORMULARY

Creates and revises standards for the purity of medicines, drug substances and dietary supplements.

A- AMERICAN

N- NATIONAL

S- STANDARDS

I- INSTITUTE

Enhances global competitiveness and quality of life by promoting standards and ensuring their integrity.

N- NATIONAL

F- FIRE

P- PROTECTION

A- ASSOCIATION

An organization that works to reduce the burden of fire and other hazards around the world. Develops codes and standards that influence building safety.

Class II: Less serious Risk

-Means there is a possibility that the product will cause a temporary or medically reversible adverse health problems, or there is a remote chance that the device will cause serious problems.

-The manufacturer must notify customers and sometimes ask them to inform the product’s recipients. Generally, neither the FDA nor the manufacturer issues a press release.

A-Accreditation

C-Commission for

H-Health

C-Center

ACHC

Under current regulations, who is required to report suspected medical device-related deaths to the FDA?

Healthcare facilities and Device manufacturers

[workbook] If soiled instruments are to be transported to an offsite facility for processing, they should be:

Transported following federal and state department of transportation (DOT) guidelines

[workbook] Which of the following items is NOT regulated by the FDA?

Detergents

[workbook] The (blank) writes standards relating to the processing of flexible endoscopes

Society of Gastroenterology Nurses and Associates (SGNA)

[workbook] Which of the following is NOT considered a professional association

FDA

[workbook] Voluntary standards developed by professional associations:

Are developed according to best practice

[workbook] An FDA Class 1 medical device recall:

Means high risk: there is a reasonable chance the product will cause serious health issue or even death

[workbook] Which of the following is a professional organization consisting of perioperative nurses and others who are dedicated to providing optimal care to the surgical patient?

AORN

A-American

S-Society of

H-Heating

R-Refrigerating

A-Air conditioning

E-Engineers

• Responsible for ANSI/ASHREA/ASHE standard 170, ventilation of Health Care Facilities.

• This standard identifies the operating parameters for healthcare heating, ventilation and air conditioning (HVAC) systems

H-Healthcare

S-Sterile

P-Processing

A-Association

HSPA