CHAPTER 5 - REGULATIONS AND STANDARDS

Voluntary standards

Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these.

* Regulations and voluntary standards may include disinfection and sterilization practices. These standards and regulations may be helpful in pre-purchase product evaluation.

* By careful compliance with statutes, regulations and voluntary standards, patient safety is at its highest level of quality of care.

CS professionals are affected by statutes, regulations and voluntary standards, and they must be familiar w/ applicable regulations & statutes for the following reasons:

* Statutes & regulations must be followed and failure to comply with them may result in legal consequences to the healthcare facility; * Regulations and voluntary standards may include workplace safety issues, which may help protect CS professionals from exposure to infectious agents and toxic substances;

Regulatory standards

A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties.

Medicaid

A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines.

Medicare

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

Best practice

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

Medwatch

A safety information & adverse event reporting system that serves healthcare professional and the public by reporting serious problems suspected to be associated with the drugs & medical devices they prescribe, dispense or use.

Standard

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

Statute

A written law adopted by a legislative body that governs a city, county, state or country.

Greenhouse gases

Any of the gases that absorb solar radiation are responsible for the greenhouse effect, including carbon dioxide, methane, ozone and fluorocarbons.

Technical Information Reports (TIR's)

Reports developed by experts in the field that contain valuable information needed by the healthcare industry. TIRs have not undergone the formal approval system that standards are submitted to and may need further evaluation by experts. TIR may be advised or withdrawn at any time because they address a rapidly-evolving field or technology.

Regulation

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

Health Insurance Portability and Accountability Act (HIPAA)

The HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates, and gives patients an array of rights with respect to that information. hhs.gov

Standards (AAMI)

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

VOLUNTARY STANDARDS

are strongly suggested for better patient care, but are not mandated with legal consequences for non-compliance.

REGULATIONS AND STATUTES

are laws that must be followed. Statutes are created by legislative bodies or by the electorate. Regulations are rules issued by governmental administrative agencies. Violations of statutes and regulations may have legal penalties.

REGULATORY STANDARDS

are those with requirements imposed by government agencies. These standards can yield legal penalties if not followed.

(EPA) U.S. ENVIRONMENTAL PROTECTION AGENCY

created as a regulatory agency in 1970 for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress. The EPA is responsible for minimizing greenhouse gases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing pesticide regulation.

FDA - US Food and Drug Administration continued

devices, also regulates the sterilants & high-level disinfectants (HLDs) used to process critical and semi-critical devices. Prior to marketing these chemicals, rigorous testing a broad range of microorganisms is required along with packaging materials, sterilizers & quality monitors, such as biological indicators, are regulated by the FDA.

(CDC) CENTER for DISEASE CONTROL and PREVENTION

is a federal agency organized within the US Dept of Health & Human Services. It works to promote health and quality of life by preventing and controlling disease, injury and disability, and by responding to health emergencies.

(DOT) U.S. DEPARTMENT OF TRANSPORTATION

is a federal government agency dedicated to ensuring a fast, safe, and efficient transportation system. Laws relating to healthcare include those concerning the transportation of minimally-processed instrumentation for repair, reprocessing and the transportation of hazardous and radioactive wastes. The DOT inspects and cities organizations for statute violations.

FDA - U.S. Food and Drug Administration

is the federal agency responsible for ensuring that foods, cosmetics, human/veterinary drugs, biological products, medical devices, and electronics products that emit radiation are safe & effective for public use, also functions within the Public Health Service of the US DHS. FDA regulates the manufacture of all medical devices & requires pre-market clearance of new medical

MEDICAL DEVICE CLASSIFICATION

the level of regulation placed on any device depends upon how the FDA classifies that device:

Class 11 Devices

these are devices considered to pose potential risks great enough to warrant a higher level of regulation. Class 11 devices include most types of sterilization equipment, biological/chemical indicators. Manufacturers are required to submit a pre-market notification application 510(k) before they can sell their these products.

Class 111 Devices

these are the most stringently regulated devices and include heart valves, pacemakers, and other life-sustaining devices. Manufacturers of new Class 111 devices must obtain a pre-market approval (PMA) from the FDA to demonstrate product safety and efficacy.

Class 1 Devices

these include low-risk devices, such as most hand-held surgical instruments and ultrasonic cleaners. include registration and device listing, medical device reporting, and quality system regulation and labeling. Most Class 1 devices are exempt from a pre-market notification approval.

PRE- & POSTMARKET REQUIREMENTS

unless a device is listed as exempt from regulation, a 510(k) submission is required for class 1 and 11 devices. Class 111 devices may required either a 510(k) or a PMA. A 510(k) application is a comprehensive package of information designed to demonstrate that the new product is "substantially equivalent to one or more medical devices already being marketed.