Regulatory Environment

Part
01
of two
Part
01

Healthcare Biohazard Waste Management Regulatory Environment

The Environmental Protection Agency (EPA) is the primary regulating agency for federal programs for proper handling and disposal of any type of waste that may impact human health or the environment. The Food and Drug Administration (FDA) regulates the manufacturing of sharps containers. The Occupational Safety and Health Administration (OSHA) regulates the handling of medical waste by healthcare employees to assure their safety. The Department of Transportation (DOT) oversees regulations for the sorting, packaging, and transportation of biohazard wastes. Individual states have primary authority over how biohazard waste is handled and disposed.

TO WHAT SPECIFIC REGULATIONS DO HEALTHCARE FACILITIES AND/OR THE VENDORS THAT SERVICE THESE FACILITIES ADHERE TO

  • The OSHA operates through 24 separate state programs and monitors biohazard waste disposal, including sharp medical equipment, standards for biohazard waste containers, proper labeling, and education/training for medical field employees to maintain a safe environment for healthcare workers. This protects medical employees and consumers from “the risk of exposure to blood borne pathogens.”
  • There are state regulations that govern the proper “packaging, storage, and transportation of medical waste.” Individual states regulate whether medical facilities must be permitted and registered to handle biohazard wastes. These may include required contingency plans, methods for the treatment and sterilization of on-site waste, adequate biohazard training for employees, and administrative waste record-keeping with reporting methods to government authorities.
  • The US Environmental Protection Agency (EPA) imposes regulations over allowable emissions from medical facilities with biohazard waste products, including waste Incinerators. The EPA also enforces the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which governs biohazard waste treatment facilities that utilize treatment technology and/or waste treatment chemicals.
  • Due to serious liabilities and dangers associated with shipping biohazard waste from medical facilities, the DOT oversees and regulates healthcare waste shipments from medical sites to disposal areas.

GOVERNING BODIES THAT OVERSEE THESE REGULATIONS

  • Numerous other government agencies also enforce laws that concern biohazard waste disposal, including OSHA, the Centers for Disease Control (CDC), the FDA, the DOT, and also the Drug Enforcement Administration (DEA).
  • Some departments of health in individual US states also regulate biohazard waste disposal, including Missouri and Oklahoma, and in states such as Colorado, the state department of health serves as the primary authority.
  • State medical waste regulations are all governed by the federal Resource Conservation and Recovery Act (RCRA).
  • The OSHA is the primary governing body that regulates medical waste handling standards, ensuring healthcare employee safety.
  • While the DOT monitors how biohazard waste is handled during road-based shipping, the United States Postal Service (USPS) also plays a role in regulating medical waste shipped by mail.
  • The EPA also serves to regulate medical waste handling procedures that may affect the environment and/or human health.

HOW OFTEN THESE FACILITIES INSPECTED

  • Environmental Health and Safety (EHS) at Weill Cornell Medicine (WCM) provides biohazard waste disposal tracking and documentation for at least two years.
  • Medical waste disposal documentation is required to be kept for Environmental Health and Safety (EHS) inspection that occurs every two years.
  • Hospitals in the United States produce approximately 5.9 million tons of hazardous medical wastes each year. This amounts to nearly 33 pounds of biohazard waste relative to each staffed hospital bed per day.

REGULATIONS SURROUNDING THESE INDUSTRIES

  • The EPA has increased penalties in recent years for improper medical waste disposal, enforcing cooperation with the RCRA.
  • It is predicted that further rules and regulations are to be implemented by government agencies for adequate disposal of biohazard waste, expected to improve medical waste management during forecasted healthcare market growth.
Part
02
of two
Part
02

Preventative Healthcare Equipment Maintenance Regulatory Environment

The regulations that healthcare facilities and/or the vendors that service these facilities have to adhere to include Medical Device Reporting (MDR), Quality System (QS) regulation 21 CFR Part 820, and Medical Equipment Standards. The governing bodies that oversee these regulations are the Food and Drug Administration (FDA), which inspect facilities every 2 years; The Center for Devices and Radiological Health (CDRH); and Joint Commission, which inspects facilities every 3 years (labs every 2 years).

Preventative Healthcare Equipment Maintenance Regulatory Environment

1) Regulations that healthcare facilities have to adhere to
2) The governing bodies that oversee these regulations
  • The Food and Drug Administration (FDA): They are responsible for the regulation of medical devices with an aim to ensure safety and effectiveness of the devices.
  • The Center for Devices and Radiological Health (CDRH) is an FDA component and is designed to oversee the device program led by the regulating body.
  • The Joint Commission: Their aim is to "continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value."
3) Frequency of inspections
  • The Joint Commission inspects facilities every 3 years (labs every 2 years).
  • The Food and Drug Administration (FDA) expects facilities every 2 years.
4) Changes in regulations
  • The FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices.
  • This regulation became effective on December 18, 1978, and was codified under part 820.
  • In 1990, the FDA undertook the start of the revision of the CGMP regulation to add the design controls authorized by the Safe Medical Devices Act.
  • The CGMP regulation was made to be consistent with the International Organization for Standards (ISO) 9001, the part 820 revision was published on October 7, 1996 (61 FR 52602).
  • In 2017, the Congress tasked the FDA to address the issue of device services.
  • In 2019, the FDA held a public workshop for medical device servicing and remanufacturing.
Sources
Sources

From Part 01
Quotes
  • " In response, Congress enacted the Medical Waste Tracking Act (MWTA), which required EPA to create a two-year medical waste demonstration program."
  • "The regulations promulgated under the MWTA expired on June 21, 1999."
  • "State Medical Waste Regulations. Nearly all 50 states have enacted medical waste regulations to some extent. However, unlike state hazardous waste regulations, which are all based on the federal RCRA standards, state medical waste standards vary diversely. Some state medical waste rules are fashioned after the Medical Waste Tracking Act, while others have little or no resemblance to this historical law."
Quotes
  • "Several federal bodies maintain laws concerning medical waste. These include the Occupational Safety and Health Administration (OSHA), the Centers for Disease Control (CDC), the U.S. Food and Drug Administration (FDA), the Department of Transportation (DOT), and the Drug Enforcement Administration (DEA)."
  • "Healthcare waste is regulated by the DOT, EPA, OSHA, and the DEA. "
Quotes
  • "FDA regulates the manufacturing of sharps containers. OSHA regulates the handling of medical waste by employees to assure their safety. USPS regulates how regulated medical waste is shipped through the mail. DOT regulates how regulated medical waste is shipped over the road. Finally, states regulate the disposal of regulated medical waste."
Quotes
  • "The Environmental Protection Agency (EPA) - the primary regulating agency for federal programs for proper handling and disposal of any type of waste that may impact human health or the environment "
  • "The Drug Enforcement Agency (DEA) - stipulates regulations regarding the handling and disposal of controlled substances."
  • "The US Food and Drug Administration (FDA) - suggests guidelines regarding the disposal of unused medications."
  • "The Occupational Safety and Health Administration (OSHA) - identifies regulations regarding handling of blood borne pathogens, worker safety, and handling and labeling of wastes in all healthcare scenarios."
  • "Department of Transportation (DOT) - oversees regulations for the sorting, packaging, as well as transportation of wastes."
Quotes
  • "All records must be kept for inspection for 2 years. "
Quotes
  • "GENERATOR CATEGORY WEIGHT PER YEAR (LBS) INSPECTION FREQUENCY 1 Less than 50 Every 5-7 years 2 50-200 Every 3-5 years 3 200-300 Every 2 years 4 300-1000 Every year 5 Greater than 1000 Twice per year "