MET 103- Safety regulations stuff

Thalidomide Tragedy

Thalidomide, a medication used to treat morning sickness, caused severe birth defects. This incident highlighted the need for stricter regulations on pharmaceuticals and medical devices. 1960s

Ralph Nader Expose: Danger in Our Hospitals

Played a crucial role in shedding light on safety issues within the healthcare system. Specifically, his focus on the danger of Micro-shock, a phenomenon involving small electric shocks, and the broader issue of unsafe hospitals spurred public awareness and discussions.

1970s

Medical Device Amendments

The U.S. Congress passed the Medical Device Amendments, part of the Food, Drug, and Cosmetic Act. This marked the first comprehensive regulatory framework for medical devices. 1976

What happened in medical device safety during 1960-1970

escalating concerns about medical device safety emerged, prompted by incidents such as the Thalidomide tragedy, media influences, leading to the introduction of the Medical Device Amendments in 1976 as an initial response to ensure comprehensive regulatory oversight. 

What happened in medical device safety during the 1980s

a wave of heightened awareness and advocacy swept through the healthcare landscape, driven by emerging concerns about medical device safety and fueled by unquestionable data, prompting critical examinations of existing regulatory frameworks and advocating for reforms to better safeguard patient well-being. 

Dalkon Shield (Intrauterine Device - IUD) Disaster

In the late 1970s and early 1980s, the Dalkon Shield, an intrauterine contraceptive device, became the center of controversy. It was associated with serious health risks, including infections and infertility in women. The device was eventually withdrawn from the market, and lawsuits followed.

MDR System

Medical Device Reporting: The Food and Drug Administration (FDA) implemented the Medical Device Reporting (MDR) system. This system was designed to collect and analyze information about adverse events and product malfunctions associated with medical devices.

FDA Medical Device Approval Process

Shaped the landscape of medical device regulation in the United States, emphasizing the importance of continuous oversight and responsiveness to emerging safety concerns throughout a device's lifecycle. 1986

Congressional Hearings for medical device safety

Congressional hearings were held to address concerns raised by Public and others about the safety of medical devices. Testimonies and investigations shed light on the need for regulatory improvements. 1989

What happened in medical device safety during the 1990s

In the critical period of 1989-1990, spurred by heightened awareness of healthcare safety concerns and influenced by advocacy efforts, legislative action took center stage as lawmakers responded to calls for regulatory enhancements, leading to the enactment of pivotal laws aimed at fortifying the oversight of medical devices and advancing patient safety. 

SMDA

Safe Medical Devices Act: In response to growing concerns about medical device safety over the years, congress passed the Safe Medical Devices Act. The SMDA aimed to strengthen the FDA's regulatory authority over medical devices, enhance post-market surveillance, and improve communication between manufacturers, healthcare facilities, and regulatory bodies. 1990

Implementation of SMDA Provisions

The SMDA provisions were implemented, including enhanced reporting requirements, increased FDA oversight, and improved mechanisms for tracking and monitoring medical device safety. 1991

SMDA and FDA authority

It represented a significant shift in regulatory focus from post-market surveillance to a more proactive approach to medical device safety.  

SMDA and “comprehensive regulatory oversight”

It aimed to address shortcomings in the existing regulatory framework and equip the FDA with enhanced tools to ensure the safety and effectiveness of medical devices. 

SMDA and mandatory device registration

mandated that device manufacturers register with the FDA.

This requirement aimed to create a systematic and centralized database of all medical devices in the market, allowing the FDA to have a clearer picture of the types of devices available and their respective manufacturers.

SMDA and “submission of adverse event reports and responsibilities”

One of the crucial provisions of the SMDA was the requirement for device manufacturers to submit reports on adverse events associated with their products. This mandatory reporting was designed to facilitate a proactive and systematic approach to monitoring the performance and safety of medical devices in real-world clinical settings.

SMDA and timely identification of safety concerns

required manufacturers and importers to submit reports on adverse events, aimed to expedite the identification of potential safety concerns.  User facilities must report a suspected medical device-related death to both the FDA and the manufacturer, and also medical device-related serious injuries to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

“device user facility”

a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. 

who can report this, to who, and when: ‘30 day reports of deaths, serious injuries and malfunctions’

manufacturer report to FDA, within 30 calendar days of becoming aware of an event.

who can report this, to who, and when: ‘5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health’

manufacturer report to FDA, within 5 work days of becoming aware of an event.

who can report this, to who, and when: ‘deaths and serious injuries’

Importers to FDA + Manufacturer, within 30 calendar days of becoming aware of an event.

who can report this, to who, and when: ‘malfunctions'

importers to manufacturer, within 30 calendar days of becoming aware of an event.

who can report this, to who, and when: ‘Device-related Death’

User Facility to FDA & Manufacturer, within 10 work days of becoming aware.

who can report this, to who, and when: ‘Device-related Serious Injury’

User Facility to manufacturer, FDA only if manufacturer unknown, within 10 work days of becoming aware.

who can report this, to who, and when: ‘Annual Summary of death & serious injury reports’

User Facility to FDA, January 1st for the preceding year.

ACA

Affordable care act: transformed the U.S. healthcare landscape, aiming to increase access to healthcare services, improve quality, and reduce overall costs. impacted device acquisition, maintenance, and replacement strategies. 2010

OSHA

Occupational safety and health act: Sets standards to ensure safe and healthy working conditions. Standards to regulations related to hazardous materials, bloodborne pathogens, electrical safety, and other occupational health and safety considerations.  

HIPAA

Health insurance portability and accountability act: Safeguarding patient confidentiality and ensuring the security of health information. Rights of patients and the obligations of healthcare providers to protect the privacy of patient information.

Regulation

In the context of safety, regulations often prescribe standards and requirements to ensure the well-being of individuals, prevent harm, and maintain a safe environment.

Compliance

the act of adhering to and following established rules, regulations, standards, or guidelines. In a safety context, compliance involves meeting the requirements set forth by regulatory bodies, accrediting organizations, or industry standards to ensure a safe and secure environment. Non-compliance may lead to legal consequences or penalties.

Accreditation

formal recognition or certification granted by an authorized body to an organization, program, or institution that has demonstrated compliance with established standards. In safety-themed contexts, accreditation may be awarded to healthcare facilities, educational institutions, or other entities that meet specified safety standards and practices.

standards

Authoritative safety standards are established benchmarks that ensure consistency, quality, and safety. They provide guidelines for designing, producing, and using products or systems to reduce risks, and compliance may be voluntary or required depending on regulations.

OSHA Key Standards in Healthcare

Bloodborne Pathogens Standard

Hazard Communication Standard (HCS)

Electrical Safety Standards

Personal Protective Equipment (PPE) Standards

Bloodborne Pathogens Standard

Applies to all employees with occupational exposure to blood or OPIM. Employers make Exposure Control Plan (ECP)s, treat every liquid as infectious (Universal precautions), have devices that eliminate/minimize bloodborne pathogens, and have work practice controls

work practice controls

These controls focus on behaviors and practices that can reduce the risk of exposure.

HCS

Hazard Communication Standard: AKA "Right to Know" standard, was established by OSHA to ensure that employees have the right to be informed about the chemical hazards they may encounter in the workplace. Chemical labels, Gas coloring, safety data sheet, employee training, etc.

Chemical Labels

Hazard Communication Standard (HCS) from Occupational Safety and Health Act (OSHA) requires that all industries color-code safety equipment locations, physical hazards and protective equipment.

ANSI

American National Standards Institute

Red according to OSHA

Must be used for fire-related hazards, as well as emergency switches, bars, and buttons on hazardous machines. Universally recognized as super dangerous, death/serious injury will be certain if hazard is not avoided

yellow according to OSHA

Caution and is used for physical hazards, including striking against, stumbling, falling, tripping, and “caught in between.” Most commonly, these signs warn against unsafe practices, communicating hazards that may lead to worker injuries if not avoided

orange according to OSHA

dangerous machines or equipment that may crush, cut, shock, or injure workers in other ways. used on “warning” signs and labels when hazard may result in death or serious injury, but not bad enough for a “danger” sign.

green according to ANSI

general safety signs, which offer safety-related messages that don’t touch on specific workplace hazards. (ex. sanitation reminders)

blue according to ANSI

information unrelated to personal injuries and other hazards (most commonly on “Notice” signs). It is most commonly associated with maintenance work and other safety precautions. (ex. overhead clearance of a area)

Medical Gas Color Coding (US): Grey

Co2, most widely used in applications requiring inflation, propulsion, evaporative cooling and mechanical energy

Medical Gas Color Coding (US): red

Medical instrument air that is compressed

Medical Gas Color Coding (US): yellow

Medical grade compressed air, is clean air used in hospitals to help patients breathe, give medicine, and power machines like ventilators.

Medical Gas Color Coding (US): Black

N2, used in hospitals to run medical tools, test how a person breathes in low-oxygen air, and to freeze and store blood or tissue. It can also freeze and remove unhealthy tissue.

Medical Gas Color Coding (US): Blue

Nitrous oxide, clear-safe gas used by doctors and dentists to help people feel calm and relaxed during medical or dental procedures.

Medical Gas Color Coding (US): Green

O2, used to help people breathe under anesthesia, first aid resuscitation in emergencies, and when they are sick and need extra help breathing.

Safety Data Sheet (SDS) have what

• The properties of each chemical

• The physical, health, and environmental health hazards

• Protective measures; and safety precautions for handling, storing, and transporting the chemical.

Employee Training

responsible for training employees, including all healthcare workers, on the hazards of chemicals in the workplace, how to interpret labels and SDS, and the appropriate protective measures. 

Equipment Grounding and Isolation

Component of electrical safety, makes sure medical devices are safely grounded and insulated so people don’t get shocked when the equipment is used.

Safe work practices

Component of electrical safety, rules tell BMETs to work carefully by turning off equipment before maintenance, using safe tools, and locking equipment so no one gets hurt by electricity.

Emergency response protocols for electrical incidents

Component of electrical safety, BMETs know what to do in electrical emergencies, like fires or electric shocks, and who to call for help. They also know which medical machines can run on emergency power and how each device needs electricity to work safely.

Training on testing and inspection

Component of electrical safety, BMETs are trained to check and test medical equipment so they can find electrical problems and make sure the devices are safe and working properly.

Lock out Tag out from OSHA safe work practices

• Lockout means turning a machine off and putting a lock on it so it cannot be turned back on.

• Tagout means placing a warning tag on the machine that says “Do not turn on—someone is working on this.”
  
  Prevent machines from turning on by accident and stopping dangerous energy from being released while equipment is being fixed or serviced.

Procedures for “Lockout” from ‘lockout, tagout:

1) Tell all workers that a machine needs to be fixed and that it must be turned off and locked so it cannot start while it’s being worked on.

2) Check what kind of energy the machine uses and why it could be dangerous.

3) Turn the machine off the normal way if possible

4) Disconnect it from all power sources.

5) Lock out the energy isolating device(s) with assigned individual lock(s).

6) Release any leftover energy (like pressure, motion, or stored electricity).

7) Double-check that the machine cannot turn on, then put controls back to “off.”

procedures for ‘Tagout’ of ‘lockout, tagout:

1. Make sure the machine and area are clear and everything is put back correctly.

2. Check that all workers are safely away.

3. Set the controls to “off” or neutral.

4. Remove the locks and turn the machine back on (some blocks may need power to remove safely).

5. Tell everyone that the machine is ready to use again.

NFPA

National Fire Protection Association: is a nonprofit group that creates safety rules for fire protection and saving lives. Applied in many places but in hospitals, NFPA 99 is especially important because it focuses on healthcare safety

NFPA 99 electrical safety requirements

provides guidelines for electrical safety measures related to medical equipment, including grounding, electrical system inspections, and testing protocols.

NFPA 99 maintenance requirements

It stresses the need to regularly maintain, test, and inspect medical equipment so it works correctly and meets safety rules.

NFPA 99 equipment location requirements

code explains where medical equipment should be placed and how much space it needs around it so it can be safely used, cleaned, and repaired.

NFPA 99 Fire Detection and Suppression requirements

explains how fire alarms and fire-control systems help protect medical equipment and keep patients, staff, and visitors safe in healthcare buildings.

NFPA 99 Emergency Power requirements

code sets rules for backup power, like generators, so important medical equipment keeps working during power outages or emergencies.

accreditation

organization has been officially checked and approved to meet certain quality and safety standards.

reasons for accreditation from other agencies

• Shows a healthcare facility is safe and high quality

• Builds patient trust and confidence

• Helps reduce mistakes and improves patient safety

• Encourages constant improvement over time

• Keeps care up to date with best practices

• Required to receive Medicare and Medicaid funding (CMS)

• Gives facilities a competitive advantage

• Improves the facility’s reputation in the community

• Supports staff professionalism and job satisfaction

• Helps follow laws, rules, and regulations

• Creates chances for collaboration and learning with other healthcare organizations

Role of accrediting organizations

• Create and update healthcare safety and quality standards

• Inspect and survey facilities to check compliance

• Award accreditation to facilities that meet the standards

• Provide education and training for healthcare staff (including BMETs)

• Promote patient safety (infection control, equipment safety, emergency response)

• Encourage continuous improvement and monitoring

• Support best practices, new technology, and evidence-based care

CMS and Accreditation

Centers for Medicare & Medicaid Services: a U.S. government agency that runs Medicare, Medicaid, and CHIP and helps make sure people get affordable, good-quality healthcare.

Key Responsibilities of CMS

• Administering healthcare programs

• Setting standards

• Regulatory oversight

• Financial management

CoPs

Conditions of Participation : CMS has rules that hospitals must follow to get Medicare and Medicaid money, and accreditation helps facilities meet or go beyond those rules.

Food and Drug Administration (FDA) key responsibilities

• regulatory oversight

• product approvals

• post-market surveillance

• public education

FDA and medical equipment management

The FDA makes sure medical devices are safe and work properly, and its rules affect how BMETs maintain, fix, and use medical equipment in hospitals.

FDA and ‘device classification and regulation’

The FDA groups medical devices by risk level, from low-risk (Class I) to high-risk (Class III), and BMETs need to know a device’s class because it affects the rules and requirements they must follow.

FDA and ‘510(k) clearance and premarket approval (PMA)’

BMETs need to know how medical devices are approved, since some go through a 510(k) process and higher-risk new devices need full FDA approval before they can be used.

FDA and ‘post-market surveillance for medical devices’

After devices are sold, the FDA keeps watching them for safety, and BMETs must pay attention to recalls or alerts and act if there is a problem.

FDA and ‘compliance and inspections’

The FDA checks healthcare facilities to make sure rules are followed, and BMETs help by following those rules and keeping proper records for medical equipment.

when does a medical device recall happen

when a device is unsafe or faulty, and it is removed or fixed to protect patients.

Class I recall

most serious recalls and happen when a medical device could cause serious injury or death if used.

what class of recall: “A cardiac pacemaker is found to have a critical malfunction that could result in a life-threatening arrhythmia or cardiac arrest if the malfunction occurs during use.”

class I

what recall: “An infusion pump used to administer fluids intravenously has a design flaw that may cause inaccurate delivery rates, leading to the potential for under-dosing or over-dosing of medications, which could result in temporary harm to patients.”

Class II

Class II recall

when a medical device might cause temporary or easily treatable health problems, but serious harm is unlikely.

class III recall

least serious and involve devices that are unlikely to cause health problems.

what recall: “A non-sterile tongue depressor is recalled because it has been found to have a packaging defect that may compromise sterility. While the risk of adverse health consequences is low, the recall is initiated to maintain the quality and safety of the product.”

Class III

procedures of recall process

1. manufacturers and regulators notify healthcare facilities, explain the problem and risks, and give instructions on what to do with the device.

2. Healthcare facilities must find any recalled devices they have by checking records, suppliers, and device serial numbers.

3. Information about the recall is shared with staff in the hospital so everyone knows about it and can respond properly.

4. If patient safety could be affected, healthcare facilities may inform patients about the recall and explain the risks, what to do, and any follow-up care needed.

5. Healthcare facilities must remove recalled devices and replace them with safe alternatives if needed.

6. Healthcare facilities must report to regulators on how they are finding and fixing recalled devices so the recall can be tracked effectively.

7. Healthcare facilities may train staff on how to handle recalls and stress following the rules to keep patients safe.

8. Healthcare facilities keep records of what they did during a recall, which helps with audits and meeting regulations.

TJC

The Joint Commission: nonprofit group started in 1951 that works to improve healthcare quality and safety by accrediting hospitals and other healthcare facilities.

EPs

Elements of Performance: specific criteria or expectations that organizations must meet to demonstrate compliance with TJC standards.

• HR

• infection prevention and control (IC)

• info management (IM)

• Leadership (LD)

HR in EPs

Focuses on the verification of staff qualifications and competency, as well as ongoing training and performance evaluations

IC in EPs

infection prevention and control: standards for hand hygiene, environmental cleaning, and protocols to prevent healthcare-associated infections. 

IM in EPs

Information management: This area focuses on the appropriate management of protected health information (PHI), including HIPAA (Health Insurance Portability and Accountability Act) compliance.

Leadership in EPs

emphasizes the importance of proper organizational structures, and accountability of policies and procedures.

EC

Environment of Care: Focuses on ensuring a safe, functional, and well-maintained physical environment in healthcare facilities.

• Safety and security management

• Hazardous materials and waste management

• Fire safety

• Medical equipment management

• Utility systems

• Egress management (make sure there are clear routes for emergencies)

• infection control

• Ligature risks (stuff that can tug on you, like a loose cord)

Environment of Care Meeting

meeting where staff from different departments come together to make sure the hospital’s buildings and spaces are safe, secure, and healthy for everyone.

DNV GL Healthcare and NIAHO

DNV Healthcare accredits hospitals using standards that focus on patient safety, managing risks, and continuous improvement. Its NIAHO program uses a risk-based approach and follows ISO 9001 quality management principles.

ISO

International Organization for Standardization: international organization that creates standards to help ensure products and services are safe, high quality, and efficient, and companies follow them to show they meet global quality standards.

Quality Management System- ISO 9001

explains how organizations should run a quality management system so they can consistently provide safe, reliable products and services. Based on ISO 9001: having strong leadership support, involving staff in quality efforts, and using clear, organized processes to deliver healthcare services.

PDCA cycle

Plan-Do-Check-Act : helps organizations continuously improve their processes, and ISO standards encourage using feedback and data to check performance and make improvements.

Patient safety- ISO 45001

This means keeping everyone safe by:

• Putting safety rules and protections in place

• Regularly checking for risks or hazards

• Having plans ready for emergencies

Together, these steps help prevent accidents and manage risks before problems happen.

ISO 13485

Infection prevention and control:
This means stopping the spread of infections in healthcare by:

• Making sure staff follow proper handwashing rules

• Keeping areas and equipment clean and disinfected

• Using isolation when needed to protect others

Following these steps helps keep patients and staff safe from infections.

ISO 17025 and ISO 14971

Medical equipment management:

This means making sure medical equipment is safe by:

• Keeping an accurate list of all equipment

• Performing regular maintenance and testing

• Recording the condition and status of each device

BMETs are key to this by managing equipment, maintaining it on schedule, and keeping proper records.

ISO 14001

Hazardous materials and waste management

This means handling dangerous materials safely by:

• Clearly identifying and labeling hazardous materials

• Storing them properly and securely

• Disposing of them according to environmental laws

Following these rules helps protect people and the environment.