Code or Standard?
This is a voluntary set of technical definitions and guidelines
Standard
Standard EC.02.04.01: The hospital manages _______ __________ risks.
medical equipment
Per NFPA 99, it is defined as a space, within a location intended for the examination and treatment of patients, extending 1.8 m (6 ft) beyond the normal location of the patient bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 2.3 m (7 ft, 6 in) above the floor.
What is Patient Care Vicinity
TJC HAP EC.02.04.01 EP4
The hospital identifies the activities and associated frequencies, ___ ________, for maintaining, inspecting, and testing all medical equipment on the inventory. These activities and associated frequencies are in accordance with manufacturers’ recommendations or with strategies on an AEM program.
in writing
Effective January 1, 2022, TJC updated the definition of this key term as follows:
"A patient safety event (not primarily related to the natural course of the [patient’s] illness or underlying condition) that reaches a [patient] and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm)."
What is a Sentinel Event
Staff competence is initially assessed and documented as part of orientation.
standard
TJC HR.01.06.01 EP5
The Joint Commission standard requires the hospital to evaluate its medical equipment management plan every __________ months.
12 (annually)
This code is also referred to as the National Electrical Code (NEC)
NFPA 70
These are the four major CMS approved accrediting organizations for hospitals
The Joint Commission, Det Norske Veritas (DNV), the Center for Improvement in Healthcare Quality (CIHQ), and the Healthcare Facilities Accreditation Program (HFAP)
A relocatable power tap (RPT) must not be connected to these
Other RPTs or extension cords
NFPA 99 10.2.3.6(4)
User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
Code
FDA: Medical Device Reporting (MDR) regulation (21 CFR Part 803) & Safe Medical Devices Act of 1990 (SMDA)
This tool was developed to provide health care organizations with the information they need to prioritize resources and focus corrective action plans in areas that are most in need of compliance activities and interventions.
What is the "Survey Analysis for Evaluating Risk” (SAFER) matrix?
For Relocatable Power Taps (RPTs) the sum of the ampacity of all appliances connected to the outlets must not exceed this percent of the ampacity of the flexible cord supplying the RPT
75%
NFPA 99 10.2.3.6(2)
These device types are not eligible for AEM
-Medical laser devices
-Imaging and radiology equipment (whether used for diagnostic or therapeutic purposes)
-New medical equipment with insufficient maintenance history
This authority allowed the FDA to approve in vitro diagnostics for the detection and/or diagnosis of COVID-19 (February 4, 2020), personal respiratory protective devices (March 2, 2020), and other medical devices, including alternative products used as medical devices (March 24, 2020), for use during the COVID-19 outbreak.
Emergency Use Authorization (EUA)
Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act
Equipment which may become contaminated with blood or other potentially infectious material (OPIM) shall be decontaminated before servicing or shipping unless decontamination is infeasible. If so, a readily observable label in accordance with (g)(1)(i)(H) shall be attached to the equipment and also state which portions of the equipment remain contaminated.
Code
Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030.
This TJC EP was eliminated in 2017 because it addresses a “routine part of operations of clinical-care processes,” and “organizations already have multidisciplinary teams in place to give input on equipment.”
EC.02.04.01, EP 1 required hospitals to solicit input “from individuals who operate and service equipment when it selects and acquires medical equipment.”
According to NFPA 70 (517.20), receptacles within the area of this type of location must have ground-fault circuit-interrupter protection for personnel if interruption of power under fault conditions can be tolerated or be served by an isolated power system if such interruption cannot be tolerated.
Wet procedure location
The July 2022 edition of TJC Environment of Care chapter requires that hospitals that use TJC for deemed status purposes must comply with this year edition of NFPA 99
2012 edition of NFPA 99
Patient Matched Medical Devices (PMMD) (ex. Ortho Maxio Facial Cutting Guide) that are created using 3D printing/additive manufacturing must follow these standards regardless of the location of their manufacture
FDA Good Manufacturing Practices (GMP)
Following installation of a water treatment, storage and distribution system, the user is responsible for regular surveillance of the microbiology of the system and for complying with the requirements of this document, including those requirements related to action levels.
Standard
ANSI/AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies
The hospital’s plan for managing its resources and assets describes in writing the actions the hospital will take to sustain the needs of the hospital for up to ___ hours based on calculations of current resource consumptions.
96 hours
TJC EM.12.02.09 EP3
For appliances that are used in the patient care vicinity, the resistance between the appliance chassis, or any exposed conductive surface of the appliance, and the ground pin of the attachment plug shall be less than 0.50 ohm under these conditions
When the cord is flexed at its connection to the attachment plug or connector AND its connection to the strain relief on the chassis
NFPA 99 10.3.2.1
Prior to a new wireless medical telemetry system being installed in a hospital the system must be registered with this organization to assure frequency coordination
American Society for Health Care Engineering (ASHE) per the Federal Communications Commission (FCC)
This is the term FDA uses to categorize medical Artificial Intelligence (AI)/Machine Learning (ML) software
Software as a Medical Device (SaMD)