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Departments are often known as Biomedical Engineering or Clinical Engineering and perform repair of medical equipment.
What does the department do?
Compliance and Standards
Policies and Procedures support these functions.
Issues to deal with
Supreme Court Decisions
2014/2015 changes to Environment of Care Standards related to Healthcare Technology Management/Biomedical Engineering for deemed sites.
EC.02.04.01, EP 2 – Inventory must now include all medical equipment.
EC.02.04.01, EP 3 – Evaluate what equipment is high-risk to the patient or staff if they fail to perform correctly. This is equal to the CMS expression “critical equipment”.
EC.02.04.01, EP 4 – Keep a record of inspection procedures and inspection frequencies. Hospitals must follow manufacturer recommendations or an alternative plan. The alternative plan can not reduce safety and must be based on standard practices. Joint Commission referred to ANSI/AAMI EQ56 as an example of standard practices. George Mills referenced ANSI/AAMI EQ89 at the AAMI 2015 annual conference in Denver.
EC.02.04.01, EP 5 – The following equipment must be inspected according to manufacturer’s recommendation: Medical Laser Devices, Imaging and Radiological devices, Equipment subject to federal or state law, Equipment subject to Medicare Conditions of Participation. A plan more stringent than manufacturer recommendations can be followed. New medical equipment must be inspected according to manufacturer’s specifications unless there is enough history to justify a change.
EC.02.04.01, EPs 6, and 7 – Determinations to use AEP must be made by an individual qualified according to HR.01.02.01. The AEP assessment must consider “How the equipment or component is used; consequences of failure, including the seriousness and prevalence of harm; availability of an alternative or a backup in the event that the tool fails or malfunctions; incident history of identical or similar equipment; and maintenance requirements of the equipment.”
EC.02.04.03, EP 1 – Safety, Operational and Functional checks must be performed before use of equipment and after major repairs.
EC.02.04.03, EPs 2 and 3 – 100% compliance with the Manufacturer’s requirements is required for all high-risk equipment, with included life support equipment.
The above is alignment with CMS code 42 CFR 485.623(b)(1),
Facilities / Utilties – EC.02.05.01, EP 2, EC.02.05.01, EP 3, EC.02.05.01, EP 4, EC.02.05.01, EP 5, EC.02.05.01, EPs 6 and 7, EC.02.05.05, EPs 2 and 3 apply the same or similar rules to utilities and their components.
What is Life Support Equipment? What is High Risk?
All Life Support Equipment is also high-risk equipment. EC.02.04.01 and EC.02.04.03 now require our customers to determine what is high risk equipment.
We would like your feedback as we develop this list. We will move our updated list online for further review. If you find any of the names inaccurate or redundant, please comment.
Balloon Pump, Intra-Aortic (IABP)
Extracorporeal Membrane Oxygenation (ECMO)
Heart-Lung Bypass Machine (Pump, Extracorporeal Perfusion)
Heart-Lung Bypass Heat Exchanger
Pacemaker, Cardiac External
Pump, Blood, Extraluminal (Roller Pump)
Ventilator / Respirator
Intermittent positive pressure breathing (IPPB) machines
High Risk Equipment:
Apnea monitor for infants (24 months and under)
Electrosurgical Unit (Including hyfrecators)
Heat Exchanger, Heart-Lung Bypass
Monitor, Airway Pressure
Warmer, Blood / Plasma
Are these High Risk?
Ablation Unit, Ultrasonic
Air Flow Guage
Balloon Pump, Gastrointestinal
Continuous Fluid Management Renal Replacement
Cryosurgical Unit, Cardiac
Electric nerve stimulator
Nebulizer, Electrostatic and Ultrasonic
PCCTS Work Station
Phaco and Vietretomy System
Power Supply on Life Support Device
Pressure pads and pump
Vacuum, Curettage System
Ventricular Assist Device Drive Console
Warmer, Radiant, Infant
Water Treatment System, RO
Wound Drainage Pump
Xenon Ventilation System
We have a couple more questions.
Is there any equipment that is high-risk only when used in special circumstances?
(Quadriplegic care, home care, neonate care, etc)
Are there any ventilators or anesthesia equipment that are not high-risk?
What equipment can harm staff if it fails?
Iron Lung is on the list because NIH reports that they have been reintroduced for neonatal use.
Please use this form to provide feedback:
US FDA is requiring medical device manufacturers to use a unique value to identify all equipment. The new math is UDI = DI + PI.
Class II and Class III devices will require both a device identifier (unique to the specific item) and production identifier (unique to the model or version) which will be presented as a barcode and text description. Class I devices and devices expect from GMP (good manufacturing practice), such as bed pans, will require only the production identifier.
Where necessary, devices such as reusable surgical instruments and implants will be marked on the device. Standalone software that is not an integral part in a medical device will be required to display the production identifier when run.
What makes a model a model? Standard manufacturer methods for determining when a model has change can be used to determine this, with some exceptions:
• A change in the specifications, performance, size, or composition of the device to an extent greater than the specified limits requires the device to receive a new UDI.
• A change to the device package (for example, from a package containing 10 devices to one containing 12) or the addition of a new device package would entail a new UDI.
• A change that could significantly affect the safety or effectiveness of the device would require a change in the UDI.
• A change from sterile to non-sterile (or vice versa) would require a change in UDI.
• A device that is relabeled (with a change to a label that entails more than an addition of information such as a distributor’s name and contact information) would need to receive a new UDI. [Source: Eastern Research Group Lexington, MA]
Code included in the UDI
(01) Device unique identification
(21) Serial Number
(11) Manufacture date
(17) Expiration date
(10) Lot number
10/24/2015 – Life Sustaining and Life Supporting devices (Extended 8/14/15 by FDA notice)
9/24/2016 – Class III devices and devices licensed under Public Health Services Act
9/24/2018 – Class II devices
9/24/2020 – Class I devices and unclassified devices
21 CR 801.45(b) states that a device package and device may have different UDI labeling. If we are reading this correctly, should we be advising user to read the UDI only from the actual device?
Global Trade Identification Numbers (GTIN) – GS1
The Brookings Institution Washington, DC
Eastern Research Group Lexington, MA
Access GUDID at nih.gov
U.S. Department of Health and Human Services, Draft, Unique Device Identification: Direct Marking of Devices, June 26, 2015