Healthcare Technology Management - December 30th, 2016

Departments are often known as Biomedical Engineering or Clinical Engineering and perform repair of medical equipment.

What does the department do?

  • Maintain Equipment Data
  • Work Orders, Unscheduled, Service
  • Work Orders, Scheduled
  • Parts and Materials
  • Contract Management and Negotiation
  • Purchase equipment, materials and services



  • Patient Safety
  • Costs
  • Reliability

Compliance and Standards

  • TJC, The Joint Commission
  • DNS, others
  • State

Policies and Procedures support these functions.


  • Occupied beds, surgeries, inpatient count, outpatient visits, costs of operation.
  • Total cost of medical equipment inventory
  • Total cost of building
  • Total income
  • Total cost of maintenance
  • Total cost per cost center
  • MTBF, Mean Time Between Failure
  • Completion of tasks within a safe period
  • Uptime
  • Employee use of time
  • Contract costs

Issues to deal with

  • Independent evaluation standard for determining inspection program
  • Mergers affecting hospitals and data
  • Access of information to all parties that repair equipment


  • Are there fewer hospitals in the US, in the world?
  • Are there fewer beds in the US, in the world?
  • How many hospitals single, 2-10, 11-40, 41+ in group


  • Reason equipment is needed
  • Alternatives to purchasing (sharing, leasing, other alternatives)
  • Compared to extending life
  • Affect on income, customer acquisition
  • Lower other costs, efficiency, productivity

Supreme Court Decisions

  • Access to Parts, Training, Documentation
  • Electronic Records?

Risk Factors

  • Likelihood of failure causing negative outcome
  • Failure is not Noticeable
  • Availability of Replacement

Mitigating factors

  • System has reliable self-check
  • System has long model-wide history without failure
  • System will not operate in failed state.
  • Failure is easily mitigated by human action (i.e. using another thermometer)


Joint Commission Environment of Care - August 9th, 2015

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.

Other Standards

EC.02.04.01 EP 1 – When purchasing equipment, hospitals must consider the opinion of those who operate and those who service equipment.
EC.02.02.01 EP 18 – All Radiation workers must have exposure monitoring.
EC.02.02.01 EP 19 – Procedures for disposal of hazardous materials and waste.
EC.02.03.03 EP 3 – 50% of fire drills must be unannounced.
LS.02.01.20, EP 1 – “Doors in a means of egress are not equipped with a latch or a lock that requires the use of a tool or key from the egress side.”
George Mills has been clarifying the meaning of EC 02.05.07 EP 4 & 7, regarding the number of days allowed for quarterly, semi-annual and annual inspections:
The above slide is copyright The Joint Commission.  We are seeking a direct link to their location to display the slide.
Joint Commission defines medical equipment as “Fixed and portable equipment used for the diagnosis, treatment, monitoring, and direct care of individuals.”
Joint Commission defines high-risk medical equipment as “Any device for which there is a risk of serious injury or death to a patient or staff member if the device fails”
Life Support and High Risk medical equipment - August 5th, 2015

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.

Life Support:
Anesthesia Machine
Apheresis System
Balloon Pump, Intra-Aortic (IABP)
Extracorporeal Membrane Oxygenation (ECMO)
Heart-Lung Bypass Machine (Pump, Extracorporeal Perfusion)
Heart-Lung Bypass Heat Exchanger
Iron lung
Pacemaker, Cardiac External
Pump, Blood, Extraluminal (Roller Pump)
Ventilator / Respirator
Intermittent positive pressure breathing (IPPB) machines
Suction machine

High Risk Equipment:
Apnea monitor for infants (24 months and under)
Dialysis Machine
ECMO Equipment
Electrosurgical Unit (Including hyfrecators)
Heat Exchanger, Heart-Lung Bypass
Monitor, Airway Pressure
Resuscitator, Infant
Warmer, Blood / Plasma

Are these High Risk?
Ablation Unit, Ultrasonic
Aerosol tent
Air Compressor
Air Flow Guage
Angioplasty System
Aquapheresis System
Balloon Pump, Gastrointestinal
Bed Alarm
Continuous Fluid Management Renal Replacement
Cryosurgical Unit, Cardiac
Electric nerve stimulator
Gas Outlet
Heater, ECMO
Imaging Equipment
Infusion pump
Liposuction Unit
Nebulizer, Electrostatic and Ultrasonic
Oxygen Concentrator
PCCTS Work Station
Phaco and Vietretomy System
Power Supply on Life Support Device
Pressure pads and pump
Surgical Robot
Terminal Cabinet
Tourniquet, Pneumatic
Urinary Catheterization
Vacuum, Curettage System
Ventricular Assist Device Drive Console
Warmer, Radiant, Infant
Water Treatment System, RO
Wax Warmer
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?
Lab Equipment


Iron Lung is on the list because NIH reports that they have been reintroduced for neonatal use.


Please use this form to provide feedback:


UDI Unique Device Identification - July 28th, 2015

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

Compliance Dates:

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

Open Questions:

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

U.S. Department of Health and Human Services, Draft, Unique Device Identification: Direct Marking of Devices, June 26, 2015

24×7 Soapbox: CMS, Santa Claus, and the Preventive Maintenance Reality - March 5th, 2014
Binseng Wang weights in on the CMS vs reality debate.   Easy to read and well stated.
Soapbox: CMS, Santa Claus, and the Preventive Maintenance Reality
This is the most important line to me:
“While it is perfectly logical that hospitals should evaluate the safety and effectiveness of their AEM programs, it is interesting to note that no regulation requires the manufacturers to do the same or to present any rationale.”
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