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)
Defibrillator
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)
Fibrillator
Heat Exchanger, Heart-Lung Bypass
Monitor, Airway Pressure
Resuscitator, Infant
Vaporizer
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
BIPAP/CPAP
Capnograph
Continuous Fluid Management Renal Replacement
Cryosurgical Unit, Cardiac
Electric nerve stimulator
Fluidotherapy
Gas Outlet
Heater, ECMO
Hypo/Hyperthermia
Imaging Equipment
Infusion pump
Insufflator
Irrigation
Laser
Lift
Liposuction Unit
Morcellator
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
Ultrasound
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
Notes
Iron Lung is on the list because NIH reports that they have been reintroduced for neonatal use.

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?
Terms:
Global Trade Identification Numbers (GTIN) - GS1
Sources:
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

Ask support@MediMizer.com for further information on any of these.
* Class and Model user-defined fields can be used for list views at the equipment and work order levels.
* Class and Model links can be viewed in the equipment links.
* The User table is now used for iRequestManager and Web Dashboards. The Employee file is no longer used for these features.
* iRequestManager now offers an equipment list.

We recommend running recalculation of work order related information after a months work has been completely entered and before it is reported.

What does it do - Recalculate work orders reprocesses all services as if they were removed and re added in date and time order. This has the affect of being sure all current rules are applied and all dates are updated correctly. In theory, this may have no effect on data. But in the case where rules were changed and not applied correctly, or if a new update has been installed, it can make an important correction of data. Changes to service code rules or equipment status settings would be examples of rules that would be applied correctly to work orders in the period recalculated. There are also some special cases when the work order "overdue" flag will be set correctly by this function.

"Recalculate" option is under the "Manager" menu.

In this form, ensure that the first option "Recalculate Work Orders - related Information" is enabled. You can select either of the related options "All Work Orders" or "Work Orders change on or after X". Keep in mind that the first option will take a lot longer time to process as it will review all work orders in your database. If you want to process a specific time forward, such as last month, you will select the second option and specify the first of the previous month. The other options available on the Recalculate form can be left on or off as you deem necessary. "Recalculate Average Time..." is also a good tool to run monthly.

Preemption of a scheduled work order - This feature causes a scheduled work order to be automatically closed as complete if the exact type of work schedule has already been completed.

How it works - The number of days (X) prior to the inspection period to be considered is set in Options. If left at zero, this feature is disabled. X is the value set by you, in Options -> Program Setup -> Scheduled Work Orders -> "Do not created Scheduled Work Orders if procedures was completed in last X days". If the "Generate Preempted Inspection Work Orders" option is disabled, MediMizer X3 will skip the creation of any work order for a piece of equipment that has had an inspection code that satisfies all inspections types that would be due during the month. If the options is enabled, it will create the work orders for the piece of equipment, BUT, the work orders will be marked as Closed and have text in the Service Request field noting that the work order was preempted by a prior work order. Enabled is the best choice for most circumstances.

Concerns - If this feature is used, it is important to use service codes for inspection very specifically. If an item is serviced in the window (X), and a service code is used that indicate a normally scheduled event was completed, that will cause preemption. It is a good practice to have a service code to use for a less-complete or basic inspection after service. "Checked Operation after Service" would be appropriate wording. Such a code would not preempt a scheduled inspection.

MediMizer is currently working with Fluke medTester and Datrend V-Pad and 601.
We have completed and are testing a link to Fluke ANSUR which will allow us to work with many Fluke analyzers.
Some Pronk equipment works with the Datrend link and we are discussing with them interfacing to other equipment.
Rigel has attended MediMizer user group and we are in early discussions regarding an interface.
Please email sales and let them know which products you need us to link to for your benefit.

Federal Consensus Standards for Medical Devices

The Center for Devices and Radiological Health (CDRH), which is a part of the Food and Drug Administration (FDA), is responsible, in conjunction with the Standards Management Staff (SMS), for the development and implementation of both national and international medical device consensus standards. This involves working closely with the Standards Developing Organizations (SDOs) and advertising standards liaison representative positions to maintain an appropriate standards database. SMS publishes updated medical device standards no less than twice annually.

See organizational and contact information for the SMS below or visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm:

Recognized Consensus Standards The FDA’s database of recognized consensus standards can be accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Procedures for the Use of Consensus Standards
The CDHR and SMS believe that conformance to their domestic and international consensus standards ensures the safety and/or effectiveness of a health device. Designers and manufacturers of new health devices can benefit from conformance to these standards since such conformance often eliminates the need to review the test data that applies to the standards when seeking regulatory approval. It should be noted, however, that conformance to the consensus standards will not always be a satisfactory basis for waiving regulatory decisions about a new device.
The CDHR and SMS believe that compliance with their consensus standards represents “the least burdensome approach in all areas of medical device regulation,” but also encourages those who believe an alternative approach would be less burdensome to contact the CDHR Ombudsman at this email address: CDRHOmbudsman@fda.hhs.gov. More information about the office of the Ombudsman can be found at www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.

General Use of Consensus Standards in the Premarket Applications Review Process
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence and, thus, streamline the premarket review process.
Applicants referencing a national or international standard should include a completed Standards Data Form for 510(k)s (FDA Form #3654, Form Approved OMB #0910-0120) as part of their 510(k).

Declaration of Conformity
If a manufacturer decides to conform to one or more recognized consensus standards in its premarket review process for a new device, the manufacturer must submit a “declaration of conformity” to the standards. A manufacturer can use in-house testing or third-party analysis to determine a device’s conformance to consensus standards. The manufacturer is also expected to maintain all records relating to its compliance with the standards.
The FDA recommends that submissions showing a device’s compliance with a consensus standard indicate “yes,” “no,” or “not applicable” for all sections of that standard. Any deviation from the standard should also be clearly indicated.
The FDA states that a declaration of conformity to a recognized consensus standard should do the following:

identify the applicable recognized consensus standards that were met
specify, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations as described below
identify, for each consensus standard, any way(s) in which the standard may have been adapted for application to the device under review, e.g., identify which of an alternative series of tests were performed
identify, for each consensus standard, any requirements that were not applicable to the device
specify any deviations from each applicable standard that was applied (e.g., deviations from international standards that are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70)
specify what differences exist, if any, between the tested device and the device to be marketed and justify the use of test results in these areas of difference
provide the name and address of each laboratory or certification body that was involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations, if a test laboratory or certification body was employed

Review of Documentation
When a manufacturer’s declaration of conformity is deemed to conform adequately to FDA-recognized consensus standards, the aspects of the device addressed by the consensus standard are acceptable. There are, however, occasions in which a reviewer may have specific concerns and request additional information from the manufacturer.

Recognition of New and Revised Consensus Standards
To recognize a new standard or a new version of an existing standard, the FDA will post updated information in one of the Supplemental Information Sheets on CDRH's internet page and publish a notice in the Federal Register. The FDA will accept a declaration of conformity to a standard after it is recognized.

Additional Information
Scott Colburn, Director, Standards Management Staff, Office of the Center Director (OCD), is available to answer questions on consensus standards and issues related to declarations of conformity. He can be reached at (301) 796-6287.

The MediMizer interface to Fluke Ansur device software is scheduled to release during the last quarter of 2015. The new interface allows MTT files to be linked to scheduled procedures. The procedure can call Ansur from an inspection service and return the results into history. The data can be analyzed and reported down to the level of specific readings. Only MediMizer supports this level of detailed reporting.
Email Sales@MediMizer.com to receive more information.

I just returned from Dreamforce. Dreamforce is hosted in San Francisco and was attended by 150,000 people interested in cloud computing. I attended a number of sessions which opened my eyes to new development. One session was on phone and device apps. The message was make them small and an app is not a tiny version of a computer. Apps need to meet just the immediate customer need.
Dreamforce was about programming in the cloud. Speaking to one of our hospitals about the cloud, the equipment manager said, "we just invested 35 million dollars in our storage, I don't think they are looking to move data off site".
MediMizer, Inc. has polled hospitals many years, and we have found up to now, Microsoft SQL Server is the preferred method of storing data. Sites also have Oracle but find SQL more affordable.
More and more, our users are storing data on virtual servers. I am wondering if SQL and virtual servers will become more like the cloud in allowing secure commands to cross the entire structure, making it easier to gather data from many sources without compromising security.
MediMizer will be keeping an eye on new storage technology and how we can take advantage of it.
Mark

MediMizer Software is attending an October 25th 2014 symposium presented by the Healthcare Technology Management Association of the Mid-West, formerly the Kansas City Biomedical Society. Held at the Crowne Plaza in Downtown Kansas City, MO, they will offer educational classes for technicians and managers, a lunchtime keynote speaker and ample opportunity to socialize with other Healthcare Technology Professionals from the Greater Kansas City area. More information at: http://www.kcbiomed.org/event-1716841#sthash.GQWHWSxU.dpuf