MediMizer is an independent biomedical and facilities software company that developed the leading CMMS or “computerized maintenance management software” used for clinical engineering, biomedical engineering, facilities, environmental departments in hospitals as well as the biomedical service organizations that service hospitals.
PartsSource is the world’s largest provider of medical replacement products and services, with over 4 million parts and services that extend across more than 3,000 suppliers in the industry. PartsSource partners with leading healthcare organizations to maximize medical equipment uptime and utilization through the only comprehensive managed service designed to empower clinical engineering leaders with the people, processes and technology to achieve high-performance HTM.
Clinical Engineers and Technicians can spend significant amount of time during their day shopping for parts. To streamline the part sourcing and purchasing, MediMizer and PartsSource have created a Lite integration between the MediMizer CMMS and PartsSource.com. This integration provides your biomed technicians with a simple, single-click access to easily find and source parts and equipment they need to repair and improve equipment uptime.
The Lite integration provides clinical engineers with easy access to the parts and services from within MediMizer’s work-order or inventory features. By providing integration from MediMizer to PartsSource.com, your biomed department can:
The Lite integration provides a simple search capability between systems without any IT or connectivity challenges. Customers using the Lite Integration will get an immediate pathway into the search experience in PartsSource.com. The standard integration is a much more robust integration designed for enterprise customers that would like to connect the CMMS more extensively and PartsSource products. The standard integration supports SSO (Single Sign-On) and can share additional data sets including part cost and purchasing data between systems for advanced reporting but requires additional IT resources to implement.
To help ensure that you get the best possible pricing for the parts you are purchasing, MediMizer has created reports that you can send to your PartsSource rep and obtain their help negotiating the price. You can access these reports and next steps information by going to the “Parts” section and clicking on the “PartsSource” submenu.
Technicians can search the PartsSource.com catalog for products without registering. However, to purchase products, technicians will need to register. Registering with PartsSource is fast and easy. Technicians can register with us once you click on the quick link in MediMizer or by going to the PartsSource website here: https://www.partssource.com/register. You simply insert your basic contact information and you are all set.
No, it is completely free to register with PartsSource.
PartSource’s Customer Care team members are dedicated to providing support to our customers across a variety of help topics. You can speak to a customer care representative with questions about registering and/or our suite of products and services, by calling: 877-497-6412.
MediMizer’s Support department is available to answer any questions you have about this new feature. You can reach them via phone, by calling: 760-642-2008 or by emailing: Support@MediMizer.com
The FDA has not seen any evidence of any cyberattack on an in-use medical device but knows they might be "impacted". Laboratory testing has shown the ability to hack medical devices. According to United Press International, the FDA has issued five product-specific safety communications since 2015 on cybersecurity vulnerabilities. The problems were found in Abbott's implantable cardiac devices and implantable cardiac pacemakers, Merlin's home transmitter of implanted cardiac devices, and Hospira's and Symbiq's infusion systems.
Commissioner Scott Gottlieb, M.D. announced the release of a cybersecurity “playbook” to assist health care delivery organizations, as well as the signing of two memoranda of understanding to promote information sharing, preparedness, and response around cybersecurity risks. The book was prepared by MITRE Corporation for the FDA. The full title is “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.” The MOUs cover plans for the sharing and distribution of information about threats. The Department of Homeland Security is one agency that shares information with the FDA and performs simulations and post-event reviews that assist the FDA.
Part of the playbook presents exercises to help staff recognize a cyberattack in an emergency. Learning what actions to take during the cyberattack is the goal after recognition.
MediMizer Software helps the HTM community by offering full IT/HIPAA/Cybersecurity documentation for the patient equipment.
"The hospital has a library of information regarding inspection, testing, and
maintenance of its equipment and systems.
Note: This library includes manuals, procedures provided by manufacturers,
technical bulletins, and other information."
10.5.3 Servicing and Maintenance of Equipment
10.5.3.1 The manufacturer of the appliance shall furnish documents containing at least a technical description, instructions for use, and a means of contacting the manufacturer.
10.5.3.2 The documents specified in 10.5.3.1 shall include the following, where applicable:
10.5.6 Record keeping – Patient Care Appliances
10.5.6.1 Instruction Manuals
10.5.6.1.1 Instruction and maintenance manuals shall be accessible to the group responsible for the maintenance of the appliance
10.5.6.1.2 Instruction and user maintenance manuals shall be accessible to the user
10.5.6.1.3 Any safety labels and condensed operating instructions on an appliance shall be maintained in legible condition.
10.5.6.2.1 A record shall be maintained of the tests required by this chapter and associated repairs or modifications.
10.5.6.2.2 At a minimum, the record shall contain all of the following:
10.5.6.3 Records Retention. The records shall be maintained and kept for a period of time in accordance with a health care facility’s record retention policy.
The FDA is charged with improving the safety of reused devices.
According to the FDA, "Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes." and "Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among various stakeholders. This includes the FDA; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and other organizations"
FDA list of higher risk reusable devices 510 k submissions for these devices have to be very detailed in outlining their plans for safety.
AAMI has held joint conferences with the FDA and has publications to assist the industry. "AAMI TIR12:2010, Technical Information Report. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical
device manufacturers" has a title long enough to describe its contents.
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.
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.
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