Today cyber attacks are more common than we think and system hijacking or ransomware is a sensitive issue that institutions, companies, and especially hospitals have put on the table to take urgent cybersecurity measures.
It has been shown that the issue of cybersecurity is growing stronger and that it is now easier to protect personal use devices connected to the internet in order to protect our sensitive personal data. For health institutions, the real issue of cybersecurity focuses on patient information and the protection of the medical equipment network, cyber attackers always look for the vulnerability of the equipment to access the network, block access to their use and all the information that is stored in the equipment to then ask for a reward in exchange for the release, this delicate information is the key to keeping the patient safe and, without that information, patients are at risk.
According to Security Boulevard, at least one in five Americans was a victim of cyberattacks in their health care last year and are worried that ransomware make the movement again and affect their care, also a third of the persons who were interviewed are thinking to switch providers.
If you want to protect your medical equipment network from ransomware, the first step to take is to have a good management system with an extended inventory of the pieces of equipment that includes equipment digital persona, data security fields (Bluetooth, USB interfaces and ePHI) and, a model control profile. By having a centralized management system, you will be able to monitor the technology that are vulnerable to this type of situation, identify the constant failures, administrate the maintenance cycle, and which equipments are affected before, during, and after a cyber attack.
Call the manufacturer: medical equipment needs patches every certain time and unlike a computer, they do not automatically download and install, so you need to ask your provider for the patches available for your equipment, this is a really hard task for the Clinical Engineering department since in a hospital there can be thousands of equipments and not all will be of the same brand or manufacturer but with the last update of “right to repair” law, clinical engineers will be able soon to get the patches from the manufacturers and install them themselves with a faster response time, the only little obstacle will be the OEM since all installations, patches, and other endpoint security solutions for medical technology need to have validation by they first.
TI department and CE department need to make a good team evaluating constantly all the medical technology and prevent every vulnerability they will found on medical equipment, update all the patches available and management maintenance cycles, protect leaks of ePHI data and always keep an eye on the alerts and in this way hackers will have no opportunity to attack the network or at least it will not be easy.
Our CMMS MediMizer has integration with ASIMILY, a smart solution for the IoMT risk management where you can correlate the data based on several parameters to enrich inventory, initiate automatic remediation of vulnerabilities detected, and plan activities.
The results of 3D printers have been impressive for years, but printing human tissue is the next step for NASA. The two finalist teams from the Wake Forest Institute for Regenerative Medicine, aimed to create human organ tissue in a lab, this had to be similar enough, strong and durable for at least 30 days, and they achieved it, an advance for the study of artificial organs and bioengineering.
The teams had to take two different approaches and methods to replicate a functional tissue that fulfilled all the functions of a human tissue, in the end they both agreed to print it in three dimensions. A study of this magnitude allows us to take the next step towards the creation of functional organs for transplantation.
Laura Niklason, a professor of anesthesia and biomedical engineering at Yale University, stated, “The biological effects of low gravity are becoming more and more important, especially as the world is considering private and commercial space travel, and this is a great tool to help us understand it.”
NASA has a breakthrough in studies of the creation of organic tissue under microgravity and with this collaboration, they are one step away from solving the long waiting times that patients have to receive an organ, as well as more alternatives to regenerative and tissue medicine.
The winning team of the challenge will have the opportunity to continue their research on the International Space Station (ISS) as well as a bonus of $300,000. They certainly have an exciting and difficult task for the future of artificial organs.
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.
This single matrix is now used to evaluate risk instead of various criteria that varied by EP. It is a simple 3 level risk evaluation relative to a 3 level scope. The new evaluation has no effect on events that are an immediate threat to life and therefore this is shown above the matrix.
Placement on the matrix is based on surveyor experience, definitions, context and team discussion. "Anchors" are specific examples which have been compared to a pain scale indicating the examples have various levels of severity. We read one report that a "library of anchors" will be produced by TJC over time. (Compass Clinical Consulting, Feb 20, 2017)
If there is an ITL (Immediate Threat to Life), the organization has 72 hours to eliminate the ITL. If it can not be eliminated in that time, an emergency plan that can take up to 23 days (including the 72 hours) to complete.
In all other cases, there are 60 days to show evidence of compliance, including Who, What, When and How.
For non-compliance in the red or dark orange regions, the evidence much also include leadership involvement and preventive analysis. Also these will be consider for special consideration in future surveys through the next full survey.
Leadership involvements looks first at the sustainability of changes and support from the top levels of leadership. Examples give of support are providing resources, speaking out on behalf of the change and establishing plans for period measurement of and reporting on the changes.
Preventive analysis assures that the corrective action is global and not only a solution for the specific case. The analysis reviews underlying reasons. The focus is in preventing future incidents.
The SAFER matrix applies to the entire organization and results will be included in the report as the EC (Environment of Care) rules cited displayed on the matrix. If examples or one EP fit into more than one risk group, it will appear in the most severe group.
Initial evaluation (June 2016) roughly estimated about a fifth of findings were in the widespread and about 2/5ths were limited. The JC Extranet site further defines Likely as harm that can happen at any time without any contributing factors. Moderate likelihood may require other contributing factors or conditions.
(Key Sources: Presentations by George Mills and Caroline Heskett of The Joint Commission 2016-2017)
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Compliance and Standards
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Issues to deal with
Supreme Court Decisions
Automation of lab work, more efficient diagnostic testing, and electronic medical records have transformed the speed and accuracy of medical diagnoses. A vital part of this advancement has been medical imaging. By pinpointing the bleed, tumor, or site of infection, modern medical imaging confirms a physician’s suspicion based on clinical evidence, and in many cases identifies problems that are not detectable by physical examination alone. Four innovative medical imaging modalities are reviewed here: optical coherence Doppler tomography, capsule endoscopy, a single-chip catheter-based device, and positron emission tomography.
Optical coherence Doppler tomography (ODT) is a way to see blood vessels in real-time without piercing the skin. The arteries carry oxygenated blood to our body, and an interruption in this rich blood supply (whether due to a cholesterol plaque growing on the inner wall, a blood clot from the heart clogging the artery, stiffening of the artery due to uncontrolled high blood pressure, or weakness of the artery’s wall because of diabetes) can wreak damage instantly in the case of a stroke, or slowly in the case of decades of uncontrolled hypertension. The adage that prevention is the best medicine rings true today. If physicians could study the health of their patients’ blood vessels in an inexpensive and efficient way (for example, in the office), then there would be a potential to intervene earlier to possibly prevent the heart attack, stroke, or amputated foot. ODT is a technology that can acquire tomographic images (“slices”) of biological tissues at the level of micrometers (one millionth of a meter – the width of human hair is 17 micrometers). Just as ultrasound uses sound waves that strike the target and are deflected back to a receiver, ODT uses light waves. ODT is based on optical coherence tomography (OCT), which uses a reference light and back-scattered light from the tissue to visualize it. The Doppler aspect comes from the scattering of light as blood cells move towards or away from the detection site. The technology has been applied to human health in the early 2000’s, to scan the retina as surveillance for a known complication of diabetes or for the diagnosis of optic nerve injury seen in multiple sclerosis. Recent studies in animals have demonstrated the ability of ODT to visualize blood vessels under the skull. In time, these newer applications will be validated in humans and then applied to the non-invasive visualization of other organs. The maintenance of OCT and ODT devices is important to their proper functioning and should be performed by a trained clinical engineer or technologist.
Not all imaging is non-invasive. The digestive system consists of the esophagus, stomach, small intestine, and large intestine. An upper endoscopy or colonoscopy can be used to look for abnormalities in the stomach/esophagus and colon, respectively. However, sometimes a patient is bleeding and the source is not identified on these two endoscopic approaches. It would be difficult to advance a semi-rigid camera to the middle of the digestive tract. This lack of access led to the innovation of capsule endoscopy, which was approved for use in humans by the Food and Drug Administration (FDA) in 2001. The capsule is the size of a large pill yet contains all the necessary hardware (lens, LEDs, semiconductor imager, battery, transmitter, and antenna) to safely travel through the digestive system, taking snapshots of the small intestine along the journey. Just as pictures from outer space being relayed to NASA on earth, the capsule endoscope transmits the pictures via radio telemetry to a recorder that the patient wears on his/her belt. Within 72 hours, the capsule exits the body. The benefits of this invasive yet safe technology include: that the patient can be at home (saves costs to the healthcare system), doesn’t need to extremely modify his/her activities (patient flexibility), and is able to get a diagnosis of a disease of the small intestine that was previously not possible. The capsule costs approximately $500, which is less expensive than a standard colonoscopy. This LED many technologists, engineers, and physicians to investigate follow-up technologies that may be able to serve as substitutes for the traditional colonoscopy or CT scan of the abdomen. As a result, the FDA approved the PillCam® COLON 2 Capsule Endoscopy System in January 2014.
Capsule endoscopy takes advantage of one of the body’s natural conduits, the digestive system. Cardiologists would benefit from being able to visualize small blood vessels from the inside as well. This would enable to them to understand patient’s risk factors for cardiovascular disease and intervene preemptively in cases of eminent danger (for example, a fatal heart attack due to a gradually narrowing left anterior descending coronary artery, the so-called “widow maker,” that finally seals off). Just as gastroenterologists use the GI system as their atlas, cardiologists use the complex highway of blood vessels to navigate their way to the heart. Using the gold-standard technique of coronary angiography to tunnel a catheter (with a camera located at the tip) from the femoral artery to the coronary arteries on the surface of the heart, the blood flow through these critical vessels can be visualized. A breakthrough technology published this year may lead to real-time 3D images from within the heart and blood vessels. Researchers at the Georgia Institute of Technology have developed a 1.4 millimeter chip that contains ultrasound transducers and on-board processing hardware that, when attached to the angiography catheter, could provide such real-time images. This technology is in the very early stages and next needs to be studied in animal models before it can be tested in humans. Thus, this is yet another imaging modality that may become commonplace in the future and save thousands of lives through earlier detection of subtler abnormalities.
Positron emission tomography (PET) is a nuclear medicine study in which radioisotope-labeled tracers are injected into the bloodstream and their decay signal (positron emission) is detected by the PET scanner, a gamma ray detector. Unlike MRI and CT scans, which provide static anatomic images, PET scans provide functional imaging. In other words, they reveal areas of the body that are consuming a disproportionately increased amount of the radiotracer. PET is most commonly used in the field of cancer and FDG, a radio-labeled form of glucose, is most often used. Because tumor cells are rapidly dividing and need to consume a lot of energy (in the form of glucose) to grow and form the cancer, the PET scan of a patient with a lung tumor would “light up” in the area of the lung containing the tumor. This area may not be seen on anatomical MRI or CT imaging alone. Thus, the combination of the structural and functional information can improve the accuracy of a cancer diagnosis. Based on its size, the brain consumes more glucose than other organs. Therefore, using FDG-PET to diagnose brain tumors is difficult because it is not clear whether the increased radiotracer uptake is due to cancer or just an area of the brain that is active. New radiotracers have been developed to help diagnose and monitor patients with brain tumors. For example, tracers based on the amino acid dopamine are now being studied in human clinical trials. Because dopamine is not used up at such a high rate by the brain as is glucose, it may prove to be a more specific way of distinguishing brain cancer from the normal background brain activity.
In summary, these four imaging methods provide a small insight into the exciting role of innovation and engineering in the field of medicine for the betterment of human health. Although they are in varying stages of development and clinical application, they represent the potential for innovation when biomedical technology is applied to the human body.
Single-chip catheter-based device