Matt Dimino, Medical Device Security Consultant with CynergisTek joins us today to discuss challenges that we are facing during the COVID-19 Crisis, the use of medical devices, and the threat of not having enough equipment to accommodate COVID-19 patients’ during the crisis. Matt talks in-depth about strategic measures clinical leadership, information technology teams, and clinical engineering should be taking over the next couple of months. As well, Matt dives into basic medical equipment and how they can be the most impactful during the COVID-19 Crisis.
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To read more about supporting medical device equipment demands during COVID-19 read our latest blog post written by Matt at https://insights.cynergistek.com/blog/supporting-medical-equipment-demands-during-covid-19
Hello and welcome to CTEK Voices: The Risk Perspective. I’m your host Lauren Frickle. Today I’m joined by Matt Dimino, Medical Device Security Consultant with CynergisTek. Matt is considered an expert in medical device cyber security and risk management and today he will be discussing the topic of supporting clinical equipment during a time of high demand.
Hi Matt, thanks for joining us. I’m looking forward to your discussion.
Hello, thank you Lauren. Yes, again, my name is Matt Dimino. I come with a large background and clinical engineering to CTEK, but I’ve got 14 years’ experience in clinical engineering environment working in the healthcare field specifically at a hospital. So, I had managed servicing equipment imaging equipment managing equipment managing projects. So, I have several years of working with cyber security within that hospital system itself.
I’m also an Associate Professor at Indiana University-Purdue University Indianapolis, part of the Healthcare Technology Management Program in Indianapolis. So, they it’s produced School of Engineering and Technology is the school that is a part of that. And I’ve been teaching for about six years with the university now teaching all kinds of courses and health care clinical engineering related many of which have come to cybersecurity. So, I have got a pretty diverse background all around with clinical equipment cybersecurity and managing risk with equipment regarding cybersecurity.
So, I come to CTEK and the last several months to bring my expertise to try and grow the program teach and educate our customers more on the topic.
So, with that, I’d like to thank you for taking the time to listen to me today. And what I’d like to briefly discuss is what many of us may not realize their understand is how these difficult times can influence the extensive and your unique use of medical devices and the threat of not having enough equipment to accommodate COVID-19 patients.
What I mean is that medical devices, obviously the purpose they’re designed their tested manufactured and then procured and used for their intended purpose. But sometimes these intended purposes must change or be adapted reconfigured or even modified to some degree to be used in special circumstances such as the one we’re in today. So, these discussions today are based on how you can help or what you can do to assist the clinician and clinical technology staff on utilizing their available assets to the greatest extent.
Now so first off, we’re finding a lot of off-site or special testing sites designed to offer assistance and testing for this virus. Now aside from testing a lot of healthcare organizations are creating and using isolated areas clearing out or cleaning up as much as 30% of their beds to handle the influx of patients in a facility to treat those in need most. Now these isolated areas may or may not be designed to accommodate these patients and have the technologies to interface with the clinical, necessary to treat COVID-19 patients.
Therefore, it may take some strategic improvising between clinical leadership information technology and clinical engineering. Now reorganization is unique in its desirability to support clinical equipment based on numerous factors from third-party oversight to OEM contracts to in-house clinical engineering programs.
The idea here is to who is maintaining these critical technologies the groups of individuals should have the knowledge the ability the tools, the resources, and the wants and desires to help during this crisis. So, it’s important to get the message out to them so they can quickly plan and assist the organization’s strategic objectives and goals during this time.
So, what I’m suggesting is that the clinical engineering or HTM program within the healthcare organization should have a tremendous role in assisting the organization’s strategic objectives, their mission or goals and values by helping out in any way they can and offering assistance when needed. And what this can entail is at the discretion of clinical leadership help maybe convert single patient rooms into double patient rooms. Helping with moving configuration and setup of physiological monitors beds nurse call communication systems thermometers, ventilators, and so forth.
So, right now I would suggest clinical engineering have a strong presence at the preparation and clinical strategies to accommodate COVID-19 patients. Some organizations may utilize clinics or outpatient centers to treat or evaluate COVID-19 patients with this type of atmosphere. HTM or clinical engineering can assist in configuring devices for data collection integration into the electronic medical record or any kind of necessary attributes that need to be derived from patient vitals for data. And this may require mounting of hardware configuring, middleware, or data captures, and helping with the activation of data jacks and ensuring wireless connectivity is adequate with in some of these areas.
These sites may not be currently equipped to do so. So, in some cases data may be collected stored and then transmitted at a later time. So clinical engineering has the knowledge of what technologies or infrastructure requirements may be needed for the devices and that might be placed in these areas. Additionally, clinical engineering must work with clinical leaders to voice their concerns before shifting of resources takes place again oftentimes these individuals are the Experts and can offer more insightful information before a decision is reached.
And now many have indicated that the use of stationary imaging equipment is not recommended during this time due to cleaning procedures and the potential virus exposure to other patients and staff. So, what we’re finding is a lot of use a lot more use of mobile x-ray is recommended and being utilized for those that need this service. Now as patients are in isolation practicing standard precautions and other measures these devices are more likely to be used in these environments and see a lot more wear and tear more frequently as well as become more urgently needed. So, turning it into a what you would call a mission-critical device, and this can mean more regular service calls more calibrations and the need for more spare parts. So, with that, we often have to look at our in-house clinical engineering group to maintain and services. We might even have to look at our third parties or our manufacturers and vendors to service these devices as well.
And clearly one of the largest departments impacted by this crisis is this the hospital’s clinical lab now lab equipment will likely be heightened and there are for the needs and wants for this department should be a priority. Now it’s not common for in-house clinical engineering to maintain the equipment in the clinical labs, but they may be first call and as first call responsibility is critical and often requires the engagement of the manufacturer where the vendor. It’s important to escalate the clinical lab’s needs no matter how small during this time. So, they’re going to find a lot of prolonged use and it’s likely that the vendors are going to be very busy with other calls. So, having things ready like purchase orders is advisable to prevent any delays or extended downtime. We want to keep this equipment up and running as frequently and as long as we can with these devices.
And then with the recent enforcement policy from the FDA for ventilators and accessories and other respiratory devices during this emergency it be critical to a plan when converting these devices. So, this enforcement policy by the FDA has indicated that if necessary, anesthesia machines can be used for ventilation devices for patients with COVID-19. Now because non-essential surgeries are not being performed or scheduled at the moment the use of these anesthesia devices may be necessary. The clinical engineering group should take part in the discussions of using and transporting these devices as they’re significantly different than a standard ventilator. They may have the knowledge to assistant updating hardware or software to make them more adaptable to this new environment.
Now the next topic is a part of this discussion is looking at how we can prevent contaminated medical devices. During an outbreak critical to treat reusable medical devices as potential sources of transmission. This presents its own set of concerns, but we can all do our part. So, treating all surfaces as if they’re infected requires knowledge of what to do. Can a surface be sanitized and what how long does it take? Where should I do it and so forth?
So, one of the most important things you can do is read the instructions for use for a medical device. Now the instructions can use come with all medical devices. Now they may be online, they may be physically attached to the device, and they might be in a cabinet or closet somewhere. But read this document, go over it with staff, go over it with nurses. Verify you and everyone understands what services can be sanitized, and what services cannot, and what can be sterilized.
The next question is if you have devices that have been exposed to patients with COVID-19, what do we do with it when we’re done? What is the process? So, working with Sterile Processing Departments will be one of the most critical things you or anyone does for that matter. You should work with these departments to ensure proper documentation, properly tagging these devices, understanding workflow, how is the device is going to be handled, and how they will be identified. So, planning this workflow beforehand is critical and to do their jobs effectively and efficiently the Sterile Processing Service Departments must be given the resources and time needed to properly follow medical device manufacturers guidelines to decrease the risk of disease transmission from contaminated devices. So, making sure sterilizers are fully up operational and passing their daily, weekly, and monthly tests will be amongst the central the Sterile Processing Department in the clinical engineering department.
Now during a disease epidemic instruments used for patient care may see higher use rates per a given period. Respiratory illness outbreak, for example, like the one we’re in bronchoscopes and laryngoscopes could be in high demand with clinicians waiting on instruments to be decontaminated or sterilized between patients. In addition to a shortage of available devices those devices and circulation may see increased narrates yet not taken out of circulation for service and repair. So, worn or I’m just the viruses may not perform as intended and could contain pathogens kind of sequestered and cracks can’t be reached with standard cleaning and decontamination methods. Therefore replacing parts on devices have cracks anything that appears damaged have them replaced will be necessary.
And this also brings up the criticality of the organization sterilizers making sure sterilizers are fully operational limiting any downtime and passing the again their daily and monthly tests. The level of concern with these devices is heightened right now and downtime is just not an option right now. So, ensuring that we have parts on hand or parts in stock will be necessary. And as mentioned with a clinical have even considering having particulars or some sort of retainer with the vendor might be necessary as well.
Now in a situation as such as the one we’re in today basic items, like thermometers or these arms are detrimental and therefore there are high priority. So, asking the chemical engineering shop to fix these items and move them out to get the parts in and get them back into circulation isn’t too much to ask. They don’t require any special knowledge or training to fix. Therefore, should be an easy ask and any additional items that may be needed or necessary to accommodate. These items should be fairly straightforward and be reasonable requests.
Items like wheels and locks from sink cabinets these are some of the most basic items that we often take it for granted because it doesn’t contain the technology that the other device do. But the medicine and live in cabinets are critical in maintaining operations, with the use of so many resources the reallocation of spaces the departments and facilities these cabinets, which are in many cases mobile didn’t really move much but now they need to be moved so the cabinet may have I’ve been locked and now they may need to be locked. So, the clinical engineering department may not be responsible for these items and it may just be one of those where no one really knows who’s responsible for these items. But regardless, you know, this group has the skill sets the tools and everything necessary to install and fix things like bearings and casters, the bushings and drawers, replacing casters, and wheels and brakes. So, these are very important items that again, we don’t see every day that we don’t put that kind of value until they’re in such a demand such a need like they are today.
And while in crisis we often forget it at the non-essential I am that run or power are more essential items. So, for instance, batteries, these are found in nearly all portable medical devices and equipment and they are going to be used regularly to treat and monitor COVID-19 patients.
So, having batteries fully stocked for the equipment is warranted and absolutely necessary. If we’re trying to keep our devices segregated and without the need to swap between care units and between isolation or not isolation having a fully stocked cabinet of batteries is really essential.
So now I leave you with this. When in crisis, there’s nothing too small, too odd, too little. We can all do our part, even the most basic devices such as wheelchairs, beds and linen cabinets, and cards all need for attention. All clinical facility supporting staff can assist while staying safe.
Alright, thank you so much, Matt, for that information on supporting clinical equipment during the time of high demand. Just a reminder to our listeners content related to this topic can be found on our website at cynergistek.com.
Thanks for joining us Matt and thank you for listening.