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How Clinical Engineering Can Address Medical Device Shortages
Many may not realize or understand how these difficult times during the COVID-19 crisis influence the extensive and unique use of medical devices and the threat of not having enough equipment to accommodate COVID-19 patients. Medical devices understandably have a purpose, they are designed, tested, manufactured, and then procured and used for their intended purpose. Sometimes these intended purposes must change or are adapted, re-configured, or even modified to some degree to be used in special circumstances, such as the one occurring today.
A lot of offsite or special testing sites have been designated to offer assistance in testing for or treating patients with this virus. Aside from testing, a lot of healthcare organizations are creating or using isolated areas, discharging patients to clear beds to handle the flood of patients in their facility to treat those who need it most. These isolated areas may not have been designed to accommodate these patients or have the technologies to interface with the clinical equipment necessary to treat COVID-19 patients, therefore it will take some strategic improvising between clinical leadership, information technology, and clinical engineering.
Clinical Engineering Departments Have an Essential Role with Medical Devices
Every organization is unique in its desire and ability to support clinical equipment and medical devices based on numerous factors from third-party oversight, original equipment manufacturer contracts, to in-house clinical engineering programs. The idea is regardless of who is maintaining these clinical technologies, these groups of individuals should have the knowledge, ability, tools, resources, and wants and desires to help during this COVID-19 crisis. It is important to get the message out to them so they can quickly plan and assist with the organization’s strategic objectives and goals during this time.
Clinical engineering should have a tremendous role in assisting the organization by helping out in any way they can and offering assistance when needed. What this can entail is, at the discretion of clinical leadership, helping convert single patient rooms into doubles. Helping with the moving, configuration, and setup of physiologic monitors, beds, nurse call and communication, thermometers, ventilators, and so forth. Right now, clinical engineering has a strong presence with 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, clinical engineering can assist in configuring medical devices for data collection integration into the electronic medical record. This may require mounting hardware, configuring middleware or data captures, helping with the activation of data jacks, and ensuring wireless connectivity is adequate. These sites may not currently be equipped to do so, in some cases, data will be collected, stored, and then transmitted at a later time. Clinical engineering knows what technologies or infrastructure requirements may be needed for the devices that may be placed in these areas. Additionally, clinical engineering must work with clinical leaders to voice their concerns before the shifting of resources takes place.
Many have indicated that the use of stationary imaging equipment is not recommended due to the cleaning procedures and the potential virus exposure to other patients and staff. The use of a mobile x-ray is a recommended method for those that need this service. As more patients are in isolation, practicing standard precautions and other measures, these medical devices are more likely to be used in these environments and will see more wear and tear more frequently, as well as become more urgently needed, turning it into a mission-critical device. This could mean more regular service calls, calibrations, and the need for spare parts.
One of the largest departments impacted by this crisis is the use of the hospital’s clinical laboratory. Lab equipment use will likely be heightened and therefore that department’s needs and wants should be a priority. It is not common for in-house clinical engineering groups to maintain equipment in the clinical labs, but they may be the first call. This first call responsibility is critical and often requires the engagement of the manufacturer or vendor. It’s important to escalate the clinical lab’s needs no matter how small. During this time of prolonged or irregular use, it’s likely that vendors will be busy so even having purchase orders ready is advisable to prevent any delays or extended downtime.
With the FDA’s recent enforcement policy for ventilators, accessories, and other respiratory devices during this emergency, it will be critical to carry out a plan when converting medical devices. The enforcement policy by the FDA has indicated that if necessary, anesthesia machines can be used for ventilation for patients with COVID-19. 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 medical devices. They may have the knowledge to assist in upgrading hardware or software to make them more adaptable for this new environment.
Preventing Contaminated Medical Devices and Medical Equipment
During a disease epidemic, it’s critical to handle reusable medical devices as potential sources of transmission. Treating all surfaces as if they are infected requires knowledge of what to do. Can this surface be sanitized and with what? How long does it take, where should I do it, and so forth? One of the most important things anyone can do is read the instructions for use for a medical device. Read this document, review it with staff, thoroughly explain it with nurses, verify everyone understands what surfaces can be sanitized, what surfaces cannot, and what can be sterilized. Device have to be wiped down regularly and most staff often use the wrong product or a product that can damage screens or seep into crevices of devices. It is recommended to use the EPA’s List N: Disinfectants for Use Against SARS-CoV-2. Before applying any of the listed products, it is best to contact the manufacturer of the medical device to ensure it is safe to use on the surface.
The next question is what to do with medical devices that are not in use that have been exposed to patients with COVID-19, what is the process? Working with central sterile processing departments will be necessary to ensure proper documentation, tagging of equipment, workflow, and determining how is the device going to be handled and how will it be identified.
A healthcare delivery organization must continuously offer resources to the central sterile services departments to properly follow medical device manufacturer guidelines to decrease the risk of disease transmission from contaminated devices. For example, GE recently shared a FAQ page on cleaning and disinfection. Central sterile services departments may be overwhelmed with an influx of medical devices to reprocess which can induce pressure and this can quickly turn to error. This also brings up the criticality of an organization’s sterilizers and the taxing effect reprocessing may have on them. Making sure sterilizers are fully operational, limiting any downtime, and passing routine tests will be critical.
The FDA has also issued an enforcement policy for sterilizers, disinfectant devices, and air purifiers, providing guidance for the healthcare industry. This document is used to help expedite turnaround time of sterilized or disinfected medical equipment. The FDA has indicated that during this emergency, they do not intent to object to minimal modifications or distribution to already FDA cleared or FDA approved sterilizers, disinfectant devices and air purifiers that intend to be effective against the COVID 10 virus. Therefore, these devices and disinfectants that can minimize the viability of the COVID 19 virus can be used or modified as long as they continue to meet performance standards. The modifications may allow some devices to reduce their cycle time or count to process more medical devices after being in contact with COVID 19.
During an outbreak, instruments used for patient care may see higher use rates. For example, bronchoscopes could be in high demand, while clinicians wait on instruments to be decontaminated or sterilized between patients. In addition to the scarcity of available devices, those devices in clinical use may see increased wear rates. Worn or damaged medical devices likely will not meet performance standards and could contain pathogens hiding in crevices that can’t be reached with standard cleaning and decontamination methods.
Basic Medical Equipment Can Be the Most Impactful During COVID-19
In situations such as the one today, basic medical equipment like thermometers, whether tympanic or oral can be detrimental, and therefore of high priority. Ask the clinical engineering department to fix these items and move them back into circulation. Basic low-risk medical equipment and devices typically do not require any special knowledge or training to fix, therefore it should be an easy request with quick turnaround time.
One of the most basic items taken for granted is medicine and linen cabinets. Maybe because they don’t contain all the technology like many other medical equipment, but the medicine and linen cabinets are critical in maintaining operations. With the use of so many resources, the reallocation of spaces, departments, and even facilities, these cabinets which in many cases are mobile, but never really moved, need to be moved. These cabinets that were maybe never locked, need to be locked. The clinical engineering department may not be responsible for these items or maybe they are, regardless, they should have the skill sets and tools necessary to help with the installation and fixing of things like bearings, bushings, drawers, replacement of casters, wheels, and brakes.
While in crisis the non-essential medical equipment that runs or powers the more critical items are often forgotten. For instance, batteries are found in nearly all portable medical devices, devices that are or will be used to treat and monitor COVID-19 patients. Having batteries fully stocked for the medical equipment is warranted and necessary. If and organization is trying to keep devices segregated and without the need to swap between care units, having batteries on hand is essential.
When in crisis, there is nothing is too small, too odd, or too little, we can all do our part. Even the most basic devices such as wheelchairs, beds, linen cabinets, and carts need attention. All clinical and facility supporting staff can assist while staying safe.
- Visit CTEK COVID-19 Communications for the latest information for healthcare during the coronavirus crisis.
- FDA Enforcement policy for Clinical Electronic Thermometers During the Coronavirus Disease.
- FDA Enforcement policy for Infusion Pumps and Accessories During the Coronavirus Disease.
- Contact us if you have any questions or need help with creating user awareness.