By John Wallace
Reports abound about the latest novel coronavirus outbreak. The World Health Organization (WHO) has declared COVID-19 to be a pandemic and the increasing number of patients support that decision.
News reports have questioned the availability of adequate medical devices to treat and care for patients. The accounts mention everything from hospital beds to ventilators.
Along with the need to acquire medical devices is a need to be able to maintain and repair devices as the COVID-19 patient population continues to grow.
Many manufacturers do not provide access to repair documentation, limiting who can repair the equipment, according to a news release from the U.S. PIRG Right to Repair campaign. That discourages third-party medical repair companies or in-house medical engineers from trying to fix things, the news release added.
“In order to keep equipment that is critical to treating COVID-19 working with the least possible downtime, medical device manufacturers should immediately release all repair documentation and software, schematics and manuals for that equipment, especially ventilators,” said U.S. PIRG Right to Repair campaign director Nathan Proctor. “The fastest repair service is when hospital technicians have what they need to do repairs in-house, or can hire qualified technicians at their discretion. Preventing repair is generally a bad idea. That is even more true in a crisis, when systems are under stress. It could mean the difference between life and death.”
In addition to ventilators, other equipment needed to diagnose and treat COVID-19 will likely see increased use and require maintenance. Imaging equipment used to evaluate patients and determine pulmonary conditions is likely to see increased maintenance requests and also benefit from additional repair information.
In a statement, GE Healthcare said, “GE is committed to the safe and compliant servicing of life-saving and sustaining regulated medical devices. GE will continue to provide all appropriate access to service this equipment by our own employees, customers and third-party service providers.”
Some manufacturers have previously claimed that independent repair is less safe or reliable than those performed by OEM staff. However, an in-depth study showed there are no safety issues with non-manufacturer repair. In 2018, the Food and Drug Administration investigated repair and maintenance issues and found that non-manufacturer repair was safe, saying that independent technicians, hospital technicians and manufacturers all “provide high-quality, safe, and effective servicing of medical devices.”
“Whether or not they are employed by the manufacturer, a qualified technician with the right information and tools can fix the equipment. Obviously, this is an all-hands-on-deck moment, and we should remove barriers that prevent qualified technicians from servicing medical equipment,” said Gay Gordon-Byrne, executive director of Repair.org, a national coalition backing Right to Repair.
“Manufacturer-only repair policies hamstring our medical systems. Repair information should never have been withheld,” added Proctor. “I urge manufacturers to release the information hospitals need to keep treating COVID patients – and for government leaders to step in if they do not. In this time of crisis, we must put patients’ lives first.”
Binseng Wang, vice president of program management at Sodexo, addressed this subject in a recent LinkedIn post where he shared an article titled “Farmers Fight John Deere Over Who Gets to Fix an $800,000 Tractor.” Some in health care argue that costly OEM training sessions mandated as necessary to be able to work on equipment, expensive parts only available through the OEM and inaccessible equipment manuals are obstacles to affordable medical device maintenance and repairs.
“Doesn’t medical equipment deserve at least the same level of attention as farming equipment in terms of the Right to Repair?” Wang asks in his post.
When asked if he or his colleagues had experiences during this COVID-19 situation that is impacting patient care in a negative way, he pointed to preventative maintenance (PM) schedules and other concerns.
“We all experience human and material resources challenges in this crisis and are working with the accreditation organizations to seek some flexibility from CMS on the 100% PM requirement. We need to focus our limited resources on the ICU and respiratory support equipment for the sake of the COVID-19 patients,” Wang wrote.
International Association of Medical Equipment Remarketers and Servicers (IAMERS) President and Executive Director Diana Upton said it is vital that technicians be able to service equipment.
“The health care ecosystem is experiencing extraordinary stresses and needs,” Upton said. “Demands are changing dynamically. It’s vital to the whole health care ecosystem, and with respect to the imaging industry, that device servicers have access to service keys and technical information needed to safely maintain the equipment. No doubt this cooperation will help for accurate diagnosis and contribute to saving lives.”
Steven Kelley, regional director of biomedical engineering for Piedmont Healthcare in Atlanta, said he is experiencing issues in regards to a shortage of equipment, including ventilators (vents).
“Yes, we are dealing with trying to get more vents. The issue we run into is the vents that are available are not our standard and how to get quick training on them,” Kelley explains. “Another issue is some vendors have said they are stopping PMs and any non-critical service events. We have contacted DNV and they say the PM is critical and the equipment is considered unsafe when it is past the recommended PM schedule time. They did say if we cannot get a vendor in then we should make sure to document everything. I have contacted the vendors and asked for a statement on their letterhead of how long a device can go without a PM and still be considered safe. I have told them that we will take that info and change all our PM schedules going forward,” Kelley writes in an email “Because if it is safe now it will be safe always. So far they have backed down and are providing any help we need.”
The Right to Repair issue is also causing concerns as some OEMs have restricted travel for employees, including service personnel. Also, many health care facilities are not allowing non-hospital employees within facilities.
Perry Kirwan, vice president technology management at Banner Health, shared his thoughts.
“It is interesting to me to see that OEMs are not in complete alignment with regulatory agencies. Some OEMs are not considering scheduled/preventative maintenance as a critical activity however the regulatory agencies (for now) are slow to relax those requirements,” Kirwan said.
“In the end – a lot of this is going to point to the value of in-house, third-party and OEM all working together in a coordinated way to make this work,” he added.
David Francoeur, senior vice president marketing and sales at Tech Knowledge Associates LLC, is familiar with this issue. He has attended several meetings, FDA workshops and AAMI events regarding the servicing and remanufacturing on medical devices.
“In response to your questions, as well as in general, there are a few dynamics going on right now in light of the pandemic regarding servicing/maintaining of medical devices, in particular, ventilators, in health care facilities,” Francoeur explained. “This all stems from the COVID-19 pandemic. In many situations, health care facilities are not allowing service representatives into their facilities to perform maintenance, or for any reason. In many cases the in-house HTM professional doesn’t always have the manufacturer’s support in terms of documentation, technical support and/or parts to name a few. Within each health care facility, there are typically hospital employees or independent service organizations performing the necessary management of medical devices for the individual facilities which are allowed and required to be on site to support the maintenance of all medical devices.”
“From where I sit, this is a perfect storm scenario. Non-hospital employees are not being allowed to go into health care facilities for concern they may be carrying the virus,” he added. “This is creating the perfect occasion where the original equipment manufacturers (OEM), and the non-manufacturer independent service organizations (ISO) as well as in-house healthcare delivery organizations’ (HDO) HTM professionals can and should be working together to support the patient. By having ISO/HDO HTM professionals on site, they can be the eyes and arms of the manufacturer, and ensure through proper support to include, but not limited to, documentation, communication, technical support, parts procurement, key metrics demonstrating appropriate levels of quality in areas of preventive and corrective maintenance actions. These types of activities could include service manuals, phone support, possible Facetime/Skype-type technology, parts, etc.”
“Working collaboratively, manufacturers and non-manufacturers providing support will ensure the best possible outcomes for the most crucial medical devices needed to properly care for the patients,” Francoeur said. “The COVID-19 virus attacks the respiratory system, and ventilators are essential in managing a patient’s care. Two very legitimate concerns we all should have; 1. Do we have enough ventilators and other like devices to support the need? 2. Are the devices we have in good working condition and ready for use?”
“A third thought we may want to start thinking about is can we initiate a process where, if the demand in one geographic area is greater than another, can we find ways to share and move the devices to the need? Ventilators will be crucial to a patient’s successful outcome,” he continued. “While most manufacturers have a pretty good understanding of their products and their territories/market share, they do not necessarily have a solid grasp on the whole picture.”
In closing, a collaborative community is the solution everyone needs.
“Working together, OEMs, ISOs and HDOs as an HTM community, having oversight of all products that are available and in what condition within each health care facility, will be paramount to our overall success,” Francoeur said. “Let’s use this opportunity to demonstrate to the health care community that we can come together for the sake of the patient to do whatever it takes to ensure the highest level of safety and quality for maintaining ventilators/medical devices that we can. I believe everyone within the HTM community is aware and impacted on their level. What I’m not confident in, is that there is a big picture perspective that is looking for solutions that will have the great opportunity for the overall success and would be most valuable and meaningful across the board.”
Patient safety is the goal for all involved. Individuals with the training, knowledge and experience to maintain and repair medical equipment is what health care facilities need, and many think it should not matter if the individual is employed by a hospital, an ISO or an OEM.
For now, Kelley said he and his colleagues are here to help.
“We feel we are in the medical field. This is what we do. We are around contagious patients all the time every day. This is nothing new. It is time for the biomed industry to stand up with all the medical providers and do our part to make sure our equipment is safe to use and assist with training and user support,” Kelley wrote.
Note: Several OEMs were contacted for this article. The article will be updated if they comment.
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