By K. Richard Douglas
In a car dealership, if a car comes into the service department for an oil and filter change, it is likely to go to the lube guy or girl. A car with a dent in the quarter panel would go to the body shop specialist and a car needing more extensive mechanical work, or a recall repair, may go the one of the automotive technicians assigned to the service bays.
There is a clear delineation of responsibility in the service department of the dealership and tasks are well understood. It is not likely that the sales department will call a technician to the sales floor of the dealer to sell a prospective customer a car. It is equally unlikely that the lube bay in the service department would call up a salesperson to do an oil change.
The responsibility for certain mechanical and electrical devices in a health care setting may be less clearly delineated. At the dealer, this problem may mean that a customer is not met in the showroom by a salesperson or a car coming into the body shop is not evaluated. These situations don’t have the same urgency as the well-being of a patient.
In the health care setting, there are many types of equipment that can fall into gray areas. This gray area equipment may not have a clearly defined responsible party assigned to it for repairs or maintenance. There are no national standards that clearly define responsibility for this gray area equipment.
There is increasing overlap between HTM, facilities, IT/IS and security; which creates confusion. Integration of many devices has made this trend even more pronounced between biomed and IT. Reporting structure can often play into these determinations.
The importance of defining responsible parties isn’t only to aid in expediting service for that equipment but also in order to clearly document and classify it in CMMS as part of that biomed department’s medical equipment management program (MEMP). It is important that this equipment be defined as medical equipment.
In 2022, AAMI’s Technology Management Council (TMC) brought focus to this situation by conducting a survey of HTM leadership at about 120 healthcare delivery organizations (HDOs) to determine how responsibility is assigned for gray area medical equipment.
TMC utilized the experience of its members to identify several devices that might be categorized as gray area and asked survey participants to identify any additional equipment not included in the survey. The survey asked participants to select the department at their facility that was tasked with managing and maintaining the listed gray area equipment.
The TMC pointed out that it is important to have written documentation and a stated policy clearly delineating departmental responsibilities for these gray area devices and systems. This will help expedite service calls and ascertain that proper maintenance is performed throughout that equipment’s life cycle.
Whether it’s a nurse call system, beds, OR booms or a fetal monitoring network; the responsibility isn’t always handled the same way. Has the hospital bed morphed from a piece of furniture to a medical device? How do tele-health or home healthcare devices impact responsibilities?
According to an AAMI press release about the survey; “The TMC compiled a list of more than 45 types of medical and non-medical equipment that tend to fall into gray areas.”
The results of the survey and resulting report don’t seek to be a prescription for biomed and other departments as to the correct roles and responsibilities for this equipment, but rather the survey presents data that suggests some guidance for the equipment referenced.
Beyond the data gathered in the survey, the personal experience of HTM leaders provides insights into the practical application of assigning gray area responsibility. TechNation queried several leaders and included their real-world experiences and insights.
Salim Kai, MS, CBET, director of clinical engineering at Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio, says that the issue of gray area equipment and responsibilities isn’t new, but it has gained more focus today with advancing technology.
“It has always been challenging to define the boundaries and responsibilities of managing some of the equipment,” he says.
Kai says that it may be more noticeable today because of all the sensor automation, connectivity, cybersecurity and interoperability with devices.
“Also, the lines between consumer electronics and medical devices are more blurred. For example, the heavy use of the Internet with smartphones, tablets and software apps by health care professionals to display biomedical data is an expectation and no longer [just] nice to have,” he says.
It Has Always Been that Way
Jim Fedele, CBET, senior program director of clinical engineering, BioTronics for the North Central and Central Regions at UPMS in Williamsport, Pennsylvania, says that clinical staff should not be left in a quandary because of any gray area confusion.
“In my professional journey, it seems that whenever there’s an issue with equipment, a system, or a general nursing challenge, the resolution often falls to the biomed department. Take, for instance, exam tables, overhead lights, stretchers, beds and, lately, items like RTLS location tags and temperature tags. It makes sense, though; biomed departments excel at customer service, which naturally leads nursing staff to seek solutions from us,” Fedele says.
He says that during his tenure at Aramark, he often helped price new accounts and noticed many items that seemed beyond the department’s usual scope.
“I’ve always found this to be a quandary. I aim to please, and turning down someone in need doesn’t sit well with me. I’ve seen the exasperation of nurses trying to provide patient care while caught in a blame game. Ultimately, it’s the patients who suffer, as the nursing staff’s focus shifts from them to resolving these issues,” Fedele says.
Many areas of responsibility were simply decided years ago and these decisions remained written in stone regardless of advances in technology.
“I have had the opportunity to work at multiple hospitals and organizations. One of the first things I ask when joining a new organization is checking on these gray areas. Beds, gurneys, blanket warmers, sterilizers, nurse call, applications, PACS, radiology and networking access,” says Renato Castro, CHTM, CBET, BSBMET, assistant manager of biomedical engineering at Stanford Health Care Tri-Valley in Pleasanton, California.
He says that these delineations, of who owns these, are usually decided early on and then it becomes one of those decisions that leadership tends to say “it has always been that way.”
“This is usually understood by staff that have been around for a while and is just taught as tribal knowledge. These gray area items are rarely explicitly discussed during new hire orientation,” Castro says.
Networked equipment most often crosses lines of responsibility.
Some firsthand perspective comes from Leo Velasquez, manager of clinical engineering and central equipment at Cook Children’s Medical Center in Fort Worth, Texas.
“One recent example was a project to bring the Etiometry Platform (an automated data aggregation and analytics platform) to the cardiac intensive care unit,” Velasquez says.
He says that a work team consisting of an MD, nursing, biotech, lab IS and clinical engineering worked together to bring together patient specific information in an aggregated format with predictive analytics.
“We have learned from experience that when we get new equipment – like EKG carts, portable X-ray machines or ultrasound machines – that is networked, we need to have someone from biotech available to make sure we get the connectivity to the correct location working correctly,” Velasquez says.
He says that clinical engineering also works with facilities or plant operations for all electrical, plumbing, medical gases and structural needs. In areas like sterile processing, it relies on them heavily.
“The area of responsibility is roughly the same where we handle the device itself and they have everything coming into and going out of the unit. We do work closely with both biotech and facilities/plant ops,” Velasquez adds.
Temperature and Humidity
Steam, that vaporous gas form of H2O, can be the catalyst for biomed and facilities to get involved with connected projects. It can also be the impetus for areas of responsibility; mostly already defined, but often requiring joint resolution.
“Our team was called to evaluate issues with our sterilizers because the device did not pass the morning test. After performing numerous troubleshooting techniques our team discovered that the issue was coming from the steam generators that are maintained by the facilities operations team,” says Ralph McCall, assistant director of healthcare technology management at Texas Children’s Hospital in Houston, Texas.
He says that his department partnered with the facilities team and discovered that the steam generator had a heating element that was faulty. Once the heating element was replaced, the HTM team ran multiple tests and all tests passed.
“One of the things that helped to troubleshoot this issue was noticing that more than one device had the same issue so our team looked into the device that was supplying the steam. When it comes to sterilizer or washer devices it can be challenging for our clinical teams to identify which department can resolve their issues. Overall, these devices usually create a close partnership with facilities and HTM because the items facilities maintain supplies steam and water, and we support the medical equipment,” McCall says.
Kai recalls a time when temperature variation and a lack of monitoring impacted $50,000 of medications.
“Temperature Trak system was purchased by the hospital to provide 24/7 remote monitoring and documentation of temperature and humidity in pharmacy and dietary. It offers a range of hardware, software and accessories to suit different needs and comply with regulations,” Kai says.
He says that there are two components to the system: Wi-Fi transmitter and the probe (hardware). This was a multiphase project with dietary and pharmacy to go first. HTM had to configure units, facilities had to install physical hardware units, support after installation was assigned to IT/facilities and HTM.
“IT to address access point wireless issues, HTM to provide system maintenance and swap outs as needed and facilities to provide service coordination for refrigerator/freezers or warmers,” Kai says.
He says that HTM would do a little trouble shooting to confirm whether or not the problem is because of the TempTrak hardware probe or the Wi-Fi system. HTM would follow through as appropriate: If the issue is related to a Wi-Fi transmitter replacement because of the TempTrak OEM. If issue related to the network system, open an iSupport ticket, to be assigned to IS network engineering, if due to Wi-Fi system. HTM would work directly with IS network engineering to troubleshoot and resolve the problem. Probe calibration is annual or whenever there is doubt by a user calibration is validated.
Kai says that this example is about managing technologies that affect patient care which has an IT and Facilities component, where HTM shines through. Kai offers these tips for success; “assign a project manager to track the deliverables and project expectations. Have solution-oriented content experts from each department to participate. Have a project charter and statement of work with the vendor that defines deliverables.”
Depend on Biomed for a Solution
The example of steam in McCall’s example, as the centerpiece of a multi-departmental effort, is not unique. Much like networked devices, when responsibilities overlap into two departments, the responsibility for steam has required biomed to correct a problem that involves facilities.
Jim Arnold, director, east region of biomedical engineering for Piedmont Healthcare in Georgia, points to the need for facilities engineering to provide quality “dry” steam to sterilizers in sterile processing departments. He says that one way this can be accomplished is by implementing and executing a strong steam trap maintenance program. He had one experience with this in the distant past.
“We hired a steam expert, which resulted in finding some measurements within and some measurements just outside the acceptable steam quality range. Our problems were intermittent and it was still a challenge to convince FE that house steam was an issue,” Arnold says.
He says that when this happened, the biomed department had a very strong and resourceful biomedical technician on staff who had primary responsibility for maintaining the SPD equipment.
“He left no stone unturned as he researched potential solutions. He researched online, spoke with vendors in the field, read articles and spoke with anyone who had an opinion. Ultimately, he came across what we deemed to be a great solution that we, (biomed), could implement ourselves,” Arnold remembers.
He says that biomed ended up installing cyclonic steam separators just in front of the steam entry point to the sterilizers, which solved the issues as a result of their ability to very effectively remove moisture from the steam prior to its entry into our steam sterilizers.
“The positive impact was recognized immediately and we learned so much from the experience,” Arnold says.
Arnold suggests that HTM document its steam, water and air quality and pressure when machines are working properly. Knowing what one should see when things are working well can be very helpful when troubleshooting issues and comparing readings. Also, daily rounding in an SPD environment to inspect the readings can effectively help a technician keep his or her finger on the pulse of equipment.
With more medical equipment and systems crossing lines of responsibility, or advances in technology creating more medical devices, it is important to have written guidelines to identify service providers. Whether it be steam or networked devices, hospital beds or nurse call, the need to expedite and document a service response is crucial to patient care.
