Keeping pace

Medical devices are no longer pieces of equipment that stand alone by themselves. They are networked devices in systems of care that require a different skill set to maintain and keep operational. The old days of biomed technicians fixing isolated mechanical devices are long gone.

For those who manage or contract these services, it may be a critical time to examine how networked medical devices are changing clinical care and, therefore, to examine the approach to planning for medical devices and their maintenance.

Biomedical engineering (BME), clinical engineering, and health technology management are a few of the possible names that commonly are used for this service, and the profusion of titles is indicative that the skill set for medical equipment maintenance and management has been upgraded.

Senior hospital leadership must assure that it is getting the best medical equipment maintenance service for its inventory of medical devices. The medical device world has changed and hospitals have to keep pace to remain on the cutting edge.

New rules and regs

While hospital leaders may not be fully aware of the changing role of clinical engineering, the medical device industry has recognized the new challenges and is putting new rules and standards in place.

Primary among these is the International Electrotechnical Commission (IEC) 80001 Application of Risk Management for IT-networks Incorporating Medical Devices, which currently is a voluntary standard that requires a systems approach to medical device and network management. IEC 80001 applies to wired or wireless networks that include at least one medical device. As medical devices are added to the network, network performance issues may become more challenging, and information technology (IT) and BME both need to be involved in planning capacity and resolving any issues.

The Food and Drug Administration's (FDA's) classification and regulation of medical device data systems (MDDSs) came into effect last year and, unlike IEC 80001, the MDDS regulation is not voluntary. In simple terms, MDDSs transfer, store or display medical device data or convert medical device data formats within preset specifications, without controlling or altering the function or parameters of any connected device.

The MDDS regulation states that if a hospital builds its own MDDSs (including systems that were built before the ruling and that are still in use), it must comply with the same types of regulatory rules to which medical device manufacturers are subject. This includes registering the hospital with the FDA, listing the MDDSs with the FDA, complying with the FDA's quality system regulations, and reporting MDDS-related problems to the FDA. How many of a hospital's doctors tinker with data electronically? And how many of their BME departments are ready to inform them of the issues?

And, as most of the health care industry knows, the electronic medical record (EMR) will be meaningfully used at hospitals as IT departments and chief information officers continue to deploy systems and integrate them closely. As the idea of the entirely connected world — or the "Internet of things" — develops, the hospital environment will be no different; stand-alone medical devices will become extinct. As these devices are integrated, the ability to handle software upgrades in a networked environment requires new policies and procedures so that the network is not brought down when a device is repaired.

As a point of fact, hospital BME departments should know the Internet Protocol addresses for already-attached medical devices. They should know the software version running on the system (it is also helpful for them to track the software versions for all the equipment on their inventory — even for devices not connected to the network — so that they can process updates and recalls). Neither question will be answered easily.

The nonprofit ECRI Institute, Plymouth Meeting, Pa., recommends that all medical equipment maintenance programs be reevaluated to ensure that they can meet these new challenges. This applies to both in-house staff and contracted services, regardless of who maintains the device. The bottom line is that anyone has the capability to bring down the network.

Imagining the now

Physiologic monitors, anesthesia units and ventilators are not the only devices that transmit essential data. The patient admission process is evolving into one that routinely includes devices that transmit data automatically to the EMR. For example, vital sign monitors and scales may electronically transmit heart rate and weight to the EMR, alleviating the intake nurse from having to enter these and other information manually into the patient chart. Patient beds may be used to monitor weight gain, as water retention can signify heart failure. Infant incubators may transmit body temperature to an alarm-management system.

What's even more interesting is that these devices now are so much better designed — whether or not they are transmitting data to the EMR — than devices acquired even seven years ago. However, many BME departments and other service providers still are using inspection and preventive maintenance policies that originated 20 or 30 years ago, when medical devices experienced many more electrical and mechanical failures.

Additionally, when devices fail these days, they power down or cease operation, and usually do no harm to the patient. It is a rare event when preventive maintenance can be linked directly to the prevention of a failure. However, this should not be interpreted as a reason to abandon medical equipment preventive maintenance.

For many years, the Joint Commission has allowed BME departments to lengthen the inspection and preventive maintenance (IPM) intervals established by the medical equipment manufacturers if they have sufficient evidence that longer intervals are safe. Unfortunately, the Centers for Medicare & Medicaid Services (CMS) issued a memo to their inspectors on Dec. 2, 2011, that conflicts with the Joint Commission policy and severely limits the ability of BME departments to change the maintenance intervals or procedures for equipment critical to patient care and safety. (The document can be accessed at http://www.cms.gov/surveycertificationgeninfo/pmsr/itemdetail.asp?itemid=CMS1254595.) ECRI officials are discussing the impact of this change with the CMS and the Joint Commission as well as with biomedical engineers.

Finding the time

So, BME departments are using IPM policies developed years ago that result in minimal or no additional benefit to the hospital or patient while new needs require that they devote more time to support networked medical equipment. How do they find the time?

Hospital support departments have to demonstrate their value and BME departments can do so by benchmarking their performance — firstly, internally over time and, secondly, against peer organizations. With data collected from IPM activities, each department should evaluate where it is having the greatest impact with its IPM activities and where it can cut time in order to devote more resources to support networked medical devices and carry out other value-added tasks like medical equipment planning for new construction projects.

Why bother to routinely inspect infusion pump flow rates when a hospital's fleet of pumps has never experienced any variation in flow rates that are outside the permitted range? Instead of inspecting each pump annually, can the BME department analyze failure records and transition to an inspection of infusion pumps every two years or, perhaps, monitor a small sample of the pumps?

ECRI Institute recently analyzed the maintenance of infusion pumps for a large hospital and found that staff could save almost half a full-time equivalent (FTE) employee's time by lengthening their IPM intervals. The time saved could be used for other activities. Now, if the same thing were done with electrical safety testing programs for video monitors and other electrical apparatus common to medical devices, soon the hospital would find one FTE or more to support new clinical engineering initiatives.

If a BME department sees that it can save time by lengthening inspection intervals, it will need to delay the implementation of the new intervals until it gets clarification from CMS that changes to the intervals are permitted. Obviously, inventory management is essential, not only to find device groups in which IPM practices may be changed, but also to add the networked information to each device so safety is increased.

Besides IPM frequencies, other good ways to benchmark health facility BME services may include these commonly used questions:

• How does the BME department's performance this year compare with that of the last three years?

• How does the department stack up against BME departments or contracted services in similarly sized hospitals in the area?

A networked world

BME departments have to change and change quickly if they haven't already started. Because medical devices now are networked, BME and IT must work collaboratively to ensure patient care.

Facilities directors supervising BME departments will be expected to meet this challenge. As the skill sets change, job descriptions and training to maintain competencies also may need to change. Leaders with authority for BME may need to navigate service-level agreements with IT department leaders.

One hospital is meeting this challenge by having its IT program and BME department formalize their operating procedures and relationships to include the following elements:

• A formal BME/IT alliance committee that meets via webinar or teleconference at least quarterly and more frequently, if necessary. It comprises senior BME and IT leadership who work together to oversee the creation of policies and procedures and to enhance communication about implementation changes.

• Shared staff ensure a strong communication loop and have written device network responsibilities. Basically, BME is responsible for the connectivity and hardware to connect medical devices to a network, while IT handles connectivity issues from the wall plate to the hospital networks for most devices. However, there are still a few gray-area devices and networks where responsibility may be unclear.

• BME and IT have established degrees of separation to understand the role of the device and to determine maintenance responsibility. For instance, a "0" indicates that the device touches the patient and is the responsibility of the BME department. On the other extreme, a "3" indicates that the device or system is fairly removed from the patient and more of an operational tool than a clinical device, so IT would be responsible for maintenance.

A "1" or a "2" device (e.g., blood gas analyzer) does not necessarily touch the patient, but it may measure the patient or it is vital to patient diagnosis (e.g., image print network). Devices that are either a "1" or a "2" have primary departmental responsibilities assigned that may cross both departments. This usually means that the responses of the help desk must be carefully coordinated to ensure that clinical staff is not bounced between departments.

At another hospital, a new position was created — clinical systems engineer. This position is responsible for liaising with IT, liaising with regulatory bodies and developing a strategic medical device integration plan for the EMR. Every hospital may not be able to allocate the resources to such a position, but the freed time found through an IPM analysis may allow existing staff to assume some of these roles.

Planning for change

As the number of networked medical devices continues to expand, the BME's ability to repair a freezer or respiratory analyzer soon will be overshadowed by the need to ensure that information gets from the medical devices to the EMR.

The sooner a health facility starts planning to provide value-added BME services that ensure this kind of medical device integration, the smoother will be the ultimate transition.

Robert Maliff is a director for the Applied Solutions Group at ECRI Institute, Plymouth Meeting, Pa. He can be reached at rmaliff@ecri.org.