FINIAL MIVP REPORT

DEPARTMENT OF THE ARMY US ARMY MEDICAL DEPARTMENT BOARD

2599 WILSON WAY, SUITE 369 JBSA FORT SAM HOUSTON, TEXAS 78234-7803

REPLY TO ATTENTION OF

MCCS-FB-TM 26 April 2013 MEMORANDUM FOR Defense Medical Materiel Program Office (DMMPO), 693 Neiman Street, Room 2E-118, Fort Detrick, MD 21702 SUBJECT: Multi-Channel Intravenous Infusion Pump Customer Assessment Report (USAMEDDBD Project 7-12) The use of trade names in this plan does not constitute an official endorsement or approval of the use of such commercial hardware or software. This plan may not be cited for the purpose of advertisement. 1. INTRODUCTION. a. Purpose. The Defense Medical Materiel Program Office (DMMPO) requested that the US Army Medical Department Board (USAMEDDBD) conduct a customer assessment (CA) of the Multi-channel Intravenous Infusion Pump (MIVP). The performance data collected on the three candidate MIVPs will assist the joint Services in their decision-making process. Medical personnel from all the Services, working in a simulated operational environment, provided performance data that were compiled and analyzed to produce this CA report. The CA assessed the operational utility, functionality, and usability of each candidate MIVP using threshold values from essential characteristics (ECs) provided by the DMMPO. b. System Descriptions. The three systems assessed are commercial off-the-shelf intravenous (IV) infusion pumps that can be used in the process for fluid replacement. Two of the candidates were single-channel IV infusion pumps and one was a dual-channel IV infusion pump. The systems are designed to deliver measured amounts of IV solution with added medications over time. A multi-channel capability configuration is used by stacking multiple single-channel infusion pumps. The following system descriptions were taken from each manufacturer's operator manual: (1) System A is a single-channel infusion pump of modular design and infusion technology for stationary, mobile, or private use. Up to three infusion pumps can be connected together using L-rails on the bottom of the system and grooves on the top. The infusion pumps can then be fastened to a drip stand or rail using the pole clamp provided. The infusion pumps are supplied with power via an integrated power supply and built-in cables. Alarms are signaled by a row of light-emitting diodes and a loudspeaker. The housing mainly consists of the bottom part, the upper part, the front part, and the operating device. The battery is inserted in the rear of the housing upper part. The thrust bearing of the tube pump (peristaltic pump), the

MCCS-FB-TM SUBJECT: Multi-Channel Intravenous Infusion Pump Customer Assessment Report (USAMEDDBD Project 7-12)

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spring-mounted pressure elements for the two pressure sensors, the air-in-line sensor, and the shackle for the slide clamp of the line are located at the rear of the operating unit. The infusion pump is mechanically locked in its closed position via three metal pins. A motor-driven door bolt is used to lock the hinged control panel. In case of an emergency, the control panel can be opened through an opening on the left side of the housing top. During normal operation, this opening is closed with a plug. A picture of system A is shown in figure 1.

Figure 1. System A Single-Channel Infusion Pump.

(2) System B is a dual-channel pump. It comes with multi-programming capabilities to provide a highly accurate fluid delivery rate from one or both channels. It is operated using a customized administration set and comes with a rechargeable internal battery. The battery charger that has a molded-in clamp assembly and infusion pump can be attached onto the IV pole. System B incorporates an anti-free-flow protection valve on the administration set. The customized IV lines (on each channel) of the system are equipped with an anti-siphon valve that prevents free-flow toward the patient when the IV line is not attached to the pump. When the pump is attached to the IV line and delivering fluid, the pressure delivered by the pump opens the valve. The one-way valve prevents one channel from infusing into the other channel. The pump comes with an anti-bolus system. The anti-bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm. Upon the detection of a downstream occlusion, the alarm is activated and the pump returns the IV line pressure to neutral within 15 seconds. Neutral line pressure is achieved by the reverse operation of the pumping mechanism and measurement of the IV line pressure through the in-line pressure detection system. To improve the detection of air in the IV line, the system uses an air-in-line accumulation system in addition to the standard single bubble detection. This feature monitors the volume of air that passes through the IV line by accumulating the volume of individual bubbles of 1 milliliter (mL) over a moving window of 15 minutes. The limit is not configurable. Although an individual bubble may not exceed the preprogrammed threshold, the cumulative volume of bubbles of 1 mL in volume may exceed the limit during the 15-minute window and


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initiate an air-in-line alarm. A picture of system B, dual-channel infusion pump, can be seen in figure 2.

Figure 2. System B Dual-Channel Infusion Pump. (3) System C is a single-channel infusion pump intended to be used for controlled administration of IV fluids. These fluids may include pharmaceuticals, blood, blood products, antibiotics, various nutritional fluids, and mixtures required for patient therapy. System C is intended to be used in conjunction with IV administration sets and medications provided by the user. System C is suitable for many user facility applications such as, but not limited to, hospitals, outpatient care areas, home care, and ambulatory care services. System C is intended to reduce operator interaction through automated programming, thereby helping to reduce errors associated with complex device programming. A picture of system C, single-channel infusion pump, can be seen in figure 3.

Figure 3. System C Single-Channel Infusion Pump.

c. Scope and Methodology. The USAMEDDBD CA was conducted from 25 February through 1 March 2013. Phases one and two of the CA were conducted at the Medical Simulation


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Center (MSC) at Lackland Air Force Base (AFB), Texas, and the third phase was conducted at the Deployable Medical Systems Equipment for Training (DMSET) site at Camp Bullis, Texas. Each morning the assessment players received a briefing on the day’s events and were given scenarios to review before starting the assessment. The assessment players were given assessment player surveys to complete on each of the systems and then participated in an after-action review (AAR) on the last day of the assessment. Additionally, biomedical equipment specialists (BMESs) from the US Army, US Navy, and US Air Force conducted equipment acceptance verification checks on each of the three systems, participated as part of the medical team members, and completed a BMES survey. The data collected from the assessment player and BMES surveys, BMES observations, and assessment player comments were used to produce this CA report. 2. CA CONDUCT. a. Phase One. Briefings were given to the assessment players by the USAMEDDBD assessment team on safety, the MSC protocol, and the scenarios. The medical providers were organized into three-person medical teams. Familiarization instructions were provided by a manufacturer’s representative for each of the three systems. The assessment players received 1 1/2 hours of familiarization training on each system. Familiarization training included, but was not limited to, operations, utility setup, and safety issues. During this phase, the BMESs conducted acceptance verification checks on each system. b. Phase Two. The assessment players used specific medical scenarios that required each of the three systems to be operated on 110 to 120 volts alternating current (VAC), 60 hertz (Hz) commercial power and internal battery power. The assessment players were given notional doctor’s orders to use for the treatment of their simulated patients. The assessment players started the specified scenario from inside a notional combat support hospital (CSH) and then transported the patient to the flight line. Then, the assessment players loaded the patient, who was connected to an IV pump, into the UH-60 Black Hawk simulator located at the MSC and ran the system on its internal battery power. At the conclusion of the scenario, the systems were repacked into containers provided by the manufacturers and transported from Lackland AFB to Camp Bullis by the USAMEDDBD assessment team. c. Phase Three. Days four and five were conducted at the DMSET site. The assessment players assessed the functionality of the IV pump systems within a simulated operational environment that included providing care in the CSH. The IV pumps were powered using 110 VAC commercial power, 220 VAC generator power, and internal battery power. The assessment players loaded patients into the front-line ambulances (FLAs) while patients were connected to one of the IV pumps. The assessment of various light environments was done by the assessment players prior to loading patients (CSH lighting), during the loading of patients (full sunlight), and during transport of patients inside the FLAs (vehicle internal lighting). The


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patients and assessment players were transported over primary, unimproved roads, and rough terrain for approximately 5 miles. Upon return to the CSH, the patients, still connected to the IV pumps, were off-loaded and moved inside the CSH. 3. TRAINING RESULTS. a. Table 1 presents the overall rating results provided for each system by the assessment players on the familiarization training received.

TABLE 1. RATE THE OVERALL FAMILIARIZATION TRAINING OF THE SYSTEMS

System Number of

surveys

Number of survey ratings

Ratings

1 Poor

2 Good

3 Neutral

4 Very Good

5 Excellent

A 12 11a 0 2 2 7 0 B 12 12 1 1 8 2 0 C 12 12 0 2 0 7 3 a One assessment player did not rate the training for system A. b. Table 2 presents the assessment player ratings of the hands-on portion of the familiarization training.

TABLE 2. RATE THE HANDS-ON PORTION OF THE FAMILIARIZATION TRAINING

System Number of

surveys


Ratings

1 Poor

2 Good

3 Neutral

4 Very Good

5 Excellent

A 12 12 0 4 4 4 0 B 12 12 0 4 3 5 0 C 12 12 0 2 0 5 5 c. Table 3 presents the assessment player responses on the trainer’s knowledge of each system.

TABLE 3. WERE THE TRAINERS KNOWLEDGEABLE?

System Number of

surveys Survey

responses Responses

Yes No A 12 12 12 0 B 12 12 11 1 C 12 12 12 0

d. Table 4 provides assessment player responses on the ability of the trainers to answer questions relating to their system in a manner that the users understood.


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TABLE 4. WERE THE TRAINERS ABLE TO ANSWER QUESTIONS RELATED TO EACH SYSTEM IN A MANNER THAT

WAS UNDERSTOOD BY THE USER?

System Number of

surveys

Number of survey

responses

Responses

Yes No A 12 12 11 1 B 12 12 9 3 C 12 12 12 0

e. Table 5 provides assessment player responses on the training covering the clinical aspects of what might be encountered in an operational environment.

TABLE 5. DID THE TRAINING COVER THE CLINICAL ASPECTS OF WHAT MIGHT BE ENCOUNTERED IN AN OPERATIONAL

ENVIRONMENT?

System Number of

surveys

Number of survey

responses

Responses

Yes No A 12 12 7 5 B 12 12 6 6 C 12 12 6 6

f. Overall Training Analysis and Conclusion. The familiarization training in phase one went extremely well. The training teams arrived on time at the MSC and were set up and ready to conduct their training by 0800 and made excellent use of the time that was allotted to them. The training teams were professional, knowledgeable, and able to answer questions pertaining to each individual system within a clinical environment. Unfortunately, the trainers did not understand the real-world operational environment of the different Services, which made it difficult for the trainers to clearly articulate the clinical or field aspects of the various operational environments. The assessment players would have benefited more from the training if the trainers had more knowledge about use of the IV pump system in an operational environment such as Afghanistan or Iraq. The training teams from the manufacturers did a great job of facilitating the familiarization training. The training team for system C provided the best training: The system C manufacturer had more representatives present than the other two manufacturers, which enabled them to provide more trainers during the hands-on portion of the training. Lastly, the team representing system C provided handouts with additional information, which was helpful in understanding the system. Overall, the assessment players benefited from the familiarization training, especially the hands-on portion, because it gave them an opportunity to become acquainted with each of the three systems prior to the actual start of the CA. 4. PHASE TWO AND THREE RESULTS. The results were taken from the assessment player surveys. Questions on the assessment player surveys were derived from the ECs provided by the


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DMMPO. a. EC 1. The functionality of the system supports the medical mission. Table 6 shows the question and responses for EC 1.

TABLE 6. DOES THE FUNCTIONALITY OF THE SYSTEM SUPPORT THE MEDICAL MISSION?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 8 3 1 0 B 12 12 9 2 0 1 C 12 12 9 2 1 0 (1) Results. (a) System A. A majority of the assessment players responded that this system was able to support Role 2 or 3 medical missions. The assessment players liked the mobility and ease of stacking the pump for ground or air evacuation. The assessment players also liked the versatility and convenience of the medication library. (b) System B. A majority of the assessment players responded that this system would be able to support medical missions. The assessment players also agreed that this system could be used during ground and air evacuations. One of the assessment players did not respond, but did comment that this system could not support the medical mission. The IV pump did not have anti-free-flow tubing to prevent excess fluid from being infused into a patient.

(c) System C. A majority of the assessment players responded that this system would be able to support the medical missions of each of the individual Services. The system was able to infuse both basic and complex pharmaceutical type infusions. The system was compact in size, lightweight, easy to use, and had an extensive medical library with safety warnings. This system was able to perform all functions effectively and could be used to care for a critical care patient. (2) Analysis and Conclusion. The functionality of all three systems could support medical missions of each of the three Services. Each of the systems had its own unique qualities that made it effective in the treatment of patients and support of the medical mission of the US Armed Forces. All three systems were compact, lightweight, easily programmed, and could be used in an operational environment. System A incorporated a mounting bracket assembly, which allowed the IV pumps to be stacked. The dual-channel design of system B had an advantage of having two channels for infusion with one IV pump. System C had the most up-to-date technology. The one major concern surrounding all three systems was their durability in an


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operational environment, since none of the commercial IV pump systems appeared rugged enough. b. EC 2. The system is portable and easy to move to different patient locations in an operational environment. Table 7 shows the questions and responses for EC 2.

TABLE 7. THE SYSTEM IS PORTABLE AND EASY TO MOVE TO DIFFERENT PATIENT LOCATIONS IN AN OPERATIONAL ENVIRONMENT

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know or

No response

A 12 12 9 3 0 0 B 12 12 10 2 0 0 C 12 12 8 4 0 0 (1) Results. (a) System A. The majority of the assessment players responded that this system was transportable. The system clamped easily to the litter handles and the carousel of the UH-60 Black Hawk simulator. Three of the assessment players commented that the stackable configuration of system A did increase the weight and bulkiness of the stacked systems during patient transport when clamped to the litter IV pole. (b) System B. The majority of the assessment players responded that this system was transportable. The assessment players liked the idea of a dual-pump system. In the event that one of the pumps became disabled, the user still had another IV pump to use during transport. The assessment players did comment that there were concerns regarding this system. One concern was having the clamp assembly molded as part of the battery charger pack. Another concern was that the channel size of the molded clamp limited the securing of the system to anything larger than the standard IV pole during transport. The last concern was that the system with battery charger would have to be laid on a patient during transport by air or ground evacuation (see figure 4).


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Figure 4. System B Secured to the Litter. (c) System C. The system was lightweight and transportable while connected to a patient. The battery of the system could be easily switched out during transport in the event of battery failure. The alternating current (AC) cord was not easily disconnected from the system in preparation for transport and required the use of a screwdriver to be removed (see figure 5). The assessment players had to take precautions in securing the system whenever it was transported and not clamped to the IV pole due to the system not being ruggedized (see figure 6).

Figure 5. System C Power Cord.

Four securing screws prevent the power cord from being disconnected


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Figure 6. System C Screen After Being Dropped.

(2) Conclusion and Analysis. All of the systems could be used during patient transport, whether by sea, ground, or air evacuation. All three systems could be attached to the standard IV pole for moving a patient in the CSH. All three systems were portable enough to be secured to the patient during ground and air evacuation. Precautions would have to be taken to secure all three systems before transporting them onboard a ground or aircraft evacuation platform. The modularity of system A provided a compact size, but added to the weight factor when stacked, and the versatility to be clamped onto other fixtures within a ground or aircraft evacuation platform. Systems B and C did not have an integrated bracket to secure multiple systems as one stacked group. c. EC 3. Is the system stackable? Tables 8 and 9 show the questions and responses/ratings for EC 3.

TABLE 8. IS THE SYSTEM STACKABLE?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know or

No response

A 12 12 12 0 0 0 B 12 12 1 11 0 0 C 12 12 3 9 0 0


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TABLE 9. RATE THE EASE OF THE SYSTEM STACKABLILITY

System Number of

surveys

Number of survey

responses

Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 6 3 3 0 0 B 12 5* 0 1 4 0 0 C 12 7 1 2 3 1 0 *It should be noted that seven assessment players did not answer this survey question. It was their opinion that this question was nonapplicable to this system. (1) Results. (a) System A. The system was stackable using the bracket provided. The assessment players regarded system A as the easiest to stack and to affix to the standard IV pole, a litter handle, or the carousel of the UH-60 Black Hawk simulator (see figure 7). However, there were negative comments about this system. Once the system was stacked, the IV lines became entangled. When the system was stacked on its side, the screen did not rotate (similar to an I-phone screen), which made it difficult to read.

Figure 7. System A Stacked on the IV Pole.

(b) System B was the only dual-channel IV pump system. The clamp had a molded design that was part of the battery charger. The molded design of the clamp limited its ability to be secured to anything other than the standard IV pole (see figure 8). Each system would have to be stacked individually on the IV pole (see figure 9). The system, when detached from the


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battery pack, could be laid on the patient or litter individually during relocation of a patient or transport.

Figure 8. System B With and Without Battery Pack.

Figure 9. System B as a Stackable Setup.

System B without its battery charger

System B attached to its battery charger, which provides the clamp system


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(c) System C. Because of its compact size, more than one system could be affixed to the standard IV pole for multiple infusions (see figure 10). The assessment players commented that the clamp was easy to use. The assessment players had negative comments regarding system C. The plugs of system C were bulky and became easily entangled. Also, due to the design of the clamp securing knob, one knob stripped after repeated use.

Figure 10. System C as a Stackable Setup.

(2) Analysis and Conclusion. The understanding of what is considered “stackable” may have played a significant factor in the assessment player responses for systems B and C. Since system A had an interlocking design and the other two systems did not, it posed a visual mindset that they were not stackable. All three systems could be stacked on standard IV poles. The exception being that during the transport phase, some assessment player teams chose not to secure the systems, but rather laid the systems on the patients. The clamp design for all three systems varied in different ways. System A had a clamp design that allowed three systems to be stacked and supported by one clamp (see figure 11). The clamp design of system B only allowed one IV pump to be attached to the battery charger at one time (see figure 12). The clamp design of system C only allowed one IV pump to be attached to the clamp at one time. The clamp of system C had interchangeable parts that could be transferred from one IV pump to another (see figure 13).


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Figure 11. Clamp for System A.

Figure 12. Clamp for System B.

Notice the way the clamp is molded into the battery charger

System A clamp


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Figure 13. Clamps for System C.

d. EC 4. Are there any special tools needed to stack the system? Table 10 shows the question and responses for EC 4.

TABLE 10. ARE THERE ANY SPECIAL TOOLS NEEDED TO STACK THE SYSTEM?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 1 11 0 0 B 12 12 2 6 0 4 C 12 12 3 6 0 3 (1) Results. Systems A, B, and C did not need special tools to be stacked. (2) Analysis and Conclusion. No special tools were needed to stack any of the three systems. All of the systems could be hand tightened to the IV pole or bracket if needed. The assessment players who answered yes to this survey question confused accessories like the IV pole or bracket system with tools such as a wrench or screwdriver. In the event one of the clamps becomes stripped, the user may want to have a pair of pliers or a multipurpose tool on hand to tighten or loosen the clamp to remove it from an IV pole. e. EC 5. The system incorporates a free-flow protection system. Table 11 shows the question and responses for EC 5.


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TABLE 11. DOES THE SYSTEM INCORPORATE A FREE-FLOW PROTECTION SYSTEM?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 12 0 0 0 B 12 12 12 0 0 0 C 12 12 12 0 0 0 (1) Results. Systems A, B, and C incorporated a free-flow protection system. (2) Analysis and Conclusion. All three systems came with their own free-flow protection system. The free-flow protection devices of each system provided additional safety mechanisms to ensure patient safety. System A used a proprietary safety key that had to be inserted into the rear of the system to initiate the free-flow protection system (see figure 14). System B had IV lines equipped with an anti-siphon valve that prevented free-flow of fluid toward the patient when the IV line was not attached to the pump. System B also had a one-way valve that prevented one channel from infusing into the other channel. System C had its own proprietary key that had to be inserted into the top of the system to initiate the free-flow protection system (see figure 15).

Figure 14. System A Green Free-Flow Clamp.

The green free-flow clamp


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Figure 15. System B Blue Safety Key.

f. EC 6. The system has a dose error reduction system (DERS) incorporated. Tables 12 and 13 show the questions and responses for EC 6.

TABLE 12. DOES THE SYSTEM HAVE A DOSE ERROR REDUCTION SYSTEM INCORPORATED?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 10 2 0 0 B 12 12 10 2 0 0 C 12 12 12 0 0 0 TABLE 13. RATE THE EASE OF SETTING UP PROGRAMMING AND USING THE DERS OF

THE SYSTEM

System Number of

surveys


Responses 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 0 3 6 3 0 B 12 12 6 3 3 0 0 C 12 12 7 4 0 1 0 (1) Results. All three systems had a DERS.


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(2) Analysis and Conclusion. System A had a DERS incorporated that had to be preprogrammed prior to use. System A came with visual alarms set at soft and hard limits to warn and prompt the user1. The DERS software of system B was not user-friendly. The assessment players favored system C over the other two systems. System C was user-friendly, and the screen display was easier to read than the other two systems. System C displayed a large “warning” sign if the dose given exceeded the soft limit. The scrolling screen of system C provided more information than the other two systems. Because it had the most current technology, system C was easier to set up, program, and use the DERS. g. EC 7. The system has a monitor to digitally display the identification of medication being given to the patient. Four tables show the questions and responses/ratings for EC 7. (1) Identification of Medication (See Table 14). TABLE 14. THE SYSTEM HAS A MONITOR TO DIGITALLY DISPLAY THE IDENTIFICATION

OF MEDICATION BEING GIVEN TO PATIENT?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 12 0 0 0 B 12 12 10 2 0 0 C 12 12 12 0 0 0 (a) Results. All three systems had a monitor to digitally display the identification of medication being given to the patient (see figures 16, 17, and 18).

1Soft and hard limits are the dosing range for safe medication administration. A system administrator may set a soft limit that can be temporarily exceeded by the user. The system will not allow users to exceed their hard limit. The soft limit must be less than the hard limit.


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Figure 16. System A Medication Display.

Figure 17. System B Medication Display.


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Figure 18. System C Medication Display. (b) Analysis and Conclusion for Table 14. The display screen of all three systems varied in size, shape, and brightness. Each system had similar features such as visual prompts, the type medication that could be given, the dose, and the rate. System A had a small display screen, and the monitor did not always display the drug and dose being given. System B displayed both channels when the pump was affixed to the battery charger, but only displayed one channel at a time when the battery charger was disconnected from the system. The display of system C was easy to see and read. The word “warning” displayed in red when the dose given was beyond the programmed soft limits. The scrolling screen of system C displayed the medication being given, the dose, and the start and end times of medication administration. (2) Reading the Digital Display in Daytime (see table 15).

TABLE 15. RATE THE EASE OF READING THE DIGITAL DISPLAY FOR MEDICATION

IDENTIFICATION IN VARIOUS LIGHTING ENVIRONMENTS (DAY)

System Number of

surveys


Ratings

1 Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 5 6 0 1 0 B 12 12 4 6 2 0 0 C 12 12 10 2 0 0 0


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(a) Results. All three systems were rated “easy” or “very easy” regarding reading the digital display for medication identification in various lighting environments (day). (3) Reading the Digital Display at Night (See Table 16).

TABLE 16. RATE THE EASE OF READING THE DIGITAL DISPLAY FOR MEDICATION IDENTIFICATION IN VARIOUS LIGHTING ENVIRONMENTS (NIGHT)

System Number of

surveys

Number of survey

responses

Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 3 8 0 1 0 B 12 12 2 3 1 3 3 C 12 12 7 2 2 1 0 (a) Results. Systems A and C had majority ratings of “easy” or “very easy” to read the digital display for medication identification in various lighting environments (night). System B had the most significant ratings of “difficult” or “very difficult” to read the digital display. (4) Reading Digital Display Using a Flashlight (See Table 17).

TABLE 17. RATE THE EASE OF READING THE DIGITAL DISPLAY FOR MEDICATION IDENTIFICATION IN VARIOUS LIGHTING ENVIRONMENTS (FLASHLIGHT)

System Number of

surveys


Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 3 6 2 0 0 B 12 11* 3 5 2 1 0 C 12 11* 8 2 1 1 0 *One assessment player responded nonapplicable. (a) Results. All three systems were rated “easy” or “very easy” regarding reading the digital display for medication identification in various lighting environments (flashlight). (5) Analysis and Conclusion for Tables 15, 16, and 17. The various lighting environments (day, night, and flashlight) encountered by the assessment players provided some important insights as to the versatility of the displays and keypads. Light discipline was a concern for all systems due to the brightness of the display screens. The red-light lettering on the display screen of system C was difficult to see under the red-light flying conditions in the UH-60 Black Hawk simulator. The keypads on systems B and C did not have backlighting, which caused difficulty inputting information. A flashlight had to be used and pointed directly at the keypad to visualize it. The display screen on system C combined a light background with


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dark-colored numbers and text, which assisted in reading information in bright sunlight. h. EC 8. The system will revert back to keep vein open (KVO) rate once the programmed volume is delivered. Table 18 shows the question and responses for EC 8. TABLE 18. THE SYSTEM WILL REVERT BACK TO KVO RATE ONCE THE PROGRAMMED

VOLUME IS DELIVERED

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 11 8 2 1 1 B 12 12 11 0 1 0 C 12 11 10 1 0 1 (1) Results. The majority of assessment players agreed that all three systems reverted back to the KVO rate once the programmed volume was delivered. (2) Analysis and Conclusion. All three systems had the capability for reverting to the KVO infusion rate after medication treatment was completed. System A continued to infuse with the preset KVO rate after a preset amount of volume had been infused. System B used an alarm and flashing light to alert the user when the infusion was complete. System C also used an alarm to alert the user when the infusion was complete. Three assessment players responded no to the survey question for EC 8; however, their comments were not applicable to the question. i. EC 9. The system shall be provided with a suitable bracket to enable attachment to an IV pole. Table 19 shows the question and ratings for EC 9.

TABLE 19. RATE THE EASE OF ATTACHING THE SYSTEM TO THE IV POLE USING THE BRACKET PROVIDED

System Number of

surveys

Number of survey

responses

Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 6 5 1 0 0 B 12 12 4 5 2 0 1 C 12 12 5 3 3 1 0 (1) Results. A majority of the assessment players rated all three systems as being either “very easy” or “easy” to attach to the standard IV pole using the bracket that was provided. Six assessment players did not have an opinion (neutral), one thought system C was difficult to attach to the IV pole, and one thought system B was very difficult.


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(2) Analysis and Conclusion. All three of the systems could be attached to the standard IV pole. System A attached to a litter handle (see figure 19), the frame of the carousel of the UH-60 Black Hawk simulator (see figure 20), and the Special Medical Emergency Evacuation Device (SMEED) bracket. System B attached to a standard IV pole, but was limited to the type platform it could be secured to, because the clamp was built into the battery charger (see figure 21). System C had individual clamp pieces that were interchangeable and could be switched out with other components if needed. System C attached to the portable IV pole (see figure 22), the SMEED Bracket (see figure 23), and the carousel frame of the UH-60 Black Hawk simulator. The only issue with system C was that one of the clamps stripped after several uses.

Figure 19. System A Clamped to a Litter Handle.


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Figure 20. System A Clamped to the Carousel Frame of the UH-60 Black Hawk Simulator.

Figure 21. System B Attached to the IV Pole.


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Figure 22. System C Attached to the Portable IV Pole.


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Figure 23. System C Clamped to the SMEED Bracket. j. EC 10. The system accepts a variety of currently fielded IV sets. Table 20 shows the question and responses for EC 10.

TABLE 20. DOES THE SYSTEM ACCEPT CURRENTLY FIELDED IV SETS?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 0 12 0 0 B 12 12 2 10 0 0 C 12 12 3 7 1 1

Clamped to the SMEED bracket


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(1) Results. A majority of the assessment player responses indicate that all three systems had their own proprietary tubing and were not compatible with other IV infusion sets. (2) Analysis and Conclusion. All three systems are intended for use with proprietary tubing sets. The IV tubing of all three systems was designed with patient safety in mind. System A had a green key as part of its free-flow system. System B had a customized IV line that had an anti-siphon valve, which prevented a gravitational free-flow hazard. System C used a blue free-flow clamp to lock and unlock the door to insert the tubing. k. EC 11. The system has visual and audible alarms for the detection of air in line, occlusion status, infusion complete status, empty fluid container, flow error, set disengagement, system malfunction, and low battery. The following tables show the eight questions and responses for EC 11. (1) Alarms for Air in Line (See Table 21).

TABLE 21. DOES THE SYSTEM HAVE VISUAL AND AUDIBLE ALARMS FOR THE DETECTION OF AIR-IN-LINE?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 12 0 0 0 B 12 12 12 0 0 0 C 12 12 11 1 0 0 (a) Results. All three systems had visual and audible alarms for the detection of air in line. (2) Alarms for Occlusion (See Table 22).

TABLE 22. DOES THE SYSTEM HAVE VISUAL AND AUDIBLE ALARMS FOR THE DETECTION OF OCCLUSION?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 12 0 0 0 B 12 12 12 0 0 0 C 12 12 11 1 0 0 (a) Results. All three systems had visual and audible alarms for the detection of an occlusion in the line.


28

(3) Alarms for Infusion Complete Status (See Table 23).

TABLE 23. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF INFUSION COMPLETE STATUS?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 12 0 0 0 B 12 12 11 0 1 0 C 12 12 11 1 0 0 (a) Results. All three systems had visual and audible alarms for the detection of infusion complete status. (4) Alarms for Having an Empty Fluid Container (See Table 24).

TABLE 24. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF EMPTY FLUID CONTAINER?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 6 5 1 0 B 12 12 7 3 2 0 C 12 12 8 2 1 1 (a) Results. A majority of the assessment players responded that systems B and C had visual and audible alarms for the detection of an empty fluid container. Assessment players responded almost equally with “yes” and “no” for system A having a visual and audible alarm for the detection of an empty fluid container. The analysis of assessment player comments regarding the split decision for system A revealed that system A did not have a specific alarm for detection of an empty fluid container, but used the same alarm for detection of all system defects. (5) Alarms Detecting a Flow Error (See Table 25).

TABLE 25. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF FLOW ERROR?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 10 1 1 0 B 12 12 10 1 0 1 C 12 12 10 2 0 0


29

(a) Results. All three systems had visual and audible alarms for the detection of a flow error. (6) Alarms Detecting Set Disengagement (See Table 26).

TABLE 26. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF SET DISENGAGEMENT?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 9 1 2 0 B 12 12 8 2 0 2 C 12 12 8 1 1 2 (a) Results. All three systems had visual and audible alarms for the detection of a set disengagement. (7) Alarms Detecting System Malfunction (See Table 27).

TABLE 27. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF SYSTEM MALFUNCTION?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 11 10 0 1 1 B 12 12 12 0 0 0 C 12 12 11 1 0 0 (a) Results. All three systems had visual and audible alarms for the detection of a system malfunction. (8) Alarms Detecting a Low Battery (See Table 28).

TABLE 28. DOES THE SYSTEM HAVE VISUAL OR AUDIBLE ALARMS FOR THE DETECTION OF LOW BATTERY?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 11 0 1 0 B 12 12 10 0 2 C 12 12 12 0 0 0


30

(a) Results. All three systems had visual and audible alarms for the detection of a low battery. (9) Analysis and Conclusion. All three systems had some type of visual and audible alarm systems. Several discrepancies are worth noting for this particular EC. While all of the systems had visual and audible alarms, not all of the systems had the same type of alarm. For example, only systems A and B had an alarm to detect an empty fluid container, but they had different names. Not all of the systems had flow error alarms, but they all had occlusion alarms. Another example was differing terminology. If the door was open on system B, this could have been seen as a system malfunction. The different types of alarms could have been the underlying reason why the assessment players marked “no” when completing their survey. The assessment players were able to hear the alarms while operating in the CSH treatment areas and were able to visualize the alarms when operating in the UH-60 Black Hawk simulator and while riding in the back of the FLAs. Being able to hear and visualize the alarms in different settings was a positive point that the assessment players liked about all three systems. l. EC 12. The system does not pose any actual or potential safety hazards to personnel, equipment, or facilities. Table 29 shows the question and responses for EC 12.

TABLE 29. DOES THE SYSTEM POSE ANY ACTUAL OR POTENTIAL SAFETY HAZARDS TO PERSONNEL, EQUIPMENT, OR FACILITIES?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 6 6 0 0 B 12 12 6 4 0 2 C 12 12 10 1 0 1 (1) Results. (a) System A. Six assessment players did not think that any of the three systems posed any safety hazards, and six thought that the systems posed a potential safety hazard. One of the safety concerns mentioned by the assessment players was that the extra tubing between the pump and fluid bag could present a possible line identification issue that could lead to a medicine dosing error to a patient. (b) System B. Only four assessment players felt that system B was safe to use, and six felt that there were hazard and safety concerns. The pump had to be primed while the tubing was affixed to the pump, which could be hazardous to the patient if the patient receives too much fluid. Receiving too much fluid could lead to fluid intoxication or an accidental overdose.


31

(c) System C. Assessment players stated a concern that if this system had to be sent away for repairs (shipped out of country or off a ship), this would decrease the ability of the healthcare providers to treat patients in need of fluid replacement during that time. (2) Analysis and Conclusion. Most of the assessment player responses to this particular EC were mixed; however, a majority of the assessment players felt that all three of the systems were safe to use. A lot of safety concerns were expressed for all three systems. On two separate occasions during the CA, assessment players used faulty tubing, and the alarms of system A never went off. Too many steps were involved in replacing the battery of system A, which could result in delayed treatment to the patient during patient transport. Lastly, the alarm for system A did not always detect low-flow occlusions, which could have significant adverse patient outcomes such as not getting the proper amount of fluid or medication. Total reliance on the pump for flow verification of system B could be a potential patient safety issue. The assessment player had to pause channel one to change the mode from basic to dose in channel two, which could cause problems with vaso-active medications with a short half-life. System C would have to be sent away for repairs if the BMESs were not properly trained. If system C were to become inoperable while deployed or out to sea, the entire system would have to be shipped back to the manufacturer. The healthcare provider would lose a valuable piece of equipment, which would limit patient care. m. EC 13. The system delivers a volume within 1-999 milliliter (mL) and provides an infusion range from 1-999 mL/per hour (mL/hr) in no more than 1 milliliter increments. Tables 30 and 31 show the questions and responses/ratings for EC 13. TABLE 30. CAN THE SYSTEM AN ADJUSTED DELIVERY VOLUME FROM 1 to 999 mL/hr IN

MORE THAN 1 mL INCREMENTS?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 10 2 0 0 B 12 12 11 0 1 0 C 12 12 11 1 0 0

TABLE 31. RATE THE EASE OF ADJUSTING VOLUME ON THE SYSTEM TO WITHIN 1 to 999 mL

System Number of

surveys


Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 12 12 2 4 3 3 0 B 12 12 2 6 3 1 0 C 12 12 2 6 4 0 0


32

(1) Results. The majority of users of systems A, B, and C were able to adjust the delivery volume from 1 to 999 mL/hr in 1 mL increments (refer to table 30). However, there were two responses for system A and one response for system B that the systems could not adjust delivery volume from 1 to 999 mL/hr in 1 mL increments. On the ease of adjusting volume (refer to table 31), two assessment players rated systems A, B, and C as “very easy,” six assessment players rated systems B and C as “easy”, and four assessment players rated system A as “easy” to use. Three assessment players rated system A as “difficult” and one assessment player rated system B as “difficult” to adjust volume. (2) Analysis and Conclusion. Dosing rate is very important to patient care. The assessment players had concerns about the ability to adjust the volume of all three systems. System A had an easy to adjust delivery volume from 1 to 1200 mL/hr; however, this system used an arrow keypad instead of number keys. During an emergency, this could increase the amount of time needed to adjust the volume to be infused (VTBI) time. The up and down arrows of the keypad also increase the number of steps involved in adjusting the infusion and dose rate to be given to the patient. System A had the ability to adjust the rate and VTBI without interruption of the infusion. System B had a number keypad, which made inputting dosing and medication information easier than in system A. System B displayed a warning to disconnect the IV tubing from the patient prior to priming the IV pump. The user must pause channel one, “running fluids,” to change the mode from basic to dose in channel two, which could cause problems with vaso-active medications with a short half-life. System C had an easy to read number pad, which made it easy to adjust the volume. System C had visual prompts that assisted the assessment player in verifying the correct dose being given (rate advisory screen). The delivery rate of a bolus or medication was able to be adjusted without having to stop the current flow rate; however, the system did not keep track of the bolus delivered. n. EC 14. The system can be cleaned using the standard cleaning materials and cleaning solutions. Table 32 shows the question and responses for EC 14.

TABLE 32. CAN THE SYSTEM BE CLEANED USING THE STANDARD CLEANING MATERIALS AND SOLUTIONS?

System Number of

surveys

Number of survey

responses

Responses

Yes No Did not know

No response

A 12 12 5 4 2 1 B 12 12 6 6 0 0 C 12 12 7 4 0 1 (1) Results. All three systems could be cleaned in accordance with the instructions in the operator manual.


33

(2) Analysis and Conclusion. The assessment players read the operator manuals, which clarified the type of cleaning products that could be used. The assessment players could either follow local cleaning procedures or the guidance provided in the operator manuals. The cleaning instructions in the operator manual for each system were very specific and included step-by-step instructions for proper cleaning. 5. BMES SURVEY. The BMES responses came from the BMES surveys. a. EC 15. The system will have Food and Drug Administration (FDA) clearance. Table 34 shows the question and responses for EC 15.

TABLE 34. DOES THE SYSTEM HAVE FDA CLEARANCE?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 3 1 1 B 5 5 3 1 1 C 5 5 5 0 0

(1) Results. All three systems had received FDA approval for use in a healthcare environment. (2) Analysis and Conclusion. All three systems had approved FDA certification letters; however, the certificates were not on hand during the CA, which led the BMESs to question whether or not the systems had FDA approval. b. EC 16. The system shall operate on 110–120 VAC, 60 Hz and 220–240 VAC, 50 Hz and internal rechargeable battery. Three tables show the questions and responses for EC 16. (1) Operate Using 110 to 120 VAC (See Table 35).

TABLE 35. CAN THE SYSTEM OPERATE USING 110 to 120 VAC?

Systems Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. All three systems were able to operate on a commercial power source of


34

110 to 120 VAC. (2) Operate Using 220 to 240 VAC (See Table 36).

TABLE 36. CAN THE SYSTEM OPERATE USING 220 to 240 VAC?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. All three systems were able to operate on 220 to 240 VAC generator power.

(3) Operate Using Internal Battery (See Table 37). (a) Results. All three systems were able to operate using an internal rechargeable battery.

TABLE 37. CAN THE SYSTEM OPERATE USING AN INTERNAL

RECHARGEABLE BATTERY?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(4) Analysis and Conclusion. During various times of the CA, all three systems were run on commercial power, battery power, and generator power. No issues were reported using commercial power with systems A and B. System A had the most user-friendly plug system. The plug system for system A used one plug with branches, which reduced the likelihood of the cords getting tangled (see figure 23). System C had a large plug that could not be plugged into adjacent sockets of certain outlets like the horizontal power strip shown in figure 24. System C required a specific power strip like the one shown in figure 25. The internal battery for all three systems held its charge with no issues reported. A concern was the ability of the user to change out the battery in all three systems in a timely manner; however, this could be remedied by training. All three systems operated on generator power with no issues reported.


35

Figure 23. System A 3-in-1 Plug System.

Figure 24. Standard Power Strip.


36

Figure 25. System Power Cord and Plugs.

c. EC 17. The system can transition from a commercial power source (110–120 VAC/60Hz or generator power 220–240 VAC/50Hz) to internal battery power source without interrupting operations. Table 38 shows the question and responses for EC 17.

TABLE 38. DOES THE SYSTEM TRANSITION FROM A COMMERCIAL POWER SOURCE TO AN INTERNAL BATTERY POWER SOURCE WITHOUT

INTERRUPTING OPERATIONS?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(1) Results. All three systems were able to transition from commercial power to an internal battery power source without any interruption of operations. d. EC 18. The system’s battery life shall be greater than 4 hours at 125 mL/hr and the system shall include a power cord and AC adapters that automatically charge the battery while operating on AC. Two tables show the questions and responses for EC 18. (1) Operate on Battery Power (See Table 39).

Special power strips may be needed for stacking multiple systems


37

TABLE 39. CAN THE SYSTEM OPERATE FOR LONGER THAN 4 HOURS ON BATTERY POWER AT 125 mL/hr?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. Systems A, B, and C were able to operate on their internal battery power for more than 4 hours and infuse fluids at a rate of at least 125 mL/hr. (2) Recharge AC Adapter (See Table 40).

TABLE 40. CAN THE BATTERY BE RECHARGED USING AN AC ADAPTER WHILE THE SYSTEM IS OPERATING?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. All three systems were able to be recharged using an AC adapter while the systems were still operating. (3) Analysis and Conclusion. During phases two through four, the assessment players were able to transition from a commercial power source of 110–120 VAC, 60 Hz to internal 12-volt battery power. During phase three at the DMSET site, all three systems were able to operate on a tactical generator power source of 220–240 VAC, 50 Hz. All three systems were able to operate on their internal battery for longer than 4 hours during phases two through four when the assessment players performed the various scenarios and administered medication and fluid treatment using battery power. e. EC 19. The system shall include a battery capacity gauge or other display showing the state of charge. Two tables show the questions and responses/ratings for EC 19. (1) State of Charge (See Table 41).


38

TABLE 41. DOES THE SYSTEM HAVE A BATTERY CAPACITY GAUGE OR OTHER DISPLAY SHOWING THE STATE OF CHARGE?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. All three systems had some type of battery capacity gauge that displayed the state of the battery charge. (2) Reading Battery Capacity Gauge (See Table 42). TABLE 42. RATE THE EASE OF READING THE BATTERY CAPACITY GAUGE IN VARIOUS

LIGHTING ENVIRONMENTS

System Number of

surveys


Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 5 5 1 3 1 0 0 B 5 5 2 2 0 1 0 C 5 5 3 1 1 0 0 (a) Results. The BMESs rated all three systems favorably in regard to being able to see the display screen in the various lighting environments. These environments included daylight, dark, and flashlight. A majority of the assessment players rated all three systems as either “very easy” or “easy to see.” (3) Analysis and Conclusion. All three systems had some type of indicator to alert the user that battery power was being used. System A had a trend indicator display in the upper corner of the display screen (low, medium, and high) and a red flashing light warning the user that the battery level was low. System B had a low-battery indicator to alert the user that the battery had 30 minutes of battery life remaining. System B also had an end battery indicator that alerted the user that the battery was depleted. System B used a red light to indicate that the battery was both empty and charging and was fully charged, which had the potential to cause confusion. System C had seven battery life icon displays and in the upper-left corner of the display screen (for example, battery 100-percent charged, 50-percent charged, and 25-percent charged). System C also had several on-screen displays accompanied by an audio alarm to alert the user of the battery level.


39

f. EC 19. The system has a dose calculation rate software incorporated that is upgradeable. Two tables show the questions and responses/ratings for EC 19. (1) Have Dose Rate Calculation Software (See Table 43).

TABLE 43. DOES THE SYSTEM HAVE A DOSE RATE CALCULATION SOFTWARE INCORPORATED AND IS IT UPGRADEABLE?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(a) Results. All three systems had dose calculation rate software incorporated into the systems, and the software was upgradeable.

(1) Ease of Upgrading Software (See Table 44).

TABLE 44. RATE THE EASE OF UPGRADING THE DOSE CALCULATION RATE

SOFTWARE

System Number of

surveys


Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 5 5 0 2 2 1 0 B 5 5 0 2 1 2 0 C 5 5 4 1 0 0 0 (a) Results. Overall, the BMESs were able to upgrade the software of all three systems. The BMESs rated system C “very easy” to “easy.” Systems A and B had mixed ratings. The BMESs determined that upgrading the software on the systems was a little challenging. (3) Analysis and Conclusion. Of the three systems rated, system C received the highest rating based on its up-to-date technology. System C had Bluetooth and Wi-Fi capabilities and used a Universal Serial Bus port to transfer information. System B had software to update the medications list; however, software to upgrade dose calculations was not included. It would be beneficial if the manufacturer could develop a software program that incorporates both dose calculations and medication updates. System A had current up-to-date software; however, the only drawback was that a laptop computer was needed to update the medication and dose calculation software.


40

g. EC 20. The system delivers a volume within 1 to 999 mL and provides an infusion range from 1 to 999 mL/hr in no more than 1 mL increments. Tables 45 and 46 show the questions and responses/ratings for EC 20.

TABLE 45. DOES THE SYSTEM DELIVER A VOLUME RANGE FROM 1 TO 999 ML/HR IN NO MORE THAN A 1 ML INCREMENTS?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

TABLE 46. RATE THE EASE OF ADJUSTING THE DELIVERY VOLUME ON THE SYSTEM

FROM 1 TO 999 ML

System Number of

surveys

Number of survey

responses

Ratings 1

Very easy

2 Easy

3 Neutral

4 Difficult

5 Very

difficult A 5 5 0 3 2 0 0 B 5 5 5 0 0 0 0 C 5 5 3 2 0 0 0 (1) Results. All three systems were able to deliver a volume range from 1 to 999 mL/hr in no more than 1 mL increments. (2) Analysis and Conclusions. The rating on the ease of adjusting the delivery volume for each system was “very easy” to “easy.” The BMESs indicated that the technology and software of the systems were user-friendly. More interfacing and familiarization time on the three systems would increase the ease of BMESs in performing these types of technical functions. h. EC 20. The System has electronic and hard copies of the operator and service manuals available. Two tables show the questions and responses for EC 20. (1) Operator and Service Manuals (See Table 47).


41

TABLE 47. DOES THE SYSTEM HAVE AN ELECTRONIC AND HARD COPY OF THE OPERATOR AND SERVICE MANUALS AVAILABLE?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 4 0 1 C 5 5 5 0 0

(a) Results. All three systems had both a hard copy and an electronic copy of both the operator and service manuals. (2) Parts Layout and Parts Numbers (See Table 48).

TABLE 48. THE SERVICE MANUALS FOR THE SYSTEMS INCLUDE A PARTS LAYOUT WITH PARTS NUMBERS FOR EACH REPLACEABLE COMPONENT

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 1 4 0 C 5 5 5 0 0

(a) Results.

1. The system A service manual had a detailed colored diagram with step-by-step instructions for such things as troubleshooting, assembly, and disassembly. Each replacement part had a designation with the order number.

2. The system B service manual had both color and black-and-white photos with diagrams describing each piece of the pumps. System B had several troubleshooting guides, but it did not have any replacement part numbers or diagrams to order replacement parts. 3. The system C service manual had a detailed diagram with step-by-step instructions for such things as troubleshooting, assembly, and disassembly. The service manual also had a bill of materials that described the part name, the part number, and the quantity that should be kept on hand. (3) Analysis and Conclusions. The USAMEDDBD assessment team ensured that hard and digital copies of the operator and service manuals for each system were on hand for the CA.


42

The manuals for systems A, B, and C were available to the assessment players and BMESs upon request. On several occasions, the assessment players referenced the operator manual during the CA. The service manuals of all three manufacturers were well written, comprehensive, and easy to read and understand. Essentially, the service manuals for each system were set up the same way: each starting with a brief description of the system and transitioning to the more technical aspects. The service manuals for systems A and C were broken down in a manner that made it easy to locate replacement parts; however, this information was not in the service manual for system B.

i. EC 21. The system is maintainable by the BMES using standard tools without voiding any warranties. Table 49 shows the question and responses for EC 21.

TABLE 49. ARE THE SYSTEMS MAINTAINABLE BY THE BMES USING STANDARD TOOLS WITHOUT VOIDING ANY WARRANTIES?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 4 0 1 B 5 5 4 1 0 C 5 5 3 2 0

(1) Results. All three systems would require BMES to attend special training to perform repairs that would not void the warranty.

(2) Analysis and Conclusions. The BMES can perform a limited number of repairs for each individual system without voiding any warranties on the IV pumps. For the most part, to be able to independently repair each of the three systems, the BMES would have to attend specialized training at the manufacturer’s facility. After completing the training, the BMES would be able to order parts and perform certain services. Without this specialized training, it could be problematic if there were not any BMESs in a given theater of operation who had been trained. Also, the system would have to be shipped out of country or off a ship to get it repaired. j. EC 22. The system has visual and audible alarms for the detection of air in line, occlusion status, infusion complete status, empty fluid container, flow error, set disengagement, system malfunction, and low battery. Tables 50 through 57 show the questions and responses for EC 22.


43

TABLE 50. DOES THE SYSTEM HAVE A VISUAL OR AUDIBLE ALARM FOR AIR IN LINE?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

TABLE 51. DOES THE SYSTEM HAVE A VISUAL OR AUDIBLE ALARM FOR

OCCLUSION?

System Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

TABLE 52. DOES THE MIVP HAVE A VISUAL OR AUDIBLE ALARM FOR

INFUSION COMPLETE?

Systems Number of

surveys

Number of survey

responses

Responses

Yes No

Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

TABLE 53. DOES THE MIVP HAVE A VISUAL OR AUDIBLE ALARM FOR EMPTY

FLUID?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 4 0 1 C 5 5 5 0 0


44

TABLE 54. DOES THE SYSTEM HAVE A VISUAL OR AUDIBLE ALARM FOR FLOW ERROR?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0


SET DISENGAGEMENT?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 3 0 2 C 5 5 5 0 0


MALFUNCTION?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 4 0 1 C 5 5 4 0 1

TABLE 57. DOES THE MIVP HAVE A VISUAL OR AUDIBLE ALARM FOR LOW

BATTERY?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 4 0 1 C 5 5 5 0 0

(1) Results. There was one BMES response stating that the occlusion alarm was not very sensitive. No specific system was identified with this response. BMES responses were part of the acceptance checks and verifications prior to the CA. (2) Analysis and Conclusion. The visual and audible alarm systems of IV pump systems A, B, and C were verified by the BMESs during their acceptance test and during the CA by the assessment teams. No negative responses by either the BMESs or assessment players


45

identified that none of the visual or audible alarm indicators of the three systems presented any issues. The assessment teams input various system conditions to verify the alarm systems during the CA. All three IV pump systems had working alarm systems. k. EC 23. The systems will come with two shipping cases, a hard case, and a soft case? Table 58 shows the question and responses for EC 23.

TABLE 58. DID THE SYSTEM COME WITH TWO DIFFERENT SHIPPING CASES?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 0 5 0 B 5 5 0 4 1 C 5 5 0 3 2

(1) Results. None of the three systems came with either a hard or soft shipping case. (2) Analysis and Conclusion. The shipping containers in which the systems were packed were not rugged enough for the operational environment. The shipping containers were commercial cardboard boxes with the contents wrapped with standard wrapping paper. l. EC 24. The system maintains a flow rate to within 5 percent of the rate set. Table 59 shows the question and responses for EC 24.

TABLE 59. DOES THE SYSTEM MAINTAIN A FLOW RATE WITHIN 5 PERCENT OF THE RATE SET?

System Number of

surveys

Number of survey

responses

Responses

Yes No Unsure or no

response A 5 5 5 0 0 B 5 5 5 0 0 C 5 5 5 0 0

(1) Results. The BMES responses indicate that the three systems were able to maintain a flow rate within 5 percent. (2) Analysis and Conclusion. During the acceptance testing by the BMESs, the flow rate was verified and then verified again during the CA by assessment teams as they conducted the various scenarios and system checks.


46

6. AAR. Upon completion of phase three, the assessment players and the BMESs conducted an AAR to discuss the strengths and weaknesses of each system. The assessment player comments from the AAR are as follows: a. System A. (1) Strengths.

• The pumps were stackable as one unit using the clamping bracket. • The lighted keypad enhanced readability during non-daylight conditions. • The pump came with an interconnecting 3-in-1 power cord. • The pump was field serviceable and stayed stable while attached to the litters and

other frames. • The pump was compatible with a syringe. • The pump had a good free-flow tubing design. • The battery was easy to replace and did not interfere with patient care (disruption of

the infusion). • The user can create a dose rate to fit the needs of doctor orders.

(2) Weaknesses.

• The design of the tubing and excess tubing created tangles (see figure 26). • The user could not use another type of tubing with this pump. • The bolus function was difficult to perform. • One accidental free-flow occurred with no alarm sounding. • The occlusion alarm was delayed when a situation was introduced. • The durability of the door design was not robust. • The software did not compensate for changes when the pump configuration functions

were changed.


47

Figure 26. Tangled IV Tubing on System A. b. System B. (1) Strengths.

• The system was compact, lightweight and portable. • The numerical format of the keypad made it more detailed for inputting information. • The illumination of the keypad made it easy to use in various lighting environments. • The design of having dual pumps in one unit made it easier. • The integrated clamp assembly made it easy to secure to litters. • The simplicity of operator maintenance and BMES troubleshooting was a good

feature. • The extension tubing came in handy during usage of the IV pump. • The system had the ability to create a patient-specific drug label. • The system had a charging base and a universal power cord.

(2) Weaknesses.

• The user could not conduct a hot swap out of batteries during an infusion. • The keypad did not light up when it was disconnected from the battery charging base. • The user lost the dual-screen display when the pump was removed from the battery

charging base.


48

• The pump did not have up-to-date technology (no Wi-Fi capability). • The clamp had limitations due to its design; the clamp was molded as part of the

battery charging base. • The system did not have a bracket for the stacking of IV pumps. • The upstream tubing was too short; it did not include a drip chamber or roller clamp

on the tubing. • The pump had an inadequate priming process.

c. System C. (1) Strengths.

• The pump was easy to use and very user-friendly. • The pump was lightweight, and it was easy to load patient information into the pump. • The tubing was free-flowing and adjustable. • The pump had multiple safety warnings built into the pump system. • The pump had Wi-Fi technology incorporated into the system design. • It was easy to upload and update pharmacy data and to change the battery. • The display screen was large and used color. • The clamps were interchangeable between IV pumps. • The pump had a visual automatic flow sensor. • The pump had good prompts for verification of a percent of increase or decrease of

fluid flow.

(2) Weaknesses.

• The power cord was not a universal cord. • The pump used several proprietary parts. • The pump was not field serviceable and would have to be sent to the manufacturer for

repairs. • The keypad was not backlit, which made it difficult to read during various light

environments (darkness). • The red numbers did not work well under red light conditions. • The soft screen face would not be durable in a field environment. • The clamp knob stripped and was not durable. • The clamp knob design made it susceptible to hanging up or getting caught on objects. • The individual IV pumps had to be individually placed on the IV pole for stacking.

7. TEST OFFICER ANALYSIS AND CONCLUSIONS. Overall, the entire CA went well, and it would not have been as successful as it was without the help of the 17 assessment players who


49

took part in this event. The medical providers from each of the Services brought a wealth of operational knowledge and varying experience levels, which enhanced the outcome of the CA. All three systems had their own strengths and weaknesses that were identified during the CA. No specific system was identified as the preferred system. Each assessment player represented explained that due to the differing operational environments one system that may be appropriate for one Service environment may not be appropriate for the other Service environment. Upon examining the results of the CA, it is clear that all three systems could be used in support of the Services in an operational environment. However, if they were subjected to use in an austere environments as encountered in Afghanistan, Iraq, or Haiti, the three systems would not do well. Before any decision is made about which system should replace the current IV infusion pump, the systems would need to be certified for use on a ship and aeromedical evacuation platforms. Included in this report is supplemental information that may assist in the decision-making process. Enclosure 1 has additional comments from the assessment players. Enclosure 2 has additional comments from the BMESs. Two incidents during the CA required a Modified Test Incident Report (MTIR): MTIR 001 (Enclosure 3) and MTIR 002 (Enclosure 4). 8. The USAMEDDBD point of contact for this project is SFC Dale Scherberger at COMM: (210) 221-290, DSN: 471-2901, or email: [email protected]. 4 Encls MATTHEW J. SCHOFIELD as COL, MS President, US Army Medical Department Board

Encl 1

ADDITIONAL ASSESSMENT PLAYER COMMENTS ON MULTI-CHANNEL INTRAVENOUS INFUSION PUMP CANDIDATES

1. System A.

• The pump lacked the durability and reliability needed in a combat zone. • No back key was available. If incorrect information was input, the user has to restart. • The intravenous (IV) tubing packaging was good; it kept the tubing clean and safe from

contamination. • For patient safety, the bolus button provided 10 seconds of dosing. • The IV tubing was difficult to load into the pump. • The screen and keypads were user-friendly. • The pumps were heavy when all three were stacked. • The design for stacking the pumps was good. They had the ability to carry three or more

pumps at once. The design of the plugs reduced tangles.

2. System B.

• The assessment players stated that they liked the dual-channel design. • The assessment players did not like the clamp, which was separate from the actual pump. • The users could only bolus by volume and not dose. • The pump was very portable, had a good drug library, and appeared to be durable. • The IV tubing did not have a drip chamber. • The keypad did not light up in a dark environment. • This pump would not be very useful in a combat environment. • This pump would be better suited for an inpatient setting. • When making changes to the program, the pump defaulted back to channel one. • The pump defaulted back to the last mode, making the pump not easily interchangeable.

3. System C. • The pump was very user-friendly. • The pump was lightweight and very portable. • The pump had limited biomedical technician capabilities and would have to be sent back to

the manufacturer for repairs. • The IV tubing loaded into the pump very easily. • When an occlusion was fixed, the alarm went off automatically. • The pump had a clinical advisor for the medications. • The pump had Wi-Fi capabilities. • The pump accepted secondary tubing that could be used; it could come from another vendor. • The pump had an easy to use medication dosages program, and it automatically started again

after repositioning. • The red light of the system could not be seen in a red-light environment, for example, in an

aircraft.

Encl 2

ADDITIONAL BIOMEDICAL EQUIPMENT SPECIALIST (BMES) COMMENTS 1. System A.

• The pump was double insulated. • The pump could be used as either a single pump or a triple pump and had piggyback

capabilities. • This system only used one power cord when all three pumps were connected together. • The display screen of the pump did not have number keys, so navigation and setting volume

and rate took more time. • The pump had an indicator that showed pressure buildup. • The door hinges could break easily. When closing the door, it had to be held closed until the

pump closed itself. • The pump had a gap in the door that could allow dust and sand to work its way into the

pump. • The three pumps stacked became a little heavy and bulky to carry; the handle was a plus. • The light-emitting diode (LED) screen had fewer barriers for protection in case it is dropped,

and the keypad did not light up. • The pumps were cumbersome due to the right-to-left design; IV lines could get tangled more

easily. • The pump display was bright and visible with crisp lettering, but it lacked a main menu

feature.

2. System B. • The pump had an internal battery that could not be changed out by the user. • The charging time for the pump was 8 hours, and the pump ran for 8 hours on battery power. • The battery display only came on when the pump was running on battery power. When

plugged into the docking station, the LED display showed that it was connected to alternating current (AC) power.

• The pump used a “must-press” function to check the battery capacity. • There should be a battery charging display during normal operations. • The battery gauge of the pump worked properly and was visible to read. • Updating information could be difficult if the user does not have a laptop computer and

connections. • It was difficult to scroll through the drug library of the pump. • No software was available to change the dose calculations. • Users would need a standalone computer to be separate from the hospital network to install

software updates. • The BMESs were not presented any information on how to upgrade the software. • The technicians would need additional training from the manufacturer to be able to upgrade

software. • Sometimes the pump would revert back to pump one when setting pump two. • The keypad of the pump was user-friendly, and it was very easy to change flow rates. • Hard and electronic copies of the service and operator manuals were on hand during the CA. • The service manuals were not sufficient; the BMESs could not order parts without any

additional training.

2

• The manual did not have any information about replacing or repairing certain items on the pump.

• The manual did not have a parts breakdown or listing. • The pump did not come with step-by-step instructions on how to disassemble the pump. • The pump could be opened and troubleshot without any additional training from the

manufacturer. • A special calibration tool was needed for the door, which was pressure sensitive. • The BMESs had concerns over the air sensors being damaged by the user and the durability

of the door latches. • For an upstream occlusion, it gave the “air-in-line” alarm, which could be confusing to the

user. • The pump did not have an alarm for an upstream occlusion. • The drug library seemed difficult to navigate through, and there was no conversion of the

different units of measurement. • The manual settings did not allow the user to truly adjust the parameter settings, which could

cause unnecessary work orders. • The service manual was incomplete and did not have a parts breakdown or numbering, which

is critical for biomedical repairs. • The clamp was not large enough to clamp onto anything larger than an intravenous (IV) pole. • The IV tubing did not have a drip chamber, which is a patient safety issue. • It had a dual reading on the screen, even when it was not attached to the charger. • The pump could be calibrated by a BMES. • The pump could be used if one of the pumps went down. • The pump was small, lightweight, and portable.

3. System C.

• The pump had a single-channel design, but came with a three-pump carrier for multi-channel

use. • The biomed mode enabled the BMESs to set up the preventive maintenance date, which lets

the user know when it is due for maintenance. • The alarm messages were displayed in red. • The pump had a silicone strain relief. • The keypad did not light up, and it did not have a backlight for use in the dark. • The AC cord was attached to the pole clamp by a strain relief device. A strain relief was also

located on the back of the pump. • The display was large and would need a stronger LCD protector to be resistant to breaking if

it were dropped. • The BMES support for this pump was limited, since most repairs and services for this pump

would need to be sent back to the manufacturer. • The service manual had a listing of every error code and what it pertained to. • The pump was easy to calibrate with the BMES code, but sending it back to the manufacturer

could jeopardize the mission. • The BMES needs to have more access to the internal components.

Encl 3

MODIFIED TEST INCIDENT REPORT 001

PROJECT TITLE: MULTI-CHANNEL IV INFUSION PUMP

PROJECT NO: 7-12 INCIDENT NUMBER: 001

TEST AGENCY: US Army Medical Department Board

MULTI-CHANNEL IV INFUSION PUMP REGISTRATION NUMBER:

MAJOR ITEM DATA: MULTI-CHANNEL IV INFUSION PUMP SERIAL NUMBER: II. INCIDENT DATA

TITLE: CA DATE: 003/01/2013 TIME: 1000 (MMM/DD/YYYY) HH:MM

PROBLEM TYPE: Persistent OBSERVED DURING: Phase three of the CA for the Multi-Channel IV Infusion Pump

III. INCIDENT DESCRIPTION

Give a full description of the incident: The clamp on IV Infusion Pump G00000986005 stripped and could not release the clamp from the IV pole.

IV. CORRECTIVE ACTION TAKEN

Give a full description of action(s) taken and results achieved: The assessment player used pliers to loosen the clamp and removed it from the IV pole; the infusion pump was still operational but could not be mounted to an IV pole. NAME, TITLE, & PHONE NUMBER OF PREPARER: SFC Dale Scherberger 210-221-2901

PROJECT OFFICER (SIGNATURE):

ORGANIZATION/LOCATION: USAMEDDBD, Fort Sam Houston, TX

COMMERCIAL PHONE/TERMINAL: 210-221-2901

Encl 4

MODIFIED TEST INCIDENT REPORT 002

PROJECT TITLE: MULTI-CHANNEL IV INFUSION PUMP

PROJECT NO: 7-12 INCIDENT NUMBER: 002

TEST AGENCY: US Army Medical Department Board

MULTI-CHANNEL IV INFUSION PUMP REGISTRATION NUMBER:

MAJOR ITEM DATA: MULTI-CHANNEL IV INFUSION PUMP SERIAL NUMBER: II. INCIDENT DATA

TITLE: CA DATE: 003/01/2013 TIME: 1020 (MMM/DD/YYYY) HH:MM

PROBLEM TYPE: Persistent OBSERVED DURING: Phase three of the CA for the Multi-Channel IV Infusion Pump

III. INCIDENT DESCRIPTION

Give a full description of the incident: During the transportation phase of the CA, IV Infusion Pump G00000986022 fell off the litter while the FLA was traveling on an unimproved road and hit the floor of the FLA. The display screen cracked and caused the screen to become distorted (see attached figures).

IV. CORRECTIVE ACTION TAKEN

Give a full description of action(s) taken and results achieved: The IV Pump was removed and taken out of play; this did not impact the assessment.

NAME, TITLE, & PHONE NUMBER OF PREPARER: SFC Dale Scherberger 210-221-2901

PROJECT OFFICER (SIGNATURE):

ORGANIZATION/LOCATION: USAMEDDBD, Ft Sam Houston, TX

COMMERCIAL PHONE/TERMINAL: 210-221-2901

2

Figure 1. Damaged Screen of System C.

Figure 2. Damaged Screen of System C.

Documents

FINIAL MIVP REPORT