Medical Devices in Nursing: Blood Glucose Monitoring Device

• Melissa Cassar

Write a short account of the devices used in your area of practice (200 words)

As a reliever nurse at Sir Paul Boffa Hospital, I mainly work at the Dermatology Department which consists of; a Dermatology Ward, Minor Surgery Theatres, Follow-up/ New-cases Clinics with consultants, the Leg Ulcer Clinic, the Phototherapy Unit, Patch testing, Wart Clinics and Skin Tag Clinics. From this sub-department a number of medical devices are used, the most commonly used devices are:

1. Blood pressure machines and stethoscope
   • Used to measure a patient’s blood pressure
2. Blood glucose monitoring machines
   • Determines the approximate concentration of the patient’s glucose in their blood
3. Hand held Doppler
   • Used in the leg ulcer clinic for assessing ankle brachial pressure index of the lower limbs
4. Thermometer
   • A tool that measures and monitors body temperature
5. Scale
   • Used in assessing patient’s weight
6. Measuring tapes
   • Used to measure the surface of a wound
7. Dermatoscope
   • An easy-to-use tool used for examining the skin surface and making measurements of different skin lesions

Choose a particular device for detailed study and describe the device and its clinical use (if applicable including interaction of device and ICT)

From the above mentioned medical devices, the Blood Glucose Monitor or more commonly known as ‘glucometer’ was chosen. Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade (Colwell, et al., 1987). Individuals who suffer from diabetes and healthcare professionals are able to check and read blood glucose levels regularly by using these portable lightweight devices. These devices are often used in hospitals to avoid having to wait for laboratory glucose tests as the device returns a blood glucose reading in a matter of seconds.

Predominantly, most of my working hours are spent in the Leg Ulcer clinic, where we treat and manage patients who suffer from leg ulcers. Diagnosis is an important factor in leg ulcers as it determines the correct treatment pathway. As stated by the Clinical Practice Guidelines (2006), a full clinical history and physical examination should be conducted on a patient presenting with either their first or recurrent leg ulcer and assessment should be ongoing thereafter. Required laboratory tests, physical examination and clinical history including previous and current blood glucose measuring to check for Diabetes mellitus, assess and determine the patient’s diagnosis revealing the cause of leg ulcer and identify the required treatment needed.

Hackett (March 1994), states that most blood glucose monitoring devices consist of glucose test strips and a reflectometer to determine glucose concentrations in whole blood. Some systems depend on a glucose oxidase-colorimetric reaction that occurs when a drop of blood is placed on a reagent-impregnated pad. Hackett also continues that the test pad contains the enzymes glucose oxidase and peroxidase, and color indicators. When whole blood is placed on the test pad, glucose is oxidized to gluconic acid and hydrogen peroxide with glucose oxidase acting as a catalyst. The hydrogen peroxide that results from this reaction oxidizes an oxygen acceptor in the presence of peroxidase to form a color change, the intensity of which is directly proportional to the amount of glucose in the blood sample (Hackett, March 1994).

Blood glucose tests are used to measure blood glucose and if blood glucose is high this results in hyperglycemia whereas if blood glucose result is low, hypoglycemia is detected. Screening patients who are at risk of having diabetes is essential as some patients show no early indication or apparent symptoms. This test is essential as a mean to prevent arising complications or deterioration due to an advance level of diabetes.

In the Maltese Health-Care system, glucose levels found in blood by the glucose monitoring device are measured in millimoles per liter (mmols). All blood glucose measuring devices are small in size (fit in the palm of your hand) thus making them highly efficient in portability, are battery powered and are assembled together with solid-state electronics making the device robust in case of any accidents by dropping the device.

The device’s accuracy is important as not only the patient’s well-being could be in jeopardy but may also result in a patient’s death due to severe undetected hyperglycemia or hypoglycemia.

Associated Documentation

1. Title page of the user manual –

On Call Platinum Blood Glucose Monitoring System

2. Sample output from the device –

3. List of persons in charge of device management –

If device failure occurs, it is important for nurses to remove the device from service immediately, tag it with a label describing the problem and report the incident to the nurse in charge which will then be escalated by reporting the faulty device to the maintenance within the facility so it can be evaluated and repaired or returned to the manufacturer if required.

4. Existing training procedures for new users –

At Sir Paul Boffa Hospital, there are currently no training procedures provided to any new users. The blood glucose monitoring technique is supervised and taught by a mentor to any student nurses during their placements done during their three year course at University of Malta. If one of the new users has never learned how to use the device, an experienced senior nurse shows and explains the procedure to the unskilled nurse and helps the new user master the skill.

Analyse critically the specifications of the device (list of specifications can be found in the user manual).

There are many different types of blood glucose monitor devices on the market. Each device comes with a unique set of specifications according to the user’s specific need. The blood glucose device used in the Dermatology Out-Patient Department is manufactured by ACON Laboratories, Inc. and is found by the name of ‘On Call Platinum’.

One of the features the ‘On Call Platinum’ offers is the measurement range which lies between 0.6 – 33.3 mmol/L (10 – 600 mg/dL. If the patient has a mmol/L reading of less than 0.6 or more than 33.3, the device will not be able to return a result. The result calibration feature involves measuring glucose concentrations in plasma and not the whole blood. Glucose levels in plasma are generally 10%–15% higher than glucose measurements in whole blood. The glucose meter uses an equation that has been hardcoded into the device to calculate the plasma equivalent from the whole blood glucose reading. The minimum volume of blood sample needs to be 0.8 μL. Devices requiring smaller volume reduces the frequency of unproductive pricks to the patient‘s body. The ‘On Call Platinum’ test time is five seconds. This results in faster, more accurate results and reduces chances for errors. Battery life can serve up to a minimum of 3,000 measurements (without considering data transfer and test reminder alarms) and therefore can be used for long term. The device is pre-set to either millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the standard of the country it is being used in. Here in Malta, the millimoles per litre (mmol/L) is used. This specific type of blood glucose monitor has a memory storage up to 300 records with time and date and thus is ideal for keeping tracks and records of patients. Another important feature is that the device automatically shuts off in two minutes of no interaction. This type of specification helps in preserving battery life when the device is accidentally left switched on after its last use. The blood glucose meter size is 90mm x 58mm x21mm weighing 66g (with battery included), approximately the size of the palm of the hand therefore making the device light, easier to use and portable. Its display size is 41mm x 37mm with brilliant backlit display making reading the numbers easy anytime, anywhere. The ‘On Call Platinum’ operating temperature ranges between 5 – 45 ℃ and its operating humidity ranges between 10-90%. This means that the device operates in most environments. Another specification is that the hematocrit range needs to be between 20%-70% and if the ratio of the volume of red cells to the volume of whole blood (in anemic patients) falls below or is above the required value, it can give false glucose measurements. With the data port feature it allows information from the machine to be loaded easily on most computers using a USB cable. The device also has a strip ejector which allows easy strip disposal for the safety of the user. Last by not least, the ‘On Call Platinum’ also has an advanced testing feature of ketone, hypo and hyper warnings alert for each necessary action.

Identify any physical and chemical agents associated with the device, and list precautions for patient and user safety, scrutinize the user manual to identify any physical and chemical agents impacting the effectiveness of the device.

As stated by WorkSafe Services (March 7, 2014), a chemical agent is a term used to describe all chemical elements and compounds in a natural state or in a processed state and their by-products, the exposure to which insufficient quantities and duration may result in illness or injury to human health. In addition, WorkSafe Services (March 7, 2014), also states that physical agent is a term used to describe energies, the exposures to which insufficient quantities and duration may result in illness or injury to human health. Physical agents include noise, ionizing or non-ionizing radiation, extremes in temperature and pressure, vibration, electric and magnetic fields.

In regards to the blood glucose monitor, factors that affect accuracy include test strip problems. To prevent this, strips need to be stored in their sealed container, kept away from moisture, humidity and heat. Extreme temperatures and altitude may diminish the effectiveness on the glucose meter and test strips so it is important to keep the device and its accessories at room temperature. Alcohol, dirt or any other substances on the patient’s skin will give a false reading. The patient’s hands (or the area which is going to be pricked) needs to be washed and air dried thoroughly before lanced. Improper coding is also a factor that affects accuracy. The user must make sure that the code number in the blood glucose devices matches the code number on the test strip bottle. The monitor can also give problems. The user needs to make sure that the test strips are fully inserted into the monitor and the monitor batteries need replacement if required. Not applying enough blood to the test strip is another factor that impacts the device from giving the correct result. To elude this, the user needs to be sure to apply a substantial drop of blood to the test strip. Sources of strong electromagnetic radiation are to be avoided as they may interfere with the devices’ operation giving an inaccurate reading. To acquire a very accurate reading the blood glucose sampling should be obtained from a fingertip as samples from alternate body parts have a probability to return an inaccurate result. Finally, if the patient is anaemic or dehydrated, there is a high probability of a less precise result.

Scrutinize the user manual and list what checks must be carried out to ensure that the device is working properly before being used with patients.

Glucometer “controls” are performance tests that are to be completed on the glucose meter, to ensure that the device is functioning properly.

As instructed by Vickery & Beinhaker (2012), the quality control process allows users to monitor the “variables” of blood glucose testing in order to consistently obtain reliable test results. It is highly recommended that this test should be done when a test strip container has been opened for a period of time, whenever a new container of test strips has been opened or when there is a possibility that test strips have been damaged. If the device is dropped, suspected that it is not working properly or the machine is repeatedly giving unexpected blood sugar results, it is important to ensure that such procedure is carried out. Moreover, once a week, there should be a routinely check-up to make sure that the device is working properly and to its full potential.

With the blood glucose machine kit comes a control solution bottle. A control test consists of first shaking the control solution bottle for the glucose solution to be distributed evenly. Then, a test strip should be inserted into the meter for the machine to be switched on. A drop of control solution is to be applied to the test strip and the reading is then shown on the display. The given result needs to then be compared with the acceptable test range identified on the control solution package. If the value obtained is within the given range, the blood glucose machine is fully functional.

Write a step-by-step protocol for the effective and safe use of the device (i.e., ensuring the purpose in using the device is achieved, that the device is used with patient and user safety in mind and checked before use). Include images of each step.

1. Explain the procedure to patient and gain verbal consent.

2. Collect the needed items to perform the procedure, that include alcohol wipes, a pair of gloves, single-use lancet (preferably auto disabling), blood glucose meter and test strip, band aids, sharps container and gauze swabs or cotton wool.

3. Take the items to the patients’ area or to a suitable procedure area. This procedure should not be carried out in any common areas and the needed items should be preferably transported on a trolley and not inside any pockets.

4. Assess the patient’s allergies (i.e.: latex sensitivity) and verify the patient’s identity using the two of the following unique identifiers: Patients first and last name and their ID card number.

5. This procedure should be performed on a solid surface that can be cleaned and properly disinfected in the event of any blood contamination.

6. Perform correct hand hygiene by washing your hands with soap and water or else by using an alcohol-based hand sanitizer. It is also important to tell the patient to wash the site from which you are going to draw blood with soap and water. Alcohol wipes must not be used on the patient as this may give a false blood glucose reading (Burden, 2001)

7. Put on a pair of gloves and insert the prepared test strip into the blood glucose meter.

8. Wait for the signal on the blood glucose meter to tell you to put the drop of blood on the strip. Normally the blood areaglucose meter gives you a symbol, such as a sign that resembles a drop of liquid.

9. Prick the patient using the single-use lancet. After, immediately discard the used sharps in an approved sharps container.

10. Wipe off the first drop of blood as it could be contaminated.

11. Draw and place the second drop of blood on the test strip.

12. Wait until a result is shown on the blood glucose monitor. The meter will initiate a countdown sequence once the blood is applied to the strip and the meter detects it. The meter will beep or sound an alarm, when a reading is generated.

13. While still wearing gloves, complete the procedure by detaching the test strip from the blood glucose meter and disposing of it in a sharps container.

14. Apply a cotton wool to the pricked area and advice the patient to keep in place in order to stop the bleeding.

15. Remove gloves and place them in the appropriate trash container.

16. Perform correct hand hygiene by using an alcohol-based hand sanitizer or washing your hands with soap and water.

17. Ensure the blood glucose meter is properly cleaned and disinfected after use according to the manufacturer’s recommendations and store the machine appropriately (i.e., in a storage case).

Supply proof of own competence – signed testimony of local person responsible for training confirming that s/he has observed you using the device and that you are competent in using the device effectively and safely and can check the device before use.

Write a short account of (a) the patient perspective (b) the user perspective regarding the device. Discuss ways of enhancing these perspectives.

One perspective in regards to the blood glucose device is that many patients find blood glucose testing to be very painful. Ways in reducing the chance of this happening is by pricking and drawing blood from the side of the patient’s finger rather than from the tip or pad of the finger. This will help with easing the pain as there is less concentrations of nerve endings on the finger side compared to the pad or tip of the finger. Additionally a patient can become distressed when a nurse has to prick their finger again, due to the lack of blood flow present to the tip of the patients’ finger because there might not be enough blood in the droplet in order for the blood glucose device to initiate a reading. To enhance this, before pricking the tip of the patients’ finger the user must hold the patients’ hand downwards to enhance blood flow into the finger tip.

Many patients also feel anxiety during the whole procedure due to being afraid of what the result might be. Nurses should try to comfort the patient to help them feel at ease. Another patient’s point of view is being afraid of getting an infection from using a common shared glucometer device. Ways of enhancing this perspective include performing hand hygiene in front of the patient before performing blood glucose monitoring, making sure that the blood glucose meter testing strips are sealed before using them, by wearing gloves and opening the test strip in front of the patient to show them that a sealed unused test strip will be used. Moreover, from a nurses’ perspective, to avoid any potential hazardous risks, any used sharps should be disposed of immediately in a sharps container after pricking the patient and not leaving them lying around near any of the patients’ surroundings. Disposal of any sharps is essential and should be done by the user not by one of your colleagues. Wiping the machine with 70 percent isopropyl alcoholwipes after use, properly disposing of the pair of gloves used and proper hand hygiene after every blood glucose test performed should always be done in order to sustain effective infection control.

Due to the immediate result from the blood glucose machine, users such as nurses are able to see the test as life-saver in situations where the patient falls hypoglycemic, is unconscious or is hyperglycemic as it provides crucial information that can be used to make rapid decisions as opposed to having to wait for laboratory tests results.

References

Amoore, J., & Paula, I. (3rd August 2002). Learning from adverse incidents involving medical devices. BMJ, 272-275.

Barach, P., & Small, S. (2000). Reporting and preventing medical mishaps: lessons from non-medical near-miss reporting system. BMJ, 320:759–63.

Burden, M. (2001). Diabetes: blood glucose monitoring. Nursing Times, 36-39.

Clinical Practice Guidelines. (2006). The management of patients with venous leg ulcers. London: Royal College of Nursing.

Colwell, J. A., Dudley, J. D., McDonald, J. M., Metz, R., Raskin, P., Rizza, R. A., . . . Young, D. S. (1987). Self-Monitoring of Blood Glucose. Diabetes Care, 95-99.

Hackett, J. (March 1994). Portable Blood Glucose Monitors. Health Devices, Volume 23, No. 3, 64-97.

Vickery, S., & Beinhaker, K. (2012). Blood Glucose Monitoring (BGM). Performing Quality Control (QC). Interprofessional Clinical Practice Standard- Procedure, 1-4.

WorkSafe Services. (March 7 2014). Biological, Physical and Chemical Agents- Definition and Reporting Requirenments. Occupational Health and Safety Act, 9(2)(b), 13, 42, 43(4).