Medical Devices

Phototherapy and Cooling Therapy Device Safety in Neonatal Patients - September 22, 2011

Audio Presentation

MedSun KidNet-sponsored webcast Transcript:
Phototherapy and Cooling Therapy Device Safety in Neonatal Patients

September 22, 2011
12:00 pm CT

Coordinator: Welcome and thank you for standing by. At that this time, all participants are in a listen-only mode for the duration of today's conference. I would like to inform all participants that today's conference is being recorded. If you have any objections you may disconnect at this time.

I would now like to turn the conference over to Ms. Angela James. Ma'am, you may begin.

Angela James: Good afternoon, everyone. My name is Angela James and I'm a Nurse Consultant with KidNet, a subnetwork of MedSun within the Office of Surveillance and Biometrics, within the Division of Patient Safety Partnerships at the Center for Devices and Radiological Health at the Food and Drug Administration.

I will be your moderator today and I'm happy to welcome you to the one hour MedSun KidNet sponsored webcast on Phototherapy and Cooling Therapy Device Safety in Neonatal Patients.

Today's webcast on Phototherapy and Cooling Therapy Safety for Neonatal Patients is co-presented by MedSun and Georgetown University Hospital, which is located in Washington, D.C.

I also want to mention that the opinions and assertions presented during this webcast by those not from the FDA are the private views of the presenters and are not to be construed as conveying either an official endorsement or criticism by the U.S. Food and Drug Administration.

Any discussion is not confidential. References to products, actual or inferred, made by those from the FDA are not to be construed as promotion or endorsement.

Again welcome. During today's program experts from the FDA and Georgetown University Hospital, a MedSun hospital, will discuss medical device safety when used in phototherapy and cooling device therapy in neonatal patients.

Case study examples of medical device adverse events associated with phototherapy and cooling therapy will be presented, in addition to, safety considerations for these devices.

If you have any additional questions of the speakers, you are welcome to submit them by email to following today's presentation. Answers to your questions will be addressed in a timely manner.

Again, if you have any questions or if you encounter any difficulty accessing the slides, please call MedSun at 1-800-859-9821. Again that number is 1-800-859-9821.

One nursing continuing education contact hour is available for this program. Certificates of participation with this credit will be available after the webcast by going to the registration Web site and completing a brief evaluation.

A link to the registration site can be found in your confirmation email. Please make note the one contact hour of nursing continuing education credit is available only up until Monday, September 26, 2011. Again, that date is Monday, September 26, 2011.

Our objectives for today's webcast are to describe indications for use, placement considerations, and care with phototherapy and cooling therapy for hypothermia in neonatal patients, to recognize complications associated with phototherapy and cooling therapy, to identify safety tips and risk reduction strategies that promote neonatal patient safety with phototherapy and cooling therapy and, finally, to discuss the importance of recognizing and reporting actual and potential problems with medical devices.

And now I would like to briefly introduce today's presenters. Again my name is Angela James and I will be your moderator today. Our first Georgetown presenter is Alice Pengra. Alice is currently the Pediatric Specialty Director at Georgetown University Hospital and she will present phototherapy.

Our next speaker is Rose Kane. Rose is the Clinical Nurse Educator for the NICU at Georgetown University Hospital and Rose will present cooling therapy.

Our last presenter is Crystal Lewis. Crystal is a Nurse Consultant at the FDA and Crystal will present case studies on phototherapy and cooling therapy.

I will now turn the presentation over to Alice who will present phototherapy. Alice?

Alice Pengra: Thank you, Angela. Good afternoon, everyone. I would like to start by first discussing the primary goal of phototherapy and why this treatment is used. It is a very effective way to decrease the concentration of circulating bilirubin or to prevent an increase in circulation of bilirubin.

Elimination of bilirubin is dependent upon the rate of formation and the rate of clearance of the photo products.

The concept behind phototherapy is that the lamps in the units give off specific wavelengths of light that help break down the bilirubin into different forms that can leave the body through urine and stool.

The rate of formation of bilirubin photo products is dependent upon the intensity and the length of the wavelengths used. It is recommended to use a range of 460 to 490 nanometers.

Neonatal jaundice is the result of the liver's inability to clear excessive bilirubin from the blood. Although this neonatal condition is not uncommon, if left undetected and untreated, it can lead to encephalopathy and kernicterus, which could result in long-term neurologic defects and deficits.

As mentioned, this is not an uncommon condition. About 60% of newborns are clinically jaundiced during the first week of life. And, as a result, 5 to 40 per 1000 late pre-term and term infants receive phototherapy before leaving the hospital.

About the same number per 1000 are readmitted for phototherapy after initial discharge. In addition, all jaundice does not require phototherapy or hospitalization, and often times those babies not hospitalized can be followed as outpatients by their physicians.

The following is a list of possible issues that can develop with hyperbilirubinemia. These physiological issues are more at the cellular level, we will not go into great detail for the purpose of this presentation, but it is important to understand that this condition can have grave consequences if left undetected or untreated.

Assessing the newborn for jaundice is usually done from head to toe. The most common practice is to blanch the skin to reveal underlying color. In addition to blanching the skin, the sclera of the eye is also assessed for yellow coloring.

For dark pigmented infants, checking the soles of the feet or the palms of the hands in addition to the blanching of the skin can help determine if the infant is indeed jaundice.

Some experts recommend transcutaneous bilirubin levels (TcB) or total serum bilirubin levels (TSB) prior to discharge. The TcB can be used as a screening for the TSB, and that level can be drawn at the same time as the metabolic screen.

It is often thought that ultraviolet light is used for phototherapy, but in reality the blue end of the light spectrum is used for phototherapy. The blue light penetrates the tissue and the light is then absorbed by the bilirubin.

This must happen in order for there to be a phototherapeutic effect. The blue end measures a wavelength of 430 to 490 nanometers, whereas the ultraviolet measurement is less than 400 nanometers.

To maximize the efficacy of the phototherapy, a common practice is to use covers over the incubators or bassinets to filter out the ultraviolet light. There are several factors to consider before using phototherapy as a form of treatment:

You must take into consideration the gestational age of the infant, the age of the infant in hours since birth, presence or absence of certain risk factors, such as isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase deficiency, asphyxia, temperature instability, sepsis, acidosis and hypoalbuminemia.

It is also important to note that therapy is used at a much lower serum bilirubin level for pre-term infants. In addition some practitioners may use phototherapy prophylactically in all infants with birth weights less than 1000 grams; however, this practice will vary between practitioners and hospitals.

The efficacy of the phototherapy depends on the irradiance or the output of the light source and the distance between the infant and the light source.

The irradiance is measured in units of watts per square centimeters or microwatts per square nanometers over a given band and that desired band range is 460 to 490 for therapeutic phototherapy.

There is a direct relationship between the level of irradiance and the rate of decline of the total serum bilirubin level. There is no standardized method for delivering phototherapy, the end-user must be educated on the fact that phototherapy units and the types of lights in these units vary widely.

Therefore, it is very important to follow the manufacturer's instructions and recommendations. Although the units may vary in operation, they all function under the same premise that the efficacy of phototherapy depends on the dose of phototherapy being administered.

In the previous slide we mentioned that the efficacy of the phototherapy depends on the dose being delivered. In addition, in order to maximize your irradiance, you must minimize the distance between the patient and the light source as well.

Infants with hyperbilirubinemia should be placed in bassinets or incubators, depending on their age, and they should be positioned to be within approximately 10 to 15 centimeters from the light source.

Caution must be taken not to position the infant any closer to the light source than the manufacturer's recommendation due to the risk of a burn. It is important to expose as much of the infant's skin surface to the light source as possible.

In addition to the overhead phototherapy lights, additional light sources, such as fiberoptic pads can be placed below the infant to maximize the phototherapy treatment.

The spectrum of light delivered by a phototherapy unit is determined by the type of light source and any filters used. Commonly used phototherapy units contain daylight, cool light, blue or special blue fluorescent tubes.

In addition to the fluorescent tube units, biliblanket fiberoptic systems are often used as well. Phototherapy dose measurements are typically reported as spectral or irradiance, which is the output from the light source.

Spectral irradiance is measured by a device called a radiometer. It is important to note that different radiometers can measure different results even when measuring the same phototherapy system.

Not only can there be a variation in readings between radiometers, but there can be a difference depending on where the measurement is taken. The reading can more than double if it is taken below the center of the light source as opposed to the periphery, and that measurement can vary between phototherapy units as well.

Ideally you should average multiple irradiance measurements taken under the area illuminated by the unit. The international Electro Technical Commission defines the surface area as the intended treatment area. The commission uses 60 by 30 centimeters as the standard surface size.

Periodic safety and operational checks of phototherapy units are important to confirm adequate irradiance is being delivered and to ensure a safe, functioning piece of equipment.

If bilirubin levels are extremely high and need to be rapidly decreased, expose as much as the infant's surface area to phototherapy as possible. Intensive phototherapy delivering high levels of irradiance in the 430 to 490 nanometer band can be used.

Phototherapy systems can provide phototherapy above and below the infant for maximum impact. Some units provide special blue fluorescent tubes for therapy above the patient and then fiberoptic blankets or pads can be placed below the infant.

The reason for the use of phototherapy will determine the efficacy of the treatment. For example, phototherapy is likely to be less effective if hemolysis or cholestasis is present due to increased direct bilirubin.

If hemolysis is present, start phototherapy at a low total serum bilirubin level for intensive phototherapy. If phototherapy fails, hemolysis is likely the cause of the jaundice.

It is recommended to use intensive phototherapy for higher total serum bilirubin concentrations, keeping in mind that the higher the TSB, the more rapid the decline in levels.

Intensive phototherapy in infants greater than 35 weeks gestation can have a decrease of 30% to 40% in the initial bilirubin level 24 hours after initiation of therapy.

The most significant decrease is in the first four to six hours, whereas standard phototherapy results in a decrease of 6% to 20% of the initial bilirubin level in the first 24 hours.

Regardless of the intensity of the therapy, it is important to maintain the infant's feeding schedule and to allow the infant to be held. Breastfeeding moms should be allowed to continue to breastfeed with close monitoring of caloric intake to make sure the infant is being properly nourished.

Just as there is no standardized method in delivering phototherapy, there is no standardization for discontinuing phototherapy either. The total serum bilirubin level for discontinuing phototherapy depends on the infant's age and the cause of the hyperbilirubinemia.

For infants readmitted to the hospital after their birth hospitalization, usually for TSB levels of 18 or higher, it is suggested that phototherapy may be discontinued when the serum bilirubin level falls below 13 to 14.

There is concern regarding a rebound effect in total serum bilirubin levels after therapy is discontinued, and these levels can be one to two milligrams per deciliter or more.

Infants at increased risk for clinically significant rebound are infants less than 37 weeks gestation, infants with hemolytic disease, and infants who have been treated with phototherapy during their birth hospitalization. However, discharge from the hospital need not be delayed if there is a concern for rebound.

If there are no other clinical indications for the infant to remain hospitalized then discharge is appropriate and follow-up with a pediatrician within 24 hours after discharge is recommended.

For those infants who may have complications or issues at the cellular level; they may experience one of the following:

Bronze baby syndrome, which is dark grayish discoloring of the skin and this presents in most patients exclusively with cholestasis. However, not all infants with cholestatic jaundice develop this syndrome. Purpuric or bullous eruptions can be the result of severe cholestatic jaundice as well.

An erythematic rash can develop if the patient is on tin-mesoporphyrin medication and if severe blistering or agitation occurs. This may be a sign of congenital porphyria. With regard to porphyria; congenital porphyria or a family history of porphyria, and the use of accompanying photosensitive medications are contraindications for phototherapy.

Prior to beginning phototherapy the healthcare team must remember to obtain consents from the guardian of the infant, ensuring all questions are answered, and provide the necessary details regarding the therapy.

Cover the patient's eyes with eye patches to protect them from the light. Inspect the patient's skin, being sure to note any blemishes or redness prior to initiation of therapy and then routine skin assessments should be done throughout the therapy.

As well as the skin assessment prior to treatment, the infant’s temperature should be obtained to establish a baseline to assure that the infant is maintaining proper thermoregulation throughout the therapy.

Fluid intake, regardless of whether it's oral or IV, should also be monitored as radiant heat may increase insensible water loss. As always, be sure to alert the physician to any changes in the infant's assessment.

As with any treatment providing education, outlining the care plan is very important to the care givers and the family.

Reassuring and supporting the nursing mother and/or caregiver can put them at ease during a somewhat difficult and anxious time. It is important to answer questions they may have throughout the course of the therapy and the entire hospitalization. One of the most troubling aspects of this therapy is the infant eye patches. Be sure to explain that the eye patches are necessary for the safety of the infant's eyes. It is comforting to the family knowing that the eye patches can be removed during feedings and when the infant is being held.

Another point to discuss is that loose stools are a side effect of the phototherapy and they will usually subside once the therapy is completed. For the healthcare team, it is important to provide ongoing communication and education to the family as needed.

With regard to the setup of the unit, be sure to visually inspect the power cord and light source unit equipment for cracks or obvious damage. Prior to positioning the light source, make sure it is secured appropriately and moves freely for positioning according to the manufacturer's recommendations.

In addition, be sure to measure the amount of light intensity with the bilimeter according to the manufacturer's recommendations. While using the phototherapy unit there are several safety tips to keep in mind:

In addition to making sure the infant's eyes are covered, those caring for the infant should take precautions and avoid looking directly at the light.

The light may affect drugs being delivered intravenously and it is recommended to cover the IV tubing being used for medication delivery with aluminum foil.

And then when using phototherapy light sources with irradiant warmer, make sure that the light source lens casing is not directly in the path of the radiant heat rays. This blocks heat to the infant and could result in a drop in the infant's temperature and it may result in damage to the light source lens casing as well.

Be sure to keep the light source unit vents unobstructed and free from blockage. Also, make sure that the cables and pads do not come in contact

with sharp and abrasive devices.

Keep pads, cables and illuminators out of liquid. When cleaning use small amounts to avoid liquid seepage into pads, cables, or the illuminator. Also avoid (unintelligible)-based cleaning solutions. Iodine-based solutions may discolor the pad and interfere with their light output. Once again, be sure to follow the manufacturer's recommendation for the appropriate cleaning of their equipment.

Make sure light pads are in an enclosure to avoid infants rolling off of the pad. If practitioners are sensitive to the blue light, use the device in a well lit area. If ambient air cools the device, follow manufacturer recommendations on ambient temperature limits.

Make sure bedding doesn't block the vents and if the lights are placed in an incubator, use room air only as the light is not designed for use in oxygen enriched environments.

Lastly, and most importantly, annual maintenance protocols for phototherapy units are necessary to confirm adequate irradiance is being delivered to the patient and to ensure the unit is safe for use. Patient safety should always be the number one priority.

This concludes my presentation on phototherapy.

Angela James: Thank you, Alice. Now we will hear from Rose. Again, Rose is the Clinical Educator for the NICU at Georgetown University Hospital. She will be presenting cooling therapy. (Rose)?

Rose Kane: Thank you, Angela. Cooling therapy for newborns is a relatively recent therapy offered as a treatment for hypoxic ischemic encephalopathy (HIE), which has gained significant attention since 1999.

There are several titles or styles for cooling. Some of these are brain cooling or whole body cooling, but this therapy is scientifically known as induced hypothermia. Although this cooling affects every organ in the infant, in the NICU we utilize this therapy primarily to benefit the brain after a hypoxic incident in the perinatal or birth period.

Cooling has been demonstrated to provide a neural protective effect in the brain. HIE is defined in the literature as an acute brain injury that occurs during the perinatal period as the result of an ischemic event. This event, which can be the result of cord prolapse, abruption, uterine rupture, or possible maternal hypertension, restricts the brain not only from oxygen but also glucose.

As a result, anaerobic metabolism leads to lactic acid accumulation. However, it is during the secondary phase that begins 6 to 15 hours later when irreversible cell death begins with reperfusion injury. A detailed explanation of the path of physiological events can be found in several of the references that follow the presentation.

HIE occurs approximately once per 1000 births. The mortality and neural developmental impairment numbers are estimated to be 20% and 25% respectively. However, some reports indicate that neural developmental issues may be as high as 60% as the result of HIE. Literature states that many of these children, who may not have severe handicap s, might still have cognitive deficits, poor scholastic achievement, and may have special education requirements.

As far back as 1981, the question remains how can we improve outcomes? NICUs did a great job of resuscitating, stabilizing and sending babies home with their parents.

However, we did a poor job neurologically as our standards of care provided supportive therapies that sometimes included resuscitation and correcting issues such as seizures, hypoventilation, electrolyte imbalances and hypotension. The quest to improve outcomes started with research in this area.

Studies found that cooling therapy was associated with adverse events such as increasing viscosity of the blood, risk of thrombosis and possible coagulopathy, decreases in heart rate and blood pressure affecting white blood cell (WBC) function and therefore, sepsis and also rebound hypothermia, which could promote neuronal injury.

Additional research fine-tuned procedures and created protocols that would provide therapies to avoid the complications, but included positive outcomes. Current research has demonstrated that providing therapeutic cooling to newborns, and utilizing best evidence, caused no additional risk to the infant. The risk of death and disability was found to be reduced.

An additional study showed that cooling was a preferred therapy. When applying the statistical numbers, cooling can protect nearly 1200 infants from severe disabilities or death each year. So, the question is who do we cool? The answer is those term infants who have a significant perinatal asphyxia event are the target population to provide a controlled period of hypothermia in order to prevent, or at least reduce, those severe neurological injuries that are associated with brain injuries from ischemic birth or pre-birth events.

The goal of cooling is managing the hypocapnia or acidosis that decreases cerebral blood flow and the rebound hyperoxia that also reduces cerebral blood flow and releases free radicals and their sequelae.

Eligibility criteria are specific to each institution. Most cooling centers utilize components on the list from this slide. They include infants at least 36 weeks gestation who have experienced an HIE. Most infants have required resuscitation efforts at birth and have an acidosis as described on this slide. Apgars are generally low, such as five or less at 10 minutes of age. If an electroencephalogram (EEG) is available, the infant will show abnormal activity.

Our institution uses a chart that includes all of these areas and was developed from an article from the Journal of Perinatology, also listed in the references. Several styles of cooling exist with special preferences that are individual for an institution. These include head cooling that have a customized cap that remains on the infant throughout the entire procedure, full body cooling, or whole body cooling that utilizes a temperature controlling mattress and then some institutions use a combination of both of these types.

The goal of treatment is to lower the infant's temperature using mild hypothermia, which is between 33 and 35 degrees centigrade. Lower temperatures or moderate hypothermia are associated with shivering and increase cardiovascular complications.

While high temperatures above 37 degrees Celsius tend to expand ischemic injuries that lead to necrosis, our institution uses 33.5 degrees Celsius as the target temperature for whole body cooling. Therapeutic cooling will continue for a period of 72 hours with the primary goal to avoid large fluctuations in the core temperature, while maintaining physiology within the target temperature range.

This means that the initiation of the cooling needs to occur at an institution where healthcare professionals are trained in cooling therapy. Cooling begins at these facilities upon arrival. One primary consideration at our institution is the requirement to obtain a goal temperature of 33.5 degrees Celsius by six hours of age. This is one of the drawbacks when we transport infants into our hospital. The entire process of transport includes identification of need at the referring hospital, physician referral, accessing the hospital by ground or air and return trip to our facility within the six hour limitation goal.

There are studies on cooling during transport occurring currently. This may change practice in the future. A baseline neurological exam is conducted at the cooling facility prior to initiation of cooling. Gauging the severity of the injury will be identified by a physician. Our facility uses a chart (previously noted with the eligibility criteria). The decision to cool an infant will follow the diagnosis of moderate to severe encephalopathy.

During this time the families of these infants will need support and education in order to make their decision for treatment. Consent for cooling may be needed and the parents will require information regarding the therapy prior to signing consent forms.

The physician will write the order for cooling therapy and the nurse will verify the informed consent. A timeout for positive identification is also necessary.

Standard procedures will be dictated by each facility. Most cooling centers include an EEG, either prior to or within the first day of cooling, with a repeat EEG on day seven or when clinically indicated, which will be individually decided with each infant, a standardized neurological exam on admission and discharge, in addition to neuro checks completed by the nurse during therapy and after therapy, an MRI after re-warming as the infant ’s condition permits, and follow-up checks such as the developmental clinic and pediatric neurology clinic.

Preparations for cooling will start prior to the physician’s order. The nurse will prepare the bedside warmer where the baby will be positioned and supplies will be gathered including a cooling unit with necessary attachments and blankets. The blankets that attach to the cooling unit and all the connections always need to be checked.

Safety is always first. Specialized monitoring devices such as esophageal temperature probes and Isolette servo control (ISC) probes, bedside continuous EEG monitors are needed and then nursing care begins with admission to the NICU.

These infants frequently have respiratory issues in addition to the cardiovascular and neurological issues. Admission, stabilizing the infant, and coordinating initiation of cooling occur simultaneously.

Venous access is a primary concern as once cooling begins peripheral vasoconstriction becomes an issue in starting a new IV. Umbilical, arterial and venous lines as well as PICC lines are highly valued during the cooling process.

Accuracy in charting is paramount. Cooling protocols are followed exactly. Once the patient begins cooling, other nursing concerns are considered. Standardized temperature assessments are part of the protocol and followed closely throughout the 72 hours of cooling.

Central temperature probes are generally used for accurate core temperature reading. These can be either esophageal or rectal. Skin assessments need to be completed frequently.

Standardized labs and PRN orders, as well as those results, must be closely monitored. Remember that the focus may be on the infant, but the family will also be a major consideration.

Maintaining our set goal of 33.5 degrees Celsius is essential for best outcome. The use of the temperature probe has been shown to accurately provide core body temperature regulation. Using a temperature probe can assist in providing core body temperature regulation.

Although there is research currently studying the correlation of axillary temps with core temps, large temperature fluctuations are avoided to circumvent adverse outcomes, either cardiovascular or neurological.

Challenges for nursing care include pain assessment as the infants are frequently sedated for a variety of reasons, including seizure control and comfort with therapy, such as intubation.

Developmental considerations are always difficult, but especially hard when the baby needs to maintain contact with the cooling device. Changing position is still completed at least every four hours. Supportive devices may be added if they do not interfere with the cooling equipment. Other developmental concerns include keeping the infant comfortable and quiet.

In a busy NICU this is a challenge. Noise and light are an integral part of an intensive care unit. In addition to everything else, the infant's temperature must be maintained per protocol.

Complications that need to be avoided are: respiratory fluctuations, skin issues, metabolic issues and sepsis, which are among the usual neonatal concerns. By close observation and care with the above items, the patient may be controlled enough to make a difference in outcomes.

Warming the infant is a very tightly controlled process that begins after 72 hours of cooling. Slowly increasing the infant's temperature by 0.5 degrees Celsius every hour is begun as per protocol orders. Quickly warming the infant places them at risk of poor neurological outcome.

Once the infant is 36.5 degrees Celsius, the warmer is turned on and by using the servo temperature probe; we will continue to maintain the infant's temperature at 36.5 degrees Celsius, hoping that large temperature swings will not occur.

During this entire period parents need encouragement to participate in the care of their infant without increasing stress for the baby. Maintaining contact with the infant is essential for parent al bonding.

Nurses will provide support with education and teaching at the bedside, as well as by phone if the patient has been transported over a distance. Most institutions have brochures to help with this process.

Having information available in English and Spanish is extremely valuable for the bedside nurse. The education that begins at admission continues through to discharge with follow-up care and planning for the developmental and clinic appointments. These parents need to become the primary advocate, care giver and teacher for these babies, and nurses must empower them as they teach.

Several studies included in the references identified that cooling does not prevent neurological damage or death in all cases, but more severe outcomes occur less frequently in the study groups when compared to the percentages of the same outcomes in the control or non-cooled group.

In a multi-centered randomized trial, (Gluckman, et al.) reported head cooling had no effect in infants classified with severe EEG changes. However, a benefit was demonstrated in those newborns with less severe EEG changes pre-therapy. This study suggests that cooling may improve neurological outcomes in this less severely effected group, possibly designated as low or moderate HIE.

The cooling equipment needed for this therapy is deceivingly simple; however, safety methods must be consistently employed. Cooling should only be attempted at centers where health teams have been trained. They're skilled in using the equipment and they follow the policies and procedures.

Accurate monitoring of core temperatures includes either the esophageal or rectal probe, as well as monitoring skin temperatures with abdominal probe measurement, but always remember to keep the overhead warmer off during the cooling process.

Consistent temperature control between 32 and 34 degrees Celsius during cooling therapy is necessary. Accurate notes and records, as always, is an absolute. This includes the initiation process of every 15 minute monitoring for temperatures within the first four hours while lowering the baby's core temperature, followed by hourly temperatures for the next eight hours.

And then, finally, every hour temperature monitoring for the remaining portion of the 72 hours of therapy. Regular patient neuro checks must also be included and should be noted in the charting.

Slow, methodical re-warming is only initiated after the 72 hours of cooling has been completed. And finally, safety. Safety dictates close observation and assessment of the skin and vital signs.

Skin condition must be assessed and must occur frequently; every four hours with care as suggested by most protocols that are in the centers today.

This concludes the presentation of cooling therapy.

Angela James: Thank you, Rose. And now we will hear from our last speaker, Crystal Lewis. Again, Crystal is a Nurse Consultant at the FDA and she will present case studies on phototherapy and cooling therapy. Crystal?

Crystal Lewis: Thank you, Angela. Good afternoon, everyone.

Cooling Therapy Case Study Number 1. FDA’s Center for Devices and Radiological Health, also known as CDRH, received a medical device report indicating approximately 24 hours into the cooling therapy treatment; the system became frozen for half an hour or less. The rectal temperature was 34.4 degrees Celsius when the machine froze. The device was rebooted and prior to completing the treatment, the device froze a second time. The device was rebooted again and used until a second backup device could be placed into service.

FDA’s CDRH has received a small number of reports that involve cooling therapy. This was one of the reports taken from our database. This report underscores the importance of patient and device monitoring. The healthcare providers made important observations and took critical action before a harmful event occurred.

Cooling Therapy Case Study Number 2. A medical device adverse event report indicates approximately 30 minutes after the cooling cap therapy system was initiated, the specialist reported that the cap temperature was not responding to settings and the cap temperature continued to fall despite increases in the set temperature. After several hours it was determined that there was a power supply issue that prohibited the machine from responding to the message from the software to increase the cap temperature.

This case study emphasizes the importance of astute assessment by the clinician. Recognizing and responding to device failures with critically ill patients is an important part of patient safety. The follow-up to date after the manufacturer's evaluation of the event has been replacement of the complete system because a single failure could not be identified.

Phototherapy Case Study Number 1. A MedSun report states that during breastfeeding, the patient's mother noticed one superficial linear abrasion along with two red linear marks on the right inner thigh of the baby.

The abrasion appeared to be a scratch. The nurse noted the plastic cover of the phototherapy tubing was separated from the biliblanket. Examination of the device by the biomedical technician indicated the integrity of the protective sheath on the patient and the tubing was compromised, exposing a sharp protrusion.

The exposed tip scratched the infant. The supplier for the fiberoptic pad requested the unit be returned for failure analysis. The hospital discarded the pad and replaced it with a new pad and tubing after it was discovered that the staff had altered the original condition of the pad and tubing. Communication with the hospital indicates that their alteration of the pad led to the pad being discarded. The alteration may have led to the failure reported.

In addition to what Alice stated earlier, FDA has previously published safety tips regarding biliblanket safety and they include inspection of the biliblanket fiberoptic pads for defects, including the cable and illuminator.

Do not alter or cut the disposable cover for the fiberoptic pad. Use the self-adhesive tabs of the cover to secure it to the fiberoptic pad. Expose the maximum amount of the infant's skin to the lighted side of the fiberoptic pad.

When a biliblanket is used, the infant may be wrapped with a blanket over the pad.

These safety tips can be found by using the link found in the references slide under safety tips and articles.

Phototherapy Case Study Number 2. MedSun received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer, thus exposing it to radiant heat from the warmer.

The light intensity delivered to the patient varies depending on the distance of the lens head from the infant. The flexible light type transmits the light from the lamp to the lens where it can be directed at the infant. When using a phototherapy light, with a radiant warmer as part of a phototherapy system, make sure the lens head is not directly in the path of the radiant heat rays as this will block heat to the infant and may damage the lens head.

This MedSun report resulted in an FDA CDRH medical device safety tip regarding phototherapy lights. The safety tip includes consulting the user manual for instructions about proper use and information about using any phototherapy lights with a radiant heat warmer and, also, to contact the device manufacturer if further assistance is needed.

These safety tips can be accessed at the Web site reference on this slide.

These are just a few examples of cases reported to FDA MedSun. Reporting problems with medical devices in clinical use plays a crucial role in promoting patient safety. The healthcare provider can participate in patient safety by identifying actual and potential problems, adverse events and close calls with medical devices. FDA and MedSun encourage reporting devices that may have caused or contributed to a death, serious injury or close call with a medical device.

These adverse events may involve a device and a patient, staff member or visitor and the reporting of these medical device safety issues can greatly contribute to patient safety and protect those involved from malfunctioning equipment and devices. This, in turn, has an impact on public health for patients and healthcare providers as clinicians and staff serve as patient advocates by providing information on adverse events and potential problems to FDA and manufacturers.

Here at the FDA we encourage you to file a voluntary report through MedWatch, the FDA's safety information and adverse event reporting program if your hospital isn’t a part of MedSun. Healthcare personnel should follow the reporting procedures established by their facilities.

This concludes my presentation of the case studies.

Angela James: Thank you, Crystal. The take-home message for medical device reporting is to recognize, remove and report devices that cause, or may contribute to, potential or actual adverse events.

FDA’s CDRH MedSun KidNet subnetwork works closely with a sample of pediatric affiliated hospitals across the nation to rapidly identify and understand problems related to medical devices. We appreciate your reports on medical device problems associated with the pediatric population and encourage you to continue to foster a climate of patient safety.

Although hospitals are required to report death and serious injuries associated with medical devices, MedSun focuses on reporting and representing potential for harm, near misses and close calls. MedSun within the FDA is able to make a significant impact on patient safety while following up with manufacturers to address reported device problems and safety concerns through changes in design, materials and instructions for use, with improved interfaces between the device and the user that reduce or prevent death or serious injuries in this vulnerable patient population.

If your hospital is a part of MedSun, follow your hospital's protocol for reporting medical device related problems. Your hospital's MedSun liaison will forward your reported medical device problems to us.

It is important to save the device and save the packaging. Having device identifiers helps FDA and the manufacturer to evaluate and address problems in real time and more effectively.

Again, one nursing continuing education contact hour is available for this program. In order to receive a certificate of participation with this credit, please get your certificate to us no later than Monday, September 26, 2011.

The link to the certificate can be found in your confirmation email and in an email that will be sent after the webcast.

This slide provides some URLs for additional FDA medical device safety websites that may be of interest to your hospital. The safety tip URL in the slide stems from a reported MedSun event involving phototherapy that Crystal previously presented as a case study.

The lower (Luer misconnection) URL has downloadable case studies with great photographs. Resources for website were co-developed by CDRH and a participating MedSun hospital.

The next three slides contain references for the material that was presented today. We'd like to thank you for listening to today's webcast as this completes today's presentation.


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