A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
The standard systems for monitoring pregnant women in labor are not very patient-friendly. They typically involve strapping a wired ultrasound transducer to the laboring woman’s abdomen. The process requires precise positioning and often involves repositioning throughout labor and delivery to continue monitoring the fetal heart rate. This inhibits the mother’s ability to walk and move and requires constant attention and interaction with the staff to keep the contraction and fetal monitor sensors in their proper location to function accurately.
“We were just in the process of the normal 510(k) submission; we already had the CE mark. [N]ow with COVID, you can avoid a lot of physical interaction between the midwife or obstetrician and the woman in labor and delivery,” Peter Ziese, general manager of monitoring analytics at Philips, told BioWorld. “[Y]ou can put it very easily to use and practice for any normal delivery, and you save very valuable time and personal protective equipment – which is scarce – because you don't need the repositioning of the transducer. You simply apply it once and it stays in place; for a normal delivery, you would need to readjust the transducers a half dozen times.
“It also is part of a system,” he continued. “The product itself is connected to a solution we call Intellispace Perinatal – that's our central surveillance tool that allows for remote monitoring of the woman giving birth and her unborn child or children, if we have twins or triplets. This technology has remote surveillance as another element. The FDA looked at us as a system provider, not just as a technology company [that] brings a simple device to market.”
A new generation of wireless obstetrics monitors has been created – but largely not yet implemented – in the U.S. In 2017, Philips competitor GE Healthcare acquired Monica Healthcare, which had been its partner previously and marketed a wearable, wireless fetal monitoring device that was FDA-cleared.
The prior argument for implementing this technology largely was confined to the comfort and ease of the patient, which was not a very effective motivation for cash-strapped hospital systems to purchase new equipment. However, the pandemic may have changed that calculus.
Now, hospitals are looking for ways to reduce the exposure of laboring patients, supportive family and hospital staff to one another. Reliable wireless maternal and fetal monitoring that does not require constant adjustment is suddenly more than a convenience, but instead a way to reduce the chances for transmission of SARS-CoV-2 by limiting the need for face-to-face interactions.
“Overall, we strongly believe cableless, remote patient monitoring will be further accelerated through what we’re experiencing with COVID right now, whether it’s in maternal and infant care or adult hospital-at-home care,” said Ziese.
Hospital to home?
The Avalon CL Fetal and Maternal Pod and Patch can be worn for up to two days and applied in the hospital and worn home. The system includes a portable monitor that can be used at home; it is battery operated and stores data for later integration into hospital medical records. It is intended to be used under the supervision of a health care provider, such as a midwife. While in the hospital, data from the system is transmitted automatically via the facility’s wireless LAN installation.
Philips also is developing a version that is intended specifically for use at home. Previously, it would’ve taken two or three years for this to happen; however, the company is operating at an accelerated pace due to the pandemic. Still, reimbursement from payers for at-home products and care remains difficult – something that still could prove a stumbling block.
Still, the disposable, single-use patch is placed on the mother’s abdomen. It enables continuous, noninvasive monitoring of the maternal heart rate, fetal heart rate and uterine activity, including contractions. While it is worn, the mother can move freely and even bathe while it is in use; it also can be used during water births, which are used more commonly by midwives at home.
The system can be used in the U.S. with any pregnant, laboring woman, regardless of COVID-19 status, although an estimated up to half a million women will give birth this year while infected with SARS-CoV-2
The Avalon CL system also is useful for mothers with a high body mass index, an increasingly common labor and delivery risk factor. With standard fetal monitoring, the extra tissue between the baby and the sensor can make it less effective. But that’s not expected to be an issue with this technology.
Philips has been rolling out several remote patient monitoring technologies into the U.S. during the pandemic. Earlier this month, it gained emergency use authorization (EUA) for several Intellivue patient monitors and active displays to enable providers to better view data remotely. Last month, it secured an EUA for a non-acute patch sensor that enables data intended to predict which hospitalized COVID-19 patients are most at risk of deterioration.
“At Philips, being able to provide the right information at the right time to caregivers has always been a top priority,” summed up Ziese. “Now more than ever, there’s an urgent need to make sure those on the frontline have all the available resources at their disposal.”