Dilapan-S® | Healthcare Economics

When units are short-staffed, saving time in the care pathway is extremely valuable

Nursing divisions were short-staffed for decades before the COVID-19 pandemic amplified the problem.^7,8

Staffing shortages represent a considerable risk to patient safety, including higher rates of severe maternal complications.^9,10

58% of OB/GYN clinicians rank nursing shortages as the top risk to patient safety in labor and delivery.¹⁰*

*Results from a survey of 1,130 obstetrics and gynecology clinicians in the 2021 Future of Obstetrics Industry Survey Report conducted by the Ob Hospitalist™ Group.¹⁰

Pharmacologic agents for cervical ripening are time-intensive for nurses
Synthetic prostaglandins require extensive fetal monitoring, and many are frequently readministered.¹¹

With Dilapan-S^®, lower-acuity care may be possible, impacting:

CLINICAL WORKFLOWS

ESTABLISHED CARE PATHWAYS

“The ideal ripening agent or procedure should be simple to use, noninvasive, and effective within a reasonable amount of time; it should not stimulate or induce labor during the ripening process or increase maternal, fetal, or neonatal morbidity.”¹¹

—Association of Women’s Health, Obstetric and Neonatal Nurses, 2020

Dilapan-S^® may allow for patients who are not considered high-risk to be cared for in a lower-acuity setting during cervical ripening¹

No additional fetal monitoring requirement unlike synthetic prostaglandins.^12-15

In situ for up to 24 hours without need for additional monitoring¹²

Limited safety concerns relative to synthetic prostaglandins^12,16

In comparison to a fully equipped labor and delivery room, lower-acuity options for cervical ripening with Dilapan-S^® could be¹:

Sharing a fetal monitor between rooms equipped for initial assessments and insertion of Dilapan-S^®
A lounge where pregnant patients can remain mobile during cervical ripening with resting, eating, and drinking facilities
Simple hospital patient rooms without fetal-monitoring facilities

IMPORTANT SAFETY INFORMATION

Indication for Use

Dilapan-S^® is for use by healthcare professionals trained in OB/GYN whenever cervical softening and dilation are desired, such as for cervical ripening during term labor induction or gynecological procedures that require cervical preparation.

Contraindication

Dilapan-S^® is contraindicated in the presence of clinically apparent genital tract infection.

Warnings & Precautions

Dilapan-S^® is intended for single use only. Do not reuse, resterilize, reprocess, or use if primary packaging has been opened or damaged. Discard after use.

Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus (see Instructions for Use—Insertion). The device should not be left in place more than 24 hours. Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse. Patients should return to the physician for removal of Dilapan-S^® at the indicated time and should be instructed not to attempt self-removal under any circumstances.

Potential Complications/Risks: Twisting of device during removal may cause the device to break (see Instructions for Use—Removal). Complications may include: device entrapment and/or fragmentation, expulsion, or retraction; patient discomfort or bleeding; spontaneous rupture of membranes; spontaneous onset of labor; cervical laceration.

Storage & Handling: Store between +15°C and +30°C and keep away from direct sunlight and high humidity.

Please click here to download the Instructions for Use.

You are encouraged to report adverse events related to Dilapan-S^® by calling 1 (888) 257-9676. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

Inpatient cervical ripening with Dilapan-S^®

may drive changes in care pathways that improve resource utilization and reduce costs of care.¹

Childbirth is a common, resource-intensive reason for a hospital stay

Improvements in the labor care pathway could have considerable implications on hospital resources and healthcare finances

When units are short-staffed, saving time in the care pathway is extremely valuable

Staffing shortages represent a considerable risk to patient safety, including higher rates of severe maternal complications.^9,10

58% of OB/GYN clinicians rank nursing shortages as the top risk to patient safety in labor and delivery.¹⁰*

Pharmacologic agents for cervical ripening are time-intensive for nurses
Synthetic prostaglandins require extensive fetal monitoring, and many are frequently readministered.¹¹

With Dilapan-S^®, lower-acuity care may be possible, impacting:

CLINICAL WORKFLOWS

ESTABLISHED CARE PATHWAYS

Dilapan-S^® may allow for patients who are not considered high-risk to be cared for in a lower-acuity setting during cervical ripening¹

Find out how Dilapan-S^® can help optimize hospital resource efficiency

IMPORTANT SAFETY INFORMATION

Inpatient cervical ripening with Dilapan-S® may drive changes in care pathways that improve resource utilization and reduce costs of care.1

Childbirth is a common, resource-intensive reason for a hospital stay

Improvements in the labor care pathway could have considerable implications on hospital resources and healthcare finances

When units are short-staffed, saving time in the care pathway is extremely valuable

Staffing shortages represent a considerable risk to patient safety, including higher rates of severe maternal complications.9,10

58% of OB/GYN clinicians rank nursing shortages as the top risk to patient safety in labor and delivery.10*

Pharmacologic agents for cervical ripening are time-intensive for nurses Synthetic prostaglandins require extensive fetal monitoring, and many are frequently readministered.11

With Dilapan-S®, lower-acuity care may be possible, impacting:

CLINICAL WORKFLOWS

ESTABLISHED CARE PATHWAYS

Dilapan-S® may allow for patients who are not considered high-risk to be cared for in a lower-acuity setting during cervical ripening1

Find out how Dilapan-S® can help optimize hospital resource efficiency

IMPORTANT SAFETY INFORMATION

Inpatient cervical ripening with Dilapan-S^®

may drive changes in care pathways that improve resource utilization and reduce costs of care.¹

Staffing shortages represent a considerable risk to patient safety, including higher rates of severe maternal complications.^9,10

58% of OB/GYN clinicians rank nursing shortages as the top risk to patient safety in labor and delivery.¹⁰*

Pharmacologic agents for cervical ripening are time-intensive for nurses
Synthetic prostaglandins require extensive fetal monitoring, and many are frequently readministered.¹¹

With Dilapan-S^®, lower-acuity care may be possible, impacting:

Dilapan-S^® may allow for patients who are not considered high-risk to be cared for in a lower-acuity setting during cervical ripening¹

Find out how Dilapan-S^® can help optimize hospital resource efficiency