RISK MANAGEMENT

1)  MEDICOLEGAL OUTCOMES
2)  CLINICAL OUTCOMES



1)  OUTCOMES ANALYSIS & JUSTIFICATION FOR ADOPTING C SAFE AS AN IN-HOSPITAL OPTION FOR PERFORMING CESAREAN SECTIONS

Current efforts regarding risk management affairs, whether from a clinical or economics outcome perspective, transcend from hospitals to CMS {IPPS Final Rule} to insurers, and of course physicians.  Today’s efforts on Quality Measures continue to grow and impact upon all parts of the healthcare system.

There aren’t many examples of medical devices specifically designed as a safety device that reduces or eliminates negative outcomes.  The C SAFE device has been engineered from the ground up with exactly this concept in mind.  This device is a result of negative health and negative economic outcomes.  It was not developed to replace an existing device, because there is no such cesarean section device available to modern medical practice.

Properly implemented, the C SAFE device should be considered by healthcare parties as part of an overall risk management & quality measures perspective.  One to which an institution may reap the following benefits:

+Reducing or eliminating fetal injuries and their negative clinical outcomes minor lacerations to acute injuries
  +short term to long term complications
  +Medical intervention related costs for managing any fetal laceration
  +Proactively addressing the medicolegal implications related to cesarean sections
  +Patient safety & improvement practices
  +Risk mitigation programs




2)  CLINICAL RISK MANAGEMENT OF CESAREAN SECTION FETAL LACERATIONS AND INJURIES

Content for Physicians

The following link contains graphic content and is intended for physicians.

Research and Development

1) RESIDENCY TRAINING PROGRAM
2) COOPERSURGICAL MOBIUS ELASTIC RETRACTOR + C SAFE SURGICAL DEVICE COMBINATION KIT
3) DEVICE REGISTRY TRIAL: 3,000 CESAREAN SECTIONS ...

Press Releases

Brolex LLC: December 12, 2012:
Brolex LLC:  June 28, 2012:​

Reviews / Articles

Med Reviews
Abstracts
References

CLINICAL BENEFITS

At a documented risk of 1.5 – 3.0%, this translates to up to 45,000 newborns that experience some level of laceration injury related to the c-section surgical procedure…

Clinical Benefits

25 - 38% C-sections (1.5 million and growing)
1.5 - 3.0% result in lacerations or nicks
45,000 newborns experience some level of laceration injury (rates are higher outside US)