PosiSep™

Technical Information

Contraindications:

PosiSep should not be used on patients who have known allergies to shellfish.

Intended Use:

PosiSep Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying splint and hemostat to:
• Separate tissue or structures compromised by surgical trauma;
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• Help control minimal bleeding following surgery or trauma;
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• Act as an adjunct to aid in the natural healing process.
PosiSep is indicated for use as a nasal hemostat to treat epistaxis.
PosiSep is intended for use under the direction of a licensed healthcare provider.

Description:

Hemostasis, LLC offers two different platforms of hemostat dressings/intranasal splints. PosiSep and PosiSep X are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep and PosiSep X expand when hydrated providing separation between the sinus tissues. However, if extra gelling properties are desired, PosiSep will form a smooth gel surface when exposed to liquids. If extra expansion properties are desired, PosiSep X will expand more than PosiSep to fill in spaces.

Warnings & Precautions:

• PosiSep is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections. Appropriate treatment to be instituted in case of infection.
• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Single Use Only.
• To prevent product contamination prior to application, always follow aseptic techniques.
• Contains material derived from shellfish.
• In rare instances, the physiochemical condition associated with nasal surgery, both with and without nasal packing, may present a risk of toxic shock syndrome (TSS).
• Appropriate treatment to be instituted in case of infection.
• In the case of prolonged bleeding seek medical attention.
• Do Not Ingest.
• Do Not Inhale.
• Do not use after the end of the year and month shown.
• When used as a topical dressing, PosiSep should be kept dry prior to use.
• This product shall be disposed of in compliance with pertinent government regulations regarding medical devices.

Instructions for Topical Dressing:

1. Peel open PosiSep pouch and remove dressing using sterile technique to maintain product integrity.
2. Blot excess blood from the wound with gauze.
3. Apply PosiSep dressing to cover wound.
4. Apply gauze over dressing and hold in place until hemostasis is achieved.
5. If hemostasis has not been achieved, repeat steps 2-4 or use an alternate method of hemostasis treatment.
6. Once hemostasis is achieved, remove PosiSep from the wound site using gentle irrigation with saline or water.
7. Discard any unused product after opening.

Instructions for Intranasal Splint:

1. Peel open PosiSep pouch and remove dressing using sterile technique to maintain product integrity.
2. Insert PosiSep longitudinally and apply to area of treatment. For added support, PosiSep may be inserted using a bayonet forceps with tips of the forceps advanced to the leading edge of the hemostat dressing.
3. If PosiSep is broken during insertion, assess if size is appropriate for application. If not, dispose and reapply PosiSep.
4. PosiSep may be removed with gentle irrigation using saline or water.
5. Discard any unused product after opening.


Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.

Content taken from 50057 Rev. E, 50156 Rev. A, 50157 Rev. A