In Your Office
Preparing Your Office
Do your due diligence
When establishing office-based MyoSure procedures, there are several agencies and resources that you should consult to help ensure that you adhere to the appropriate regulations and guidelines. These include:
- Local and State Regulatory Agencies
- Legal Counsel
- Contracted Insurance Companies
- Office Building Management
- Confirm Processes for Reimbursement
- Implement Training to Manage Emergencies
To ensure that your office is properly equipped to safely and effectively conduct office-based tissue removal, we have provided a list of equipment and supplies that may be necessary to perform a MyoSure procedure in the office. The following is a sample list of the key components you may need. It does not include prep tray or sterile pack components, additional optional tools and required safety equipment. Every physician should use his or her clinical expertise and judgment to decide which supplies are necessary for this procedure. State laws might also mandate particular equipment.
- MyoSure tissue removal system controller*
- MyoSure device
- MyoSure hysteroscope
- A fluid management system such as the Fluent® or Aquilex® system, or pressure cuff and a IV pole to hang the bag*
- ≥1000 mL bag of saline
- Cysto tubing
- Buttocks drape
- Enzymatic cleaner for the scope after the procedure
- Sterile gown
- Sterile gloves
- Betadine Solution
*The MyoSure MANUAL device does not require fluid management capital equipment. Additionally, the MyoSure MANUAL device does not require the MyoSure controller unit.
IMPORTANT SAFETY INFORMATION
The MyoSure® tissue removal system, consisting of the MyoSure tissue removal devices (LITE, REACH, XL) and MyoSure controller, is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. The MyoSure MANUAL hysteroscopic tissue removal device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. MyoSure products are not appropriate for patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed uterine cancer.
For more details on risks and benefits of the MyoSure system, MyoSure MANUAL tissue removal device, MyoSure hysteroscope and the Aquilex® fluid control system, please consult their respective IFUs.