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Title:

Manufacturer’s Representative for Invasive and Non-Invasive Procedure Areas

Origination Date:

July 1, 2005

Manual:

Materials Management Department Manual

Review Date(s):

Section:

4.0 – Vendor Policies

Revision Date(s):

Policy No.:

4.1.0

Effective Date:

July 1, 2005

Contact Dept.:

Materials Management

Approval(s):

Ronald Robinson, Director of Materials Management

Ed Ollie, Executive VP/ Chief Financial Officer

I. PURPOSE/SUPPORTING INFORMATION

Surgical and/or Procedural areas at NHHN recognize the need in the perioperative setting for education, training, and introduction of procedures, techniques, technology and equipment to practicing health care professionals. This procedure is necessary for the purposes of the patient’s safety, right to privacy, and confidentiality when a health care industry representative is present during a surgical procedure.

II. QUALIFICATIONS

The following policy governs the activity of all Health Care Industry Representatives, here after HCIR, with specialized training and who does business with the New Hanover Health Network. All health care industry representatives must adhere to the below specific procedures and NHHN Administrative and Infection Control policies as noted below:

HCIR may observe surgical/invasive and non-invasive procedures for the purpose of demonstration of new equipment or devices upon the approval of the Physician involved and Department Manager/designee. The Product Evaluation Committee and respective TAC Committees prior to trial or evaluation will approve new products. HCIR outside the hospital health care team familiar with the innovation may be present for the procedure, but may not scrub in or assist other than verbal consultation. The HCIR or Technical Support Agent with specialized training may perform remote calibration of their products to the Physician’s specification (e.g., pacemakers, pain management devices).

HCIR may not assist in any other manner such as opening of sterile supplies or have any physical contact with the patient. Presence of the HCIR is documented in the patient’s surgical procedural documentation.

Services to be provided by HCIR must be fully defined by the manufacturer.

Documentation of technical competency must be provided by the HCIR prior to providing services. The manufacturer is to provide written proof that the representative has completed all required training and acquired any necessary certifications to qualify the representative to provide these services. This information will be maintained on file in Materials Management.

Updated 9.1.06

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