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HCIR Access Requirements

Coalition for Best Practices in HCIR Requirements

AdvaMed supports the Coalition for Best Practices in HCIR Requirements (www.HCIRBestPractice.org) to streamline the HCIR Credentialing process for all stakeholders, while meeting the common goals of patient safety and confidentiality, through the advancement of Joint Recommendations, which reflect best practices and recent stakeholder progress toward consistent credentialing requirements, and an open and ongoing dialogue with all stakeholders to address emerging issues.

Background

Health Care Industry Representatives (HCIRs) may otherwise be known as vendor representatives. HCIRs represent a company or companies with respect to medical devices that are involved in the care, treatment and services provided by professional clinical staff in health care organizations. Clinical HCIRs are those representatives who provide technical support for devices during a surgical/interventional procedure. Non-Clinical HCIRs are those whose proximity to patients is incidental (e.g., the HCIR who is there to update the software in or perform preventative maintenance on a piece of diagnostics equipment).

Many hospitals now require HCIRs to comply with extensive and unique credentialing requirements to gain access to most areas of the hospital, especially procedural areas such as the operating room and catheterization laboratory. In addition, fees are routinely required, and may be applied to costs such as maintenance of HCIR tracking databases, the credentialing operations themselves (e.g., salaries, infrastructure and badges), and/or enforcement of hospital credentialing policies.

Presently, no national standard exists for HCIR Credentialing. Although all stakeholders share the common goals of patient safety and quality care, the current environment subjects HCIRs to widely varying credentialing requirements, resulting in increased costs and administrative burdens which can also impede access to technology, technical support, and educational resources.

Some existing HCIR credentialing policies impose standards and credentialing requirements that: (i) are duplicative of existing controls, training and screening processes; (ii) are not reasonably related to the duties performed by HCIRs; (iii) compromise the privacy rights of HCIRs and/or are implemented without assurances that sufficient safeguards, per state and/or federal privacy regulations, are in place; (iv) are inconsistent with existing contractual obligations; and/or (v) are inconsistent with FDA adverse event reporting requirements.