Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment.

Background: Real-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.

Objectives: To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.

The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes.

Adsorption of active ingredients of surface disinfectants depends on the type of fabric used for surface treatment.

The disinfection of surfaces in the immediate surrounding of a hospitalised patient is considered to be an important element for prevention of nosocomial infection. The type of fabric in a mop, however, has to our knowledge never been regarded as relevant for an effective disinfection of surfaces. We have therefore studied the adsorption of benzalkonium chloride (BAC), glutardialdehyde and propan-1-ol from working solutions of three surface disinfectants to four different types of fabric (A: white pulp and polyester; B: viscose rayon; C: polyester; D: mixture of viscose, cellulose and polyester).

Surface fixation of dried blood by glutaraldehyde and peracetic acid.

The difficulties of successful prion inactivation by chemical agents has led to changes in recommendations regarding the reprocessing of instruments including flexible endoscopes. One of the changes is the preference for peracetic acid instead of glutaraldehyde in order to avoid fixation of organic material, but the surface fixation by various active agents has not been fully investigated. We used a standardized amount of dried blood soil on metal carriers (on average 22 mg).

Test models to determine cleaning efficacy with different types of bioburden and its clinical correlation.

The importance of cleaning as a first crucial step in reprocessing instruments and endoscopes is recognized worldwide. However, no standards to determine the efficacy of cleaning have been established. We have therefore investigated Bodedex forte, a new cleaner, in various test models derived from critical types of bioburden on flexible endoscopes.