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Proposal for Additional Intended Uses Proposal for Additional Intended Uses and Performance Criteria for the TFM: and Performance Criteria for the TFM:

Topical Antimicrobials for Skin Site Topical Antimicrobials for Skin Site Preparation Prior to the Placement of Preparation Prior to the Placement of

Percutaneous Medical Devices Intended Percutaneous Medical Devices Intended to Remain Indwellingto Remain Indwelling

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Presented by:Presented by:Presented by:Presented by:

Steven C. Felton, Ph.D., SM(ASCP)Steven C. Felton, Ph.D., SM(ASCP)

Staff ScientistStaff Scientist

BD (Becton Dickinson and Company)BD (Becton Dickinson and Company)

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Current Performance Criteria Current Performance Criteria and Intended Usesand Intended Uses

• Surgical Hand ScrubSurgical Hand Scrub

• Patient Preoperative Skin Prep Patient Preoperative Skin Prep • PreinjectionPreinjection

• And…And…

• Health Care Personnel Health Care Personnel HandwashHandwash

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Proposed:Proposed:Skin Antisepsis Prior to Indwelling Skin Antisepsis Prior to Indwelling

Percutaneous Medical Device PlacementPercutaneous Medical Device Placement

Performance criterion that is no Performance criterion that is no worse (non-inferiority) than worse (non-inferiority) than current standard of practice with current standard of practice with regard to the risk for indwelling regard to the risk for indwelling device-related infections.device-related infections.

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Examples of Indwelling Percutaneous Medical Devices• Short-term peripheral vascular catheters (PIV)Short-term peripheral vascular catheters (PIV)• Central Venous Catheters (CVC)Central Venous Catheters (CVC)• Peripherally Inserted Central Catheters (PICC Peripherally Inserted Central Catheters (PICC

Lines)Lines)• Surgical pinsSurgical pins• Intraosseous Infusion DevicesIntraosseous Infusion Devices• Continuous Ambulatory Peritoneal Dialysis Continuous Ambulatory Peritoneal Dialysis

(CAPD)(CAPD)• OthersOthers

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Indwelling Percutaneous Medical Devices Indwelling Percutaneous Medical Devices

• Through-the-skin; break in skin barrier is held Through-the-skin; break in skin barrier is held open by the deviceopen by the device

• Intended to remain in place hours, days, Intended to remain in place hours, days, months, or longermonths, or longer

• Have significant risk of infectionHave significant risk of infection• Studies have demonstrated that the Studies have demonstrated that the

effectiveness of the topical antimicrobial used effectiveness of the topical antimicrobial used for placement can reduce the risk of infection for placement can reduce the risk of infection (Maki, 1991; Sheehan, 1993; Chalyakunapruk (Maki, 1991; Sheehan, 1993; Chalyakunapruk [meta-analysis], 2002)[meta-analysis], 2002)

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Catheter-Related Bloodstream Catheter-Related Bloodstream Infection (CRBSI)Infection (CRBSI)

• Special case Special case • Administer meds, fluid replacement, Administer meds, fluid replacement,

monitoring, collect blood samples monitoring, collect blood samples • ““Significant risk” in Central Venous Significant risk” in Central Venous

Catheters (3-10%) Maki (1994) Catheters (3-10%) Maki (1994) • Estimated costs up to $2.3 Billion Estimated costs up to $2.3 Billion

and 5-20,000 deaths/year (Mermel, and 5-20,000 deaths/year (Mermel, 2000; Widmer, 1997)2000; Widmer, 1997)

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CRBSI CRBSI (Cont’d)(Cont’d)

• The major cause of infection during The major cause of infection during the first weeks of indwelling time is the first weeks of indwelling time is from skin microorganisms.from skin microorganisms.• Rannem, Rannem, et. al.et. al., 1990, 1990• Maki, Maki, et. al.et. al., 1991, 1991• Maki (review), 1994 – 20+ referencesMaki (review), 1994 – 20+ references• Widmer (review), 1997 – 10 + referencesWidmer (review), 1997 – 10 + references

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CRBSI (Cont’d)

• These microorganisms initiate an infection These microorganisms initiate an infection cascade that progresses: cascade that progresses: • from microbes on the skin, from microbes on the skin, • to colonization of the invasive portions of the to colonization of the invasive portions of the

devicedevice• to local signs of infection (inflammation, phlebitis)to local signs of infection (inflammation, phlebitis)• to a CRBSIto a CRBSI• significant morbidity, mortality (5-20%) and added significant morbidity, mortality (5-20%) and added

healthcare expense ($5,000 to $40,000 per healthcare expense ($5,000 to $40,000 per occurrence for survivors) (Maki, 1987; Pittet, 1994).occurrence for survivors) (Maki, 1987; Pittet, 1994).

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CRBSI CRBSI (Cont’d)(Cont’d)

• CRBSI has been well studied and CRBSI has been well studied and methods to diagnose CRBSI have been methods to diagnose CRBSI have been developed and validated. developed and validated. • Maki - Semi-quantitative tip culture Maki - Semi-quantitative tip culture

matched to positive blood culturesmatched to positive blood cultures• Sherertz - Sonication method to quantitate Sherertz - Sonication method to quantitate

microorganisms on catheter SQ and tip microorganisms on catheter SQ and tip segments matched to positive blood segments matched to positive blood culturescultures

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Topical Antimicrobials and CRBSITopical Antimicrobials and CRBSI

• Studies have shown that the efficacy Studies have shown that the efficacy of topical antimicrobials is inversely of topical antimicrobials is inversely related to the rate of infection.related to the rate of infection.• Maki, 1991Maki, 1991• Sheehan, 1993Sheehan, 1993• Chalyakunapruk, meta-analysis 2002Chalyakunapruk, meta-analysis 2002

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SummarySummary• The intended uses of topical antimicrobials for The intended uses of topical antimicrobials for

placement of other indwelling percutaneous placement of other indwelling percutaneous medical devices are the same as for vascular medical devices are the same as for vascular access catheters.access catheters.

• Unlike current performance criteria in the TFM, Unlike current performance criteria in the TFM, reduction of the incidence of device-related reduction of the incidence of device-related infections can be demonstrated in clinical trials infections can be demonstrated in clinical trials in the intended use population.in the intended use population.

• The TFM should identify the need for and The TFM should identify the need for and establish performance criteria for the clinical establish performance criteria for the clinical evaluation of topical antimicrobials prior to the evaluation of topical antimicrobials prior to the placement of indwelling percutaneous medical placement of indwelling percutaneous medical devices.devices.