Application Note: Reuse of Products Labeled "for Single Use only."
Since the inception of the field of Urodynamics, it has been a common practice to reuse disposable transducers and/or transducer domes. This practice continues today, in spite of the fact that all commercially available versions of these products are labeled and FDA cleared to be marketed "for Single Use only."
Since the inception of the field of Urodynamics, it has been a common practice to reuse disposable transducers and/or transducer domes. This practice continues today, in spite of the fact that all commercially available versions of these products are labeled and FDA cleared to be marketed "for Single Use only."
A clear understanding of good infection control practices and the causes of communicable or nosocomial infections would be expected to lead practitioners to an understanding that connecting a catheter (and the body fluids it contains) directly to any device (or consumable product) labeled "for Single Use only" and then reusing that same device on other patients carries a certain amount of risk. In addition, direct connection of such wet devices that have been left sitting open to air and exposed to common environmental pathogens (i.e., pseudomonas aeruginosa, staph aureus, ...) for prolonged periods of time, add to the risk of those contaminants to cross-contamination. This risk is not to be taken lightly and the potential for severe illness and injury to patients (including fatalities) cannot be ignored.¹
Over the years, various techniques have been devised that establish a static, sterile water-filled tubing barrier between such reused devices, in an understandable effort to same time and money in busy labs. However, it is always important to remember that all of the disposable products (catheters, tubings, 1880 Interchangeable Pressure Transducer, 1888M Nova Pressure Transducer Dome, etc) marketed by Life-Tech, Inc, are FDA cleared to market, labeled and intended "for Single Use only." Any reuse of such devices shifts product and injury liability to the end-user.
Verification of Efficacy of Technique for Reuse
The FDA clearance to market devices or supplies "for Single Use only" is mandated by the type of testing (usage, cleaning, sterile processing, etc) those devices or supplies undergo as part of the FDA clearance process. The complexity and general difficulty of being able to meet the FDA requirement to reproduce all possible scenarios for reuse (number of times and types of solutions used in cleaning, number of times and types of sterile processing, handling, etc) as part of the approval process, has led to the promulgation of products labeled "for Single Use only." Manufacturers cannot rationally be expected to be able to reproduce all potential reuse scenarios in the world.
The FDA clearance to market devices or supplies "for Single Use only" is mandated by the type of testing (usage, cleaning, sterile processing, etc) those devices or supplies undergo as part of the FDA clearance process. The complexity and general difficulty of being able to meet the FDA requirement to reproduce all possible scenarios for reuse (number of times and types of solutions used in cleaning, number of times and types of sterile processing, handling, etc) as part of the approval process, has led to the promulgation of products labeled "for Single Use only." Manufacturers cannot rationally be expected to be able to reproduce all potential reuse scenarios in the world.
Recently, the FDA has promulgated regulations that will require medical facilities to proactively inform the FDA in advance of their intention to reuse devices labeled "for Single Use only." The facility is required to provide the same procedural and validative information (e.g., method of processing, safety, efficacy, etc) to the agency, as a device manufacturer would be required to provide, in order to receive clearance to reuse a device in the method described. The FDA has stated that failure to comply with these requirements will result in severe regulatory actions.
For more information on the FDA's regulation of the reuse of devices labeled "for Single Use only," go to http://www.fda.gov/cdrh/reprocessing/.
The following information on Transducers, Transducer Domes and Urodynamic Catheters is supplied to provide you with information that may be useful in your determination of whether you wish to apply to the FDA for reuse of Life-Tech's single-use devices.
Transducers & Transducer Domes
1. Use of Sterile 1880 Interchangable Pressure Transducers Technique: Replace all transducers after each use. There is no safe or effective method of resterilizing the 1880 Pressure Transducer that does not potentially damage its ability to function as intended.
1. Use of Sterile 1880 Interchangable Pressure Transducers Technique: Replace all transducers after each use. There is no safe or effective method of resterilizing the 1880 Pressure Transducer that does not potentially damage its ability to function as intended.
2. Use of 1888MA Nova Pressure Transducers Life-Tech currently offers an alternative reusable transducer with "single use only" sterile domes. This is a much more cost-effective product in high-volume labs. The parts required are listed below (refer to Consumable catalog for illustration of the transducer and dome):
- SA 1349 Pressure Transducer Cables - interface from pressure amplifier to 1888M Transducer. Requires one cable per transducer. Cable lengths are 4", 12" and 7'.
- 1889MA Pressure Transducer Holder - slotted bracket for attaching transducers to an IV pole. Requires one holder per transducer.
- 1888MA Pressure Transducer - a reasonably priced reusable external transducer with disposable, sterile domes. Includes one transducer and 5 sterile, 1887M Domes. Requires one transducer for each pressure to be measured.
- 1887MA Pressure Transducer Domes - Purchased in quantities of 5, 25 or 50.
Technique:
Replace 1887MA Pressure Transducer Domes after each use.
Replace 1887MA Pressure Transducer Domes after each use.
Catheters
The design of multi-lumen pressure measurement/infusion catheters makes it virtually impossible to safely clean them for reprocessing. There are "dead-spaces" distal to the lumen openings that typically terminate at the tip of the catheter. This space is impossible to flush completely free of organic particulate and poses a serious cross-infection risk when reused on humans.
The design of multi-lumen pressure measurement/infusion catheters makes it virtually impossible to safely clean them for reprocessing. There are "dead-spaces" distal to the lumen openings that typically terminate at the tip of the catheter. This space is impossible to flush completely free of organic particulate and poses a serious cross-infection risk when reused on humans.
