초록 ▼

Devices and methods for defining a data set, referred to herein as a signature, for a particular device having interior channels. A baseline signature is established for the particular device while the particular device is known to be in a decontaminated condition. After use of the device and subseq

Devices and methods for defining a data set, referred to herein as a signature, for a particular device having interior channels. A baseline signature is established for the particular device while the particular device is known to be in a decontaminated condition. After use of the device and subsequent decontamination of the device, a signature for the particular device is determined and compared with the baseline signature to verify that the latter signature is within an acceptable range.

대표청구항 ▼

1. A quality control method for medical devices, comprising the steps of: exposing a plurality of surface positions located in an interior of a medical device to energy emitted from an energy emitter after subjecting the medical device to a cleaning process;measuring energy reflected from each surfa

1. A quality control method for medical devices, comprising the steps of: exposing a plurality of surface positions located in an interior of a medical device to energy emitted from an energy emitter after subjecting the medical device to a cleaning process;measuring energy reflected from each surface position of the plurality of surface positions of the medical device and recording the energy reflected from each surface position of the plurality of surface positions of the interior of the medical device, wherein the reflected energy measured and recorded at each surface position of the plurality of surface positions produces a set of data points, wherein each of the data points corresponds to energy reflectivity from one of the surface positions of the plurality of surface positions, and wherein the data points produce a signature for the condition of the medical device after cleaning;establishing a baseline signature, wherein the baseline signature is established by a second set of data points of energy reflectivity for each surface position of the plurality of surface positions located in the interior of the medical device for a known clean and properly functioning medical device;comparing the signature for the condition of the medical device after cleaning to the baseline signature;determining cleanliness and functioning of the medical device by the variance of the signature of the medical device after cleaning from the baseline signature. 2. The quality control method for medical devices of claim 1, comprising the additional steps of providing an identifier for the medical device, the baseline signature and the signature, and matching the identifier the medical device and the baseline signature and matching the identifier to the baseline signature and to the signature prior to comparing the baseline signature to the signature. 3. The quality control method for medical devices according to claim 1, wherein the energy emitter is progressively transported relative to the medical device to sequentially expose each surface position the plurality of surface positions of the interior of the medical device to energy emitted from the energy emitter, and measuring energy reflected from each surface position of the plurality of surface positions of the medical device at intervals as the energy emitter is progressively transported relative to the medical device, and recording the energy reflected from each surface position of the plurality of surface positions of the medical device at each interval to produce a signature for the medical device. 4. The quality control method for medical devices according to claim 1, wherein the energy emitted by the energy emitter is ultraviolet radiation. 5. The quality control method for medical devices according to claim 1, comprising the additional steps of providing a unique identifier for the medical device, the baseline signature and the additional signature, and matching the unique identifier to the medical device and the baseline signature and matching the unique identifier to the baseline signature and the additional signature prior to comparing the baseline signature to the signature, wherein the unique identifier is a machine readable code that is associated with the medical device. 6. The quality control method for medical devices according to claim 1, further comprising the step of establishing a tolerance limit for the signature prior to comparing the baseline signature to the signature. 7. The quality control method for medical devices according to claim 1, wherein the interior of the medical device comprises an interior channel, and the plurality of surface positions are located within the interior channel of the medical device. 8. The quality control method for medical devices according to claim 1, wherein the energy emitter is progressively transported through the interior of the medical device and the reflected energy measured and recorded at each surface position of the plurality of surface positions produces a set of data points. 9. A quality control device, comprising: an energy emitter;an energy receiver;a conveyance device constructed and arranged to progressively convey the energy emitter and energy receiver through an interior lumen of a medical device; anda controller constructed to measure and record energy received by the energy receiver as a function of positon within the interior lumen of the medical device;wherein the controller is constructed and arranged to establish a decontamination signature for the medical device by exposing a plurality of surface positions located in the interior lumen of the medical device to energy emitted from the energy emitter and measuring energy reflected from each surface position of the plurality of surface positions of the interior lumen of the medical device and recording the energy reflected from each surface position of the plurality of surface positions of the interior lumen of the medical device, wherein the reflected energy measured and recorded at each surface position of the plurality of surface positions produces a set of data points, wherein each of the data points corresponds to energy reflectivity from one of the surface positions of the plurality of surface positions, and wherein the data points produce the decontamination signature for the condition of the medical device. 10. A quality control device as described in claim 9, wherein the energy emitter and the energy receiver are mounted at an end of the conveyance device. 11. A cleaning quality control device as described in claim 9, wherein the energy emitter periodically emits energy that is directed to surfaces of the interior lumen of medical device as the medical device is transported though the interior lumen of the medical device, and wherein the energy receiver receives energy that is reflected from surfaces of the interior lumen of the medical device. 12. A quality control device as described in claim 9, wherein the conveyance device comprises a cable, and the cable comprises fiber optic material through which energy is transmitted and from which energy is emitted. 13. A quality control device as described in claim 9, wherein the energy emitter comprises a light emitting diode. 14. A quality control device as described in claim 9, wherein the conveyance device comprises a velocity controlled motor.