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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
support reclassification of personal blood lancet devices in home use environments.
Response 2 FDA disagrees with the comments that there is no evidence to support the reclassification of single patient use blood lancets for home use from class I general controls to class II
special controls. At the Panel meeting on June 26, 2013, FDA presented an analysis of the risks to health associated with the use of blood lancets and new scientific data supporting these risks Ref. 2. Although the information on infection transmission was generated in healthcare settings, FDA believes the risks to health are general risks that apply to all single use patient blood lancets, regardless of the environment in which they are used. Based on the scientific evidence available to the Agency at that time, blood may be transmitted between patient and care givers by the misuse of single use only medical devices that are not intended for or labeled for reuse, because they are not designed to be cleaned or sterilized to become safe for reuse, such as needles or syringes Ref.
2. Similarly, transmission may also occur if validated cleaning and disinfection instructions are not identified and followed for multiple use blood lancets for single patient use only subset 3. After reviewing the new scientific data supporting the identified risks to health, the Panel recommended that reclassifying single patient use blood lancets from class I general controls to class II special controls will provide a reasonable assurance of the safety and effectiveness of blood lancets for single patient use.
The Panel also acknowledged that many of the adverse event reports of device problems indicate that accidental sticks are most likely when safety features malfunction, the lancet is difficult to remove, or when lancets are too dull to pierce the skin or too long to fit within the safety caps Ref. 2.
From January 1, 2015, to May 31, 2021, FDA received over 3,100 reports for blood lancets, most of which are device malfunctions. The most commonly reported problems include accidental blade sticks, the blade breaking off or remaining in a patients finger, and the blade protruding from the device cap or not retracting. In addition, FDA received numerous reports of device malfunctioning and retraction problems with the blood lancets.
FDA agrees with the Panel that reclassification from class I to class II is appropriate for single patient use blood lancets and is supported by FDAs findings reported in the 513e Proposed Order, adverse event reporting, and the
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panel executive summary Ref. 2. FDA
also agrees with the Panel that premarket notification 510k submissions are necessary for single patient use blood lancets to ensure adequacy of the labeling concerning the limitation to single patient use only, effective sharps injury prevention features that disable the lancet from further use when applicable, and blade dispense release mechanisms on multiple use blood lancets for single patient use only, as well as instructions for a safe blade disposal and cleaning and disinfection for the multiple use blood lancets for single patient use only.
These special controls are consistent with the special controls applicable to other similar device technology such as injection needles Ref. 2. As a result, FDA believes the premarket notification requirement and the established special controls are necessary to provide a reasonable assurance of safety and effectiveness for all for single patient use blood lancets, whether they are used in a home environment or a healthcare setting.
Comment 3 Several comments stated that the 513e Proposed Order, if finalized, would increase the cost of blood lancets for single patient use, putting an undue burden on patients, and would cause what one comment referred to as economic driven disruption . . . with lancet access driving use of less expensive devices in the wrong setting.
Response 3 FDA appreciates the economic concerns raised by users of blood lancets regarding the cost of this device; however, reclassification decisions are based on the level of controls necessary to ensure that reasonable assurance of safety and effectiveness requirements under 21
CFR 860.7d and e as well as section 513e of the FD&C Act are met. The regulatory requirements for blood lancets established by FDA are based on the probable benefits to health for the indications for use of blood lancet devices and the risk of the devices when used as intended, and not the costs of the device. FDA also agrees with the findings of the Panel and believes that to mitigate the known risks to health posed by these devices, the proposed special controls are necessary for single patient use only blood lancets, regardless of their environment of use.
In addition, FDA believes that manufacturers of single patient use only blood lancets may already be complying with some of the proposed special controls e.g., biocompatibility testing and package integrity testing because they are industry standard type tests Ref. 2. Therefore, FDA does not believe
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the reclassification of single patient use only blood lancets subsets 1, 2, or 3
will result in an economic disruption that will affect the availability of or patient access to these devices for these intended purposes.
Comment 4 Several comments stated that the proposed special controls related to the disinfection of skin and/
or reusable device components for single patient use blood lancets subsets 1, 2, or 3, along with the associated special controls concerning labeling and validation, were either too burdensome or not appropriate. For example, one comment did not understand why disinfection was needed for a single patient home use device; a similar comment felt that cleaning and disinfection validation was overly burdensome for single patient home use devices. A few comments stated that disinfection of the skin would adversely affect blood glucose monitoring by resulting in vasoconstriction. Also, one comment suggested that FDA should not mandate usage of Environmental Protection Agency EPA commercially registered disinfectant if a commonly available generic disinfectant agent is equally effective for home use.
Response 4 FDA believes that the special controls related to the disinfection of reusable device components, along with the associated special controls pertaining to labeling and validation, are appropriate to ensure a reasonable assurance of safety and effectiveness for multiple use blood lancets for single patient use i.e., subset 3. To reduce the risk of infection, FDA
believes that reusable components of single patient use lancets, such as reusable bases, should be adequately cleaned and disinfected i.e., reprocessed between uses. Without adequate reprocessing validation conducted initially by the manufacturer for multiple use blood lancets for single patient use under simulated use conditions, it is unclear whether adequate labeling for cleaning and disinfection between uses by the end user can be developed. Further, patient soil e.g., skin cells, oil, dirt, skin flora, and body fluids such as blood and sweat can accumulate on the reusable component over time, creating an ideal environment for microbial growth.
Although the lancet may be for single patient use, soil can become transferred from the reusable base component to the single-use lancet, thereby posing a risk of infection upon reuse of the device in the same patient.
At the Panel meeting, FDA presented an analysis of the risks to health associated with the use of blood lancets and new scientific data supporting these
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