COMMENT to FDA 2 / Third Party Strips - Who's Responsible

The FDA has proposed new guidance for blood glucose meters — that is, new accuracy standards that meters and strips will have to meet before the FDA clears them for sale. The guidance has a short paragraph on third party strips. We wonder who is responsible if there is an issue. Will the meter maker point at the strip, the strip company point at the meter or both point at the patient and assume the strip was used with the wrong meter. For more, see our blog post.

Our comments on third party strip are below. Please share them, or other thoughts on third party strips with FDA. Even if you have already commented. The extended the comment period to May 7th. We think that is more room to share.

The number of comments matters. The more FDA receives from us, the more the needs and concerns of the diabetes community will be heard. Other interests will lobby for their views. We must speak up for our own. Our health — and lives — are at stake.

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Dockets Open for Comment:

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (this refers to the meters you’d use at home)

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1446-0003

Submit comments for: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0013

Our third party strip comments — feel free to pick and choose, or write your own:

Progress

I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a big step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.

Suggestions:

Third Party Strips – Who is Accountable?

In the introduction to its proposed guidance on blood glucose meters, FDA speaks of self-monitoring blood glucose test SYSTEMS (SMBGs – caps mine.) This terminology is important because of its clearly implied meaning:  a meter and its strips are a complete system, designed to be used together.

Why is this important?

There are several reasons:

One is liability. When a third-party manufacturer makes test strips for a meter it is unclear who should be responsible for maintaining the system’s integrity and who would be held accountable in the case that something goes wrong:  the meter company, the strip company, caregiver or the patient.

Generic strips are approved for use with meters sold before specific dates. The data a meter is sold is not always clear. Patients need clarity.

FDA draft guidance speaks of third-party strips starting at line 990 of the over the counter draft guidance (1050 of POC) saying. “We strongly recommend that agreements between the third-party strip manufacturer and the meter manufacturer are in place to ensure that the third-party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.”

That is not an academic issue. Insulin is a very dangerous drug that puts over 97,000 American in the emergency room each year.  A recommendation is not enough.  The FDA’s final guidance on blood glucose meters and strips should require formal agreements (and plans) between meter manufacturers and third-party strip manufacturers as part of the criteria used for clearance. Until these standards are in place, third-party strips should not be considered part of a system. Without bing part of a system the should not be cleared for sale. Patient lives are at stake.

Additional third party strip considerations

RESPONSIBILITY – I hope FDA clearly defines who is responsible/liable when an adverse event occurs as a result of the use of a third-party strip.

ACCURACY – Third-party strips should be be held to the same standards of accuracy as all blood glucose test strips. Accuracy should advance. Strips that fail to meet new accuracy standards set by this guidance should be rapidly phased out of the market.

POSST MARKET SURVEILLANCE  – There should be a program in place to ensure the quality and accuracy of all meters and strips, including third-party, after the meters and strips have been cleared for sale

RECALL – Recalls of all strips and meters are an important post market protection. Options to recall must stay open and include third-party strips. In the case of a recall communication to users of a SYSTEM are important. Clear guidance should be in place to ensure that the safety of patients using systems that include third-party strips is not compromised.

MDR – The FDA should require all strip and meter manufacturers to establish clear procedures for Medical Device Reporting in the event of adverse events related to these meters or strips. Third-party strips will add complexity to the submission process; before they are allowed to enter the market, third-party strip manufacturers must establish a clear, robust and simple process for tracking and submitting MDR.

DME – The FDA should make clear in its guidance documents that systems of meters and strips (including third-party) that do not meet the FDA’s stated accuracy requirements cannot be considered durable medical equipment (DME) and thus should not be eligible for reimbursement by CMS or other payers.

THERAPY ADJUSTMENTS Therapy Adjustments: the FDA should also make clear that if a meter and strips cannot be used to “make therapy adjustments” — meaning to dose insulin or calibrate a CGM — then they are, by definition, not a blood glucose meter  (or strip) and cannot be considered DME (and thus cannot be reimbursed as such).

LABELING: Who is going to be responsible for keeping an accurate and up-to-date list of which third-party strips work with which meters? Until this issue is clarified, third-party strips should not be cleared for sale.

Until all of these issues are addressed, third-party strips cannot be considered parts of a self-monitoring blood glucose test system, and should not be cleared for sale.