Yes, Who is accountable? FDA Notice on Generic Strips

StripSafely asked Who is Accountable for generic test strips.  Apparently it is not a academic question. FDA today release a warning titled, "FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results"

From that release:

Recommendations:
Identify whether you are using GenStrips glucose test strips. The strips may be packaged in green and white packaging with the GenStrip name on top, similar to those shown below.


For People with Diabetes:

• Discontinue use of GenStrip Blood Glucose Test Strips.
• Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
• Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.
• As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either high or low blood sugar, contact your diabetes care provider for advice on treatment.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm

4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.  http://www.marketwatch.com/story/decision-diagnostics-responds-to-shasta-technologies-fda-safety-warning-letter-2014-04-30

Help FDA understand how generic strips can be part of their new guidance structure. Comment to the dockets and ask for clear rules to protect PWD. Copy and paste the draft comments from StripSafely below to the FDA docket HERE.

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I find many encouraging ideas in the FDA’s draft guidance.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.