Aug. 21, 2013 we hosted Peter Staley, a long-term AIDS and gay rights activist, and one of the early members of ACT Up NY.
Aug. 29, 2013 we hosted Bennet Dunlap, a passionate and dedicated diabetes advocate behind the StripSafely campaign.
Join StripSafely to Help Policy Makers Hear on Accurate Diabetes Testing Maters.
The FDA has acknowledged that inaccurate strips / meters are being imported to the USA. Faulty blood glucose readings can lead to dangerous, possibly fatal, insulin dosing. The FDA has no plan for ongoing inspecting the strips we are sold to insure safety. Substandard strips and systems is a public health issue.
We can lead the diabetes community to hold health agencies and elected officials accountable. Only devices and strips that continue to meet accuracy standards when used in real life conditions should be allowed to be sold in the US.
We will do this through a grassroots campaign in an effort that looks fun – something people will want to be part of.
At a recent public meeting the FDA acknowledged that there are some 510(k) cleared BG meters and strips that do not meet the accuracy standards in real life for which they were approved. There is no clear course of action to insure PWD are using BG strips that meet regulatory requirements.
For PWD using insulin meter are the tool used to regulate insulin dosing. Patients using meters that fail to meet accuracy standards increase the risk of overdosing insulin. Hypoglycemia can result. Under dosing can result in hyperglycemia, diabetic ketoacidosis.
Poorer health outcomes and complications may result from inaccurate meters. This can result in higher medical cost to providers and lower quality of live and shorter lives for patients.
CMS auctions establish the price of test strips for Medicare and Medicaid patients. In turn these prices impact private insurers’ reimbursement rates. These auctions are based on FDA 510k approved systems. Lower quality less costly strips are likely to win these auctions but there is no mechanism between FDA and CMS to maintain the quality of strips in the market. Disadvantaged populations relying on CMS are at an increased risk from poor quality devices.
People With Diabetes call for:
- The accuracy of BD strips is a public health and safety issue.
- 25 million People With Diabetes in USA are at risk.
- Ongoing testing of BG strips to assure compliance with regulatory accuracy standards.
- Quality assurance should be done on strips acquired through normal distribution channels.
- Standards for accuracy should improve to the latest ISO standards.
- Public awareness of how to file an adverse event complaint on BG testing systems.
- Contact information to file an adverse outcomes report should be on all BG testing devices.