THE ISSUE / Strip accuracy is a matter of safety

At a recent public meeting the FDA acknowledged1 that there are some 510(k) cleared blood glucose (BG) meters and strips that do not meet the accuracy standards for which they were approved. There is currently no clear course of action to insure people with diabetes are using blood glucose strips that meet regulatory requirements.2

The Diabetes Technology Society’s (DTS) held a conference May 21, 2013 titled, Do currently available blood glucose meters (BGM) meet regulatory standards. Diabetes industry reporters from the publication, Closer Look, said of that meeting, “Representatives from academia and industry consistently identified low-cost meters as the source of device inaccuracies on the market.”3

Glucose meters are the tools people with diabetes (PWD) use to calculate how much insulin to take. Patients using meters that fail to meet accuracy standards face increased risks.4 Inaccurately high meter readings may cause patients to take too much insulin resulting in insulin shock. Conversely, meters that incorrectly show low results may keep patients from taking enough insulin. To little insulin may cause high blood glucose and possibly risky 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 life for patients. Closer Look reported, “Multiple individuals at the (DTS) meeting suggested that (Centers for Medicare & Medicaid Services) CMS’ competitive bidding could create a dynamic where decisions are made on price alone, putting patients at risk. Indeed, we hope that payers will recognize that quality diabetes care is worth its financial cost, to avoid the much greater costs and suffering of complications.”5

The CMS auctions establish the price of test strips for their programs.6 In turn, these prices may 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. Dr. Ronald Brazg (Rainier Clinical Research Center, Renton, WA) “urged payers to take into account the adverse effects that can result from meter inaccuracy, as opposed to just initial costs.”7

Studies suggest that non-branded devices and strips are more likely to have issues. While the FDA regulatory issue is unique to the United States, the issue of strip quality has been seen in the EU as well as the USA.8 In both the USA and EU, many of these strips come from manufacturers in Asia.

Dr. Barry Ginsberg of Diabetes Technology Consultants, Wyckoff, NJ said, “We are developing a two-tier system of ‘haves and ‘have- nots.’ The have-nots are because CMS is going to competitive bidding, with prices that will be difficult if not impossible for branded-meter manufacturers to meet. The have-nots will be stuck with meters that met 20% standards several years ago but probably couldn’t meet 40% standards in post market analyses today.”9

PWD should call for:

  • Recognition that the accuracy of BG strips is a public health and safety issue.
    ◦ 25 million PWD in USA are at risk.10
  • Ongoing testing of BG strips to assure compliance with regulatory accuracy standards.
  • Quality assurance should be done on strips sold through normal distribution channels.
  • Standards for accuracy should improve to the latest ISO standards.
  • The standards that meters and strips are failing to achieve is 2003’s +/- 20%, 95% of the time
  • We need better accuracy standards than ones created in 2003.
  • CMS competitive bidding should create a process that consider quality not just price.
  • 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.

 

Sources

1 “Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians.” ‘Medical Devices Today’ Medicaldevicestoday.com, 27 May 2013. Web. 8 June 2013. <http:// www.medicaldevicestoday.com/2013/05/blood-glucose-meter-accuracy-problems-acknowledged-by-fda- industry-and-clinicians.html>.

2 Kern, Rebecca. “Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians.” The Gray Sheet Article # 01130527012 (2013): n. pag. The Gray Sheet. Elsevier Business Intelligence, 27 May 2013. Web. 11 June 2013. <http://www.elsevierbi.com/publications/the-gray-sheet/ 39/21/blood-glucose-meter-accuracy-problems-acknowledged-by-fda-industry-and-clinicians>.

3 Close Concerns. “Do Currently Available Blood Glucose Meters Meet Regulatory Standards?” Closeconcerns.com. Close Concerns, 27 May 2013. Web. 8 June 2013. <https://closeconcerns.com/>.

4 Diabetes Technology Society. Experts Agree: Inaccurate Blood Glucose Monitors On The Market May Be Putting Patients At Risk. Prnewswire.com, 28 May 2013. Web. 9 June 2013. <http://www.multivu.com/ mnr/61870-diabetes-technology-society-inaccurate-blood-glucose-monitors-risky>.

5 Close Concerns. “Do Currently Available Blood Glucose Meters Meet Regulatory Standards?” Closeconcerns.com. Close Concerns, 27 May 2013. Web. 8 June 2013. <https://closeconcerns.com>.

6 “Association Sounds Alarm about Medicare Benefits for Diabetics.” HomeCare Magazine. www.homecaremag.com, 10 June 2013. Web. 11 June 2013. <http://www.homecaremag.com/news/ association-sounds-alarm-about-medicare-benefits-diabetics?utm_source=iContact>.

7 Close Concerns. “Do Currently Available Blood Glucose Meters Meet Regulatory Standards?” Closeconcerns.com. Close Concerns, 27 May 2013. Web. 8 June 2013. <https://closeconcerns.com>.

8 Avoiding a Medical Device Disaster in Diabetes. Yumpu.com. Eurpean Association of Diabetes, 14 Mar. 2013. Web. 11 June 2013. <http://www.yumpu.com/en/document/view/11211138/easd-press-release- march-14-2013-avoiding-a-medical-device-disaster-in-diabetes>.

9 Close Concerns. “Do Currently Available Blood Glucose Meters Meet Regulatory Standards?” Closeconcerns.com. Close Concerns, 27 May 2013. Web. 8 June 2013. <https://closeconcerns.com>.

10 Diabetes Technology Society. Experts Agree: Inaccurate Blood Glucose Monitors On The Market May Be Putting Patients At Risk. Prnewswire.com, 28 May 2013. Web. 9 June 2013. <http://www.multivu.com/ mnr/61870-diabetes-technology-society-inaccurate-blood-glucose-monitors-risky>.