Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of Members of the Patient, Consumer, and Public Health Coalition
on the Draft Guidance
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices
[Docket No. FDA-2014-D-0798]
As Members of the Patient, Consumer, and Public Health Coalition, we are writing to express our opposition to the draft guidance Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices. The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree.
We examined the MAUDE adverse events database for these devices and found 224 adverse events reports; it is widely known that MAUDE drastically undercounts adverse events. MDDS devices (product code OUG) had 66 adverse events reported to MAUDE including four deaths and ten injuries associated with the devices. One of the deaths involved an “un-viewable transmission” that was a care alert.[i]
One MAUDE report stated, “Death from the delay in diagnosing and treating sepsis was narrowly avoided.”[ii] Another MAUDE report stated that a typo in an Electronic Health Record (EHR) (two apostrophes on a name instead of one) led to an injury of a critically ill patient because the EHR could not be accessed. The report states, “The vendor’s device is defective…it failed to warn of the error. These mdds devices need tighter regulation, surveillance and safety”[iii] (emphasis added).
The MAUDE database shows 65 adverse events for medical image storage devices (product code LMB) and 93 adverse events for medical imaging communication devices (product codes NGE and LMD). A report on Siemens’ Soarian/Invision EHR raised concerns about an allergy alert falling through the cracks in the electronic health records. The MAUDE report states, “We are concerned that if such a basic error is allowed to go unrecognized by these supposedly safe devices, how safe are they exactly”? (emphasis added).[iv]
In 2011, the FDA down-classified MDDS from Class III (high-risk) to Class I (low-risk). The agency stated, “Since then, FDA gained additional experience with these types of technologies and has determined that these devices pose a low risk to the public.”[v] However, all 66 of MAUDE adverse events for the MDDS (product code OUG) were from 2011- July 2014, which seems to contradict the FDA’s claim that these devices now pose a low risk.
The draft guidance states that “MDDS are not intended to be used in connections with active patient monitoring.” How will FDA enforce the prohibition on using MDDS for active patient monitoring?
By not enforcing compliance with regulatory controls, basic information will not be collected by the FDA “including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices.”[vi] This would make it much more difficult to recall a defective product such as the Class II recall in 2012 for the MDDS device (CareFusion 209 Inc.) that affected 1,676 devices, recalled because the devices “may continue to display the previous patient’s exams.”[vii]
The FDA’s core mission is to protect the public health by ensuring the safety and effectiveness of medical products. If the FDA uses its enforcement discretion to ignore regulations on devices that can seriously harm patients when they don’t work well, it will put many patients and the public health at risk.
Annie Appleseed Project
Breast Cancer Action
Connecticut Center for Patient Safety
National Center for Health Research
National Organization for Women
The TMJ Association
WARS
WoodyMatters
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org
[i] Food and Drug Administration’s MAUDE – Manufacturer and User Facility Device Experience database. Carelink System. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2260917
[ii] Food and Drug Administration’s MAUDE – Manufacturer and User Facility Device Experience database. CPOE device. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3339297
[iii] Food and Drug Administration’s MAUDE – Manufacturer and User Facility Device Experience database. Centricity device. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3913670
[iv] Food and Drug Administration’s MAUDE – Manufacturer and User Facility Device Experience database. Siemens Pharmacy. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1931378
[v]Federal Register (June 25, 2014). Food and Drug Administration Draft Guidance, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” [Docket No. FDA-2014-D-0798].
[vi] Food and Drug Administration (June 20, 2014). Draft Guidance Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.[Docket No. FDA-2014-D-0798].
[vii] Food and Drug Administration (January 13, 2012). Class II recall for NicVue Software version 2.9.2 and 3.0.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106489