A Medical Device Daily

The White House had hopes that its nomination of Kansas governor Kathleen Sebelius for the post of Secretary of Health and Human Services would run more smoothly than for the previous nominee (Medical Device Daily, March 3, 2009), but Sebelius ran into headwinds after less than four weeks due to a failure on the part of her and her husband to pay roughly $7,000 in back taxes for the tax years 2005 to 2007. The parade of financial disclosures about yet another Obama administration nominee, however, has apparently not ended.

Sebelius disclosed that her gubernatorial campaign received funds from George Tiller, MD, a Kansas physician who offers the controversial late-term abortion procedure, but misstated the amount of campaign finance she received from the physician. In her testimony before the Senate Health, Education, Labor and Pensions Committee last month, Sebelius indicated that her campaign had taken in roughly $12,000 in donations from Tiller between 1994 and 2001, and no more. However, recent disclosures indicate that Tiller donated $23,000 to Sebelius' political action committee, and that Tiller has donated $200,000 to a political action committee, ProKanDo (Wichita, Kansas), which campaigned against Sebelius' opponent in the 2002 gubernatorial election, Republican Tim Shallenburger.

The ProKanDo financing was confirmed by the publication of a September 2002 fundraising letter by Tiller, who states in a post-script that his clinic is faced with "enemies [who] have tried to close these doors with bombs, violence and threats of violence," and alleges that Shallenburger is "a politician with the same goal."

Where things stand for the Sebelius bid is difficult to establish. At least one of the Senate HELP committee's Democrats is pro-life, Bob Casey, Jr. (Pennsylvania), but Sen. Sam Brownback (R-Kansas), a decidedly pro-life candidate, is on record as saying he supports her nomination. The case for Sebelius might also be complicated – at least for Republicans – by her implicit support for the use of budget reconciliation to push through healthcare reform. However, the Senate HELP committee does not need any GOP votes to confirm her nomination.

FDA draft for retinal prosthesis IDEs

FDA published a 24-page guidance last week dealing with investigational device exemptions (IDEs) for prostheses for the retina, a timely guidance given that scientists working with nanomaterials have proposed buckypaper for retinal augmentation (Medical Device Daily, April 10, 2009).

The guidance notes that its scope is "limited to retinal prostheses, i.e., visual prosthetic devices implanted on or beneath the retina, or on the outer surface of the globe, that use electrical stimulation to provide some level of visual stimulation for persons suffering from degenerative retinal conditions." The guidance is not for IDEs dealing with devices "that stimulate the optic nerve or other higher brain areas such as the visual cortex or the lateral geniculate nucleus." Combination products are also not included within the scope of the guidance.

Of course, any such application must include pictorial representations, engineering drawings, block diagrams of circuits, and block diagrams of software interfaces, but FDA will also want to see electrical schematics and mechanical drawings for each component. The guidance calls for a failure mode and risk analysis summary for all electronic components.

For bacterial endotoxin testing, FDA urges that sponsors take a look at the guidance document titled "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices," but sponsors can alternately employ a U.S. Pharmacopoeia standard, specifically USP 30:2007.

As for pre-clinical safety trials, the agency suggests that the sponsor implant the device in several different animal models in such a way as to allow the device to be switched off. FDA also recommends "a staged testing approach that includes evaluation of several animals which are implanted long term," but the meaning of the phrase "long term" is not immediately made clear.

Needless to say, perhaps, the guidance recommends that the sponsor "inform the subject and the dispensing physician of any . . . exposure hazards" connected to imaging modalities "and incompatibilities associated with the retinal prosthesis such as metal detectors, radio-frequency identification, wireless devices, or subways, among others."

On the subject of device sterilization, FDA notes that sponsors who opt for autoclaving using ethylene oxide (EtO) should establish that residual EtO levels are "consistent with the levels specified for intraocular lenses in ANSI/AAMI/ISO 10993-7."

In one of the more interesting passages, the guidance brings up the possibility of using a sham device in the control arm for any study conducted under the exemption. FDA notes that a sham control "may be most appropriate for studies with subjective endpoints," but acknowledges that such an approach "should be used in limited circumstances." The agency also states that it "recognizes that it may be difficult for sponsors to develop a clinical study design with a sham control arm that investigators, institutional review boards, and patients believe is ethical."

FTC notification rule for breached EHRs

The Federal Trade Commission reported last week that it has inked a federal register notice seeking public feedback on a proposed rule that would mandate that vendors of electronic health records (EHRs) and others contact patients upon breach of their records.

According to the April 16 announcement, this action is mandated by the economic stimulus bill (a.k.a., the American Recovery and Reinvestment Act of 2009), which includes a requirement that the Department of Health and Human Services conduct a study on breach notification requirements "for vendors of personal health records and related entities." FTC notes that the legislation also calls for the study to be completed by next February and that FTC publish a temporary rule in the interim.

The April 16 notice also states that the interim rule, when completed, will mandate that breaches be reported to the agency and will codify "additional requirements governing the standard for what triggers the notice, as well as the timing, method, and content of [the] notice."

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