Medical Device & Diagnostic Industry

Demanding Applications

Require

Premium Quailty

DC-Motors with system FAULHABER^®skew wound technology

■ Maximum power in a compact package

■ Dynamic acceleration and

deceleration for quick

directional changes

■ Absolutely smooth rotation with no cogging for high precision positioning

■ Very long service life combined with high efficiency

■ Ideal for complex drive tasks where precision and reliability are crucial factors

MicroMo offers a broad selection of matching system components for all motors, including precision gearheads, encoders and motion controllers.

MicroMo Electronics, Inc.
Clearwater FL 33762
Toll Free: 800-807-9166
e-mail: info@micromo.com
www.micromo.com
Washington
Wrap-Up

Acknowledging the frustration—if not its cause—that dissatisfied LASIK patients have been expressing, CDRH director Daniel Schultz said in September that his center is “putting together a total strategy for LASIK, and we are trying to get some of the stuff that we are doing out [to the public].” Speaking after an appearance at the Regulatory Affairs Professionals Society’s annual meeting in Boston, Schultz acknowledged that “there is this sort of vacuum of information that looks like we had the public meeting and [that] nothing has happened. That is not right.”

According to my online research the same day, CDRH’s Web site for LASIK had not been updated since March, a month before the aforesaid Ophthalmic Devices Panel meeting that heard scads of patient testimony about injuries.

Without referring to the lack of update on the Web site, Schultz said, “We need to figure out how to get the information out. There are a lot of angry people, no question, and I think we need to be careful when we put information out, recognizing that there are [also] a lot of happy people out there.”

Pilot and others believe that information should have been made public long ago, however.

Asked whether inspections would be part of the center’s plan or whether there was a resource issue involved, Schultz answered: “No, I don’t think it is so much a resource issue. I think it should be part of an overall coordinated plan.”

GE Healthcare
Warned on
Centricity QS, MDR

An FDA inspection begun last April at a GE Healthcare facility found quality system (QS) and medical device reporting (MDR) violations, according to an Aug. 12 warning letter from FDA’s Chicago district office. The action concerns the firm’s Integrated IT Solutions manufacturing facility for Centricity Imaging and other picture archiving and communication system

products, located in Barrington, IL.

Violations noted on the FDA-483 included poor procedures for handling quality data, poor complaint-handling procedures, failure to submit and document a number of MDRs, failure to report corrections and removals, and failure to investigate the cause of adverse events.

The warning letter said some of the company’s June 2 responses appeared to be adequate, while others were inadequate because results of promised retrospective reviews had not been submitted.

The company was told to respond within 15 days on specific steps taken to correct the violations, including an explanation of the plan to prevent the violations from recurring, documentation of corrective actions taken, an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not occur again. The company must also submit a timetable for implementing corrective actions.

FDA and ICE
Serve Search
Warrant on
Spectranetics

FDA and U.S. Immigration and Customs Enforcement (ICE) served a search warrant on Spectranetics Corp. (Colorado Springs, CO) on Sept. 5. The warrant asked for information and correspondence related to the following:

• Promotion, use, testing, marketing, and sales of company products for treating in-stent restenosis, and payments made to medical personnel and an institution for that application.