Medical Device Daily Washington Editor

The incoming Obama administration will focus heavily on healthcare upon taking office – the financial crisis notwithstanding – and the selection of Tom Daschle, the former Senate leader from South Dakota as Secretary of Health and Human Services is seen as a smart choice for the post, given his chops on the subject.

The latest news on the selection, however, indicates that Daschle also will occupy a post that might be described as the healthcare czar, given that his second title will be director of the White House Office of Health Reform.

The selection of Daschle for the dual post is seen as giving the administration more influence on the bureaucratic and the policy levers, especially given the former senator's influence on Capitol Hill. Daschle also authored a book on healthcare reform, What We Can Do about the Healthcare Crisis.

The latest announcement was greeted with choruses of cheers. House Speaker Nancy Pelosi (D-California) said in a Dec. 11 statement that the move "is great news for all Americans worried about the cost and quality of their healthcare and for the millions who do not have health insurance."

Sen. Sheldon Whitehouse (D-Rhode Island) said in another Dec. 11 statement, "I look forward to working with Sen. Daschle, with the Obama Administration and my colleagues in Congress to build a national health IT infrastructure, foster quality improvements and reform the way we pay for healthcare."

Contract manufacturing still an issue

Contract manufacturing has been on FDA's radar screen all year, as the spate of warning letters on the topic suggests, and the agency's focus on this transaction shows no signs of flagging as 2008 winds down.

A Nov. 24 warning letter to PDS Manufacturing (Southlake, Texas) addressed the company's manufacture of a "cryosurgical system consisting of hand-held freezing modules" and other related equipment. The company evinced limited familiarity with regulatory requirements as FDA commenced the warning with a citation for failure to establish a quality policy and failure to "appoint a management representative" to oversee the implementation of a policy.

According to FDA, the company had not "investigated and documented why 115 devices did not cool and their global board chips were replaced" during production between March and July this year. The warning letter states that two of the devices "had this same chip replaced five times." FDA gives no indication of a response to the inspectional form 483.

The agency states that the inspection disclosed that "25 devices that had a problem with possible diode assembly errors ... were reportedly reworked before shipment" without approval from either PDS or its customer. The warning letter states also that the company lacked documentation as to whether the customer returned these units "for repeat work."

PDS was said in the warning letter to have been in possession of "a complaint form, bud did not use it to document quality issues." According to FDA, two of six complaints by the client company had no documented investigation, evaluation and corrective action, "and four complaints had not documented an investigation [as to] why power jacks were disconnected in four of the devices."

Rob Heilbrun, the company's president, told Medical Device Daily that the August inspection that led to the warning letter was their first inspection, to the best of his knowledge, and that "we've been making this device for about a year and a half."

Heilbrun said "we've implemented a quality management system" and that PDS "had a consultant come in from an ISO standpoint" after the inspection, but the company had anticipated doing so prior to the FDA inspection. He confirmed that PDS is a contract manufacturer.

He said that the inspection was "a learning experience for us" and "jump started our quality management system." The company "in the process of crafting our response" to the warning letter, Heilbrun said.

Wheelchair maker ponders exit

A Nov. 14 warning letter to Eagle Parts & Products (Augusta, Georgia), a firm that makes wheelchairs in addition to non-medical mobility equipment, cited the firm for two deviations from the quality systems regulations that were cited in the previous inspection of June 2006. However, the agency also cites two instances of wheelchair failures that could have resulted in injuries, but which were not reported to the agency as medical device reports (MDRs).

Eagle also makes golf carts, which apparently is a better trade to ply. According to the company's president, so-so returns on its wheelchair business are forcing a review of that part of company operations.

According to FDA, company management had neither established a quality policy nor appointed a management representative to oversee the implementation of a quality system (QS), which the warning letter states "is a repeat ... from our previous inspection of your facility" in June 2006.

The company apparently had a procedure for reviews of device history records, but FDA noted that as the sole element of a quality system, it was inadequate to meet the overall QS requirements. FDA notes that this condition also is a carry-over from the June 2006 inspection.

The warning letter also cited the company for failure to report an incident to FDA in which a powered wheelchair's battery "started smoking and caught fire." The patient was not injured, but FDA states the company had no documentation "to show that the incident was investigated." Another incident, which involved "a seat that broke off" a powered wheelchair, was also described as not having been reported as an MDR.

Frank Dolan, the firm's president, told MDD, "We wrote our response to the warning letter" and are waiting to hear from the agency.

Regarding the battery incident, he said, "we dropped everything we were doing and put as much attention as we could" into the incident, but they found out later "there was no fire." He said the FDA investigator "would not let that go."

Dolan stated the report was filed by someone "who was three or four people removed from the end user," adding that the battery charger "got hot and smoked, and a circuit-breaker terminated the charger," as intended. Eagle returned the charger to the manufacturer.

Dolan stated that the company has "never had an injury or a lawsuit." He also indicated that the powered wheelchair business is "not very lucrative," and when asked whether he was thinking of getting out of the powered wheelchair business, he said, "Yes we are, absolutely."