Medical Device Daily Washington Editor

The web site for China's State Food and Drug Administration (SFDA) posted an announcement recently regarding an upgrade to requirements for monitoring of adverse events related to medical devices. The move is seen as part of a broader push on the part of SFDA to upgrade its regulatory structure for food, drugs and devices. However, the announcement was short on details and did not provide a link to the regulatory requirements in question.

The Jan. 5 statement notes that the update "defines the main responsibilities of medical device adverse event monitoring and re-evaluation nationwide and within each [of the] provinces" and that the mandates, "comprising five chapters and 43 articles, came into effect as of December 30, 2008."

According to a story appearing in the Jan. 4 edition of Chinaview, SFDA now requires that device makers "report deaths within five weekdays and events that might cause severe injuries or death within 15 weekdays." The article notes that mainland China commenced with a device reporting program in 2004, and that adverse-event reports led to the revocation of registration for polyacrylamide hydrogel, which is used in a number of surgical procedures, and "dialysis powder."

The new regulations are said to apply to all regions in China (Shanghai has its own FDA-type regulatory body) and to both the manufacturer of the device and the Chinese firm that serves as the agent for the importer. However, a number of observers expect that SFDA also will publish a guidance on good manufacturing practices sometime in calendar 2009.

Steris addresses May 2008 warning letter

Steris (Mentor, Ohio) said it has completed its 510(k) submission to FDA for the System 1 sterilizer after the agency issued a warning letter in May 2008 for marketing the sterilization system without clearance. Steris received a second warning letter in 2008, dated Sept. 25, for violations of good manufacturing practices at the company's Isomedix contract sterilization plant in Coventry, Rhode Island (Medical Device Daily, Oct. 22, 2008).

The May 15 warning letter to Steris notes that the company made several changes to the System 1, including an upgrade to a circulation pump intended to correct incidents of "low flow performance and seal leakage" incurred by the previous pump. FDA redacted a number of the performance parameters from the warning letter, but noted that Steris commenced installation of the upgraded pump as far back as 1999.

Steris also reportedly changed the software used to control the System 1's operation "in response to reports that customers were receiving high pressure pump alarms due to low facility water pressure." Steris rewrote the software "to limit the operation of the high-pressure pump to the sterilant exposure phase and the final drain," but because of the software tweak, "the high-pressure pump no longer runs during the final rinse phase." FDA's position is that the lack of action from the high-pressure pump could "affect the removal of chemical residues from the processed devices and may pose a risk to patients."

According to a Jan. 20 statement posted at the company's web site, the 510(k) application filed by the company "addresses the changes referenced by the FDA in the warning letter and includes additional technology updates." The statement notes further that entities that have purchased the System 1 can continue using the liquid chemical system "without any change" and that FDA "is not requiring modification of clinical practices or notification to doctors or patients."

The statement quotes Walter Rosebrough, President/CEO of Steris, as saying, "we are pleased that our discussions with the FDA have resulted in the submission of a new liquid chemical sterilization system and a path forward in resolving the warning letter related to System 1." The statement also notes that that the unit, used primarily to sterilize endoscopes and similar surgical instruments, produces about 10% of the company's revenue stream when added to sales of associated consumables and accessories.

Steris also states that the situation "will not have a material impact on its consolidated financial results" for its current fiscal year, which ends March 31.

AHRQ: payment policy impeding trials

A clinical trial is an expensive and labor-intensive proposition, but getting private payers on board apparently sometimes proves as nettlesome as getting the Centers for Medicare & Medicaid Services to reimburse. A recent report published by the Agency for Healthcare Research and Quality states that while hard data are tough to come by, what little is available suggests that private payers could do more to encourage enrollment in crucial drug and device trials.

AHRQ notes that despite the paucity of data on the subject, there are nonetheless "a few examples of high-profile, high-budget clinical trials that have encountered problems with enrollment or retention due to payment policies." The report notes that a "lack of clarity surrounding responsibility for specific expenses exacerbates the impact of payment policy on clinical trial participation," partly because "the definitions of standard of care versus research-related costs remain unclear." While investigators and sponsors sometimes resort to covering a subject's travel and lodging costs and appealing to the subject's insurers, such work is labor-intensive and expensive, thus adding "an unnecessary layer of inefficiency" to the effort.

The agency also cites "competition between registries and clinical trials [as a] major concern in the research community," noting that registry participation allows a patient to avoid randomization to the placebo (or current standard of care) without risking reimbursement. The necessity of unblinding investigators in order to establish payment also clouds the picture.

AHRQ described "greater coordination" between CMS, FDA and NIH as "paramount," stating further that trials "could be required to provide information on their plans for managing reimbursement-related issues as part of the standard registry process" at the web site located at The report proposes that such a reporting mechanism could "be regularly queried to identify potential problems and report on them." As for the standard-of-care vs. study-cost dilemma, the report suggests that CMS develop clearer guidelines for standards of care, but it also states that financial incentives for participation in registries should not place randomized, controlled trials "in competition with registries for participants."