A Medical Device Daily

Coast IRB (Colorado Springs, Colorado) has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to what the FDA called "serious concerns about the company's ability to protect human subjects participating in clinical trials."

According to the company's records, these actions may involve roughly 300 active human research studies conducted by some 3,000 clinical investigators.

Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies. Also, the company will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrollment. FDA has issued a warning letter to Coast IRB outlining its concerns and FDA will continue to actively monitor the company and take appropriate action as necessary. These restrictions will remain in effect until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects.

Under current federal law, clinical research involving human subjects and FDA-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an institutional review board (IRB). An IRB is a panel of doctors, scientists and non-scientists charged with reviewing the clinical research to protect the rights and welfare of the subjects participating in the study.

These actions follow a recent undercover operation by the U.S. Government Accountability Office (GAO). The GAO submitted to Coast IRB for review a fictitious research study involving a purportedly FDA-cleared medical device (Medical Device Daily, March 16 and March 27, 2009). Although no human subjects were involved, the GAO operation "heightened FDA's concerns about Coast IRB's ability to protect the rights and welfare of human research subjects," the agency said.

In evaluating the information provided by the GAO investigators, FDA determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study.

Coast IRB said it is cooperating fully with the FDA to implement corrective actions to bring the company into compliance with agency regulations designed to protect human research subjects. The reforms undertaken by Coast IRB are "sweeping, designed to exceed the level of protection required by existing law," according to the company. A new board chair and new board members will be put in place "promptly," said CEO Dan Dueber. New standard operating procedures developed by former FDA clinical investigators are being implemented to ensure maximum protection for human subjects, the company noted. Coast IRB said those same experts are scheduled to provide training in implementing the new SOPs to Coast IRB's review staff and its new board. The company said it would make internal audits commonplace to guard against risks to human subjects.

"Coast is changing everything," Dueber said. "We are revamping every aspect of the company. Within the next 30 days this company will be completely different, operated by different people, relying on different standard operating procedures, even having a different name."

The FDA's action is "precautionary," the agency noted. Because of the potential risk to enrolled subjects and disruption to the research if on-going studies were abruptly terminated, studies that Coast IRB has already approved will be permitted to continue. However, no new subjects will be allowed to enroll in these studies until there is assurance that the research has undergone adequate review, the FDA said. Coast IRB continues to be obligated to receive and respond to reports of unexpected and serious adverse events as well as to review progress reports submitted by clinical investigators.

IAB Pump catheters classified a Class 1 recall

The FDA has classified a voluntary device recall involving volume connectors for Arrow International's (Reading, Pennsylvania) 30cc, 40cc, and 50cc Intra Aortic Balloon Pump (IAB) catheters as a Class 1 recall, according to Teleflex Medical (Research Triangle Park, North Carolina).

FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

According to Teleflex, this recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device that is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism, the company noted.

Teleflex said instructions contained in the operator's manual fully describe the necessary warnings and precautions that will identify the issue. The recall notice restates these instructions and references the sections in the owner's manual. If these instructions are followed, the issue for which the product was recalled can be discovered immediately, and the product can be removed and replaced, according to the company.

Arrow notified both domestic and foreign hospitals and distributors via an urgent medical device recall letter on Feb. 2 that it had become aware that the blue connector for the 40cc IAB was not properly recognized by the Arrow IAB Pump system. This recall involved the retrieval of unused product, issuance of mitigation instructions for patients and/or facilities in critical need, and the replacement of pump tubing assemblies.

At this time, there have been 25 complaints of this issue and no reports of patient injury. About 423 lots are affected by this recall for a total 45,211 units.

A list of products and lot numbers affected by this recall as well as the original recall notice can be found at Arrow's website: http://www.arrowintl.com/iab_recall.asp.

Advamed Accepting presentation applications

MedTech companies interested in raising capital, partnering products or initiating strategic alliances are encouraged to apply for a presentation slot at AdvaMed 2009. Open to companies at all stages of development, presentation applications will be competitively evaluated and selected by a committee of industry leaders and stakeholders, AdvaMed said.

Applications can be submitted online at www.AdvaMed2009.com and will be evaluated on a variety of criteria including: stage of development, IP protection, timing of next capital raise, whether the technology is available for license, and overall appeal. The deadline for presentation applications is July 10. Selected companies will be assigned a nine-minute time slot to present to leading investors and potential partners attending AdvaMed 2009.

"To bring new ideas to life requires not only creativity but, also, strategic partners, market expertise and funding. These are the building blocks for successful enterprise and AdvaMed 2009 company presentations enable industry innovators to maximize their business development and capital formation opportunities," said AdvaMed President/CEO Stephen Ubl.

According to AdvaMed, 1,400 industry leaders and stakeholders are expected to attend AdvMed 2009.

No Comments