• E-mail
• Print
• RSS

Doctors want company’s involvement in device recalls changed

Ambulatory Surgery Reimbursement Update, June 28, 2005

Following recent high-profile recalls of implants such as defibrillators made by Guidant Corp. and a drug-injection port from Boston Scientific Corp., some doctors are pushing for device-makers to contact affected patients directly, according to The Boston Globe.

The Food and Drug Administration often requires companies with defective products to contact providers, putting the onus on providers to contact patients.

But this process can take time, and patients are sometimes informed of recalls through the news. Doctors in support of requiring companies to contact patients directly say it wouldn't be difficult and would speed up the process.

"We've already seen problems where physicians aren't getting in touch with patients quickly," said Stephen Seller, a Philadelphia attorney who represents a number of patients who received a Guidant device, according to The Boston Globe.

"It wouldn't take a deep or difficult database to send out a card to everyone," said Christopher J. White, a New Orleans cardiologist who last summer dealt with a recall of cardiac stents that affected some of his patients.

However, news of a recall may needlessly worry patients because they are not as informed about the devices as their doctors, said Robert B. Nicholas, a healthcare attorney who represents some medical-device companies.

"You don't want someone to be panicking over these situations, you want them to have a reasonable discussion [with their physician]," said Nicholas, according to The Boston Globe.

• E-mail to a Colleague
• Print
• RSS
• Archive