February 11, 2019

The Food and Drug Administration has proposed new guidance for the approvals process for medical devices.

For more than 40 years, device makers obtained an expedited approval if they could prove the new device was “substantially equivalent” to one in use when the regulation went into effect in 1976, according to a report by CNBC.

The change is designed to encourage manufacturers to base new products on devices no older than 10 years.

The change will not directly affect BioBridge Global and its subsidiaries, as we don’t manufacture or market medical devices at this time directly, said Adrienne Mendoza, Vice President for Global Quality & Compliance.

February 4, 2019

For patients like George Ortiz, the program has been lifesaving.

Ortiz, a construction worker from Jourdanton, suffered a severe leg injury last year while on the job, causing a dramatic loss in blood.

“What I remember is standing on top of the hole-drilling machine and removing some pins so that the rest of the stem that drills the hole could come down. Then the machine squished my leg. It felt like it tore it off," he said.

January 28, 2019

Survival rates for patients with blood cancers like leukemia and lymphoma – diseases that not that long ago were considered all but incurable – have increased dramatically.

According to the Leukemia & Lymphoma Society, the five-year survival rates for patients diagnosed with leukemia from 1960-63 was just 14 percent. Fifty years later, it reached 61 percent.

For Hodgkin lymphoma, the five-year survival rate has gone from 40 percent to 88 percent. Five-year survival rates for non-Hodgkin lymphoma has also improved from 31 percent to 73 percent since the 1960s.

“I can’t help but be proud and gratified that I work for an organization that has helped improve the survival rate of blood cancers,” said Dr. Rachel Beddard, Chief Medical Officer at BioBridge Global.

January 21, 2019

Proposed new guidelines from the Food and Drug Administration have the potential to alter the way blood centers handle platelets destined for patients.

The draft guidance, “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” would replace a draft guidance issued in March 2016.

The updated guidelines are designed to control the risk of bacterial contamination of room temperature platelets, said Dr. Samantha Gomez Ngamsuntikul, associate medical director at BioBridge Global. Platelets donations that are four or five days old are associated with a higher risk of negative reactions in patients.

January 14, 2019

At least a dozen people were hospitalized in 2019 for infections related to unapproved stem cell therapies, the Centers for Disease Control and Prevention reported.

Patients in multiple states were injected with umbilical cord blood stem cells produced by a California company. One patient spent 58 days in the hospital with a bloodstream infection and spinal problems; another was hospitalized for 30 days with an infected knee The New York Times reported.

The CDC report noted that its investigation “highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.”