A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines.
According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare facilities in the U.S. between 2005 and 2019.
Braintree, Mass.-based Haemonetics responded, saying that there is no evidence of donor, patient or user harm associated with the use of its products in the reports cited in the article by seven news organizations.
Apheresis devices are used to separate plasma from blood and then return blood to the donor. Governments around the world are encouraging people who have survived COVID-19 to donate plasma to be used in treating other patients.
In 2018, the French government enacted a precautionary suspension of a Haemonetics blood-collection device after receiving numerous reports of problems with the devices. The suspension was spurred by reports from a trio of whistleblowers alleging that the company’s apheresis devices risk exposing donors to possible cancerous substances and micro- or nano-sized particles of compounds including phenol-formaldehyde resin or aluminium trioxide. The news consortium referred to the French government’s action as a ban.
Haemonetics told MassDevice in an email that it was not a device but a “single plasma disposable kit (782HS-P-SL) used by one of our customers in France that was suspended by the French health authority, The National Agency for the Safety of Medicines and Health Products (ANSM), as a precautionary measure.”
In January 2019, the ANSM said there is no proven risk to donors or patients and lifted the ban on the use of therapeutic plasma that had been collected with Haemonetics’ 782HS-P-SL disposable kits, the company added, saying “Our devices continue to be used in France with other disposable kits to collect blood components, including plasma.”
In an email to MassDevice, Madris Tomes, founder and CEO of Device Events and a former FDA manager, agreed with the news outlets’ characterization of the suspension as a ban.
“Any time another country bans a device, the FDA should seek to understand why,” Tomes said. “The sharp increase in death reports, especially noting that they were far past the 30-day reporting deadline, concerns me. With an increased number of plasma donations from recovered COVID patients trying to help others who are ill, this could become (and perhaps is) a real issue. Haemonetics is not the only company manufacturing this type of equipment, so there is no reason why an alert has not gone out to recall, or at least, inspect the devices.”
None of the U.S.-based cases related to particles are listed in the FDA’s medical device report (MDR) database, according to the consortium. In a 5-page statement, Haemonetics said that total particle complaints represent approximately 0.0006% of estimated total plasma-collection procedures over the 15-year period.
The presence of particles associated with medical devices and injected drugs “cannot ever be reduced to zero,” the company added. “Our product design, our manufacturing process and the procedures followed by our customers in the use of our products aim to minimize the occurrence of particles as much as possible to continuously ensure the safety of donors, patients and the customers who use our devices.”
Haemonetics added that its devices are made from biocompatible materials and tested according to stringent international standards to ensure that they are not toxic to the human body.
The consortium, which includes the Herald and McClatchy newspapers, in conjunction with The Signals Network, claims the problem with particles was also reported in Germany, China, Japan, Taiwan, Canada, Sweden, Netherlands, United Kingdom and Australia. The news group did not pinpoint a source for the particles, but reported that some of the particles have been found to contain trace elements of metals, including zinc.
The consortium also reported a “sharp increase” in deaths tied to Haemonetics’ PCS2 device over the past 3 years — with 35 deaths reported to the FDA after use of the machine since 2018. Most of those medical device reports (MDRs) were made in 2020, “much later than they actually occurred,” the news report said.
Haemonetics countered that the increase in death-related MDRs was the result of a voluntary change to its adverse-event reporting process in 2018 “to be more conservative and to align with the reporting practices of our plasma customers.” The change meant Haemonetics began filing a report for any plasma donor fatality reported to it “regardless of whether the device may have caused or contributed to death or serious injury,” the company said in a statement. Before 2018, “qualified personnel” made a determination of whether an event reported to the company also merited a report to the FDA, Haemonetics said.
“Following our voluntary change in reporting approach in 2018, we have routinely reported all deaths reported to us by our plasma customers whatever the cause (such as road traffic accidents) and there were no MDRs during this period that associate any death with the use of the PCS2 or NexSys PCS products,” the company said. “Prior to 2018, Haemonetics did meet the regulatory requirements to complete MDR reports.”
Haemonetics said that the consortium reports “tie together pieces of information, comments taken out of context and isolated matters that have been resolved to draw false and misleading conclusions.”
“It is highly unfortunate that these baseless assertions about our devices are being made at a time when, according to the Plasma Protein Therapeutics Association (PPTA), roughly 750,000 people across Europe and North America alone rely on plasma for life-saving therapies, and the need for plasma is critical and growing. Donors around the world absolutely can and should feel confident in the safety of our devices used during the collection process,” the company added. “We are confident that any balanced, fair and accurate assessment of our decades long record in safe blood component collection and our commitment to investigating and resolving any matter pertaining to the quality and safety of our products would present an entirely different picture of our company.”
Shares in HAE were trading up 1.71% at $91.37 at midday today.
This article has been updated with more information from Haemonetics.