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Large-scale recall of Philips respiratory equipment

04 Jul 2021

See clarifications and mitigations around the recall

By: Adam Dendauw, BSRC RRT, respiratory manager, respiratory care

On June 14, Salem Health was informed there was a large-scale recall encompassing a variety of Philips respiratory equipment - CPAPs, BIPAPs and advanced BiPAP devices.

On June 17, we received confirmation that the Philips V30 BIPAPS used in our acute care setting, were identified as part of this recall.

While we believe that the risk to our patients is minimal based on the recall notice and the mitigation plan, we felt it prudent to put out a Common Ground communication clarify any confusion or concerns regarding the recall.

For background, the recall centers around a manufacturing defect: The insulating sound-dampening foam can break down over time which could lead to patient inhalation and/or ingestion of the small foam break-down products. Off-gassing of potentially hazardous gas may also occur. Use of ozone-cleaners appears to hasten the breakdown of the foam. Please see the Philips communication below.

“Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals.”

The recall states the issue has not caused severe patient harm, but can lead to upper airway irritation, nausea, sore throat and in some cases, asthma exacerbation – no deaths or hospital admissions have been report.

To our knowledge there have not been any reports of patients at Salem Hospital exhibiting these symptoms or that any harm has be caused by the use of our equipment.

The short term mitigation plan in the acute inpatient setting, is to place a bacteria filter in-line with the equipment to prevent particles from reaching the patient.

Using a bacteria filter in-line, is and has always been our standard for all respiratory equipment. Salem Health does not use ozone based cleaning products. We recognize these filters do not stop or contain any off-gassing. Moving forward, in all circumstances where patients are treated with this respiratory equipment in-house, the benefits of choosing to use CPAP or BiPAP in-house will have been deemed superior to the low risks.

We will continue to use the bacterial filters and clean with hospital approved products which do not contribute to foam breakdown, per our standard.  This will minimize the risk of harm to our patients and will allow us to continue to utilize our equipment safely to serve the patient in the acute care setting.

Local DMEs have also adopted this standard so they can continue to serve customers until Philips establishes a long-term solution.

The Salem Health Sleep Center also has recalled in-lab positive airway pressure testing equipment. Use of this equipment was suspended the day of the recall (6/14/21). Testing with this equipment will only be used for life-threatening or very severe respiratory cases. The Sleep Center has purchased new testing positive airway pressure devices for the lab and will be running at full capacity in the near future.