Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices.
New York-based Apos Medical Assets Ltd., doing business as Aposhealth, has been developing a shoe that provides some relief from pain and disability in patients who are candidates for total knee arthroplasty (TKA), and the Apos shoe seems to have gained a toehold in the U.K. market. The National Institute for Health and Care Excellence (NICE) has provided a guarded recommendation for the use of the Apos shoe in the U.K., although the agency still has questions as to how long use of the shoe can delay the need for TKA.
Medicare coverage of medical devices in the U.S. sometimes is limited to a coverage with evidence development (CED) study, a process that may soon become more stringent. A recent advisory hearing on the CED process suggests that significant changes may be in the making, including a requirement that CED studies more closely reflect the demographic diversity of Medicare beneficiaries at large, a mandate that may force device makers to apply more resources to ensure that CED study enrollments fulfill that mandate.
The U.S. FDA has finalized a guidance for class II devices for treatment of peripheral artery disease that excludes drug-coated balloons (DCBs), which are regulated as class III devices. One of the issues the med-tech industry may have with the guidance is that it fails to acknowledge that a device accessory is in some instances exempt from the requirements of the 510(k) program even though the agency has a policy specific to that consideration.
Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master files for sterilization of medical devices. This program is for single-use PMA devices only made by nine companies and allows the manufacturer or sterilizer to document the switch to radiation sterilization with an expedited review process.
Developers of clinical decision support (CDS) software have their hands full with a recent U.S. FDA final guidance on these products, but the picture promises to become more byzantine with the publication of a draft rule by the Office of the National Coordinator (ONC). The new ONC proposal would require a demonstration of transparency for decision support intervention (DSI) predictive functions in order for that software to qualify for ONC certification, a requirement that might not overlap neatly with the FDA’s own transparency requirements.
The U.S. Environmental Protection Agency (EPA) has proposed a new set of requirements for control of emissions of ethylene oxide (EtO), a standard the agency claims will “slash” emissions by 80% per year. The problem for med-tech trade associations is that EPA expects that the abatements be implemented within 18 months, a pace that industry says is too aggressive and could lead to shortages of critical devices and products used in surgeries and other procedures.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
In December 2013, the U.S. FDA held an advisory hearing on spinal spheres used in intervertebral fusion procedures, a hearing that generated a recommendation that the agency classify these devices as class III devices. The agency finally followed through on that recommendation with a final rule that requires a PMA filing for these devices, concluding a process that took much longer than the typical rulemaking.
The International Medical Device Regulators Forum (IMDRF) has posted a guidance that spells out the use of a common document for regulatory review for member regulatory authorities, a mechanism that might ease the lives of manufacturers across the globe.
