FDA inked an Aug. 8 warning letter to the Children's Medical Ventures division at Philips Healthcare (Andover, Massachusetts), and the inspection could have been quite troubling given that FDA was evaluating the company's compliance related to the SmartMonitor 2 PS due to the fact that the device is indicated for vital sign monitoring for neonates and infants. However, Philips was able to leverage its resources sufficiently to win a nod of approval for the firm's responses to each of the warning letter citations despite that the second of the two company responses to the form 483 came after the 15-day deadline.
The inspection ran March 10-28, and Philips responded with proposed corrections dated April 16 and April 29, the second of which was 31 days past the closing date of the inspection. The first citation dealt with Philips' handling of non-conforming product, stating that complaints with the SmartMonitor 2 PS were triggered by device failures attributed to a wiring issue associated with 311 of the battery packs used with the devices.
The wiring problem is said to have caused the monitors to "constantly alarm," and to interrupt monitoring of respiration, heart rate and oxygen saturation. The warning letter stated that Philips and/or its contract supplier had quarantined more than 160 of the affected battery packs, but that 99 of the packs had not been accounted for as of March 3. FDA offered no details as to the company's corrections, stating only that the responses "appear to be adequate," and that the corrections would be verified during the next inspection.
FDA described the second deviation from the quality systems regulations briefly, stating that the company did not maintain complaint files for 27 work service orders, although it was not clear whether the service orders were associated with the problematic battery packs. Again, FDA said the two responses "appear[ed] to be adequate" and would be confirmed in a subsequent inspection.
The battery pack failures also fed a citation for medical device reporting (MDR) violations. FDA said the company did not forward the information to the agency, but this citation, too, was adequately addressed by the company's responses to the form 483.
Philips said in an e-mailed response to Medical Device Daily that a contract manufacturer had supplied the batter packs, adding that Philips has "addressed the battery pack issue for all distributed units in April 2014 via a recall, with no reports of patient harm, as well as addressing defective replacement battery packs."
The company indicated it has "implemented updated complaint handling procedures" and that it is "committed to working with the FDA to achieve a prompt and appropriate resolution. Philips will respond to the warning letter, as requested by the FDA," the statement noted.
Vention hit for EM in warning letter
The days when environmental monitoring (EM) conditions routinely peppered FDA warning letters may be gone, but the July 1 warning letter to Vention Medical (Barreal de Heredia, Costa Rica) shows that the issue still surfaces from time to time. FDA advised the maker of thermotherapy systems, cord blood processing systems, and negative pressure wound therapy equipment that its responses to the inspectional findings for five citations was not up to par, suggesting the possibility of a protracted compliance effort for the company.
FDA led the warning letter with a citation for failure to validate an in-house test method for maintaining cleanliness of controlled environment, including cleanrooms, gowning areas, and quality labs. As was the case in the warning letter for Philips (see story above), the agency offered no details as to the company's March 26 response, stating only that the adequacy of that response "cannot be determined" because Vention had not completed its proposed corrective actions.
The agency's response to Vention's proposed corrections for the second citation was identical to that of the first, with EM issues again creating problems for the company. FDA said an EM control procedure did not address maintenance of a clean air system, but also observed that the FDA investigator had noticed a gap of redacted width between an uncontrolled room and an unspecified adjacent room. The letter stated that the company's facilities maintenance manager indicated that no action "has been taken to fix the gap." This citation also lists several problems with particulate matter counts, including four excursions from particulate matter limits.
Among the other citations in the warning letter was one stating that the company did not analyze data from monthly environmental samples "to identify the existing and potential cause of non-conformances related to airborne and surface particulate exceeding the alert limit."
Vention did not respond to contacts for comment.
CMS offers flexibility for EHR cert
The Centers for Medicare & Medicaid Services announced Aug. 29 a final rule describing a more flexible set of requirements for healthcare providers to demonstrate meaningful use for incentive payments. CMS said the greater flexibility would allow more providers to meet meaningful use objectives such as drug interaction and allergy checks, providing clinical summaries to patients, electronic prescribing, reporting on key public health data and reporting on quality measures.
CMS administrator Marilyn Tavenner said the agency "listened to stakeholder feedback and provided CEHRT flexibility for 2014 to help ensure providers can continue to participate in the EHR Incentive Programs [going] forward." She also cited "overwhelming support for this change."
CMS said that eligible providers can use the 2011 edition certification schedule or a combination of 2011 and 2014 certification schedules for Medicare and Medicaid incentive programs. However, the agency advised that all eligible providers will have to make use of the 2014 schedule next year. The agency said the rule "also finalizes the extension of stage 2 through 2016 for certain providers," and sets the timeline for stage 3, which CMS said "will begin in 2017 for providers who first became meaningful EHR users in 2011 or 2012."