Validation of Medical Devices—From a “Necessary Evil” to a Disaster
Medical devices and equipment—from sterilizers to thermal disinfectors (such as the MelaTherm)—are subject to mandatory periodic validation, revalidation, and performance qualification. Even though the benefits and frequency of these measures are certainly controversial among practitioners, there is a legal obligation to carry them out, which—for the reasons outlined below—should not (and cannot) be circumvented.
Validation involves verifying that a system, product, or reprocessing procedure is capable of reliably meeting the specified usage and hygiene objectives.
In particular, the failure to validate or revalidate a sterilizer or thermal disinfector in medical and dental practices—or to do so in a timely manner—often leads in practice to considerable additional effort, additional costs, and—increasingly in recent times—the initiation of administrative or criminal proceedings.
Validation verifies whether the device in use corresponds to the actual and target states with respect to the specified reprocessing outcome and whether it meets and reproduces all specified requirements in practical use. The obligation to perform regular validation stems from Section 8(1) and (2) of the Medical Device Operator Regulation (MPBetreibV). The fact that failure to comply constitutes an administrative offense (including pursuant to Section 17(5) of the MPBetreibV) is enshrined in the Medical Device Law Implementation Act (MPDG) and may be punishable by a fine of up to 30,000 EUR (Section 94 MPDG).
The investigative and administrative penalty proceedings conducted by the competent authorities (in Baden-Württemberg, the Regional Council)—initiated, for example, by a notice of hearing pursuant to Section 55(1) of the Administrative Offenses Act (OWiG)—are not “merely” nerve-wracking. They are directed personally against the treating physicians and not, for example, against the practice or group practice as a whole. This makes the legal assessment of the internal distribution of work and responsibilities within the practice (e.g., delegation of staff duties or assignment of the role of quality management officer or the person responsible for medical devices), since a clear delineation of responsibility can lead to the dismissal of proceedings against the individual physician under Section 170(2), sentence 1, of the Code of Criminal Procedure (StPO) in conjunction with Section 46(1) of the Administrative Offenses Act (OWiG).
But that is not “enough”: In practice, there is now even a trend among investigative authorities to directly initiate criminal proceedings for negligent bodily injury (Section 229 of the German Criminal Code (StGB)) when hygiene deficiencies are identified in combination with missing or expired validation. The legal background: Without valid validation, there is no proof that the reprocessing process reliably guarantees sterility. If unvalidated and hygienically deficient instruments are used on patients, public prosecutors’ offices consider this a serious breach of the duty of care that creates a direct risk of infection. A violation of the Infection Protection Act (Section 75 of the IfSG) is also likely for anyone who, intentionally or negligently, spreads pathogens or disregards protective measures in violation of the IfSG—even independently of any specific bodily injury in an individual case. Depending on the region and the specific circumstances of each case, such investigations may result in fines or imprisonment—and, where applicable, serious professional disciplinary consequences, including the revocation of a medical license.
In the context of regulatory inspections, increasing attention is being paid to the proper conduct and comprehensive documentation of validations, revalidations, and periodic performance assessments, which—no matter how much effort and expense they may entail—are absolutely essential.
At VOELKER, we possess the necessary expertise in medical law as well as criminal and administrative offense law. We assist you in structuring the distribution of tasks within your practice in a legally compliant manner to minimize risk and effectively defend you against regulatory authorities such as the Regional Council and the public prosecutor’s office to ensure that proceedings are dismissed at an early stage. Please feel free to contact us if needed.