FDA:n ohjeet yleisistä eläintutkimuksia koskevista näkökohdista: testijärjestelmän seuranta | RegDesk

Sisällysluettelo

- Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to general considerations for animal studies involving medical devices.

The document provides a general overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved in order to ensure compliance thereto.

Samalla ohjeen säännökset eivät ole oikeudelliselta luonteeltaan sitovia, eikä niillä ole tarkoitus ottaa käyttöön uusia sääntöjä tai asettaa uusia velvoitteita.

Lisäksi viranomainen ilmoittaa nimenomaisesti, että vaihtoehtoista lähestymistapaa voidaan soveltaa, jos tällainen lähestymistapa on voimassa olevan lainsäädäntökehyksen mukainen ja siitä on sovittu viranomaisen kanssa etukäteen.

Test System Monitoring: Key Points 

First of all, the FDA emphasizes the need for animal study protocols to adhere to current veterinary standards, particularly for device-related procedures.

The study director must collaborate with veterinary staff to create plans for monitoring and managing anticipated adverse events throughout each study phase. This monitoring is crucial not only for the humane treatment of animals but also for distinguishing spontaneous conditions from device-related events.

Anesthesia and Analgesia in Animal Studies

Many animal studies necessitate the use of anaesthesia and analgesia, especially for procedures causing more than slight pain or distress.

The study director needs to consult with a veterinarian to establish appropriate anaesthetic and analgesic protocols.

These protocols should consider the species, age, weight of the animals, and the nature of the procedure. Proper anaesthetic and analgesic plans help to prevent the introduction of confounders to the study data.

Impact of Pain on Physiological Systems

Pain can adversely affect various physiological systems like wound healing, behaviour, metabolism, and body system functions.

Predicting the type and extent of pain an animal might experience enables the veterinarian to plan for suitable analgesics and supportive therapeutic measures.

Anticipating the kinds of pain expected also guides the frequency and type of assessments required for effective pain management.

Intra-Procedural Monitoring

During anaesthesia, the FDA advises recording vital signs like heart rate, respiratory rate, oxygen saturation, end-tidal CO2, body temperature, and blood pressure at regular intervals.

Additional monitoring, such as imaging or clinical pathology assessments, might be necessary. All monitoring data should be correlated with the timing of the device’s use, including the use of contrast agents or other associated materials.

Post-Procedural Recovery and Monitoring

Post-anesthetic care should follow the standard laboratory animal care practices, replicating human clinical care where possible.

Monitoring for pain, temperature changes, hydration levels, and mental state is crucial.

Establishing preemptive standard operating procedures for potential complications is recommended.

Multimodal analgesic plans, established before the study, can be highly effective.

In-Life Monitoring

For periods post-recovery, the FDA recommends twice-daily observations, especially during active times such as feeding.

Abnormal behaviours or clinical signs should prompt immediate notification to the veterinarian; such parameters as general appearance, appetite, mentation, respiratory rate, posture, and elimination patterns should be monitored daily.

Weight monitoring and body scoring are also advised as supplementary observation methods.

If the study involves specific in-life monitoring procedures, the sponsor should plan for efficient protocol execution.

Minimizing stress through grouping activities that require chemical restraint is beneficial. Furthermore, the authority also recommends conditioning certain animals for compliance without restraint, depending on the species.

Imaging methods like radiography or MRI can be valuable for evaluating device safety.

As also mentioned by the FDA, following current standards in veterinary record-keeping, such as the POVMR, ensures effective data collection and accessibility for key personnel.

Yhteenveto

In summary, the present guidance document provides a detailed overview of the FDA recommendations for monitoring and managing animal studies in the context of device testing.  The document highlights the key criteria and factors to be monitored in order to ensure the accuracy and reliability of study results.

lähde

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-animal-studies-intended-evaluate-medical-devices

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