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Start with the procedure, not a downloaded checklist

The form should tell a reviewer what is being considered. Record the manufacturer and exact model, planned applicator, intended body site and every proposed function. Link the record to the current model-specific IFU, including its revision or date and relevant section. Confirm the intended user and setting in that document; a salon booking does not settle either question.

Do not treat “cavitation” as a complete procedure description. Separate low-frequency nonfocused ultrasound, focused mechanical ultrasound, thermal high-intensity focused ultrasound (HIFU), and a system described only as 1 MHz ultrasound. A frequency label alone does not identify focusing or mechanism. Radiofrequency (RF), vacuum, light and muscle-stimulation accessories need their own applicable review. Do not transfer one function’s restrictions to another by default.

The core record needs procedure identity, relevant history, medication and implant details, proposed-site information, professional review and referral status, a documented visit outcome, and repeat-visit changes. As a practical design method, give each screening question a source reference and a review route. For example: question → applicable IFU section → reviewer → unresolved information → next action. These are documentation suggestions, not a tested screening instrument. If a requirement is unclear or conflicts with another document, record the conflict and obtain clarification. Do not invent a rule to fill the space.

What should the form capture?

The following groups are a starting structure to adapt, not a universal list of exclusions. Keep client-reported information distinct from observations, professional advice and the operator’s documented decision. Use an uncertainty option and room for explanation; do not convert a blank response into “no.”

On small screens, scroll within the table to read all three columns.

Match health-history questions to the actual technology

The FDA’s body-contouring guidance asks people to disclose medicines and supplements, implants, prior surgery in the area, relevant health conditions, skin problems, pregnancy and breastfeeding. These are disclosure topics; they do not all carry the same decision rule. [1]

For the form, turn an applicable topic into a clear question with space for the detail a reviewer needs. An implant entry, for instance, should preserve the reported type and location, plus any uncertainty about its identity. A pregnancy, breastfeeding or postoperative-history entry should preserve the relevant information for assessment; it should not calculate a universal waiting period. Use the exact IFU and appropriate professional advice to resolve the question.

Distinguish disclosure from a documented restriction

In its ultrasound section, the FDA advises against procedures with open wounds, compromised skin, active implanted devices or metal under the skin. Its RF section separately addresses implants and metal-containing tattoos, and directs people with an intrauterine device to seek medical advice. [1]

Label the source and technology beside a restriction in the working form design. This US technology-level guidance is not an exact-model IFU or authorization for an unnamed low-frequency machine. Do not turn a restriction into “ask a doctor, then proceed”: professional advice does not override an applicable device exclusion.

Make review and referrals visible

Client-service staff should preserve what the client reports and route safety-related concerns to the appropriate reviewer. They should not decide that a disease is “mild enough,” interpret an unknown implant, or reassure someone that a medicine is compatible.

A useful referral entry records the precise unresolved question, the proposed procedure and site supplied to the professional, the response date, and any conditions or limits in the advice. Identify whether a statement is reported by the client or supported by a document. Do not reduce conditional advice to a single “cleared” box.

Record the follow-up owner and the visit outcome in plain language, such as “assessment requested; appointment deferred” or “additional device information required.” These examples describe recordkeeping, not medical decisions. Do not schedule treatment on the assumption that an unanswered referral will be favorable. Neither a signature nor external advice establishes legal authority to offer the service.

Keep three records conceptually separate

• Screening: information, concerns, review and unresolved questions.
• Consent: the procedure-specific discussion and agreement required in the applicable setting.
• Session record: what actually occurred, if a procedure is undertaken.

They can be linked in one record system, but a signed screening page does not substitute for the other purposes.

Review changes before repeat visits

Add a dated update section rather than copying the original answers forward. Ask whether the information relevant to this procedure has changed since the last review, and let the client explain a change without having to judge whether it matters.

1. Reconfirm the proposed procedure. Record changes to the device, applicator, function, body site or applicable instructions. Review their impact before relying on the earlier form.
2. Capture new information. Revisit the applicable history prompts, including medication changes, new implants or surgery, skin changes, and pregnancy or breastfeeding information.
3. Record the previous response. Ask about unresolved symptoms or concerns after the last visit. Record onset, location and what the client reports; do not automatically call a reaction normal.
4. Close or carry forward each question explicitly. Date the review, identify the reviewer, and record the action and any outstanding referral. An earlier uneventful visit is not a current suitability assessment.

The point is to preserve changes and their review, not to impose a treatment interval or a fixed recovery timeline.

Collect enough information for the purpose

Ask for information relevant to the defined procedure rather than a complete medical biography. The UK Information Commissioner’s Office describes data minimisation as keeping personal information sufficient, relevant and limited to its purpose. Its guidance is under review; this principle is cited as context, not a global privacy-compliance checklist. [2]

Before putting a form into service, locally verify the rules for collecting and using health information, access, storage, sharing, retention and deletion. Do not invent a worldwide retention period. Explain the purpose of the questions and how unanswered items are handled. If needed information is withheld, document the unresolved assessment rather than treating silence as a favorable answer.

Common design mistakes

• Copying exclusions from another machine without checking their applicability.
• Letting software mark someone eligible because every answer is “no.”
• Leaving no place for uncertainty, conditional advice or follow-up.
• Carrying an old review forward after a procedure or health change.
• Using a signature to imply safety, diagnosis or permission to operate.

A record that supports the next decision

A useful form connects the identified procedure to relevant information, a responsible reviewer and documented follow-up. Build it so another authorized reviewer can understand what is known, what has changed and what still needs resolution.