HI595 Unit 4 Literature Review Example

Four Design Decisions, Sources Grouped by Question: A Unit 4 Capstone Literature Review for Recording Implants Before MRI

[Student Name]

Purdue University Global

HI595: Master's Capstone in Health Informatics

Unit 4 Literature Review

[Instructor Name]

[Date]

Carrowby Health and its project are composite; every source reviewed is real.

Introduction

This review answers four questions that the specification in Unit 7 must decide. It is not a general survey of MRI safety. For each question, sources are presented from the strongest design to the weakest: comparative or multi-site evaluations first, then single-site reports, then expert guidance and regulation, each labeled for the weight it can bear. The review draws on peer-reviewed studies, professional guidance and federal regulation, and it states plainly where evidence is thin.

Question 1: Coded Fields or Free Text?

The strongest evidence on structured implant capture comes from the federal demonstration of unique device identifiers in health systems. Drozda et al. (2018) reported on a multi-site effort to capture device identifiers at the point of use, store them in structured form and link them to clinical records for device evaluation. Their central finding for this project is practical: identifiers scanned from packaging at implantation were reliable and complete, while information transcribed into notes was inconsistent and hard to retrieve. The demonstration was designed for post-market surveillance rather than MRI screening, so its relevance is indirect, but the data problem is the same.

A recent review of identifier capture from the surgeon's perspective reaches a similar conclusion, describing barcode scanning in the operating room as the most dependable source and noting that most systems still fail to carry the identifier from the supply record into the clinical record a later clinician would read (Lopez et al., 2025). Federal rules require a unique device identifier on the label of most implants and a corresponding entry in a public database (21 C.F.R. § 830.300, 2024), which makes structured capture technically possible.

Decision: implant details should be stored as coded fields populated from the device identifier where available, with free text reserved for an explanatory note.

Question 2: Who Owns the Implant Record?

Evidence here is weaker and mostly descriptive. MRI safety guidance places responsibility for the screening decision with trained MRI personnel and a supervising radiologist (Harwood et al., 2024), but it says little about who should keep the underlying implant list current. The identifier demonstration found that ownership was the hardest organizational question, because devices are implanted by surgeons, purchased by supply chain, documented by nursing and needed by radiology (Drozda et al., 2018). A sociotechnical view of health IT predicts exactly this difficulty: information that crosses several departments tends to have no single owner unless one is assigned (Sittig & Singh, 2010).

The review found no comparative study of ownership models. The specification therefore relies on reasoning rather than evidence: the operating room should create the entry because it holds the identifier at the moment of implantation; health information management should own the entry's completeness, as it does other parts of the record; and MRI screening nurses should verify and annotate entries for outside implants.

Decision: shared ownership with defined roles, stated as a design choice supported by guidance and the demonstration's experience rather than by comparative trials.

On ownership the literature describes the problem well and offers almost no tested answer, and the review says so rather than borrowing confidence it has not earned.

Question 3: Do Patient-Held Implant Cards Help?

Screening guidance recommends asking patients for device cards and documentation and notes that patients often cannot name their devices accurately from memory (Shellock & Spinazzi, 2008). Updated guidance on implanted devices repeats that a card or manufacturer documentation can confirm the model, but that cards are frequently lost or out of date (Harwood et al., 2024). No study located for this review measured whether giving patients a standardized card reduces MRI delays.

Decision: include a wallet card as a low-cost supplement generated from the structured entry, so the card and the record agree, but do not rely on it as the primary source.

Question 4: Which Labeling Vocabulary?

Device labeling for the MRI environment uses three terms defined in an industry standard: MR Safe, MR Conditional and MR Unsafe (ASTM International, 2023). Conditional labeling specifies the scanner field strength and other limits under which scanning is acceptable. Radiology guidance uses the same terms and adds practical categories for devices whose labeling is unknown, which must be handled as if unsafe until identified (Harwood et al., 2024).

Decision: the entry will use the three standard labeling terms plus "unknown," and for conditional devices will record the conditions as a link to the manufacturer's labeling rather than retyping them, to avoid transcription errors.

Where the Sources Disagree

The main tension is between relying on structured data and relying on screening conversation. Screening guidance treats the conversation with the patient as essential and warns against assuming a record is complete (Shellock & Spinazzi, 2008), while the identifier literature emphasizes structured data as the reliable source (Drozda et al., 2018). These positions are compatible: structured data should arrive before the scan so that the conversation confirms rather than discovers. The specification is designed on that basis.

What the Review Rules Out

Two tempting designs are ruled out by the evidence. Retyping manufacturer conditions into a free-text field, a common local practice, invites the transcription errors the identifier literature warns about, so the entry links to labeling instead. And building a local list of approved devices, which some departments maintain in spreadsheets, duplicates a public database that federal rules already require manufacturers to populate, and it ages quickly as models change. Both choices would feel faster at first and would become liabilities within a year.

Gaps

Three gaps matter for evaluation. No study measured MRI delays before and after structured implant recording. Evidence on ownership is descriptive. And evidence on patient cards is limited to expert advice. The evaluation plan in Unit 9 is designed to produce local evidence on the first gap.

Search Approach

Sources were located through searches of biomedical and informatics databases using terms for implant documentation, unique device identifiers and MRI screening, supplemented by the reference lists of the guidance documents. Studies were kept when they addressed one of the four questions directly.

How the Review Shapes the Specification

Each decision above becomes a section of the Unit 7 specification: coded fields from identifiers, defined ownership, a card generated from the record, and the standard labeling vocabulary with an unknown category.

References

ASTM International. (2023). Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (ASTM F2503-23). ASTM International.

21 C.F.R. § 830.300 (2024). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-E/section-830.300

Drozda, J. P., Jr., Roach, J., Forsyth, T., Helmering, P., Dummitt, B., & Tcheng, J. E. (2018). Constructing the informatics and information technology foundations of a medical device evaluation system: A report from the FDA unique device identifier demonstration. Journal of the American Medical Informatics Association, 25(2), 111-120. https://doi.org/10.1093/jamia/ocx041

Harwood, M., Fahrenholtz, S. J., Wellnitz, C. V., Kawashima, A., & Panda, A. (2024). MRI in adult patients with active and inactive implanted MR-conditional, MR-nonconditional, and other devices. RadioGraphics, 44(3), e230102. https://doi.org/10.1148/rg.230102

Lopez, A. J., Dave, A., Sathe, T., & Lee, H. (2025). A surgeon's primer on unique device identifier (UDI) capture: Where do we stand on implant surveillance and how can we improve? Health Sciences Review, 16, 100234. https://doi.org/10.1016/j.hsr.2025.100234

Shellock, F. G., & Spinazzi, A. (2008). MRI safety update 2008: Part 2, screening patients for MRI. American Journal of Roentgenology, 191(4), 1140-1149. https://doi.org/10.2214/AJR.08.1038.2

Sittig, D. F., & Singh, H. (2010). A new sociotechnical model for studying health information technology in complex adaptive healthcare systems. Quality and Safety in Health Care, 19(Suppl 3), i68-i74. https://doi.org/10.1136/qshc.2010.042085